NICE INTERNATIONAL. Report to the Department for International Development on the early activity of NICE International

Transcription

1 NICE INTERNATIONAL Report to the Department for International Development on the early activity of NICE International 1

2 CONTENTS 1.0 Executive summary Jordan Colombia Ghana Strategic direction Background to NICE International and DFID s Support Evidence-informed decision-making: an unmet need in developing countries What NICE has to offer The business model for NICE s international engagement Services and expertise Exploratory project funding by DFID Three Case Studies: Jordan, Colombia and Ghana Case study 1: Jordan Case study 2: Colombia Case study 3: Ghana An update on non-dfid sponsored work (as of February 2009) NICE International: Strategic Direction Background Sourcing expertise Funding sources and types of project International engagement strategy: developing a work programme Governance arrangements Alternative business vehicles for NICE International Appendix A: The people Appendix B: Invoice breakdown

3 1.0 Executive summary Fostering health policy and systems research and making ethical and effective use of innovations in medical technology and pharmaceuticals are relevant for all countries; health technology assessment should be used to support more informed decision-making WHO European Region Ministerial Conference, The Tallinn Charter Disease burden estimations cost-effectiveness studies of interventions independent evaluations of programme implementation are examples of the kind of work that needs to be undertaken. In the absence of such capacity, current policy-making is ad hoc and driven by individual perceptions. National Indian Commission on Macroeconomics and Health, 2005 Since its establishment in 1999, the National Institute for Health and Clinical Excellence (NICE) has developed a global reputation for using evidence to inform clinical and public health practice. NICE has worked with governments and academics from over forty countries to transfer its knowledge in making decisions about the use of new treatments, developing clinical and public health guidelines and assessing the safety and efficacy of new surgical procedures. Since May 2008, NICE has been exploring the potential of formalising these arrangements by providing consultancy services to international organisations who want to reform, strengthen or develop their health systems by using evidence to inform decisions on health policy and practice. This service is being provided by a small unit (currently 3.4 WTE) within NICE, drawing on the expertise of external experts, science based consultancies and NICE staff. In order to support NICE in the early stages of its international activity, the Department for International Development (DfID) provided funding to enable NICE to undertake an exploratory project. The aims of this project were: To undertake exploratory missions in Jordan, Colombia and Ghana, in order to: inform policy makers of NICE s international activities and form links with governments, academics and funders upon which future collaborations can be built. 3

4 evaluate the scope for NICE engagement in these countries and to put together specific proposals, in collaboration with local stakeholders, for potential funding support. To develop - based on these missions - a strategy for international engagement. To interact more closely with DfID to identify strategic priorities and build synergies across the NHS and UK government systems abroad. The following sections outline the work undertaken during each of the missions, the key findings from each country, and areas where NICE could add value in the specific country setting. In fact, in Jordan and Colombia, follow-up projects are underway, whilst in Ghana we are in the process of exploring potential funding sources for a hands-on pilot in collaboration with local decision makers. 1.1 Jordan Jordan was chosen for this exploratory project, as its government has recently undertaken significant reform of health service provision, including the development of an essential drugs list. Following initial discussions with Jordanian policy-makers, it was thought that NICE may be able to add value to the reform efforts. Jordan is a pilot country for the Medicines Transparency Alliance (MeTA), a multi-stakeholder alliance working to improve access to, and affordability of, medicines. MeTA s aims and objectives are consistent with NICE s core principles of transparency, inclusiveness and scientific robustness and NICE s involvement in MeTA pilot countries could help build experience applicable in other MeTA countries as this initiative develops. Between August and December 2008, NICE International had the opportunity to interact with a number of senior Jordanian policy makers, MeTA consultants and World Bank, WHO and DfID colleagues actively involved in the ongoing healthcare reforms in Jordan. Drawing on these exchanges, including two site visits to Amman in August and October 2008, we describe below specific activities where involvement by NICE and its academic partners could add value in high priority health policy areas. Improving transparency, including efficiency considerations in healthcare resource allocation decisions and engaging with patients and the public are key prerequisites for reaching and sustaining broader coverage for the Jordanian population, an explicit commitment of the Jordanian government. 4

5 1.1.1 Development of best practice Standard Treatment Guidelines (STGs) Based on NICE s experience in the UK, NICE can provide advice and support on developing STGs, including identifying best treatment protocols for chronic diseases with a focus on prevention and efficiency. NICE could provide advice on harmonising existing guidelines and on adapting and developing new guidelines for high-burden diseases. The process could be developed through an initial pilot based on a specific disease area and should incorporate international guidelines and locally developed protocols Updating the Rational Drug List (RDL) A review of RDL was identified as a key priority by both the Jordanian MeTA Council and the World Bank. Drawing on its health technology assessment experience, NICE can contribute to its review and update. This could include advice on: The methods and processes of making listing and delisting decisions Incorporating cost and cost-effectiveness analysis into listing and de-listing decisions Increasing transparency by setting up consultation rounds, appeals and contestability mechanisms Achieving stakeholder buy-in, including from industry and clinicians Implementing rational prescribing practices based on the RDL Patient and public involvement Jordanian officials we spoke consider involving patients and the general public in policy decisions to be a policy priority. NICE can draw on the experience of its Citizen s Council and Patient and Public Involvement Programme to provide support to Jordanian policy makers. This could be through setting up the appropriate networks for gaining lay input and through allowing lay input in listing and delisting decisions. Following-up: In January 2009, NICE secured funding from the World Bank to provide a training course to senior Jordanian policy makers. This will take place in March 2009 and may inform a longer term engagement in Jordan. 5

6 1.2 Colombia Since its healthcare insurance reforms of 1993, Colombia has made significant improvements in coverage rates, efficiency of its healthcare spending and health outcomes. The current insurance system consists of two separate regimes. Individuals who are able to contribute do so through a salary-based premium; poorer individuals and households are covered by a subsidised regime, financed by the national government. A recent Constitutional Court ruling called for the unification of these two packages, the establishment of a fair process for deciding which services the basic package should include, as well as a process for communicating these decisions to the public. This has led to the launch of an effort, led by the Ministry, radically to reform many aspects of Colombian healthcare system. In December 2008, NICE was invited to Bogota by the Colombian Minister of Social Protection. We met with a wide range of health professionals, technical experts, the Minister and members of the ministerial task force responsible for acting upon the Constitutional Court decision. Following these discussions, we are have been able to identify, in conjunction with our Colombian colleagues, specific areas where NICE could add value to the reforms Improving contestability NICE can provide strategic advice on how to strengthen the current contestability mechanisms in healthcare decision-making. This could include general information on the NICE appeal process and specific learning from key challenges NICE has faced over the years Patient and public involvement NICE can provide input on strengthening current public involvement processes in Colombia, including advice on running a Citizens Council, training lay members to participate in advisory committees and translating guidance into lay versions. NICE can continue to provide longer-term advice once these processes are operational Clinical guideline development process NICE can help strengthen the guideline development process in areas such as stakeholder identification and involvement, consensus reaching, consultation and quality control Incorporating economic considerations into clinical guidelines Based on NICE s experience of making cost-effectiveness decisions, NICE can offer advice on incorporating economic evaluation methods into clinical 6

7 guideline development. This can include advice on possible measures of cost-effectiveness and assistance with modelling the potential cost impact of specific benefits that may be added to benefits plans Topic selection NICE can provide an overview of its process and advise on how it could be adapted to the Colombian setting. Following-up: On 17 January 2009, NICE signed a memorandum of understanding with the Colombian Ministry of Social Protection, outlining the major areas of collaboration, as listed earlier. A project plan and contractual arrangement are being negotiated with the Colombian government. 1.3 Ghana Ghana has recently introduced a broad National Health Insurance Scheme (NHIS) and is committed to expanding affordable coverage to all its citizens. Efficiency and good governance in decision-making are clearly core requirements for the long-term success of this scheme. Like Jordan, Ghana is a pilot country for the MeTA programme. Its academic strengths and commitment to health policy reform make it an ideal setting to run a pilot focussed on using evidence to inform policy and practice. Like other low-income countries, Ghana is experiencing an epidemic of noncommunicable diseases, more common in the more affluent parts of the population, living in the urban centres. Interestingly, it is amongst these groups (especially in the capital, Accra) where NHIS rates are the lowest. NICE, with the help of the World Bank, organised a visit to Ghana in December 2008 and meetings were held with colleagues from academia, the ministry of health, NHIS, MeTA Ghana, teaching hospitals and foreign aid agencies. Based on these discussions, we highlight below areas where NICE input may be of value Setting up a process for rationalising drug listings Many colleagues highlighted the need for an independent process with multistakeholder participation to advise on the methods and processes for rationalising decision making on drug listings. NICE could contribute process and technical advice to a pilot exercise in a high burden disease area. The pilot could inform the setting up of a standing committee to advise NHIS on listing decisions. Such decisions are currently often made on an ad-hoc basis. 7

8 1.3.2 Training and capacity building NICE could help with a review of current academic capacity and highlight areas which may need strengthening. Some colleagues drew attention to the need to train systematic reviewers and meta-analysts. This could be carried out in conjunction with the pilot programme outlined above Benchmarking prescribing practices NICE could assist in comparing current prescribing levels (readily available through the NHIS claims data) to international best prescribing practice or NICE guidelines. This could help identify variation in prescribing practices and potential efficiency savings and could target drug listing and guideline development. Following-up: Following the December elections, there has been extensive correspondence between NICE, Ghanaian colleagues, the World Bank and the DfID representative in Ghana. However, so far, no concrete plans have been made to further NICE s involvement on the ground in Ghana, mostly due to the lack of a clear (non-research focused) source of funding. A survey of formal and informal decisionmaking processes may help identify precisely where NICE involvement would be useful. This could take place within MeTA, led by local academics and with NICE input and could inform NICE s future engagement in Ghana. 1.4 Strategic direction Between September 2008 and February 2009, we have been able to demonstrate that there is significant interest from governments and policy makers from around the world in the decision making model NICE applies in the NHS context. High income economies as well as low and middle income ones, feel the need to develop rational, evidence-informed and procedurally fair mechanisms for allocating their healthcare resources and see the NICE experience of doing exactly that in the NHS over the past 10 years, as a potentially helpful source of support. The future of NICE International will be discussed at the NICE Board in June At this meeting, the Board will consider this report as well as a briefing of the newly established Advisory Group (see appendix A) for NICE International. The NICE model may not be transferable to other countries; however aspects of it are of direct relevance to policy makers around the world. Our methods and processes, our organisational structure and relation to the NHS, our specific guidance products and underpinning evidence base, and our overarching principles 8

9 can add value in various international settings. In the months to come, we will continue exploring ways in which this can be achieved so that each individual country s needs are met whilst NICE s costs are recovered. Exporting NICE s experience is an innovative policy intervention in the global aid setting. We will seek insight and support from governments, international financing institutions, academic and private groups and individuals, in Britain and abroad, to make this effort a success. 9

10 2.0 Background to NICE International and DFID s Support 2.1 Evidence-informed decision-making: an unmet need in developing countries Finite healthcare budgets are a reality for all countries, irrespective of level of wealth. However, financial pressures are greater in low and middle-income countries (LMIC) where health spending remains disproportionately low. According to a recent analysis by the World Bank 1 : Developing countries account for over 80% of global population and 90% of global burden of disease but only 12% of global health spending High-income countries spend 30 times more than low-income countries (population-weighted and purchasing power-adjusted). More than half of the overall expenditure is out-of-pocket, the least equitable and efficient form of financing Demographic changes and the shift from communicable to chronic diseases will make the burden of healthcare needs greater in developing than developed countries in the near future: an estimated 2-3% annual increases in expenditure on health in developing countries will be necessary in the short term solely to meet the demographic change Despite the growing need, health spending, or at least its publicly financed component is not growing fast enough, or, in some cases, declining. At the same time, LMIC are spending an increasingly high fraction of their health budgets on pharmaceuticals, proportionately more than richer economies. Furthermore, the pressure to adopt new expensive treatments may intensify as high-income countries are becoming more successful in implementing cost-containment strategies in their own settings. Challenges such as chronic disease, inequity in access and health outcomes, unwarranted variation in quality and lack of professional best practice standards are also pressing concerns for policy makers in LMIC. The public s dissatisfaction with the, often nominal, promise of universal access to a basic package of services for those that cannot afford supplementary insurance or out-of-pocket charges adds to the pressures To manage the tension between the political commitment for best care for all and the reality of finite resources, developing countries need to establish legitimate that is, transparent, accountable and inclusive - home-grown structures to: Identify high priority areas requiring targeted investment Make evidence-informed decisions about resource allocation between technologies and services in high priority areas, taking account of scientific evidence of clinical and cost effectiveness, budgetary constraints and society s values 1 Gottret and Schieber, Health Financing Revisited, The World Bank,

