First Plenary Session CONVERGING OR DIVERGING MODELS OF HTA IN EUROPE. Jean-Luc Harousseau, MD

Transcription

1 First Plenary Session Speaker CONVERGING OR DIVERGING MODELS OF HTA IN EUROPE Jean-Luc Harousseau, MD President and Chairman of the Board Haute Autorité de Santé (HAS) Saint-Denis La Plaine, France HTA in Europe Jean-Luc Harousseau Chairman of the Board Haute Autorité de Santé, France ISPOR Berlin October

2 01 Current situation and perspectives in France The French healthcare system National Health Insurance (NHI) Statutory, coverage > 90% of the population Three major funds: salarees, rural workers, self-employed Universal Medical Coverage (CMU) since 2000: for uninsured patients and supplementary coverage under threshold income Supplementary Health Insurance: 92 percent of the population subscribe to supplementary health insurance Which medical services are covered? Hospital care, ambulatory care, prescription drugs For prescription drugs:coinsurance level depends on the therapeutic value. 100% coverage by NHI in 29 chronic diseases 4 2

3 HTA, Reimbursement and Pricing for a new drug: The actors HAS: HTA guidance CEPS Economic Committee for Healthcare Products Price Ministry of Health, M. of Social Security Decision L I S T I N G NHI Union Copayment Level 5 From HTA to pricing and reimbursement Literature Dossier from Pharmaceutical Company ASSESSMENT HAS internal assessors Review of available data APPRAISAL HAS Transparency Committee HAS Guidance Economic Committee Ministry of Health NHI funds Decision on P&R H T A Request for additional data collection 6 3

4 Initial assessment: From HTA to decision making on price and reimbursement Dimensions Criteria Results Clinical aspects clinical efficacy clinical effectiveness Actual Benefit Insufficient Sufficient No reimbursement relative effectiveness Other aspects disease characteristics target population impact on public health impact on healthcare organisation (qualitative) Clinical added value No added value Added value Reimbursement only if price inferior to comparators Price may be higher than comparators P R I C I N G HTA: HAS Guidance Decision: Ministry Pricing: Economic Committee 7 ACTUAL BENEFIT (SMR): reimbursement and copayment level SMR Level of reimbursement by NHI Important 60% moderate 30% minimal 15% insufficient NO REIMBURSEMENT 4

5 ADDED CLINICAL BENEFIT (ASMR) Major (I) Important (II) Moderate (III) Minimal (IV) No Added benefit (V) USED FOR PRICING Link between guidance and decision HAS Guidance Added clinical benefit (ASMR) Price Target population Price Volume agreements Request for additional study Risk sharing agreements 10 5

6 Rules governing price setting Primary considerations when setting prices: added clinical benefit (ASMR), forecast sales volumes, clawback payments in case of overshooting (236 million paid by companies to NHI for 2009) prices of comparators, Link between ASMR and price drugs that provide no added clinical benefit (ASMR V) as assessed by HAS and no savings on treatment costs cannot be reimbursed International reference pricing system when clinical added benefit is major to moderate (ASMR I to III) Internal reference pricing system (using price of therapeutic comparators) for drugs with no or minor clinical added benefit 11 Rules governing price setting Spending objective: ONDAM Parliament adopts every year a national health spending objective (ONDAM), indicative, not compulsory. CEPS task is to obtain the most advantageous price and financial conditions for the NHI system, whilst taking into consideration both the pharmaceutical market as a whole and the limitations of the ONDAM budget, as well as public health needs and the obligation to treat all the companies equally. 12 6

7 Sales of reimbursable drugs : growth is currently controlled Total sales 2010: Euros 25.5 billion. 1.3% increase / 2009 (3% in average for the previous 5 years) In 2012 might be 1.5% (negative for the first time) Slowing down of growth due to : Drugs with insufficient SMR are no longer reimbursed lapsing of patents growing generic substitution Reduced number of new innovative drugs, impact of price management promotion of rational prescribing ( maîtrise médicalisée ) June Why French policy is going to change? Obviously for financial reasons (as in other European countries) - NHI budget (ONDAM) had to be cut down from 2.8% to 2.5 % in 2012 while GDP growth will be near 0% - In 2010 sales of reimbursable drugs represented 18% of NHI Budget - Very high cost of new therapies ( anticancer agents up to Euros / year) CHOICE will become necessary 7

8 Why French policy is going to change? But also for more specific reasons General suspicion regarding healthcare system - the Benfluorex crisis : unknown number of deaths related to a 30 year-old drug due to drug misuse and late recognition of pharmacovigilance signals - More recently publication of a «best seller» book edited by two well-known professors - out of 4000 drugs sold in France 20% might be dangerous and 50% might be useless HTA in France: Current concerns Frequently addressed questions French P/R decision process is too complex, not transparent, non predictable results 8

9 HTA in France: Current concerns Frequently addressed questions French system is too complex, not transparent, non predictable results Are drugs more expensive in France? PRICES OF NEW DRUGS IN EUROPE (2008 IMS Health) France Germany Italy Spain UK ASMR I/II ASMR III ASMR IV ASMR V

