JSA in Germany with BfArM/PEI and G-BA
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2 JSA in Germany with BfArM/PEI and G-BA 16 th DGRA Annual Congress Bonn, 8 May 2014 Thomas Mueller Head of Pharmaceuticals Department Federal Joint Committee (GBA)
3 Seite Thomas Müller AMNOG in brief
4 Assessment Principles - Key Point What is the additional benefit over the appropriate comparator (standard treatment)? Quantitative extent of additional benefit? Differences between subpopulations of patients? Patient-relevant endpoints: mortality, morbidity, quality of life, adverse events? Surrogate endpoints: Validation for patient-relevant endpoints? Biomarkers for relevant populations of patients? Lack or gaps of evidence, additional study requirements? Re-assessment after period of time? Seite Thomas Müller
5 Results (February 2014, since 2011) Seite Thomas Müller
6 Resolution by therapeutic area - examples Resolutions in Diabetes (February 2014) Resolutions in Oncology (February 2014) Seite Thomas Müller
7 Price Negotiations - results arbitration decisions market exit between manufacturer and organization of statutory health insurance funds (on the basis of the G-BA resolutions) completed Price negotiations 41 Arbitrations decisions 3 Market exit: (Aliskiren/amlodipine, collagenase clostridium histolyticum, linagliptin, linaclotide, lixisenatide, retigabine) 6 Seite Thomas Müller
8 Outcome AMNOG Free pricing for newly introduced drugs is replaced by negotiation on the basis of an early benefit assessment No CBA, no CEA (no ICER, no threshold) Unchanged: Early market entry and drug availability in Germany, even for expensive drugs Free pricing for first 12 months Market launch and early benefit assessment in parallel AMNOG does not hinder innovation; it promotes intense discussion on open scientific questions and values Seite Thomas Müller
9 Five Ws of Consultations WHO? G-BA advices industry WHAT? In particular advice on: - Appropriate comparator, - Study design, - Endpoints, Biomarkers, Surrogates, - Patient groups. WHEN? Best before phase III, but any time is possible (e.g. phase IV) WHERE? At the G-BA office, Berlin (teleconference is possible) WHY? Assistance to undergo the procedure Seite Thomas Müller
10 Consultations with the G-BA: course Request for consultation Discussion within G-BA (working group, subcommittee): Proposal by secretary, agreement on key points At week 8: Consultation meeting with meeting minutes Meeting minutes have to be attached to the future dossier If necessary: new consultation on comments of the pharmaceutical company at the G-BA office Fees apply depending on complexity and scope of questions Free of charge: Written answers concerning questions concerning procedures or dossier submission Seite Thomas Müller
11 Consultations with the G-BA: course Request for consultation Comments If necessary Check completeness, Processing request Literature review, evidence synopsis G-BA Working group, subcommittee Consultation meeting Meetin g minutes If applicable Week 8 Comments to questions regarding regulatory affairs Seite Thomas Müller
12 Participation of BfArM or PEI (national regulatory authorities) - Standard involvement (legal base SGB V 35b Abs. 7) - Before phase III trial or during planning of a new clinical study Course: Request for consultation before phase III or during planning of clinical study BfArM or PEI will be informed and get questions & complete dossier (exception: pharmaceutical company excludes participation) Comments of BfArM or PEI (on market authorisation aspects) Discussion within G-BA (considering BfArM / PEI comments) Consultation meeting with meeting minutes Comments of pharmaceutical company on meeting minutes If applicable new consultation on comments of the pharmaceutical company and change of meeting minutes BfArm or PEI get copy of final meeting minutes (exception: if pharmaceutical company denies) Seite Thomas Müller
13 Consultation: Documents Documents to submit: - Request form /#abschnitt-2 - Filled in German (therapeutic area, question, positions) - Attachments in English accepted (e.g. Study protocols, literature) - Minutes of advice meetings with regulatory authorities - Concept of clinical studies if applicable #abschnitt-7 Documents provided after the advice meeting - Meeting minutes - Systematic literature survey (standard treatments in the claimed indication) - Overview about all treatments considered as comparator - Comments of BfArM or PEI on marketing authorization aspects (if applicable) Seite Thomas Müller
14 Consultations: Facts and Figures Number of consultations Seite Thomas Müller
15 Consultations: Facts and Figures proportion of topics - Main focus on questions regarding comparator - Increasing interest on comments to study design - Questions regarding procedure drop Seite Thomas Müller
16 Consultations: Facts and Figures selected therapeutics areas Seite Thomas Müller
17 Experiences from interaction with regulatory bodies Dealing with comparators: lack of evidence, off-label-use, no comparators, missing data accessibility Dealing with (patient relevant) endpoints and validity Dealing with surrogates (incl. discussions with experts) Dealing with conditional approval (time limited resolutions) Data generation after authorization (safety and efficacy) Dealing with uncertainties: early crossover, open label studies, indirect comparison, Study population: label differs from investigated population Seite Thomas Müller
18 Pilot- /Project- joint/parallel advice with EMA and other European HTA agencies (May 2014) Pilots EUnetHTA (Lead Partner HAS, France): 10 G-BA participations Pilots of multi-stakeholder consultations in early-stage drug development, EMA: 10 G-BA participations Seite Thomas Müller
19 Interaction G-BA Regulators - HTA HTA Network activities (BMG/G-BA) EMA-multi-HTA Pilots for parallel scientific advice EUnetHTA JA Scientific and technical cooperation SEED (Shaping European Early Dialogues) multi-hta pilots Seite Thomas Müller
20 Parallel Scientific advice (EMA + HTAs) EMA/HTA Company GBA [G-BA consultation procedure] Letter of Intent Briefing book Prevalidation TC with copany Distribution to participating agencies Request for advice EMA: list of open issues TC Response Meeting with individual respons e of agencies Mee ting min utes com ment s (HTA only) - 4 mo day 0 day 15 day 30 day 45 day 90 Seite Thomas Müller
21 Early Dialogue SEED / Eunetha EUnetHTA Company Letter of Intent (early dialog ues@ hassante. fr) List of clarifications Briefing book Prevalidation Distribution to HTA TC Resp onse Distribution to HTA TC Meeting with individual respons e of HTA Mee ting min utes com ment s - 4 mo day 0 day 15 day 30 day 45 day 90 day 100 Seite Thomas Müller
22 Licensing and HTA: Harmonization? Licensing: Focus on safety and product quality HTA: Focus on (additional) benefit, value, listing decisions, reimbursement, budgets, allocation, opportunity costs Clinical trials = evidence basis for both licensing and HTA decisions Clinical trials = need early & global organization, resources (human, financial and time) Possible harmonization for: study design, patient groups, integration of standard of care (active control), relevant endpoints, relevant clinical difference (effect size) No harmonization for: appraisal of effects, listing decisions, willingness (and ability) to pay EMA/HTA advices: first positive step, but need for further development (legal framework, coordination, HTA involvement) Seite Thomas Müller
23 Transparency of information Seite Thomas Müller
24 Seite Thomas Müller
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