11 Highlight evidence gaps where more research is required to drive policy and practice 2.2 What NICE has to offer NICE has developed a global reputation for using evidence to inform clinical and public health practice. We are regarded as a leader in the application of health technology assessment in making decisions about the use of new treatments, in developing clinical and public health guidelines for setting quality standards in disease prevention and management and in assessing the safety and efficacy of new interventional procedures. Furthermore, we have pioneered methods for designing and operating transparent processes for engaging stakeholders in decision-making NICE can work together with local decision-makers, donor agencies and academic partners to provide technical and strategic advice empowering LMIC to make the most of their limited healthcare budgets. Through helping build capacity and develop a country s decision-making capital, through establishing new structures or improving the performance of existing institutions, NICE advice can add value if adapted to the changing economic and political circumstances of each individual country The cost of inaction is great: with weak decision-making structures, both donor agencies and local governments will find it increasingly challenging to demonstrate optimal return on investment, in terms of outcomes, population satisfaction and efficiency The potential for NICE supporting the development and management of health system structures in developing countries was highlighted by Lord Crisp in the 2007 UK Global Health Partnerships report: Organisations like the National Institute for Health and Clinical Excellence (NICE) working in technology assessment and public health, are particularly in demand for advice and help and to share experiences and knowledge. 2.3 The business model for NICE s international engagement The NICE approach to decision making has attracted interest from many developed and developing health systems. The Institute has hosted visits from governments and academics from - and its staff have travelled to - over forty countries around the world. However, NICE has never engaged in international projects other than in an ad hoc fashion. In a small number of these cases NICE has also made a charge for it services During the second half of 2008, NICE has been exploring the potential for engaging in international projects, working either directly with countries and/or through third party funders through the establishment of a new notfor-profit stream of work, NICE International. NICE International was set up in May 2008, to provide advice on building capacity for assessing and interpreting evidence to inform health policy and for designing and using methods and processes to apply this capacity in high and LMIC settings. The business case for this new venture was presented and approved by the NICE Board at its public meeting in May A small NICE unit (3.4 WTE since Dec 2008), accountable to the Chief Executive, is currently providing this new service using external experts and partnerships with other science-based consultancies and academic institutions, as well as NICE staff. For information on the NICE business model see section 3. 11

12 2.3.3 As highlighted earlier, the demand for policy consulting arises from high and also LMIC who want to reform/strengthen/develop their health systems by setting up sustainable processes and structures for using evidence to inform decisions on health policy and practice. This may involve building on existing structures and processes or prioritising new ones based on local needs with a focus on ensuring accountability, governance, transparency, inclusiveness, sustainability and fitness-forpurpose. A major common objective of such procedural reforms is improving access to good value services (including new drugs and other technologies) through evidence-informed healthcare resource allocation decisions Since its establishment, NICE International has developed links with foreign governments and large funders, such as the World Bank and UK s Department for International Development, as well as U.S.-based philanthropic foundations. It has also engaged in a growing number of international projects including in Estonia, Jordan, Thailand, Turkey and Colombia. 2.4 Services and expertise The services NICE offers foreign governments and governmental entities fall into four broad categories: Strategy: strategy advice on setting up and improving evidence-based policy-making public entities Methodology: technical advice on the methodology of critical appraisal and technology assessment to inform decision-making Process: input on processes and decision-making frameworks with a focus on transparency, stakeholder involvement, public engagement, contestability and consultation Research and evaluation: evaluation of the effectiveness and costeffectiveness of heath system innovation interventions (such as NICElike structures), in conjunction with our academic partners In addition to support on process reform, NICE s particular areas of technical expertise are in: Health technology assessment: informing pricing and reimbursement decisions of new and existing technologies based on evidence of value to the end users Clinical and public health guidelines: setting cost-effective quality standards and performance indicators, reducing variation in practice and preventing ill health Safety and efficacy of therapeutic and diagnostic interventions Implementation support: behaviour change and stakeholder buy-in; guidance budgetary impact and uptake assessments Topic selection for guidance development; evidence-informed prioritisation Patient and public engagement in decision-making and elicitation of societal values Transparent, consultative, independent decision-making processes based on best available evidence of comparative clinical and cost effectiveness 12

13 are key characteristics of the way NICE functions and differentiate it both from academic entities focusing on the generation and analysis of evidence and from government entities making coverage decisions following opaque decision rules and processes. 2.5 Exploratory project funding by DFID NICE is obliged to cover its full costs in extending its work internationally, to avoid diverting resources from its principal UK mission In order to support NICE at the early stages of the development of its international engagement activity, the Department for International Development (DFID) provided exploratory funding to enable the NICE International to: Engage in exploratory missions in a selected group of countries in order to: inform policy makers of NICE s activities and form links with governments, academics and funders in these countries upon which to build future collaborations; evaluate the scope for NICE engagement in these countries and put together specific proposals, in collaboration with local stakeholders, for financial support by DFID, local governments and/or other funding sources Develop, informed by the exploratory missions described above, a strategy for international engagement, including criteria for prioritising demand and strategic directions for balancing bilateral projects (with either direct country or mixed third party funder/partner country funding) on one hand and broader, longer term strategic research projects on the other Interact more closely with DFID to identify strategic priorities and build synergies across NHS and broader UK government activities abroad Develop relationships with, and understand the priorities of other potential funders of NICE work in low and middle-income countries Three countries were selected, jointly by DFID and NICE, for the exploratory project: Ghana; Colombia and Jordan. Ghana and Jordan are both pilot countries for the Medicines Transparency Alliance (MeTA) which aims and objectives are consistent with NICE s core principles. Therefore, NICE can add value as these MeTA pilot countries identify their policy priorities and set out an agenda as to the major reform areas. Furthermore, NICE s involvement in the form of technical and/or process advice- in these countries may help build experience of relevance to other MeTA countries as this initiative develops. Colombia is a middle income economy undergoing significant health reform and was selected both because it represents a health insurance financing model and because leading Colombian policy-makers expressed an active interest in NICE s work. Table 1 below provides a breakdown of the three countries, including NICE s initial points of contact and planned activities. A more detailed analysis of NICE s involvement in all three countries is provided in the form of case studies in the following sections. Table 1: NICE s initial plan of engagement in the three DFID pilot countries. 13

14 Country/initiative Contacts Activities Jordan - Medicines Transparency Alliance (DFID) Ghana - Medicines Transparency Alliance (DFID) DFID; High Health Council; Joint Procurement Department; Jordanian Association of Pharmaceutical Manufacturers; JFDA Ghanaian government; National Centre for Pharmacovigilance - University of Ghana Medical School Pilot to: (a) inform potential NICE contribution to MeTA toolbox; (b) support Jordan in implementing governance structures; in developing decision criteria for making listing decisions and in producing rational prescribing guidance, as part of the recent national reform and the development of an essential drugs list. Pilot to: (a) inform potential NICE contribution to MeTA toolbox; (b) provide technical and process advice for building a formulary/basic package of medicines Colombia National Health Insurance reform (Colombian government) National Health Insurance Agency Ministry of Social Protection Support redesign of basic package of services funded by Social Health Insurance, using evidence-informed clinical and cost effectiveness criteria. Become involved in ongoing 18-month nation-wide project initiated May 2008, including methods development for making listing decisions DFID committed a total of 68,000 for the period between September 2008 and February In Appendix A we provide a break down of the cost for each project, including travel and accommodation expenses and staff time This report consists of the following sections: a. Country case studies: a description of the three case studies, including some background on each country and a rationale for NICE s involvement and key areas for potential future collaboration. In addition: In the case of Jordan and Ghana, outline of possible NICE/MeTA toolbox applicable to other countries engaged in the pilot In the case of Colombia, outline of the value of NICE-type interventions for improving efficiency and access in countries with Social Health Insurance financing models b. An outline of non-dfid related activity of NICE International over the same period Country specific projects and policy grants (past and present, active and under consideration) Business model development activity such as the development of a dedicated webpage; a process for identifying partners and subcontractors; governance arrangements. c. Strategic plan for future engagement in LMIC, including criteria for identifying partner countries; long-term strategic objectives and a financing plan/business model, to also be presented and discussed at the NICE Board in June d. Appendices Invoice breakdown The NICE international team and other NICE and external colleagues who worked with us during these projects. 14

15 3.0 Three Case Studies: Jordan, Colombia and Ghana 3.1 Case study 1: Jordan Outline Between August and December 2008, NICE International had the opportunity to interact with a number of senior Jordanian policy makers, MeTA consultants and World Bank, WHO and DFID colleagues, actively involved in the ongoing healthcare reforms in Jordan. Drawing on these exchanges, including two site visits to Amman in August and October 2008, this paper offers an overview of the situation in Jordan with regard to the country s national pharmaceutical policy and proposes an action plan, describing specific activities where involvement by NICE and its academic partners could add value in high priority health policy areas, as identified by Jordanian policy makers. Overall, NICE involvement can be of benefit in two areas of strategic importance for improving the transparency of the way the Jordanian healthcare system functions: (a) best practice standard treatment guidelines (STG), including harmonisation of existing ones and methods and processes of adapting or developing new ones in high burden of disease areas and (b) rational drug list (RDL), including the methods and processes of making listing and delisting decisions, considerations of cost-effectiveness and of affordability, and support for implementing rational prescribing practices based on RDL. In delivering on both these objectives, the role of civil society involvement and raising awareness amongst patients and the general public are important drivers for improving transparency and enhancing implementation of evidence-informed policies. To contribute effectively in these two key areas, the short-term objectives described below are focused on three types of activities: training of key Jordanian stakeholder groups; exchanging information between Jordanian senior policy makers and NICE experts to identify capacity needs and develop a plan to address those; and, designing longer-term pilots in specific disease areas to help inform and implement STGs and RDL. We provide a more detailed proposed plan of action below, after giving a general outline of the Jordanian setting with a focus on pharmaceutical policies. Pharmaceutical policies in Jordan Jordan spends over 30% of its health budget (about 3% of its GDP) on pharmaceuticals and drug price inflation is around 17%. With recent government efforts to expand insurance to the whole of the population, equitable access to and overall cost of drugs are becoming increasingly important policy priorities. A number of external agencies are active in supporting healthcare reform in Jordan, including USAID, by far the largest contributor currently focusing on issues of provision, including primary care, hospital operation and governance but with no 15

16 direct pharmaceutical policy-related projects; WHO, working, amongst other projects, on non-communicable diseases and the health of Iraqi refugees in Jordan and on improving governance; and the World Bank, with a focus on governance, strengthening the country s pharmaceutical policies and expanding health insurance. In 2008, DFID launched Medicines Transparency Alliance (MeTA), with the support of WHO, HAI and the World Bank and with the aim of improving the availability and affordability of good quality medications, through increasing transparency and accountability in the marketplace, from drug procurement to distribution and appropriate use. Jordan is a one of the seven pilot countries participating in this global initiative. Procurement is very important in the Jordanian setting. In 2004 the government established the Joint Procurement Department (JPD) reporting directly to the Minister of Health with the objective of improving the efficiency and effectiveness of pharmaceutical procurement. Currently, different public Institutions 2 (i.e. large insurers/providers) have their own procurement mechanisms (resulting in different prices for the same drugs in the public sector), formularies (preferred lists) and protocols (i.e. clinical guidelines as to the use of the procured medication) for treating the same conditions, resulting in considerable variation in availability and use of medicines across the country and fragmentation in purchasing practices. Furthermore, the private sector has a distinct process for procurement and a different set of formularies. This impacts on the public sector as, often, drugs are not available through the public system (usually due to inaccurate estimates of need submitted by providers) and insurers have to reimburse (for the eligible insured patients) the needed drugs purchased at higher prices through private sector pharmacy networks. JPD uses a Rational Drug List currently numbering more than 600 JFDA-registered drugs, developed through a multi-stakeholder disease-specific process using a number of criteria. This list is currently under review and the various advisory committees, with representation from all major stakeholders including the Institutions (see footnote), are being reconstituted. It is anticipated that an updated list will be available at the end of 2008/early As national insurance is slowly expanding to cover most of the population and chronic disease prevalence is rising, efficient spending of public money is a prerequisite to achieve the government s priority to provide high quality equitable care to all Jordanians within budgetary limits. Talking to Jordanian decision makers: emerging themes The scope of NICE s exploratory visit to Jordan was twofold: (a) to support Jordan in implementing governance structures; in developing decision criteria for making listing decisions and in producing rational prescribing guidance, in the context of recent national reforms, building on significant work undertaken in Jordan by the World Bank; (b) to inform a potential NICE contribution to other MeTA countries, by using Jordan as a pilot country, given the relatively well-developed structures for procurement and use of medications and the government s commitment to improving the efficiency of this process. 2 There are four major providers in Jordan, some of which are also insurers. Overall, they cover two thirds of the total population in Jordan. The providers (Institutions) are: MoH; Royal Medical Services (military); Universities (Jordanian University Hospital and King Abdullah University Hospital); and the King Hussein Cancer Centre. MoH and RMS are the major providers. KHCC accounts for low volumes and high costs due to the specialised nature of its activities. The major insurers/payers are: government/public HI; RMS; Refugees Insurance; private HI and Universities. 32% of the population are uninsured 16

