Russia and Ukraine: Conducting Clinical Trials in an Emerging Market

Transcription

1 Russia and Ukraine: Conducting Clinical Trials in an Emerging Market 1

2 Introductions Ø Andrei Kravchenko, MD, PhD Ø Corporate Director Medical Affairs, General Manager Ukraine Ø Clinipace Worldwide

3 Polling Question

4 Treatment-Naïve Populations Source: World Factbook: Russia; world- factbook/geos/rs.html Source: World Factbook: Ukraine; world- factbook/geos/up.html 4

5 RUSSIA

6 Health Care in Russia: Health Status 70.2 years MAIN CAUSES OF DEATH 6

7 Health Care in Russia: Level of Care Ø The health- care system consists primarily of public hospitals Ø Private hospitals account for 2% of approximately 6,500 hospitals in the country Ø 4.9 physicians (OECD average, 3.2) & 9.3 hospital beds (OECD average, 4.8) {per 1,000 population in 2012} Ø Specialized centers: Ø Cardiology Research Center Ø Oncology Research Center 7

8 Health Care in Russia: Drug Reimbursement Ø Federal funds support central procurement of drugs for 7 high- cost nosologies, Ø Regional drug reimbursement program provides vital drugs to specific populations Ø Free programs for patients with certain diseases are covered by the Prevention and preventing socially significant diseases and the National Immunization scheme Ø Specific pharmacies for these reimbursement programs Ø Cost of drugs not covered by reimbursement programs can be prohibitive 7 High- Cost Nosologies 1. Formation of malignant lymphoid hematogenic and related tissues 2. Cystic fibrosis 3. Hemophilia 4. Pituitary dwarfism 5. Gaucher s disease 6. Multiple sclerosis 7. Organ and tissue transplants 8

9 Russian Pharma Market: Growth Ø Ranked 11 th in market size globally Ø Expected to move to 8 th by 2017 Ø One of the fastest growing in the world, with an annual growth of >10% Ø Market turnover in 2013 was 1,045 billion rubles (17.4 billion USD), and the commercial segment increased by 13.5% Ø In 2014, this value had increased to 1,174 billion rubles (18.3 billion USD) in final consumption Ø While the production of drugs domestically continues to increase, ~75% of the monetary value of the drugs used are produced abroad 9

10 Russian Pharma Market: 2020 Initiative Ø Commitment of $4.8 billion USD (177.6 billion rubles) Ø Goals include: Ø Making 60% of local medicines innovative Ø Local production of pharmaceuticals to be >50% of local consumption Ø Local production to provide 90% of essential drugs by 2020 Ø Clusters have been developed as groups of geographically localized, interconnected, innovative drug- development and drug- producing companies that work closely with universities Ø Five clusters in Yaroslavl, Kaluga, Saint Petersburg, Yekaterinburg and Moscow 10

11 Clinical Trials in Russia Oncology Endocrinology Rheumatology Cardiovascular Pulmonology Hematology Neurology Infectious disease Gastroenterol ogy Oncology Pulmonology Musculoskeletal Circulatory system Neurology Others Source: Association of Clinical Trials Organizations (ACTO). ACTO newsletter No. 10: summary of 2014 results. 2015; Moscow. Available at: russia.org/files/acto_newsletter_10.pdf Source: Brennan Z. Russia sees slight dip in clinical trial approvals in Q Outsourcing- Pharma.com. April 15, Available at: pharma.com/clinical- Development/Russia- sees- slight- dip- in- clinical- trial- approvals- in- Q

12 Russian Regulatory Requirements Ø Medications cannot be registered without at least a Phase III clinical trial conducted in Russia Ø MoH of the Russian Federation Ø Organization to which clinical trial applications are submitted Ø Ensures the quality, safety and efficacy of medicines marketed in Russia Ø Roszdravnadzor Ø Control/pharmacovigilance agency Ø Performs audits on sites and CROs Ø Receives reports of adverse events and suspected unexpected serious adverse reactions (SUSARs) via the website 12

13 Russian Regulatory Reqts: Applications Clinical trial application requires: Ø Must be in Russian Ø Principal investigator must have at least three years experience in clinical trials Ø Medical institution must be accredited by the MoH to conduct clinical trials of pharmaceutical drugs for medical uses Ø Ethics review required at two levels: Ø Central (national) ethics committee at MoH Ø Local ethics committee in the institution Typical Approval Time: 40 days 5 DAYS: Initial review occurring within five working days to determine if there is sufficient information 30 DAYS: Full review within 30 working days 5 DAYS: Review of conclusions and decision within five working days 13

