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C3 - Health Technology Assessment and Pricing in France; Current Situation and evolution - Meyer - Salon C
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C3 - Health Technology Assessment and Pricing in France; Current Situation and evolution - Meyer - Salon C

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  • 1. Health Technology Assessmentand pricing in FranceCurrent situation and evolutionFrançois Meyer MDCADTH meetingSaint Jean de Terre-neuve
  • 2. 01HTAin France:Current situation
  • 3. HAS = Single HTA institution in France,with other missionsHTA : Advice to decision-makers on reimbursement andpricing of health technologies (drugs, devices andprocedures) and interventions in the field of public healthProduction of guidelines for health professionals(clinical guidelines, patient safety)Health care organizations accreditation and healthprofessionals certificationDisease management for chronic conditionsInformation to professionals, patients and the publicHAS’ mission:To improve the quality and safety of healthcare3
  • 4. 4HAS, independent public scientificbody set up in 2005Pharmaceuticals (Transparency Committee)Medical Devices, interventional and diagnostic proceduresEconomic and Public Health Evaluation (CEESP)Health care for chronic conditions, disease managementMedical information quality and disseminationAccreditation of healthcare organisationsClinical GuidelinesImprovement of Professional practices and Patient safety4
  • 5. The two main different systems inEuropeDetermination ofadded clinicalbenefitPrice negotiationand decisionHealth economicsanalysis (priceproposed by company)Decision based onthe Cost/QALYestimate comparedto threshold5
  • 6. HTAguidanceCEPSEconomic Committee forHealthcare ProductsLISTINGHTA, Reimbursement and Pricing fora new drug: The main actors66
  • 7. Clinical aspects• clinical efficacy• clinical effectiveness• relative effectivenessOther aspects• disease characteristics• target population• impact on public health• impact on healthcareorganisation (qualitative)ActualBenefitSMRSufficientInsufficientClinicaladdedvalueASMRNo CAV(V)Minor CAV(IV)No reimbursementReimbursementonly if price inferiorto comparators‘European’ PriceDimensions Criteria ResultsPRICINGHTA: HAS GuidanceDecision: MinistryPricing:Economic CommitteeInitial listing: From HAS guidance to CEPS pricingPrice may behigher thancomparatorsHigh tomoderateCAV(I,II,III)7
  • 8. ACTUAL BENEFIT (SMR):reimbursement and copayment levelSMRLevel of reimbursementby NHIImportant 65%moderate 35%minimal 15%insufficient NO REIMBURSEMENT8
  • 9. From ASMR to price setting• The retail price of drugs:− set by contract between the company selling the drug andthe CEPS, or by decree• Primary considerations when setting prices:− Added clinical benefit ASMR as assessed by HAS− Price of the drug in other European countries− Price of comparators in France,− forecast or recorded sales volumes,• Link between ASMR and price− drugs that provide no ‘ASMR’ as assessed by HAS and nosavings on medical treatment costs’ cannot be put on thelist of reimbursed products9
  • 10. Link between guidance and decision10HASGuidanceAdded clinicalbenefit (ASMR)Target populationRequest foradditional studyPricePrice – VolumeagreementsRisk sharingagreements10
  • 11. 11The French pricing system does rely on an assessmentof value: the assessment of therapeutic addedvalue undertaken by HAS and predominantly basedon individual clinical benefits– The therapeutic added value to society (social value) isnot addressed per se at first listing– The other price determinants (among which, industrialconsiderations) are weighed by the CEPS but there is nodecision traceability– Re-evaluation (every 5 years) may change thereimbursement and pricing decision but again is mostlybased on medical benefitsDecision is currently mostly based onmedical assessment
  • 12. 12PRICES OF NEW DRUGS IN EUROPE(2008 IMS Health)France Germany Italy Spain UKASMR I/II 100 120 84 90 89ASMR III 100 135 84 90 115ASMR IV 100 136 107 112 127ASMR V 100 126 99 108 119