17 Following an initial interaction during the formal MeTA launch in London, in May 2008, where the Jordanian delegation expressed their interest in further interacting with NICE, the first visit was organised to coincide with a ministerial meeting set up by the World Bank on the assessment of national drug procurement policies and a MeTA Jordan Council meeting. These meetings involved key stakeholders such as the High Health Council; Joint Procurement Department; Jordanian Association of Pharmaceutical Manufacturers; JFDA; major providers (incl. Jordan University Hospital, King Hussein Cancer, Ministry of Health and Royal Medical Services) and civil society representatives. During the second visit to Amman, in October 2008, one-to-one meetings with senior policy makers from JPD and the High Health Council were organised to follow up on NICE s proposals submitted to Jordanian officials and to DFID and WB after the first visit. During the October visit, a course of action was agreed between NICE, Jordanian stakeholders and WB. During the Ministerial meeting and the MeTA Jordan Council meeting at the first visit and also the meetings with senior policy makers form JPD and the High Council at the second visit, a number of policy priorities emerged where NICE input may add value. These are summarized below with proposed modes of NICE involvement. 1. Rational Drug Use (RDU) and Best Practice Guidelines, including generic substitution, where appropriate. Rational Drug Use is an important policy priority for Jordan (see MeTA Scoping Report (Nov 2007); WHO/HAI pricing policies meeting (Dead Sean, 2007) and the World Bank JPD Assessment Report (Aug 2008)). There is a RDU department within JFDA. Furthermore, JPD sees part of its role as contributing to RDU through selection and procurement of appropriate medicines at appropriate prices. NICE could work with JPD and JFDA s RDU as well as with leading clinicians from major Jordanian Institutions where evidence-based protocols for best practice have already been established and are being implemented, to develop rational use guidelines. This exercise would ideally take place alongside the update of RDL, on a pilot basis, and in a preselected disease area such as a common cancer. NICE can provide technical and process advice, with a focus on a specific disease area, to develop RDU guidelines based on best available evidence adapted to the Jordanian setting. This could be done using the RDL for the selected disease area as a starting point. The whole process would bring together specialists from all major Institutions, as well as pharmacists and health economists, and key stakeholders such as JFDA, and would use international guidelines and locally developed protocols (e.g. cancer treatment protocols developed at KHCC or at JUH) as its basis. Unification of protocols for use of RDL drugs in a selected disease area would be an important first step towards both increasing the acceptability/impact of RDL and reducing variation/inequity in current practice across the country. 2. Process of updating RDL, with a dual focus: (a) gaining stakeholder buy-in (including clinicians and industry) and building trust in RDL listed drugs (b) incorporating efficiency and value considerations. The review of RDL was identified as a key priority both by the Jordanian MeTA committee and also in the World Bank assessment of JPD. NICE can provide support in (a) strengthening the actual process for reviewing RDL and (b) incorporating economic evaluation considerations in the listing process. Process: Jordan has a very well designed process and explicit criteria for developing RDL (see JFDA website for further information). Furthermore, Jordan went through a multi-stakeholder consultative process for establishing RDL, through which it gained the buy-in of all major stakeholders. The forthcoming review of RDL will be critical in strengthening the status of RDL at a national 17

18 level. However, a number of areas in the process may be further strengthened this objective is very relevant to the World Bank governance initiatives and to MeTA. Drawing on its decision-making experience, NICE can contribute to the planned review and update of RDL, with a focus on the processes for announcing meetings, involving stakeholders (incl. industry and professionals), convening specialty committees, setting up consultation rounds and responses to comments, appeal and contestability mechanisms and conflict of interest policies. Strengthening the transparency and inclusiveness of the update process will impact on the relevance and uptake of RDL by the different Jordanian Institutions and their individual clinicians. We list areas of procedural support (a) below. Of course, it is up to the Jordanian decision makers to decide which steps in the process warrant a greater priority status for NICE to focus on. Identification of key stakeholders, including patient advocates and industry Broader consultation arrangements and response to public comment Appeal processes contestability mechanisms Conflict of interest policies Reporting on the decision-making rationale and evidence used to inform the decisions such as peer reviewed studies and economic analyses. Economic evaluation: The second area where NICE could contribute according to our Jordanian colleagues is the incorporation of economic considerations in making listing/delisting decisions for the National Formulary/RDL. There are 13 criteria for making such decisions, some of which incorporate cost considerations. For example, the 4 th criterion in JFDA formulary describes budget impact analysis as one input in the decision making process, whilst the 8 th Criterion for the evaluation of therapeutically equivalent drugs does not refer to unit cost. There is potential for building on existing criteria to include costs and cost effectiveness analysis as an input when making listing decisions. This is very important if health insurance is to be expanded to cover the whole of the population in a meaningful fashion, which seems to be a policy priority for the Jordanian government. The use of high quality branded generics, most of which are manufactured in Jordan, where clinically appropriate, should be encouraged based on the scientific evidence and listing decisions in RDL should reflect this. We propose to provide technical assistance coupled with analytical capacity to pharmacoeconomists and policy makers in Jordan considering the review of RDL, with a focus on a specific, high-burden for Jordan, disease area, such as diabetes or hypertension, selected by Jordanian decision-makers, where both branded generics and branded drugs are available. Comparative costeffectiveness considerations when making listing decisions for classes of drugs where adequate generics exist, may help reduce the overall cost of providing drugs through publicly-funded programmes in Jordan and improve affordability and access to needed medication for the whole of the population. Such a pilot exercise will familiarise decision makers with the process of using economic data to inform listing decisions and may inform future discussion as to how RDL should be reviewed and maintained in the future. This exercise need not be restrictive in terms of the final decision for the listing and delisting decisions. NICE can work with JFDA and JPD to review a specific disease area or drugs family using comparative evidence of clinical effectiveness and value. Such 18

19 evidence may result in listing new drugs or in restricting the use of older ones. Including such considerations in the selection process can make the latter more defensible and transparent and prepare the key stakeholders for moving away from an RDL based on historical data of what is being used to a more normative, value-based one that includes the best medications given the scientific evidence. 3. Comparative value-based methods (including cost effectiveness considerations) for informing procurement negotiations for RDL listed drugs (JPD) and possibly JFDA privately procured ones. Procurement negotiations that determine the prices of drugs available through the public network do not take account of evidence of comparative clinical and cost effectiveness but are mostly based on price/volume agreements. According to a recent HAI survey, Jordan achieves very good prices, compared to other countries, for drugs through its public procurement processes and the anticipation is that JPD will result in further cost savings. Introducing CEA for all pricing negotiations may not be feasible or necessary, especially in the case of specialty drugs. However, in drug classes where generics are available, (low price high volume drugs such as statins or antihypertensives) price negotiations for on patent drugs could be made more effective if comparative value is one of the inputs in the overall process and helps set a ceiling price. 3 Private prices are important to the extent that public insurers often have to purchase drugs through private networks when public pharmacies run out of needed supplies. JFDA uses three steps in setting private prices: (a) crossreference with Saudi Arabia (b) median price of 7 countries (c) cost effectiveness analyses. While the first two international referencing steps are usually applied, step 3 has yet to be used in determining prices. Private sector prices are relatively high in Jordan, both for generics and branded drugs and this has an impact on overall public spending. JPD is striving to improve the estimates by Institutions and reduce the need to purchase drugs at private prices but the fact that public health insurance is expanding to include more individuals is intensifying the problem. NICE, in collaboration with its academic partners, could provide a comparative analysis of value (accompanied by a budgetary impact analysis) for a selected disease area/group of drugs included in RDL for the consideration of JPD during the price negotiations. This will in no way be a restrictive input but may inform the negotiations and enhance efficiency. 4. Capacity building: There are three major, often overlapping, groups of stakeholders that should be involved in rational decision making: (a) technical experts who will conduct the assessment of the evidence including economic analyses and (b) senior clinicians who will be involved in using the available clinical and economic evidence to make policy and practice decisions (incl. development of best practice standards) and (c) senior government officials who, in conjunction with clinicians and technical experts, will be evaluating the available information to make policy decisions (e.g. listing decisions for new technologies). There may be additional areas where capacity building is necessary such as training for senior policy makers. 3 Also, for selected drug classes, especially where there are few or no therapeutic substitutes and little competition, comparative analysis of value, including as comparators best available non-drug treatments, and taking into account the overall budget constraint in Jordan, may be a useful addition to the pricing negotiations and international referencing. 19

20 NICE, in conjunction with its academic partners in the UK and Jordanian Universities as well as Jordanian Institutions such as RMS and KHCC, could offer a training programme consisting of: Tailored courses, with a technical, process or policy focus (for technical staff, clinicians or decision-makers) Educational visits to NICE including observation of committee meetings and presentations by NICE technical staff and chairs of the NICE decision making bodies, including senior clinical advisors to NICE The above can be complemented by sessions led by National Health Service experts to understand the role of NICE in the British NHS and its interaction with other governmental organisations and provider institutions in the UK. 5. Patient and public awareness and engagement: Jordanian policy-makers have identified public and patient involvement in decision making and also raising public awareness as to what individual patients are entitled to as key policy priorities. NICE has developed a sophisticated process for engaging with the public and patient organisations during the development of its methods and of individual guidance products through public participation in committees, public consultations, the use of a Citizens Council; incorporating patient expert views in evidence assessment and appraisal and disseminating all its guidance to patients and the public in a lay-friendly format. Furthermore, NICE has developed a media strategy for engaging with the press and disseminating its quality standards to professionals, purchasers and patients at a national level. NICE can assist Jordanian policy makers in engaging with patient organisations and the broader public both through setting up the appropriate networks for gaining lay input and disseminating health policy decisions and also through allowing for patient input in individual listing and delisting decisions. On the latter, we propose a pilot where lay and civil society input is actively sought in the decision making process for updating RDL in a high priority disease area. The lessons learned during this process could be used to inform future process reviews. Table 2 provides an outline of the areas where NICE could add value to specific aspects of the Jordanian health reform agenda. Table 2: Alternative modes of engagement with Jordanian policy makers in key priority policy areas Area Specific task/activity Means of support 1. Review of Rational Drug List a) Process of adding and removing drugs Stepwise support during implementation of existing process and criteria to specific drug classes/disease areas (e.g. antihypertensives; PPIs; statins) with a focus on stakeholder identification and convening of committees; consultation and responses to broader public comment; establishment of contestability mechanisms 20

21 2. Capacity building 3. Patient and public awareness and engagement b) Incorporating costminimisation and cost-effectiveness considerations when making listing/delisting decisions a) Health economics training for economists and pharmacists b) Supporting policy makers in making evidence-informed resource allocation decisions c) Raising clinician awareness of economic evaluation and cost-effectiveness analysis a) Procedural engagement during decision making including participation in committees, patient expert testimonies and consultation process b) General infrastructure for engaging with patient advocates and public representatives including educational programmes for lay committee members and dissemination of final guidance/decision in lay-friendly format Stepwise support during implementation of existing process and criteria to specific drug classes/disease areas (e.g. antihypertensives; PPIs; statins) with a focus on using information on (a) budgetary impact and (b) comparative value when making listing decisions for new drugs. In collaboration with UK as well as WHO, Jordanian Universities, RMS, KHCC and the newly formed Jordanian ISPOR chapter, NICE can develop a customised short course in pharmacoeconomic analysis for technical staff. NICE-based sessions with NICE policy makers, chairs of NICE committees and observation of NICE decision making sessions and public appeals. Process focused training sessions on transparency, consultation and good governance (incl. handling conflicts of interest; managing interactions with manufacturers ) NICE can offer a short tailored course on the use of economic evaluation in clinical decision making for leading Jordanian clinicians. Process course/presentations by NICE experts and observation of Committee meetings Pilot of involving civil society and patient advocate when reviewing RDL with a focus on a specific disease are and class of technologies. Tailored training course for Jordanian decision makers, led by the NICE Patient and Public Involvement Unit and the NICE Communications Department. Observing NICE Citizens Council deliberations and presentations on incorporating social value judgements in decision making and policy. 4. Rational Drug Use Best Practice Guidelines/Protocols Development of best practice guidance/rational drug use guidance alongside RDL update for a specific disease area. Provision of technical support; adaptation of existing NICE guidelines in selected disease area; training course in clinical guideline development and health economic evaluation in decision making. All the above activities ideally should take place alongside the RDL update in a selected high BoD area where the budget impact of listing and prescribing practices is considerable and there is some activity in developing evidence based guidelines (e.g. cancer care) 21

22 Next steps Short term activities The idea of organising a series of training courses/study tours to: (a) Help identify the key technical and governance (process) requirements for strengthening evidence-informed policy making, hence setting capacity building priorities where necessary to support the reforms (b) Allow senior Jordanian policy-makers experience real-time decision making, talk to senior NICE policy makers and identify those process or methodsrelated areas where NICE s expertise could support the ongoing reforms on Jordan was discussed and agreed with our Jordanian counterparts. Below we outline three training sessions targeting specific audiences with some overlap. These sessions could be merged and could be held either on site or at NICE, the latter would be especially useful if arranged so that NICE Committee meetings or other events held in public such as appeals, could be attended by Jordanian policy makers. The three sessions are followed by a dissemination and planning workshop. a. Policy-makers focused: A study tour to the NICE HQ in London for a small number of senior policy makers from Jordan including stakeholders from the Ministry, High Health Council, Joint Procurement Department, JFDA, major institutions etc. The study tour will provide an overview of decision-making at NICE and the National Health Service with a particular focus: the process for appraising drugs and developing clinical guidelines for the National Health Service in the UK, with a focus on transparency and inclusiveness. This will include sessions on working with clinicians and industry representatives; good governance and appeal processes; making evidence base and decision making process accessible to the public and dealing with conflicts of interest patient and public involvement in decision making including training for lay members of decision making committees; designing and running consultation processes and responding to public comment; co-ordinating public awareness campaigns social value judgements and the NICE Citizens Council interacting with national and international media public relations strategies implementation support strategies including raising awareness amongst professionals, budgetary impact assessment and planning tools for purchasers of services locally attendance of NICE decision making body session (clinical guidelines or drug appraisals committee) in addition, and subject to timing and availability, other aspects of the NHS, such as central purchasing mechanisms (PASA), or regulatory frameworks (MHRA) can also be addressed if there is interest on behalf of our Jordanian colleagues Deliverables: By the end of the visit, participants will have an overview and broad understanding of NICE s role in the NHS, its processes and methods across different programmes and a first-hand experience of how NICE s principles of transparency, inclusiveness and methodological rigour are applied to inform NHS coverage decisions. They will have had the opportunity to meet and talk to the organisation s 22