10 Generic drugs Prices are higher in France than in most European countries Average Price per unit - Holland 5 Euros - UK 7 Euros - Germany 12 Euros - France 15 Euros HTA in France: Current concerns Frequently addressed questions French system is too complex, not transparent, non predictable results Are drugs more expensive in France? Too many prescriptions? 10

11 Pharma expenditure per capita (USD) France Germany UK HTA in France: Current concerns Frequently addressed questions French system is too complex, not transparent, non predictable results Are drugs more expensive in France? Too many prescriptions? Too many drugs? 11

12 Towards relative effectiveness assessment Many new drugs do not offer clinical added value - In % sufficient SMR for new drugs - but only 8% ASMR I-IV (HAS annual report) Re-assessment is mostly based on comparisons - 3d generation pills vs 2nd generation Recent law on Drug Safety (Dec 29th 2012) - inclusion of a new drug on the positive list of reimbursed agents is linked to comparative clinical trials versus existing therapeutic strategies HAS Guidance Perspectives Clinical assessment: towards a more simple, robust and transparent criterion Towards Relative Therapeutic Index to replace both SMR and ASMR Relative effectiveness assessment will base advice on eligibility to reimbursement, on reimbursement rate as well as estimate of the added clinical benefit Transparency on the assessment methods (parameters to be taken into account, steps taken to conclude on RTI) 24 12

13 HAS Guidance Medico-economic HTA New Law and Decree to strengthen HAS role in documenting the collective added value of technologies. When? - first inscription or reevaluation Which products? - Requested ASMR I to III and - Significant impact on health care expenses (health care organization, price, professionnal practices) How? - Based on data provided by the company - Expected or observed efficiency (comparison with existing drugs or technologies) 02 HTA cooperation in Europe Frame and objectives 13

14 HTA cooperation in Europe: What is the political context? Recommendations from Highl Level Pharmaceutical Forum (2008) Legislative measure (2011): DIRECTIVE on the application of patients rights in cross-border healthcare Decision to set up of a permanent network in place of the 3-year Joint Actions Current situtation: EUnetHTA Joint Action 2 just launched (Oct Oct 2015) New permanent network will be established by November What can we do together? Can HTA bodies develop collaborative actions: to reduce duplication of work? to limit unjustified differences in HTA reports? to improve the appropriateness of the data produced? 28 14

15 Reduce duplication of work Common set of data to be used for HTA reports Core HTA information for rapid assessment of drugs and devices Health problem and current use of technology Description and technical characteristics of the technology Safety Effectiveness 29 Reduce unjustified differences in HTA report Assessment methods: EUnetHTA Methodological guidelines Already produced : 9 guidelines for the assessment of drugs - Choice of comparator - HRQoL - Clinical endpoints - Safety - Composite endpoints - Internal validity - Surrogate endpoints - Applicablity - Direct and indirect comparisons To be produced: Guidelines for the assessment of medical devices and procedures Public consultation on EUnetHTA website 30 15

16 31 Appropriateness of data (1) Early Dialogue between HTA bodies and companies Scientific advice (SA) in place for a long time at regulatory agencies, some HTA bodies implemented SA activities Some joint/parallel Regulatory + HTA SA Current initiative Multi HTA early dialogue 2 pilots conducted June and July 2012 Part of EUnetHTA work plan ( ) Drugs and non-drug technologies 32 16

17 Appropriateness of data (1) Early Dialogue (Cont.) 2 pilots of «multi HTA» early dialogue done (June and July 2012) With voluntary participation of EUnetHTA partners (Germany, UK, Austria, Belgium, Italy, Netherlands, France) Coordinated by HAS (Mira Pavlovic, Anne Gourvil, François Meyer) With support from European Commission (DG SANCO) Practical aspects: Letter of intent: Eligibility? Briefing book: Summary of available data, description of draft development plan, list of questions Meeting between sponsor and HTA bodies 33 Appropriateness of data (2) Disease specific guidelines Currently: ongoing pilot project on Alzheimer Disease Green Park Collaborative (CMTP HTAi) Starting October 2012: Disease specific guidelines part of the EUnetHTA Joint Action 2 (Work Package7) 34 17

18 Appropriateness of data (3) Additional data collection: EUnetHTA objectives Definition of criteria to select new technologies in need of further evidence (published) database (EVIDENT) to share information & facilitate collaboration on additional evidence generation (launched Nov. 5 th, 2012) For some technologies, cooperation of several HTA bodies to define a common research question and a «common core protocol» EMA EUnetHTA cooperation 35 Areas for cooperation / harmonisation Literature Dossier from Pharmaceutical Company Early Dialogue ASSESSMENT HAS internal assessors Review of available data Core HTA information Methodological Guidelines APPRAISAL HAS Transparency Committee HAS Guidance Decicion makers on reimbursement and Price Decision on P&R Request for additional data collection Additional data collection 36 18

19 Conclusion P&R decision processes and criteria for appraisal are still, and will remain, country specific Voluntary cooperation between HTA bodies received a political support and is more and more a reality Significant actions are possible within this network to reduce unjustified differences between local HTA reports/guidance and to improve the quality of the data produced by technologies sponsors Political and regulatory limits in convergence does not limit Scientific exchanges and cooperation 37 Thank you for your attention 19