  • 13. 13• New remit by Law in 2008• For public health and good practice guidelines• No cost-effectiveness analysis for drugs at firstlisting• Economic assessment performed at time of classre-assessment (of therapeutic class) with possibleimpact on CEPS price revisionStatins, Drug-eluting stents, Type 2 diabetes• For some technologies, full HTAs (inc. ethics andsocial values)Growth hormones for non deficient children2008, introduction of the assessmentof efficiency
  • 14. 02Ongoingintroduction ofeconomicevaluation
  • 15. The two main different systems inEuropeDetermination ofadded clinicalbenefitPrice negotiationand decisionHealth economicsanalysis (priceproposed by company)Decision based onthe Cost/QALYestimate comparedto threshold15
  • 16. Evolution of the French systemDetermination ofadded clinicalbenefitPrice negotiationand decision16Introduction ofeconomic evaluation tosupport decision onprice
  • 17. Evolution of the French systemDetermination ofadded clinicalbenefitPrice negotiationand decision17Proposal for newcriterion to replaceSMR and ASMRIntroduction ofeconomic evaluation tosupport decision onprice
  • 18. Why French policy is going to change ?Medico-economic assesmentGeneral economic context (as in otherEuropean countries)• NHI budget (ONDAM) had to be cut downfrom 2.8% to 2.5 % in 2012 while GDP growthwill be near 0%• In 2010 sales of reimbursable drugsrepresented 18% of NHI Budget• Very high cost of new therapies ( includingtargeted therapies)Economic analysis to be developedto better inform decisions18
  • 19. Medico-economic HTAto start OCT 2013New Law and Decree (Oct 2012) to strengthenHAS’ role in documenting the collective addedvalue of technologies.• When ?- first listing or reevaluation• 3. Which products ?- Requested ASMR I to IIIand - Significant impact on health care expenses (healthcare organization, price, professionnal practices)• 4. How ?- Based on data provided by the company- Expected or observed efficiency (comparison withexisting drugs or technologies)HASGuidance19
  • 20. • Initial assessment… time frame = 90 Days– HAS will assess the methodological quality of the economicpart of the application submitted by companies for pricing;– If appropriate, it will produce guidance on expected efficiency– Companies may ask for a hearing, then the analysis will behanded to the pricing committee (CEPS) to help with pricesetting and will be published on HAS website• Full economic analysis at the time of re-assessment– Together with other non clinical aspects (ethical, sociological,societal)– Based on additional data collectionEconomic analysis at first assessmentand at the time of re-assessment20
  • 21. Methods• General Guideavailable on HASwebsite• Proceduresto be detailedbefore October201321
  • 22. 03New criterion forclinical evaluation
  • 23. Evolution of the French systemDetermination ofadded clinicalbenefitPrice negotiationand decision23Proposal for newcriterion to replaceSMR and ASMRIntroduction ofeconomic evaluation tosupport decision onprice
  • 24. Should the criteria (SMR/ASMR) berevised?• The current system is complex with• one 4-level indicator for reimbursement (SMR)• and one 5-level indicator for pricing (ASMR)• ASMR rating is not always reproducibleand is considered not predictable24
  • 25. Added clinical Benefit ( ASMR)2008 -2012ASMR 2008 2009 2010 2011 2012I-II 7 10 4 1 6III 5 8 8 2 10% I-III 13 18 14 5 16IV 17 20 20 20 22V 48 65 46 29 58Nombretotal d’avis75 100 85 58 9925
  • 26. Towards a new criterion : ITR• Unique comparative indicator for both– reimbursement decision– pricing• Clear definition of:– relevant comparator– objectives and modalities of comparative studies• Methodological approach– semi-quantitative– sequential• Parameters– to be analyzed: efficacy, safety, practicability– might be considered: patients subgroups– not considered: severity of disease26
  • 27. 27ITR (relative therapeutic interest)Process of the sequential evaluationELIGIBILITY ?Comparator, end pointslevel of evidence (internal validity)NO YESNon inferiorityITR = 0SuperiorityinvokedImprovement onrelevant end point(0 to 3)Modulation byTolerability andpracticality (-1,0,1)Final ITR-1 to 3 or moreITR = - 1Modulation bytolerability andpracticality (-1,0,1)Final ITR-1, 0, 127