23 senior management, its technical leads and administrative staff and attend a decision-making committee. This will allow Jordanian policy makers to identify those aspects of NICE s role that may be of relevance and value in the Jordanian setting hence informing any future long term collaboration between NICE and Jordanian decision-making bodies. b. Senior clinician/healthcare professional-focused: A short course with a focus on preparing senior clinicians/specialists for participating in clinical guideline development teams. Principles of evidence based medicine for policy makers Introduction to process of guideline development: accountability; transparency; inclusiveness and scientific basis for decisions Inclusion of patient experience Consideration of costs and cost effectiveness: the role of health economic evaluation in clinical guidelines Observation of NICE Guideline Development Group day session (if held in the UK) Deliverables: By the end of the course, participants will have a good understanding of the methods and processes for developing NICE clinical guidelines that inform national quality standards across primary and secondary care in the NHS. This is of particular importance and relevance to the Jordanian setting as, in order to develop and implement any of the reforms in terms of universal quality standards or coverage decisions for drugs through JPD and JFDA, clinicians buy-in is essential. The course will focus on good governance and procedural aspects of clinician involvement and also on implementation support at the local practice level. (UK or Jordan) c. Technical analyst-focused: A technical training course organised in Jordan for experts with some familiarity with HTA; pharmacology; health service research and clinical medicine who are (or are likely to be) actively involved in the development of RDL and STGs either as committee members or as technical experts. 4 Technical focus on cost-effectiveness analysis; the use of outcome measures such as the QALY; the role of sensitivity analysis; indirect comparisons etc depending on the level of expertise and interest of the technical group. Case studies using real NICE decisions and discussing the systematic reviews/meta-analyses and economic models supporting these decisions Extra-utilitarian considerations; equity, need and social values Deliverables: By the end of the course, participants will have a good overview and understanding of NICE s technical/methodological principles as applied by the academic groups across the UK to inform the decision of NICE s decision making committees. Areas where more training/capacity building is necessary to set up similar decision-making processes in Jordan will be identified and reported by the end of the course. Developing the minimum necessary capacity to support decision makers in making evidence-informed healthcare resource allocation decisions is a prerequisite for any future pilots NICE may engage in in Jordan and, most importantly, for any structures Jordanian policy makers decide to put in place to 4 The technical course could also build on local expertise from Jordan including existing University courses (Jordan University) in pharmacoeconomics and ISPOR experts. 23

24 inform decision making. (Jordan)In addition to improving the technical expertise of Jordanian technical analysts who could in the near future work with a NICE team to pilot the development of listing decisions/stgs in high priority disease areas (see below), this initial course can also inform the development of a future training/capacity building programme. d. Dissemination and planning workshop (Jordan): It is important that the key messages/lessons from the three training/study tours set out above are (a) disseminated and discussed with a broader policy makers, clinician and technical expert audience in Jordan and (b) used to help NICE and its academic partners identify, in collaboration with key Jordanian stakeholders, those areas where NICE input would add most value. We propose that soon after the completion of the study tour and to inform the design of a longer-term engagement, a workshop with key stakeholders, including some of the course participants, is organised, with the explicit objective of setting out the key areas where NICE involvement can contribute to the ongoing reforms in Jordan. World Bank and MeTA input would be important to ensure objectives are well aligned and there is no duplication of effort. Deliverables: The deliverable would be a specific action plan that will inform NICE s longer-term engagement in Jordan through a specific pilot and/or targeted advice and technical support at specific stages during the policy making processes. Below we suggest an outline of possible longer-term NICE engagement in Jordan drawing on the NICE/Jordanian authorities interactions so far. Following the three London-based courses, we expect to refine this proposal into an actionable plan with specific deliverables, timelines and budget estimates. Medium and longer-term activities The main area where NICE experts could add value is in the field of STGs, which in turn is dependent to a great extent on the way RDL is developed and implemented. Inclusiveness, scientific basis, transparency and contestability are key prerequisites for building professionals and patients trust in RDL which then will lead to improved uptake and implementation across the country. The following three steps are crucial in supporting the way RDL is developed and increasing its uptake by providers across the country: Review of ToR/SOP/membership of RDL Committees: to improve transparency; accountability; scientific basis; inclusiveness (health economists; pharmacologists; patient input) Training/capacity building for technical staff and clinicians Disease- and drug class-specific pilot building on the revised ToR/SOP and additional capacity developed through training courses The first two objectives can be addressed to an extent through the short term training courses and study visits. The third constitutes the longer-term objective. NICE can provide technical and process advice, with a focus on a specific disease area, to: Develop STGs based on best available evidence adapted to the Jordanian setting. This could be done focusing on a specific drug class in the RDL addressing the selected disease area. The whole process would bring together specialists from all major Institutions, as well as pharmacists and health economists, and key stakeholders such as JFDA, and would use international guidelines and locally developed protocols (e.g. cancer treatment protocols developed at KHCC or at JUH) 24

25 as its basis. Unification of protocols for use of RDL drugs in a selected disease area would be an important first step towards both increasing the acceptability/impact of RDL and reducing variation/inequity in current practice across the country. Special attention will be given to sharing NICE experience in raising patient and general public awareness of their entitlement to high quality care. This will involve active engagement by NICE s public and patient involvement experts and NICE s media and communications team. Help review and update the process for making listing decisions for the RDL, with a focus on the processes for announcing meetings, involving stakeholders (incl. industry and professionals), convening specialty committees, setting up consultation rounds and responses to comments, appeal and contestability mechanisms and conflict of interest policies. Strengthening the transparency and inclusiveness of the update process will impact on the relevance and uptake of RDL by the different Jordanian Institutions and their individual clinicians. In the context of a pilot, NICE, in collaboration with its academic partners in the UK, could provide a comparative analysis of value (accompanied by a budgetary impact analysis) for a selected disease area and the corresponding group of drugs included in RDL for the consideration of JPD during the price negotiations. We propose we focus on a high burden of disease area (e.g. cardiovascular disease, or diabetes) where there are inexpensive generic alternatives high volume, low unit cost technologies with significant budgetary impact and health implications for the population. Furthermore, such a pilot could inform the procurement negotiations through providing JPD with evidence based arguments as to the maximum price for a selected drug the Jordanian public sector would be willing to pay (affordability). Progress as of February 2009 Following discussions with Jordanian policy makers, DFID, World Bank and local consultants, NICE is in the process of agreeing a contract for undertaking a technical/process training course, in conjunction with one of its academic partners, in Jordan in spring This will be followed by a high level policy meeting, including JFDA, JPD, High Health Council. WHO and local Universities, to decide next steps in the form of specific technical advice; hands-on pilots and/or further training and study tour(s) to the UK. A 3-day technical/policy course in Jordan (March 2009) will be funded by the World Bank (MeTA budget). 25

26 3.2 Case study 2: Colombia Outline Following a series of iterations with senior health policy makers in Colombia, in December 2008, NICE organised a visit to Bogota, in response to an official invitation by the Colombian Minister of Social Protection. The purpose of the visit, which was funded by the UK s Department for International Development, was to learn more about the ongoing healthcare reform in Colombia from key Colombian stakeholders, to provide a focused outline of NICE s role in the National Health Service (NHS) and to assess, in conjunction with Colombian colleagues, whether aspects of the NICE model and experience may add value in the Colombian context. During the visit the NICE team had the opportunity to interact with (a) technical experts (b) broad stakeholders including industry, academia, professionals, policymakers, insurers; (c) the small ministerial expert task force responsible for interpreting and acting upon the Constitutional Court decision and (d) the Minister of Social Protection. Based on the discussions with these key stakeholders, we highlight below the key areas where NICE involvement could add value in the Colombian context. Health and pharmaceutical policies in Colombia 5 Since the Colombian healthcare insurance reforms of 1993, Colombia has made a series of significant achievements, including: a dramatic increase in coverage rates across the Colombian population, currently at approximately 90% (up from 20% prior to 1993), with universal enrolment expected to be achieved by 2010 increased investment on health, currently at levels comparable to those of developed countries, at 7.8% of GDP (up from 3.5% prior to 1993) a reduction in out-of-pocket spending, now at around 6.9% of total health expenditure a life-expectancy of 74.5 years, and under-five mortality rate of 21 per 1,000 live births. Law 100, passed in 1993, sets the stage for Colombia's current health insurance system. Individuals with the capacity to pay including workers in the formal sector pay into the contributory regime through a salary-based premium. Workers contribute four percent of their salary, and their employers contribute an additional eight percent. Individuals and households that are poor are covered by the subsidised regime, which is financed by financial transfers from the national government to departments and cities, as well as a transfer from the contributory regime, local tax revenues, and other sources. Poverty levels are determined through a proxy means test system known as Sistema de Identificación de Beneficiarios, or SISBEN, which uses an asset-based score to classify households as poor or non-poor. There are three preset levels of benefits packages (Planes Obligatorios de Salud, or POS), originally defined in The POS for the subsidized regime (POS-S) includes preventive services, basic medical, dental, and diagnostic services, and emergency healthcare. The contributory plan (POS-C) includes additional specialty 5 Drafted in collaboration with Prof Hugh Waters, Johns Hopkins School of Public Health. Baltimore, USA 26

27 services, diagnostic tests, hospitalizations, and rehabilitation. Services that are not covered under the POS-S and services for the uninsured are in principle provided by public healthcare providers, financed by tax transfers from the federal government to the local level as well as local tax revenues. In the contributory regime, individuals enrol in health plans (Empresas Promotoras de Salud, or EPS). The EPS transfer the financial contributions to the Fondo de Seguridad Social y Garantía, FOSYGA, which in turn transfers one percent of the total revenues to the subsidised regime, and additional smaller amounts to pay for health promotion activities, sick leave, and maternity leave. In addition to funds from FOSYGA, the subsidised regime is financed through local and national tax revenues. The bulk of the funds from FOSYGA are used to pay premiums through the Unidad de Pago por Capitación (UPC) for the POS in the contributive regime directly to the EPS, and to pay claims from the EPS for reimbursement of services and drugs that are not included in the benefits plans. The value of the UPC is risk-adjusted for age and gender, but only in the contributory regime. The UPC is also adjusted for remote geographical areas for both the contributory and subsidized regimes. The EPS negotiate directly with healthcare providers, and can establish their own provider payment mechanisms and payment levels. Capitation is often used for preventive and primary healthcare services; specialists and hospitals are generally paid through fee-for-service, with some initiatives towards payment by cases or diagnoses (diagnostic-related payments). 6 A recent ruling by the Constitutional Court calling for the unification of the two basic health plans (subsidised and contributory) and for the establishment of a fair process for reaching decisions as to what services the basic package includes and communicating these decisions to the general public, has led to the launch of an effort to reform the methodological/technical, structural and procedural aspects of Colombian healthcare policy making. Despite the strong political commitment to improving access and quality, the achievements of the reform efforts over the past 15 years, the well-established technical/academic capacity across the country s universities and the availability of good quality claims data from the various EPS schemes, Colombian policy-makers are faced with a number of political, legal and methodological challenges in the reform efforts: Colombia is a lower middle-income country -- with a per-capita Gross Domestic Product (GDP) of $2,158 in unadjusted terms and $7,308 per capita when adjusted for Purchasing Power Parity (PPP). Annual health expenditures per-capita (not adjusted for PPP) are $168.30, or 7.8% of GDP. Colombia is a middle-income country, however 60% of the population lives below the poverty line; this group have a very limited ability to contribute financial resources for health. The 1993 reforms were important but incomplete, resulting in the development of a basic package with some (mostly procedural) weaknesses that remain to be addressed, including the lack of a clear process for regular review and update or of a means for engaging with and communicating any changes to the package to key stakeholders and the broader Colombian population. As a result, the basic package has remained almost static since its inception in Pinto, Diana. Chapter on Colombia. From: Pablo Gottret, George J. Schieber, and Hugh R. Waters (eds). Good Practices in Health Financing. The World Bank, Washington, D.C., Furthermore, the lack of a disease focus is another, technical weakness of the way it was initially defined currently it consists of three long lists of procedures; technologies (incl. drugs) and catastrophic care services, make regular updates more difficult. 27

