Parallel Consultations
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1 Parallel Consultations An overview of the procedure Presented by Jane Moseley on Senior Scientific Officer Scientific Advice Office An agency of the European Union
2 Outline Parallel advice with HTAs Rationale and Impact of parallel advice European level landscape for advice New procedure HTA actors, outline of the process and outcomes Experience since launch Key messages 1 SME Info Day Multi-stakeholder parallel regulators/htas advice
3 Background Starting point: Regulators and Health Technology Assessment (HTA) bodies come together early o to discuss the planned development Expectation: Optimised development plan efficient Improve access for patients How best to do this interaction? Recently launched single platform EMA and EUnetHTA as equal partners 2 SME Info Day Multi-stakeholder parallel regulators/htas advice
4 Why and how we have got here SEED EMA - HTA parallel Scientific Advice EUnetHTA's early dialogue initiative Parallel consultations As of the 4 th of July 2017 this initiative replaces the parallel scientific advice procedure by EMA and HTA bodies which required medicine developers to contact Member States HTA bodies individually. Best practice guidance for the parallel regulatory - HTA scientific advice procedure (EMA/502692/2015 ) 3 Replaced by SME Info Day Multi-stakeholder parallel regulators/htas advice Guidance for parallel consultation (EMA/410962/2017)
5 How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory HTA parallel scientific advice British Journal of Clinical Pharmacology. Tafuri et al Volume 82, Issue 4, pages , 1 JUL 2016 DOI: /bcp
6 EU-level Advice Landscape Regulator advice CHMP advice HTA observers as option subject to EMA confidentiality undertaking Parallel consultation Regulators and HTAS CHMP advice HTAS PCC PCI HTA advice Consolidated EMA as observers subject to EUnetHTA confidentiality undertaking Eligibility criteria, Fees and Legal Basis are the same for EMA 5 SME Info Day Multi-stakeholder parallel regulators/htas advice
7 New procedure EMA and EUnetHTA The main benefits of the parallel consultation procedure include: A Streamlined procedure for Applicants; Increased opportunities for mutual understanding and problemsolving ability between EMA and HTA bodies through a more structured interaction; Improved coordination with, and greater participation of HTA bodies in parallel consultations through EUnetHTA's Early Dialogue Working Party (EDWP) and the EUnetHTA ED Secretariat. This facilitates optimal and robust evidence generation for different stakeholders bringing benefits for patient access and public health. Optimised development plan Improved access for patients 6 SME Info Day Multi-stakeholder parallel regulators/htas advice
8 What is new / different? 7 SME Info Day Multi-stakeholder parallel regulators/htas advice
9 EUnetHTA Actors EUnetHTA ED Secretariat Organisation and contact point Acceptability of the Letter of Intent and all project management on the HTABs side. HAS Early Dialogues Working Party (EDWP) Is a standing committee established by EUnetHTA to ensure robust high-quality HTA outputs. All EDWP members will participate in procedures selected for Consolidated PC. The Early Dialogue Committee (EDC) Is constituted for a specific product and the members will fluctuate to a degree for each Consultation. EDC Scientific Coordinator Undertakes scientific coordination on behalf of HTAs. Facilitates discussion between HTABs in advance of meetings. co-chair for the HTABs for the F2F meeting. 8
10 EUnetHTA: EDWP selection criteria The product should aim to bring added benefit to patients i.e. by: SELECTION CRITERIA: A new mode of action for the indication AND targeting a life-threatening or chronically debilitating disease AND responding to unmet need (no treatment or only unsatisfactory treatment available). Choice of pathway: PC Consolidated PC Individual 9 SME Info Day Multi-stakeholder parallel regulators/htas advice
11 EUnetHTA: EDC For a specific product and the members will fluctuate to a degree for each Consultation. Composition (example) of the EDC for: Consolidated PC Individual PC G-BA EDWP NIPN ZIN / RIZIV-INANMI HTAB B* HTAB D* NICE HAS AIFA / RER HTAB A* HTAB C* HTAB E* + HTAB A* HTAB B* HTAB C* * From EUnetHTA WP5 The preferences of the Applicant (indicated in the Letter of Intent) will be taken into account, but participation of those HTABs cannot be guaranteed. Composition of the EDWP as of July 4th 2017: France (HAS), Germany (G-BA), United Kingdom (NICE), Italy (AIFA with alternate RER), Hungary (NIPN), and a shared seat for The Netherlands/ Belgium (ZIN/ RIZIV-INANMI) 10 SME Info Day Multi-stakeholder parallel regulators/htas advice