14 Russian Regulatory Reqts: Fees Ø Fees include: Ø Permit fee paid to the MoH Ø Payment either to hospital/institution or directly to investigators Ø Mandatory insurance for all clinical trial participants Ø Problematic to pay hospitals from abroad (contract with hospitals signed in rubles only) Ø When paying investigators directly, obligatory payments include pension fund (22%) and fund for obligatory health insurance (5.1%) Ø Mandatory health insurance is provided by organization conducting trial and can be paid either by the sponsor or CRO 14

15 Russian Regulatory Reqts: Importing Ø Approval required to import medications for clinical trials Ø Usually takes five to seven days from date of shipment to complete all customs procedures Ø To import/export biological materials, the following is required: Ø Request to import/export biological materials, with reference to clinical trial protocol Ø Backup calculation for number of units Ø Copy of officially issued permit to conduct clinical trials Ø Copies of incorporation documents and statutory registration of corporate entity and certificate of tax registration Ø Review typically occurs within 10 working days 15

16 UKRAINE

17 Health Care in Ukraine: Health Status 71 years MAIN CAUSES OF DEATH 17

18 Health Care in Ukraine: Level of Care Ø 4.4 physicians (OECD average, 3.2), 8.9 nurses & 7.9 hospital beds (OECD average, 4.8) {per 1,000 population in 2014} Ø Specialized diagnostics &treatment: Ø Patients often referred from small cities to big centers Ø Network of oncology institutes and 46 oncology dispensaries Ø Specialized oncology care organized by the MoH and includes the Ukrainian Research Institute of Oncology of the Academy of Medical Science of Ukraine 18

19 Health Care in Ukraine: Coverage 100% 90% 80% 70% 60% 50% 40% Private sources Public sources 30% 20% 10% 0% Hospitals Ambulatory Services Pharmacies and medical product vendors Health expenditure by facility type (Source: Ukrstat, 2012) 19

20 Health Care in Ukraine: Health Reform Ø National Strategy on Health Reform Ø Initiated in August 2014 by MoH of Ukraine Ø Facilitates reforms in health sector to improve quality & access to health care Ø Proposed changes will affect financing of health sector, structure and mix of private and public facilities and government agencies Ø Specific changes also targeted at reducing cost of medicines at consumer level Reforms based on 3 principles: People- centered Outcomes- oriented Implementation- focused 20

21 Ukraine Pharmaceutical Market Ø 2 nd largest market in CIS Ø Valued at 3 billion USD in 2011, an increase of 16% from previous year Ø Retail sales increased 23% in Q Ø ~70% of medications imported Ø In 2014, top 3 medication classes by sales were: Ø Alimentary tract and metabolism Ø Respiratory system Ø Cardiovascular system 21

22 Ukraine Clinical Trials Most common clinical trials (therapeutic/disease states): Psychiatric Neurological Oncological Pulmonary Rheumatic 1,281 active studies (June 2015): Phase 2 (334, 26.1%) Phase 3 (848, 66.2%) Phase 1 (30, 2.3%) Phase 4 (54, 4.2%) 22

23 Benefits of Trials in Russia and Ukraine Ø Ø Ø Large pools of treatment- naïve patients in urban areas and specialized centers Ø Ø Ø Good compliance Motivated patients and doctors Recruitment period is comparatively short Disease patterns provide opportunity to access patients not present elsewhere With efforts to harmonize regulations for Russia, Belorussia, Kazakhstan, Armenia and Kyrgyzstan (complete in 2016), additional populations will become available Ø Extensive experience in clinical trials in research centers and universities supported by the government- led initiatives Ø Quality of trials data confirmed by almost 100 Ø US FDA inspections in Russia since 1995 Costs typically lower, or at least comparative Russian Troika High patient recruitment High quality data Reduced cost of running trial (compared to US or EU) 23

24 Mitigating Potential Concerns Ø RUSSIA: recent laws actively addressing issues Ø UKRAINE: government efforts to increase transparency, APRaD actively involved Ø Results Ø Growing majority of medical professionals well educated, studied in other countries Ø Sites well equipped or suitably equipped for a specific trial can be identified by knowledgeable local CROs Ø More transparent processes Ø Faster, more stringent timelines 24

25 Summary Ø Russia and Ukraine represent emerging markets Ø Great potential for clinical trials Ø Largely untapped patient populations Ø May be some challenges during transition period as regulatory environment changes Ø Current reforms will result in drug laws and regulations very similar to EU Ø Local experts on the ground is crucial to success! 25

26 Q&A