28 Maybe because of the lack of a legitimate and transparent process for making update decisions, individual citizens use legal challenge through the Colombian Supreme Constitutional court (tutela) to include additional services to the basic package; these may be services that are missing because the package has not been kept up-to-date or services individual clinicians and/or patients may consider necessary. With no formal process for considering the comparative clinical and cost effectiveness of such services, legal challenge often becomes the only way to gain access. As a result, the Special Fund, which represents the actuarial reserves of the insurance funds made up from the surplus of members contributions, often finances technologies approved through the courts or local exception panels. However, using up the actuarial reserves, aimed at countering financial downturns (as is the case currently), compromises the long-term fiscal sustainability of the health insurance system. There are some perverse incentives in the way the Special Fund operates, both because providers are reimbursed by the Fund at list (rather than transaction) price for technologies and services offered and because insurance plans have little incentive to control spending on wasteful or unproven technologies, as they are usually bailed out by the Fund when a clinical or legal exception is made to the basic package. The decision of the Constitutional Court on unifying the basic package and setting up a fair process for informing updates to the package, comes with tight timelines. The MSP has to produce a plan no later than February 2009, for the consideration of the Court, as to (a) how the contributory and subsidised plans will be unified for children under 10 by October 2009, and (b) how the two plans will be unified for all Colombians, including a timetable/milestones and the methodology and process which will inform the merging of the plans and the development and longer term update of the basic package. The Colombian government is committed to achieving universal coverage by January Given the timeliness and resource constraints, a phased in approach in developing CGLs and gradual updating the basic package with a focus on high priority disease areas has been proposed but it is not clear how CGLs will inform the basic package and how listing/delisting and updating decisions will be dealt with in the future (e.g. through a rapid process or a CGL update). To meet some of these challenges and comply with the Constitutional Court order, MoSP has launched an important initiative, led by the Fundación Santa Fe de Bogotá, to develop and test the methods for undertaking analyses of the clinical and cost effectiveness and budgetary impact of services, in the context of a diabetes focused pilot. In addition to this technical stream, public debate, broad participation, and incorporation of social values in decision making are core principles that need to be met for the reform to be successful and accepted by the key stakeholders. It is mainly this latter area where NICE s input could offer the greatest value at this present stage of the reforms. Talking to Colombian decision makers: emerging themes This section was drafted in collaboration with colleagues from the Colombian MoSP. It identifies specific areas where NICE involvement can add value and describes the Institute s experience in these areas. The next section lists the different deliverables in the first stage of the NICE/MoSP collaboration along the major themes included here. 28

29 Both NICE and the Colombian MoSP share a commitment to improving the overall health of their respective populations, by using scientific evidence and societal values to decide on the cost-effective use of new and existing medical technologies and disease management strategies, through transparent, inclusive and contestable processes. The Colombian MoSP is planning reforms to (a) expand coverage to the whole of the Colombian population (currently at 90%); (b) unify the contributory and subsidised basic plans so that all Colombians have access to the same set of core services and (c) develop a procedurally fair and transparent process for making and communicating decisions on covered services and technologies to the Colombian population. In meeting these goals, MoSP is committed to considering both scientific evidence of clinical effectiveness and efficiency, and the Colombian society s overarching values. MoSP can draw on NICE s experience of using evidence to inform health policy and reimbursement decisions using consultative, contestable and transparent decision-making processes. The current setting in Colombia is characterised by well-developed local academic and technical capacity; strong links with foreign Universities in Latin America and the US (including the Harvard School of Public Health); good quality data on usage through EPS claims; and broad political backing for the reform. As a result, NICE s input is most likely to add value on a strategic level, with a focus around process and good governance principles rather than through hands-on technical support. If the country s commitment to the principle of universal access to a basic package of services for the Colombian population is to be met, the long-term financial sustainability of providing the listed services to those who need them is of essence. The latter can only be ensured if a prioritisation process to determine which services are essential and for whom, is designed and implemented. For such a process to be legitimate, relevant and acceptable to key stakeholders, including patients, the broader Colombian population and the judiciary, it would need to adhere to a core set of principles of transparency, consistency, independence from vested interests, inclusiveness, contestability and enforcement. The need to legitimise no decisions," as described by one of the Colombian policy makers, can only be met through procedural fairness and broad public engagement. The outline below focuses on these broad themes: contestability; public engagement; prioritisation and the methods and processes of clinical guideline development, including the technical aspects of incorporating economic considerations. Building contestability into the process Since the establishment of NICE s programme for evaluating new and existing technologies on the basis of their clinical and cost-effectiveness in order to assess whether they should be reimbursed by the NHS and for which indications and patient subgroups, NICE has developed and run an appeals process. The appeals mechanism has served three main purposes: It ensures NICE s decisions can be contested, hence increasing their legitimacy and gaining broader stakeholder buy-in It serves as an additional quality assurance process, bringing to the attention of the NICE Advisory Committees areas they might have overlooked or misinterpreted It reduces the likelihood of time and resource-intensive court challenges of individual decisions It is possible that contestability mechanisms may be applied to three distinct decisions made by Colombian health policy makers: (a) listing and delisting decisions on what goes into the basic package, (b) best practice decisions as to how those services and technologies included in the basic package should be used (indications; 29

30 subgroups) as described in CGLs and (c) the reimbursement levels for these technologies and services included in the basic package. In the UK the focus is on (a) and indirectly on (c); however the general principles NICE applies throughout its appeals process can be used, adequately adapted, at all three stages. NICE can support the building of new/strengthening of existing contestability mechanisms in the Colombian setting drawing on its UK experience. Encouraging social debate and broad public engagement NICE engages with the general public with the aim of eliciting broader societal values to apply to its own decision-making, mostly through the Citizens Council (CC) and the resulting Social Value Judgements Guideline. The Citizens Council is a group of 30 individuals, broadly representative of the socioeconomic, ethnic and gender profile of England and Wales. The Council meets twice a year for a total of 3 days at a time to deliberate and debate topics of importance to the way NICE Advisory Committees make their decisions such as the importance of disease severity when assessing the value of medical technologies or whether age should be a factor when making coverage decisions. Their recommendations are then incorporated into the Social Value Judgements guideline to NICE s Advisory Committees. NICE also proactively engages with patient organizations and consumer advocates through a dedicated NICE unit, the Patient and Public Involvement Programme. PPIP consists of experts in public and patient engagement and undertakes a wide range of activities including training of lay people and patients who join NICE Advisory Committees; supporting patient experts who testify before NICE Committees; liaising with patient organizations to encourage submission of evidence and of consultation comments during the development of individual guidance products; producing and helping disseminate lay versions of all NICE guidance products. Finally, NICE runs broad consultations on both its individual guidance products and its general methods and processes. This includes identifying relevant stakeholders; alerting them to forthcoming NICE consultations and inviting them to comment within set timelines; collating, assessing and responding to the comments, including how the guidance was (or was not) altered in light of their comments and why. MoSP expressed a strong interest in using a Citizens Council-type model for engaging with the general population in Colombia to communicate its approach to decision making. NICE could use its expertise, both in-house and with external partners, to support MoSP in setting up such a council (or citizens jury) model. This could be applied as: One-off regional council meetings across all 5 regions in the country to discuss the Constitutional Court decision; the methods and process plan for implementing this decision (i.e. the way in which the basic package will be developed in the future); and the high priority disease areas which will form the starting point for developing CGLs. This process will raise awareness of the government s efforts across the country, improve the legitimacy of these efforts and provide useful feedback to the decision-makers responsible for driving the reform effort. Regular council sessions housed within the body responsible for making listing/delisting decisions and developing CGLs. This regular CC could address general social value questions as is the case with NICE s CC. The basic principles of operation are the same for both types of CC. Strengthening the Clinical Guidelines development process NICE has long experience of developing Clinical Guidelines (CGLs) for use by patients, purchasers and healthcare professionals in the NHS. With over 80 CGLs 30

31 developed and another 40 in development, NICE runs the largest CGL development programme in the world and aims to cover all major causes of mortality and morbidity in the UK. NICE has significant expertise in (a) selecting topics for developing guidance, (b) engaging with stakeholders in the process of guidance development, (c) incorporating economic principles as a key input in the decision making process, and (d) setting up the processes to support the implementation of its guidance at the local level. All these aspects are of relevance in the Colombian setting and NICE can provide both hands-on technical and strategic advice on how to Colombianise relevant aspects of the NICE model and additional training tailored to the needs of local policy makers. Selecting high priority topics for Clinical Guideline development NICE has developed a sophisticated multistakeholder process for topic selection which it could share with Colombian policy makers and/or support the adaption of any of its aspects to the Colombian setting. Providing technical assistance in economic evaluation for Clinical Guidelines NICE has unique experience in incorporating health economics in its guidelines, both in the form of cost-effectiveness analyses and also by estimating the budgetary implications of its guidance. In the Colombian setting both these issues are of critical importance. NICE can also work with its academic partners to provide technical advice as to how to define the affordability of a certain activity (technology or service) by comparing efficiency to budget constraints. Calculating the marginal cost of additional services, both now and in the future, can greatly assist the Colombian government in making decisions about the affordability of specific proposed services. Next steps Along the lines of the emerging themes identified earlier, we list below a number of specific deliverables to MoSP: Contestability Strategic advice as to how to strengthen/revamp current contestability mechanisms applied in healthcare decision-making in Colombia. Depending on the specific attributes of the Colombian process, NICE advice could include information on: o o The overall principles of the NICE appeal process including selection of the appeal panel members and panel composition; grounds for appeal; types of legal support; policy options following upheld and rejected appeals. Based on the UK experience and specific case studies, key challenges faced and addressed over the years through different types of appeal in terms of the appellants, nature of technology and final decision. Organising attendance of NICE s public appeal session for Colombian decision makers, followed by discussion on the key issues and challenges with appeals panel chair Ongoing support after the establishment of the Colombian process, on a case-bycase basis 31

32 Patient and public engagement Specific input as to how to strengthen/revamp current public involvement mechanisms applied in healthcare decision-making in Colombia. Depending on the specific attributes of the Colombian process, NICE advice could include information on: o o o the overall mode of operation of the Citizens Council (CC) in the UK, including the criteria and process for member selection; the way the question and the agenda are crafted prior to every meeting; how the meetings are run to ensure broad participation how the views of the CC are captured, reported, consulted upon and then translated into Social Value Judgments. Providing access for a small group of Colombian colleagues to a CC held in the UK to experience how the CC works in the UK setting Advice as to how to strengthen/revamp current patient involvement mechanisms other than the Citizens Council and on how to apply them in healthcare decisionmaking in Colombia, drawing on the major activities of NICE s patient and public involvement programme (PPIP) including: o o o o o The curriculum and delivery of training sessions for individual lay and patient members of Advisory Committees before and while they serve on these Committees Modes of identification and support for patients offering expert testimonies to NICE Committees Translating NICE guidance into lay versions and disseminating to general public and the national media Supporting individuals and organizations to participate in NICE consultation. Delivering a workshop focusing on the key aspects of PPIP function of relevance to the Colombian setting (e.g. train the trainers for lay Committee members). This could be held either in the UK or in Colombia Long term support and technical advice when the Colombian public and patient involvement processes are up and running Clinical Guideline development process NICE experts participating in an advisory capacity in the currently ongoing process of developing methodological guidelines and also in the first 1-2 diseasespecific CGLs (i.e. diabetes mellitus) to provide real time input/feedback as to key aspects of the process in the form of peer review. The NICE team could provide input in aspects such as: o o o o o o stakeholder identification and involvement at different stages of the process composition and convening of the expert group to develop the CGL process for turning evidence into recommendations consensus reaching process and troubleshooting consultation quality control and peer review of final product. 32

33 Study tour to NICE s centre for short guidelines for small number of senior clinicians/distinguished professors (and other stakeholders: policy makers; academics; media; judiciary) to demonstrate how evidence is presented to and interpreted by NICE decision-makers (the independent advisory body charged with making guideline recommendations) and discuss key issues with technical and management teams. The delegates will also attend a guideline development group session and participate in a short guideline workshop. Workshop in Bogota on process and economic methods, based on training provided by NICE experts to guideline development groups prior to convening the group and launching the development process. This will include training on the generic methods of guideline development with a focus on how these are applied to NICE s Short Clinical Guidelines and training on the process of guideline development, particularly in relation to the involvement of key stakeholders in decision making. Topic selection Advice on topic selection through providing an overview of its process and advice as to how to adapt some of these aspects to the Colombian setting Incorporating economic considerations in Clinical Guidelines Based on NICE s experience of employing cost-effectiveness, NICE and its academic partner(s) will be able to offer advice on the incorporation of economic evaluation methods into guideline development. Specifically this can include: Exploring the appropriateness and potential application of Quality-Adjusted Life Years (QALYs) gained and Disability-Adjusted Life Years (DALYs) as measures of effectiveness when estimating cost-effectiveness Advice on how to encourage guideline developers to consider the opportunity costs of interventions Short workshops for key decision makers on using cost-effectiveness analysis to inform decisions Advice on the role of cost-impact analysis in guideline development Assistance in calculating the unit cost of providing services in the POS-C and POS-B, as well as for additional services that may be proposed in the future. Assistance in modelling the additional costs and impacts of specific benefits that could be added (now and in the future) to the POS-C and POS-S benefits plan. This type of analysis would include future economic, epidemiological, and demographic trends to ensure that affordability and the financial solvency of the health system are guaranteed into the future. Progress as of February 2009 On 17 January 2009, the NICE Chairman travelled to Bogota to meet with the Minister of Health and with the President of Colombia. During this visit, an MoU was signed between NICE and the Ministry of Social Protection outlining the major areas for collaboration between the two parties, as described earlier. A project plan and contractual agreement for NICE s engagement are currently being negotiated. It is anticipated that NICE technical and process assistance will be funded by the Colombian government. Additional funding may be sought from the World Bank in the Latin American region. 33