12 PC Consolidated vs Individual Parallel Consultations HTAB recruitment Mode of participation of HTABs Selection criteria Outcome Consolidated Individual Centrally via EUnetHTA ED Secretariat Full EDWP and <=3 more Applies A single written report including: consolidated HTA written answers for shared positions, and individual HTA answers to those questions without consensus. Voluntary HTAB participation Does not apply Individual HTABs provide HTABs written reports 11 SME Info Day Multi-stakeholder parallel regulators/htas advice
13 The process 3 phases Simultaneous notification Presubmission phase Evaluation phase Deadline: Day - 60 Deadline: Day - 30 As scientific advice 12 SME Info Day Multi-stakeholder parallel regulators/htas advice
14 Evaluation phase List of issues Pre F2F TC F2F meeting EUnetHTA ED Secretariat and EMA exchange Lists of Issues (LoI) To take place in the week after SAWP 2 Identification and discussion of critical issues during the TC. If possible, try identifying possible solutions At the EMA premises, and will have 2 co-chairs. Tripartite session: EDC, EMA and the Applicant. The meeting duration will depend on the range of issues to be discussed and advice format 3-4 hours 13 SME Info Day Multi-stakeholder parallel regulators/htas advice
15 Advice / outcome Parallel Consultations EMA CHMP final Scientific Advice/Protocol Assistance letter to the Applicant in accordance with the published timelines (i.e. the subsequent CHMP meeting). Consolidated EUnetHTA ED Secretariat sends final written answers to Applicant at D +75. EUnetHTA Individual Individual HTABs written answers to Applicant <=15 working days of the F2F. Final outcome letters are exchanged between EMA and EUnetHTA ED Secretariat. 14 SME Info Day Multi-stakeholder parallel regulators/htas advice
16 Experience of new procedure Number of parallel consultations (PC) requests 3 2 Start date Total number of PC requests as of 10/11/2017: 11 - Procedures started: 6 - Procedures finished: 2 1 Number of requests 18% 9% Individual Consolidated Pending decision 73% 0 Aug-17 Sep-17 Oct-17 Nov-17 Jan SME Info Day Multi-stakeholder parallel regulators/htas advice
17 Features of requests in new procedure Mostly oncology indications 6, (dermatology, ophthalmology, metabolic, connective tissue) Patient representatives involvement in all 6 started procedures SME, Orphan and ATMP appear under-represented. 8 Median no of participating HTABs Median no of participating HTABs 16 0 PCI PCC SME Info Day Multi-stakeholder parallel regulators/htas advice
18 HTABs involvement (2) 90% 80% 70% 60% 50% 40% 30% 20% 10% 86% Percentage of involvement of HTABs* 71% 29% 43% 29% 43% 57% 29% 14% 14% 14% Total number of HTABs involved in Pc procedures: 11 HTABs coordinators: AEMPS: 1 procedure HAS: 2 procedures NICE: 2 procedures G-BA: 2 procedures 0% *Numbers related to the 7 requests that have confirmed HTABs participants. 17
19 Summary Positive collaboration between EMA and EUnetHTA New platform, one gateway for all procedures for advice/dialogue Centralised HTA recruitment, HTA working party for prioritised subset with consolidated HTA advice For all parallel advice/early dialogue procedures - Streamlined logistics, greater HTA coordination Multi-stakeholder, EMA and EUnetHTA equal partners, working together, benefits patient access and public health Respect for roles and remits to facilitate optimised evidence generation for different stakeholders Building on successes of PSA and SEED and Interactive focused meetings 18 SME Info Day Multi-stakeholder parallel regulators/htas advice
20 Key messages Platform for parallel discussion on initial evidence generation for MAA/reimbursement, and post licensing evidence generation Launched 03 July Early experience so far but positive More procedures /applications for parallel consultation encouraged - What are the barriers? 19 SME Info Day Multi-stakeholder parallel regulators/htas advice
21 Acknowledgements Inês Lucas EMA, SAWP and EUnetHTA colleagues Thank you for your attention Further information Contact EMA scientificadvice Contact EUnetHTA ED secretariat European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website Follow us
22 Additional information Documents and outcomes are exchanged throughout the procedure, if the Applicant provides consent in the letter of intent More interaction amongst stakeholders, since the beginning of the procedure, leading to a more efficient process: Administrative TC Pre F2F TC Closed TC (Day 57) Closed regulators/htab interaction during the F2F meeting Follow-up procedures Procedures ongoing 21 SME Info Day Multi-stakeholder parallel regulators/htas advice
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