34 3.3 Case study 3: Ghana Outline A DFID-funded visit to Ghana was organised in conjunction with the World Bank in early December 2008 during which a NICE representative had the opportunity to meet with Ghanaian colleagues from academia, the ministry of health, the national health insurance, MeTA Ghana, teaching hospitals and foreign aid agencies active in the country. The purpose of the visit was to explore whether, in the context of MeTA or independently, there is scope for NICE involvement in supporting the health policy developments in Ghana. Health and pharmaceutical policies in Ghana Ghana has recently introduced a broad National Health Insurance Scheme (NHIS) and is committed to expanding affordable coverage to all its citizens. 8 Efficiency and good governance in decision-making are core requirements for the longerterm fiscal sustainability of such a scheme. The implementation of NHIS has led to the generation of a wealth of claims data, which can allow analyses of prescription patterns by indication, care setting and geographical location. However, there are currently practical challenges in collecting and electronically synthesising these data. Ghana has a well-developed network of academics in local Universities able and willing to undertake epidemiological and claims data analyses to inform policy decisions. At the same time, there may be a shortage of staff with expertise in interrogating medical databases; systematic reviewing and meta-analyses; economic evaluation and critical appraisal of published studies. Finally, and not unlike other low-income countries, Ghana is experiencing a noncommunicable disease epidemic, especially amongst older cohort of the population. Heath policy reform and political commitment; academic strengths; and the burden of disease profile, make Ghana an ideal country to build and run a focused pilot on strengthening local policy making structures through using evidence to inform policy and practice. Such a process, if successful, could have an impact beyond the national level, across other countries in the sub-region, interested in reviewing and rebuilding their current health policies. Talking to Ghanaian decision makers: emerging themes Below is an outline of the thoughts of various Ghanaian stakeholders we met with during the visit, on how NICE could add value in their local setting. Korle-bu teaching hospital KBTH is the largest teaching hospital in the country. It does not accept NHI for prescription drugs; instead, patients pay out of pocket or use neighbouring pharmacies that accept NHI and bring their own drugs back to the hospital. Prescription practices are almost completely dependent upon the senior hospital doctors. There is no attempt to enforce national rational drug use guidelines or efficient prescription guidance. Other than a pharmacist-run internal benchmarking exercise, whereby prescription patterns for the same disease are compared across different departments and any variation brought to the attention of consultants, there 8 World Bank Policy Note: The Pharmaceutical Sector in Ghana, December 2008 (draft) 34

35 is no system to quality assure professional practices or enforce national treatment guidelines. The hospital procures those drugs recommended by the doctors based on the latters experience of the drug s clinical performance. As a result, the hospital drugs list is driven by individual consultant opinions and may be subject to (a) industry lobbying pressures; (b) quality lapses. So, for example, branded drugs may be used instead of cheaper generics because of the perception the latter do not work as well or are of lower quality 9. Earlier attempts to enforce rational prescribing practices have been abandoned. Hospital management s attempts to control prescribing are focused on (a) training polyclinic junior doctors (the last training session was run in 2006) and (b) dispensing BNFs to encourage prescribing adhering to the BNF indications. The hospital administration felt that NICE contribution would be of benefit in the following areas: Training exchanges for clinicians and hospital administrators. NICE and the NHS could offer some training on the ground and also some front line experience of guideline development and application in the tertiary setting in UK hospitals Assessment of prescription patterns based on locally collected and analysed data and international best treatment guidelines NICE mediation to increase number of BNF hard copies for professionals to refer to not adequate numbers currently provided through British organisations of pharmacists (e.g. Royal Pharmaceutical Society). Noguchi Institute and University of Ghana Medical School The discussions with academic colleagues focused on the progress of the MeTA initiative in Ghana. MeTA aims to support an open dialogue amongst key stakeholders involved in different stages of the procurement chain for pharmaceuticals as well as data collection and analysis and/or small scale pilots of policy interventions, that could inform this dialogue. As the final 2-year pilot plan for MeTA is being developed, a number of areas were identified by local experts where NICE input may be helpful. These included: Using claims data to benchmark prescribing practices: Assessment, against NICE guidelines, of prescribing patterns, collected and analysed by local academic networks, in high burden disease areas, at a cross-section of health insurance funds and teaching hospitals in rural and urban areas of Ghana. This would be a similar albeit broader exercise to the one described earlier (bullet 2 in KBTH section) and could help identify variation in prescribing across the country and different care settings and the potential for health improvement and efficiency savings through rationalising current practice based on best available evidence of clinical and cost-effectiveness. Utilisation data (with the exception of the teaching hospitals) are already available through the NHIS claims database (even though there are difficulties capturing the data electronically and possibly centrally analysing the data) and some preliminary analyses have already been undertaken. The electronic data collection system is sponsored by the World Bank. Contributing to a decision-making pilot exercise: Technical and process support with making decisions on the selection (adding/removing from basic/nhis list) and rational use (standard treatment guidelines - STG) of medicines through helping set up an accountable, transparent, inclusive and independent advisory process to help decision makers translate evidence of what works in the 9 There are no local quality checks the hospital relies on central controls by the Food and Drugs Board of Ghana 35

36 Ghanaian setting into policy and practice. Such a process could lie downstream of or be contingent upon the main MeTA objectives around collection and analysis of local data on usage; include adaptation of international evidence to the Ghanaian setting by local experts; and encourage/link primary research (and research funding) to questions of effectiveness and cost-effectiveness important to decision makers through signalling key evidence gaps to the research community. It could be considered in the MeTA context especially if a disease or drug class-specific pilot is set up to test out this model from data collection and analysis to decision making whereby NICE experience could contribute to the process aspects of the project. MeTA is particularly well-placed in Ghana for supporting such a pilot through: o Providing the necessary platform for bringing key stakeholders together this is already happening through the Ghana MeTA committee o Funding a small policy review of the current model of decision-making e.g. who (and how) makes decisions as to the STG in National Drug Programme? Who (and how) makes listing decisions for NHIS list? Who (and how) is responsible for adapting existing/developing new guidelines for rational use for NHIS list? o Helping design, fund, analyse, report and disseminate a disease specific pilot on making listing, reimbursement and best practice (rational use) decisions for pharmaceuticals in the NHIS context. Stakeholder involvement: Involving the recently set up Ghana College of Physicians and Surgeons in STG development, possibly through participation in expert committees (already the case), consultation processes and engagement in developing and agreeing on the overall process. The recently introduced system of CME and accreditation creates the right incentives for involving the professions, which would in turn improve the legitimacy of the process and uptake of STG recommendations. Training and capacity building: The need to train systematic reviewers and experts in meta-analysis and critical appraisal was identified as a key obstacle to setting up such a process to the extent this could not be supported by a local technical team of experts. However, the possibility of (a) an initial pilot with active NICE and academic involvement providing some hands on training and (b) a longer term connection with NICE and UK academic partners to provide technical and methods support, may address this. Such a pilot could relatively inexpensively guide people to good quality freely available sources of information and show then the basic techniques for interrogating medical databases and critically appraising the results. Ghana National Drugs Programme According to a policy maker involved in developing the essential drugs list and rational drug use guidance suggested that NICE could help with setting up a national level, think-tank type group with multi-stakeholder representation and an advisory role for NDP (MoH), NHIS and regional plans on the drugs list (selection of drugs, listing/delisting decisions, reimbursement price levels). Again, along the lines of a project discussed with academics above, NICE involvement could focus on: (a) a specific high burden non-communicable disease area where prescription patterns are established and analysed across different settings incl. NHIS and teaching hospitals. This analysis could be undertaken by a local academic centre (e.g. faculty of Pharmacy, the Medical schools and Noguchi) with 36

37 some NICE input as required. A report will be produced summarising variation and spending across different treatment settings and geographical areas (b) NICE could help establish a transparent multistakeholders process with clear operating principles including transparency, inclusiveness, contestability and independence from industry and central government. In this setting the report on current prescribing practices (a) could be assessed in light of NICE guidelines and international evidence. This assessment would be led by Ghanaian academics, clinicians, NHIS with the participation of local and multinational manufacturers. (c) The process can generate specific recommendations on the pharmaceutical management of CVD (e.g. introduction of statins in NHIS package selection and price levels) to inform, the review of the basic and NHIS lists. It could also be used to update the national treatment guidelines for CVD. This could reduce waste and promote efficiency as coverage expands (d) At the same time, this pilot could inform the setting up of a standing committee to advise NHIS on listing decisions. The standing committee decisions could insulate NHIS from political and industry influences The terms of reference and procedural framework for such an advisory committee could be directly informed by the pilot. The establishment, subject to piloting, of such an advisory function using evidence to inform decisions in an accountable and transparent way would not only support and strengthen NHIS but could also serve as a model for other African countries in the process of reforming their healthcare systems. According to local policy makers, NICE brings along credibility and experience in methods and process that are important for assisting capacity building and coordination of the standing advisory committee which will be responsible for subjecting claims data and evidence to serious interrogation. The NICE brand could support the Committee members undertake these tasks independently of external pressures. Pharmaceutical Society of Ghana Along the same lines as previous stakeholders, NICE s input was discussed in the context of setting up an independent process with multistakeholder participation to advise on the methods and processes for rationalising decision making. Through a disease specific pilot, NICE could support: (a) The setting up of an advisory body that can inform listing decisions in the future in a transparent, consultative and contestable way (b) The identification of key methodological areas where more training and capacity building is required in order for the advisory body to undertake its function; NICE and its academic partners could help meet some of these technical development needs through hands on training during the pilot or tailored short courses in conjunction with Ghanaian academic units. The specific conclusions of the disease specific process could also inform, through exiting structures: (c) The update of Standard Treatment Guidelines (developed by the Ministry of Health) (d) The review of the basic drugs list (developed by the NDP of the MoH) (e) The update of the NHIS list (responsibility of NHIS) 37

38 Such an engagement would be contingent upon the success in collecting claims data through the electronic system of NHIS. Health Access Network Overall, there was interest in the type of support NICE could provide along the lines discussed earlier, using local academic analytical capacity, local epidemiological and claims data, international guidelines/evidence and local decision making structures, but providing support in setting up a process for using these data/evidence to inform decision making. The discussion focused on two points: the need to engage with civil society and NGOs when supporting the development of a multistakeholder process the importance of setting up any advisory structures to be independent of government and the MoH and hence insulated from political lobbying Dutch Embassy (DFID lead in Ghana and WHO officer) Two major areas where NICE could provide input, within or outside MeTA, were identified and further discussions will follow with the research unit of Ghana Health Service and with MoH on how to take things forward. NICE could help link up UK academic and NHS institutions with relevant Ghanaian entities. This would be in accordance to Lord Crisp s report on the global role of NHS and would facilitate a longer-term interaction between NICE and Ghanaian institutions. NICE could provide process-focussed support with a view to help build a transparent accountable and inclusive structure on the ground that can translate evidence into practice through supporting the decisions of NHIS. Such an activity would have to be led by local stakeholders and could involve (as highlighted earlier): o o o o Analyses of epidemiological and claims data reflecting current prescribing patterns (e.g. from NHIS) by local academic groups and for a selected disease area Syntheses of international/who/nice guidelines in the selected disease areas and adaptation to local Ghanaian setting by local academic and professional groups Consideration of the local and international evidence within the budgetary constraint by multi-stakeholder group including professionals, academics, industry, payers, NGOs and government Development of non-committing advice to local decision makers as to inclusion/exclusion from essential list or NHIS list NICE s main input would be in the last two bullets, with a particular focus on the governance and accountability aspects of the process for considering the evidence and turning it into actionable recommendations. Such an activity can result in a twoway interaction that can encourage decision makers to make evidence informed decisions and researchers and research funders to address (through prospective evidence generation and through evidence synthesis and retrospective claims data analyses) those areas of highest relevance to policy. 38

39 It could also help identify areas were further technical expertise is needed and set capacity building priorities and highlight where routine data need to be collected e.g. through the NHIS IT claims data system National Health Insurance Scheme The issue of the process for making listing and delisting decisions based on evidence of clinical effectiveness and value was raised by NHIS policy makers as the key area where NICE involvement may help develop/strengthen the existing process. This overlaps with earlier descriptions of a potential decision-making pilot. Linking the upstream part of generating/synthesising/appraising the evidence (clinical and economic studies and also claims analyses) with the downstream part of making a policy decision and acting upon it, was identified as the key challenge for NHIS central to its longer term sustainability. It is essential for NHIS to get buy in from key stakeholders for its listing and delisting decisions (some of which will inevitably be controversial and strongly opposed by certain parties) through a defensible process that would allow NHIS perspective to be considered, alongside that of clinicians, and possibly industry and patients. This becomes particularly important as NHIS expands to cover more Ghanaians and there is increasing anecdotal evidence of non-evidence based highly variable (geographically and in terms of clinical setting) prescribing practices with significant health and financial implications. If successful, this exercise could be a first step in insulating healthcare decision making from lobbying pressures through a methodologically defensible and procedurally fair and transparent approach, linking evidence to policy and practice. Next steps Overall, it seems that NICE s experience could make a helpful contribution to the ongoing health reform in Ghana. For this to work, NICE would need to be engaged in a well-planned focused pilot as outlined earlier, with the active leadership of local policy makers and academic groups and a secured funding source and the aim of helping set up procedurally fair and methodologically robust decision making mechanisms based on the best available evidence of what works and insulated from external pressures by disappointed stakeholders. Transparent and efficient evidence based policies are a requirement for sustainability and expansion of NHIS and could set an example for other African countries experimenting or considering similar models of health financing. The table below outlines a list of actions following the December visit to Accra. Actions Who By 1. Circulate draft summary of meetings/thoughts to Ghanaian colleagues for comments 2. Circulate draft outline of how NICE could engage with National Drugs Programme/NHIS in the context of MeTA or independently 3. Continue conversation with other parties; refine proposal; explore alternatives; follow MeTA developments 4. Submit progress report with strategic plan for future direction to DFID and the NICE Board. The report will summarise the discussions and potential areas where NICE involvement could add value to be submitted to DFID and the NICE NICE Dec 2008 NDP expert all Dec/Jan 2009 Throughout 2009 NICE Feb

40 Board. 5. Before the initiation of a pilot on the ground, an evaluation of the current formal and informal decision making on issues such as STG and rational use/guideline development and also listing and reimbursement decisions for pharmaceuticals is required. This would help establish exactly who is responsible for making such decisions in the NHIS and MoH context and how these decisions are made. In addition, such an analysis could describe the mechanisms for implementing these decisions (incentives, penalties, peer pressure ). Such a preliminary small-scale research/survey would inform the pilot and ensure existing mechanisms are identified, used and strengthened through the pilot. This will improve the efficiency and timeliness of the exercise and the likelihood that the lessons learned from it are accepted and have an impact on the existing structures. Local academic teams/nice input During 2009 Progress as of February 2009 Following the December elections, there has been a series of iterations via with Ghanaian and World Bank colleagues as well as the DFID representative in Ghana. The report presented above is the result of these iterations. However, so far, no concrete plans have been made to further NICE s involvement on the ground in Ghana especially since no clear sources of funding for policy (as opposed to research) focused work have been identified. We propose that a survey of current formal and informal decision making processes could help identify key weaknesses where NICE involvement would be useful. This could take place within MeTA, led by locally-based academics and with NICE input and set out an action plan for NICE s engagement with NHIS and NDP of Ghana. 40

41 3.4 An update on non-dfid sponsored work (as of February 2009) In addition to the exploratory work undertaken with the support of DFID in Ghana, Jordan and Colombia, NICE International has carried out a number of projects between September 2008 and February 2009 and is currently exploring many more. In this section we provide a brief update on international engagements not funded by DFID. Individual projects/initiatives are grouped into: (a) active projects; (b) projects under negotiation with the client or third party funder and (c) potential engagements where initial contact has been made. A short description of each project is also provided as well as the main contact/source of funding where the latter is known. Engagement (partners) Active (or completed) projects Policy report (Johns Hopkins School of Public Health) Policy report (HAS, IQWiG, PBAC/PBS, CMTP) Policy report (University of Tokyo) Individual consulting contract Russian Federation Contact point/funder Academy Health/Kaiser Permanente/National Institute for Healthcare Management (USA) The Commonwealth Fund (USA) The Sasakawa Foundation (UK/Japan) World Bank (USA) Description A comparative policy analysis of NICE-type entities in a number of high and middle income countries around the world to draw lessons for US decision makers. The report, published by Academy Health (Feb 2009) has informed a number of high level policy meetings in Washington DC (Dec 2008 and Feb 2009), bringing together US academics, policy makers and industry. It will also form the basis of a peer reviewed academic publication. A comparative policy analysis of comparative effectiveness research arrangements in England and Wales; France; Germany and Australia, written in collaboration with leading experts working in the respective agencies. A policy report will be published by CMWF in early 2009 and will inform policy makers meetings in the US. A two-year grant-funded project initiated in 2007 to explore the use of pharmacoeconomics in informing policy decisions in Japan, including two visits to Japan in 2007 and The project involved two visits by NICE experts to Japan and a policy report (summer 2009). During the project, NICE formed links with the University of Tokyo and individual experts from Keio University, IHEP (think tank in pharma policy), JPMA (industry association). Small-scale project involving interactions with policy makers (a) at the federal level (Moscow Academy of Medical Sciences; Moscow Higher Institute for Economics) and (b) at the state level in KMAO Western Siberia. Series of lectures, one World Bank publication 10 and in-site visits to Moscow and KMAO to meet with policy makers. 10 World Bank, Public Spending in Russia for Health Care: Issues and Options,

42 Evaluation of Thai national HTA agency HITAP (LSHTM; Thai academics) Estonia EHIF/WHO (Brunel University) Under negotiation Building clinical guideline development capacity in Turkey (a consortium of NICE partners from UK and US) Eastern European country (consortium of European partners) Bahrain (Cochrane UK/Bahrain) Korean national health insurance agency (HIRA) Initial contact made Clinical guideline development in Saudi Arabia (King Saud University Riyadh) Training for policy makers in Egypt Thai government/ third party funders WHO, Regional Office; Estonian Health Insurance Fund Ministry of Health/World Bank EU Commission Bahraini MoH/Bahrain Defence Forces South Korean government King Saud University EBM chair private sponsor (Saudi Arabia) World Bank (USA) Evaluation of HITAP s strategy and performance over first 2 years of its existence. Report to be present to Thai policy makers in Bangkok in March Study tour and training for Estonian policy makers and peer review of Estonian pharmacoeconomic guidelines for listing of services. Technical and process support for building structures and capacity in Turkey for developing clinical standards for best practice with a focus on secondary care. Support with strengthening national healthcare system; improving quality and setting standards for best practice. Support with development of clinical standards for best practice for hospital sector in Bahrain Provision of technical advice, process support and training to HIRA policy makers. MOU signed between NICE and HIRA in summer Initial study tour to Britain being discussed. Training and technical support with guideline development using NICE methods and processes for clinicians and policy makers at King Saud University in Saudi Arabia. Small scale training in decision-making processes for policy makers in Egypt Quebec Quebecois government Informal discussions with Quebecois policy makers setting up agency for comparative effectiveness research and policy making in the province India National Rural Health Mission/ Andhra Pradesh government/indian Institute for Public Health (Hyderabad) Mexico MoH (Secretaria de Salud) National Institute for Public Health (INSP) Workshop with senior clinicians and policy makers to explore potential for longer term involvement in setting best practice standards for care as part of the universal access initiative by the state government. Initial focus on secondary care. Contributing to the evaluation of Oportunidades; supporting the national obesity strategy from a technical/process angle Joint academic projects in the Mesoamerican region with a focus on 42

43 evidence-informed decision making structures; support with using pharmacoeconomics in making listing decisions for medical technologies in Mexico South Africa DH (UK)/MoH (SA) NICE contribution within MoU to support adaptation of NICE guidelines in SA setting and advise on listing of pharmaceuticals ongoing MoU limited NICE involvement Azerbaijan Public Health and Reforms Center - MoH NICE input in clinical guideline development and standard setting in the Republic of Azerbaijan Brazil MoH Study tour for senior Brazilian policy makers possible NICE input in development of Brazilian HTA function supporting healthcare resource allocations In addition to the projects listed above, NICE International had the opportunity to host/interact with a number of foreign delegations over the past 6 months, from a range of countries which contacted NICE either directly or through other channels such as DH International, DFID and HSLP Institute. Visitors included delegations from Vietnam, China, Venezuela, Taiwan, Sweden, Norway, Japan, Kenya, Armenia, Thailand and Korea. Furthermore, NICE International is involved in joint bids with academic groups to institutions such as the Commonwealth Fund, Robert Wood Johnson Foundation and the Bill and Melinda Gates Foundation. 43

44 4.0 NICE International: Strategic Direction 4.1 Background In May 2008 the NICE Board approved the business case for a policy consulting initiative to provide advice on a fee-for-service basis to governments and governmental entities abroad on the technical and process aspects of evidence-informed healthcare decision-making Since then, the Institute has had the opportunity to explore a variety of projects with a wide range of clients and funding sources, and different types of deliverable. As a result, NICE is now in the process of negotiating entering into contractual relationship with a number of clients and, at the same time, is working towards delivering on projects already agreed with the relevant parties. One of the major objectives of these early interactions and of the DFID-funded activities in particular, has been to help inform a broader strategy and a practical governance process for driving the Institute s international consulting activity in future This section of the report sets out our early thinking on NICE International strategic direction and proposes a general oversight and governance framework for further developing NICE s international activities. It also highlights, in the form of questions, areas of uncertainty where further data gathering and discussion are required to identify the best way forward This report, in addition to a report by NICE International Advisory Group of external experts (see below) will be submitted to the NICE Board in June In its June meeting the Board will decide on a longer-term plan of action for NICE International. 4.2 Sourcing expertise A major concern for NICE International is to maintain high quality services drawing on NICE s experience in the NHS, while ensuring the core product of the Institute for the NHS is not compromised by redirecting resources to the international work. To address this issue and to allow NICE International services to be complemented with expertise from individuals and institutions with a track record in global development, NICE International has developed an operating model described below NICE International draws its experts from four broad pools (see figure) NICE International Policy Consulting core team, providing technical and administrative support on a project-specific basis NICE staff seconded on a short-term basis to projects, subject to their skill-set, availability and willingness to contribute to the international work NICE academic and professional partners, traditionally working with NICE to deliver the core product to the NHS and the broader public sector NICE International partners, from a broader pool than the traditional NICE partners, including UK and international academic and consulting groups with experience in global development and an understanding of NICE s methods and processes 44

45 Q1: What other potential sources of expertise are there, NICE could draw on? Q2: What is the ideal balance of experts from the different sources listed earlier? 4.3 Funding sources and types of project NICE International has engaged in three, at times overlapping, types of project so far: international policy research and analysis usually commissioned by independent foundations (e.g. Academy Health USA); country-specific projects funded by national or state governments or governmental agencies (e.g. Estonian Health Insurance Fund) and/or by third parties such as the UK s Department for International Development (DFID), the World Bank and WHO, and general activities to raise NICE s profile internationally and build the needed experience to deliver high quality consulting and training services (e.g. hosting foreign delegations). The first two activities are undertaken on a cost-recovery basis NICE s international work has so far been based on full cost recovery through research grants and, mostly, specific project work. Securing longer-term seed funding by a national or international donor programme and/or through a paying board membership model could support (part of) the core team s pay costs and overheads and allow better flexibility in setting the organisation s work programme and in setting its rates. Q3: What other funding models are there, that are consistent with NICE s nonprofit public body status? Q4: What should the balance be between the different sources of funding (e.g. grant vs. project-specific funding)? Q5: Should NICE International consider a profit making business vehicle with (or without) a commercial partner? 4.4 International engagement strategy: developing a work programme Setting out explicit criteria for prioritising existing and for shaping new demand is necessary for building a work programme for NICE s international work. Such criteria may include: 45

46 The Institute s ability to add value Availability of funding to cover NICE s costs Potential for learning for NICE and its partners Alignment with the Institute s broader principles of transparency, inclusiveness and scientific rigour The programme of work should reflect an explicit balance in terms of: Source of funding: bilateral projects, with either direct country or mixed third party funder/partner country funding vs. broader, longer-term research and policy projects funded by grants Client countries: low and middle-income vs. high income economies Nature of services: strategic and process advice provided by NICE experts vs. technical hands-on support provided mostly by NICE s external partners Processes for interacting with major stakeholders including: DFID, the World Bank and other major global development funders NHS and other UK government initiatives engaged in international activities (e.g. DH International; HPA Global) in order to understand their objectives and priorities and build the right synergies. Q6: NICE International mission statement; how can we add value? Q7: Are the above the right criteria for identifying priorities for NICE International? What other criteria should be adopted when should NICE International say no to engagements? Q8: How should these (and/or other) criteria be applied to deliver a work programme for NICE International that is balanced and consistent with the Institute s core principles? Governance framework. 4.5 Governance arrangements NICE International Policy Consulting currently reports to the CEO of NICE who is in turn accountable to the Institute s Board of Directors. The Board established the international function in May 2008 and is due to review progress and assess its strategic direction in June This present report will form part of the material to be reviewed by the Board To help shape NICE International s strategic direction, increase it credibility and resonance with external partners and funders and broaden it client and partner basis, NICE set up an Advisory Group, with no executive responsibilities, consisting of UK and international experts in global development The role of the Advisory Group is to help develop a strategic direction for NICE s international activities and to generate ideas and identify opportunities for new work. Members of the group will: Inform the Institute s understanding of trends in global health and emerging thinking amongst global health donors and policy makers Help develop and regularly update the international engagement strategy Provide advice on the implementation of the strategy 46

47 Advise on opportunities in which the Institute s specific skills and experience can be productively applied in international settings Promote the work of the Institute s international team through members networks as opportunities arise The inaugural meeting of the Group will be in April 2009 in London. A list of the experts who have accepted to serve on the Group and their bios are given in Appendix A Finally, NICE International has established a non-exclusive framework agreement with a number of external partners in order to undertake joint work on international engagements In addition to the forthcoming report to the Board in summer 2009 which will informed in part by the present report and also by the proceedings of the inaugural meeting of the Advisory Group, the CEO includes regular updates on the progress of NICE International in his bi-monthly report to the Board. 4.6 Alternative business vehicles for NICE International There are a number of different business models for NICE International Policy Consulting to deliver its services. Each has a number of advantages and disadvantages to each of these models which are addressed in greater detail elsewhere NICE IPC is hosted by NICE as is currently the case. No legal, financial or operational distinctions are made between these activities and the rest of NICE s business. This is the model currently used by NHS and public sector organisations offering consulting services such as NHS elect and the business arm of the Health Protection Agency (HPA) NICE IPC is incorporated as a non-profit organisation legally and financially separate from NICE. NICE is the sole owner of NICE IPC and makes its intellectual property available to it for international consultancy purposes in return, NICE IPC pays a proportion of its revenue as dividend to NICE (e.g. NHS Institute) NICE IPC establishes a joint venture non-profit organisation with a commercial partner through a public tendering process (e.g. Dr Foster Intelligence). The partner may be an international consultancy or academic institution NICE IPC is established as a limited responsibility company wholly or by majority owned by NICE. Such spin-offs have been established by NHS Foundation Trusts to market their services Q9: Are there other alternatives NICE ought to consider? Q10: How should the different models be evaluated (criteria, process)? 47

48 5.0 Acknowledgements We would like to thank Saul Walker and Charles Clift for their help and DFID for funding this work. We would also like to thank the following colleagues for their valuable contributions to the DFID-funded projects described earlier: Jean-Jacques Frere, Andreas Seiter, Sally Schlippert (World Bank - USA); Rania Bader (MeTA Jordan); Leonardo Cubillos (Ministry of Social Protection Colombia); Martha Lutterodt (National Drugs Programme Ghana) and Alex Dodoo (Ghana Pharmacists Council); Marius de Jong (DFID/Dutch Embassy Ghana). The content of this report is the sole responsibility of NICE International. 48

49 Appendix A: The people NICE International is: Derek Cutler is the Coordinator for NICE International Policy Consulting, responsible for providing administrative and logistical support to the team. He has five years experience of administrative work in the NHS, having previously held positions at The Royal London and London Chest Hospitals, before joining NICE in He has a BSc (Hons) in psychology. Francoise Cluzeau is the senior adviser for NICE International Policy Consulting. For 6 years she was the technical adviser at NICE with special responsibility for writing the guidelines manual that underpins all NICE guidelines. She has over 15 years international experience in clinical guidelines. She led a 19-country collaboration of researchers (the AGREE collaboration) that originally developed the AGREE Instrument, now used as a gold standard for assessing clinical guidelines. She is the chair of the AGREE Research trust (ART) (wwww.agreetrust.org) and a founding member of the Guidelines International Network (G-I-N). She has a good understanding of health care systems in low to middle income countries after having worked 5 years in Africa on demographic and public health projects. She was one of the first public health adviser on the Famine Early Warning System (FEWS) in Mali. A psychology graduate by training, she holds a masters degree in medical demography from the London School of Hygiene and Tropical Medicine and a PhD in Health Services Research from the University of London. Her thesis was on developing the first instrument for assessing the quality of evidence based clinical guidelines. She retains a part-time lectureship at St George s University of London. Reetan Patel is a project manager at NICE, he provides project management support to all the activities of NICE International Policy Consulting. He has been at NICE for over 4 years having also worked as a project manager in the Institute s Technology Appraisal team. He has a BSc (Hons) in Business Information Systems. Kalipso Chalkidou, is the director of the policy consulting arm of NICE (NICE International). Prior to this, KC was the associate director for research and development at NICE. Between 2007 and 2008, she spent a year in the US as a Harkness Fellow, studying conditional coverage schemes for expensive new technologies (Centre for Medical Technology Policy) and US government drug pricing policies (Johns Hopkins). Before joining NICE, KC held posts as a clinical research fellow at the University of Newcastle Medical School and surgical trainee in NHS hospitals in Newcastle and Cambridge. She has a doctorate on the molecular biology of prostate cancer from the University of Newcastle upon Tyne (2003), an MD from the Athens Medical School (2000) and is an honorary lecturer in health policy at the London School of Hygiene and Tropical Medicine. In addition, the following colleagues from NICE and partner organisations contributed to the DFID-funded work described above: Jordan: Joanne Lord and Martin Buxton (Brunel University); Andrew Dillon (NICE) Colombia: Hugh Waters (Johns Hopkins School of Public Health); Francis Ruiz (NICE); Michael Rawlins (NICE) The NICE International Advisory Group members are: Ruth Levine, Center for Global Development, USA (chair) Ruth Levine is an internationally recognized expert on global health and health 49

50 policy. She is a health economist with more than 15 years of experience designing and assessing the effects of social sector programs in Latin America, Eastern Africa, the Middle East, and South Asia. As Center for Global Development (CGD) vice president for programs and operations, she is a member of the Center s senior management team. She is also a CGD senior fellow and leads the Center s work on global health policy, including chairing a series of working groups on key policy and finance constraints to the effective use of donor funding for health programs in low-income countries. Before joining the CGD, Ruth designed, supervised, and evaluated loans at the World Bank and the Inter-American Development Bank. Between 1997 and 1999, she served as the advisor on the social sectors in the office of the executive vice president of the Inter-American Development Bank. Michael Rawlins, NICE, UK Sir Michael Rawlins has been chairman of the National Institute of Health & Clinical Excellence (NICE) since its formation in He is also chairman of the Advisory Council on the Misuse of Drugs (since 1998). He is an Honorary Professor at the London School of Hygiene and Tropical Medicine, University of London, and Emeritus Professor at the University of Newcastle upon Tyne. He was the Ruth and Lionel Jacobson Professor of Clinical Pharmacology at the University of Newcastle upon Tyne from 1973 to At the same time he held the position of consultant physician and consultant clinical pharmacologist to the Newcastle Hospitals NHS Trust. He was vice-chairman ( ) and chairman ( ) of the Committee on Safety of Medicines. Anthony Culyer, NICE, and University of York, UK; University of Toronto, Canada Tony Culyer has been at York since 1969 where his main roles have been as Assistant Director of the (then) Institute or Social & Economic Research, Head of the Department of Economics & Related Studies, and Pro-Vice-Chancellor and Deputy Vice-Chancellor of the University. He currently holds a part-time chair in Health Policy and System Design at the University of Toronto, Chairs the R&D Committee of the National Institute for Health & Clinical Excellence, the Policy and Editorial Committees of the Office of Health Economics, and the Research Advisory Council of the Workplace Safety & Insurance Board in Ontario. He is a founding editor of the Journal of Health Economics, is a Founding Fellow of the Academy of Medical Sciences, an Honorary Fellow of the Royal College of Physicians, a CBE and has an honorary doctorate from the Stockholm School of Economics. His current research interests relate to problems in thinking about how equity in health is best achieved and how decisions about cost-effective technologies are best arrived at. Martin McKee, European Public Health Observatory and London School of Hygiene and Tropical medicine, UK Martin McKee qualified in medicine in Belfast, Northern Ireland, with subsequent training in internal medicine and public health. As Professor of European Public Health at the London School of Hygiene and Tropical Medicine he co-directs the European Centre on Health of Societies in Transition (ECOHOST), a WHO Collaborating Centre that comprises the largest team of researchers working on health and health policy in central and eastern Europe and the former Soviet 50

51 Union. He is also research director of the European Observatory on Health Systems and Policies, a unique partnership of universities, national and regional governments, and international agencies. He has published over 400 scientific papers and 23 books and is an editor of the European Journal of Public Health and a member of numerous editorial boards, as well as being an editorial consultant to The Lancet. He sits on a number of advisory boards in Europe and North America, in both the public and private sectors, is a Fellow of the Royal Colleges of Physicians of the UK and Ireland and the UK Faculty of Public Health. Shah Ebrahim, London School of Hygiene and Clinical Medicine, UK Shah Ebrahim studied medicine at Nottingham University (1970-5), including an inter-collated degree in community medicine, and obtained an MSc in epidemiology from LSHTM in 1981, and a DM in 1985, holding a Wellcome Trust fellowship in clinical epidemiology during this time. He trained in primary care and subsequently in geriatric medicine and have held chairs in geriatric medicine (London & Barts ), clinical epidemiology (Royal Free, ), and epidemiology of ageing (University of Bristol, ). He is a visiting fellow at the University of Bristol and visiting professor at University College London. He is co-editor of the International Journal of Epidemiology, coordinating editor of the Cochrane Heart Group, chair of the Wellcome Trust Populations & Public Health funding committee, and a former non-executive board member of NICE. He is currently based in India working on chronic disease, as a Wellcome Trust grantee. Tsung-Mei Cheng, Princeton University, USA Tsung-Mei is an expert on comparative health systems with an emphasis on Asian countries. She is also Co-Founder of the Princeton Conference, an annual national conference on health policy that brings together the U.S. Congress, government, and the research community on issues affecting healthcare in the United States. Cheng was an adviser in 2003 to the Strategic Review Board of the Science and Technology Advisory Group (STAG), a body charged with advising the Office of the Premier of Taiwan, the Republic of China on the development of science and technology. She lectures widely internationally on topics ranging from single payer systems, health care quality, financing, pay for performance focusing on East Asian health systems, to the impact of the WTO and GATS on national health policy. Currently she is working on cross-national comparisons of health systems in East Asia focusing on health reforms in China and Taiwan. Cheng is also the Host and Executive Editor of the International Forum, a Princeton University television program on international affairs focusing on economic, social, political and security issues. She is host and executive editor of the International Forum at the International Center, Princeton University, in Princeton, New Jersey. Carlos Santos Burgoa, Secretariat of Health, Mexico Carlos Santos Burgoa is a graduate of the Medical School of the National Autonomous University of México. He obtained his Masters in Public Health and Ph.D, in Environmental and Occupational Epidemiology from the Johns Hopkins School of Hygiene and Public Health. He was Chair of Epidemiology and Biostatistics and later on for six years Dean of The School of Public Health of MexicoHe was founder and General Director of the Work, Environment and Health Institute, a private academic and consulting organization based in Mexico City. He was the General Director of Environmental Health and currently is the General 51

52 Director for Equity and Health Director at the Secretariat of Health in Mexico. He is currently leading the effort of the health development initiatives at the Secretariat, in charge of the implanting innovations required by the new health reforms in Mexico, rapidly bringing knowledge and research into policy and health development. He has published extensively and has consulted for the Rockefeller Foundation in Africa, the Mexican Health Foundation, the Mexican Oil Corporation, the Mexican Ministry of Health, the Mexico City Government, the Occupational, Health and Safety Administration and the Environmental Protection Agency of the USA, the World Bank, the World Health Organization, the Commission for Environmental Cooperation, the United Nations Environment Program and the United Nations Development Program. He is an elected fellow of the National Academy of Medicine in Mexico. Rodrigo R Soares, Pontifícia Universidade Católica do Rio de Janeiro, Brazil Rodrigo R. Soares is an Assistant Professor of Economics at the University of Maryland and at the Catholic University of Rio de Janeiro (PUC-Rio). He received his Ph.D. in Economics from the University of Chicago in His dissertation, entitled "Life Expectancy, Educational Attainment, and Fertility Choice: The Economic Impacts of Mortality Reductions," earned him the 2003 Brazilian National Award for Ph.D. Dissertations in Economics. His research interests range from health and population economics to corruption, institutions, and crime. His work has appeared in various scientific journals, including American Economic Review, Journal of Development Economics, Economic Development and Cultural Change, and Economics and Politics. Recently, he was awarded - together with co-authors Gary S. Becker and Tomas J. Philipson - the Kenneth J. Arrow Award from the International Health Economics Association for the best paper published in the field of Health Economics (2005). Rob Hecht, Results for Development, USA Rob Hecht, Managing Director, joined Results for Development in April 2008, and is currently managing a growing portfolio of projects analyzing policy barriers and solutions related to AIDS and health financing and improving R&D and access to new health technologies in developing countries. Before coming to Results for Development, Dr. Hecht spent four years as vice president for Policy and Advocacy at the International AIDS Vaccine Initiative. Prior to this, he had a 20 year tenure at the World Bank, where he occupied a number of senior posts including manager of the Bank's central unit for Health, Nutrition, and Population, with oversight for global strategies, knowledge, technical services, and partnerships; chief of operations for the Human Development Network; principal economist in the Latin America region, and member of the core team and a lead author of the 1993 World Development Report, "Investing in Health." From 1987 to 1996, Dr. Hecht was responsible for World Bank sponsored studies and projects in health in Africa and Latin America, most notably in Zimbabwe and Argentina. Dr. Hecht served as a director of the Joint United Nations Program on HIV/AIDS (UNAIDS) from 1998 to 2001, where he managed technical units based in South Africa, Cote d'ivoire, and Thailand, as well as in Geneva. He received his undergraduate degree from Yale and his doctorate from Cambridge University. 52

53 Appendix B: Invoice breakdown A detailed breakdown of the total amount ( 68,000) claimed from DfID by NICE is provided below. Jordan transport 5,886 accommodation and subsistence 1,300 Ghana transport 4,627 accommodation and subsistence 692 Colombia transport 17,159 accommodation and subsistence 5,770 Comments Two trips (2 people) One trip (1 person) Two trips (5 people) fees (academic partners) 5,000 JHSPH (USA) Total expenses 40,434 NICE fees 27,600 See chart below for a breakdown by % of time spent over 6-month period no overheads included in gross costs TOTAL 68,034 53