Improving assessment process of health technologies: Towards a MCDA approach?

Transcription

1 Improving assessment process of health technologies: Towards a MCDA approach? François Meyer MD Advisor to the President, International Affairs ISPOR Amsterdam November 2014 Assessment of clinical added benefit and pricing in France HTA report Price CEPS Economic Committee Decision (Drugs, MDs) Current two criteria: Eligibility to reimbursement SMR = Service medical rendu Severity of the disease + importance of the effect of the drug SMR will serve also to determine level of co-payment Added clinical benefit ASMR Amélioration du service médical rendu from I to V Major (I) Important (II) Moderate (III) Minor (IV) No added clinical benefit (V) 2 1

2 Assessment of clinical added benefit and pricing (Cont.) Pricing Committee (Ministry) To negotiate the price taking into account the ASMR granted by HAS No added clinical benefit Reimbursed ONLY if price < comparators (ASMR 5) Significant added clinical benefit Higher price than comparators (ASMR 1 to 3, moderate to major) ASMR IV: Case by case basis. No guarantee of higher price New economic assessement (since October 2013) Complement the assessment of added clinical benefit Only for drugs with claimed significant ASMR (I to III) and significant budget impact (sales > 20M Euros) To better inform price negotiation/decision 3 Basic principle introduced in Creation of a positive list for reimbursed drugs A new drug will be reimbursed only if it has improved clinical outcomes or if it induces savings. Committee set up to evaluate drugs 4 2

3 Added clinical Benefit ( ASMR) ASMR I-II III % I-III IV V Nombre total d avis Debate on criteria: Apixaban example (1) ARISTOTLE : Double-blind, 2 arms (apixaban, warfarin), 18,201 patients, mean duration: 1.8 years. Primary endpoints: stroke or systemic embolism Secondary endpoints: Myocardialinfarction, Cardio-vascular death, all cause deaths Safety endpoints: Major bleeds 6 3

4 Debate on criteria: Apixaban example (2) The studies did not raise any particular methodological problems. The choice of the comparator seems justified Generalisability : No antidote is available The population of the study may be less at risk of stroke and bleeding than the real-life population The clinical data for apixaban in elderly patients (> 75 years), patients with renal impairment or with a low body weight, who are at risk of bleeding, are currently limited. 7 Debate on criteria: Apixaban example (3) Appraisal conclusion: The Committee considers that apixaban does not provide an improvement in actual benefit in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Lack of antidote was one of the criteria, and played a significant role in this conclusion. 8 4

5 Evolution of the French system Determination of added clinical benefit Towards a new criterion? Price negotiation and decision Introduction of economic evaluation to support decision on price 9 Current limitations of the clinical evaluation The current process is complex with one 4-level indicator for reimbursement (SMR) and one 5-level indicator for pricing (ASMR) ASMR rating subject to some variations and not always predictable some criteria for ASMR rating may be questionable => possible inconsistencies no public debate on the choice of the criteria => lack of transparency 10 5

6 New concept for clinical benefit: The Relative Therapeutic Index (ITR) Unique comparative indicator for both reimbursement decision pricing, completed by economic evaluation 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 11 ITR (relative therapeutic interest) Proposal for a sequential evaluation Assessing eligibility to REA Comparator end points Levels of evidence (internal validity) NO YES ITR = - 1 Non inferiority ITR = 0 Superiority invoked Modulation by tolerance and practability (-1,0,1) Improvement on relevant end point (0 to 3) Final ITR -1, 0, 1 Modulation by tolerance and practability (-1,0,1) Final ITR -1 to 3 or more 12 6

7 Towards preliminary determination of criteria: the experience of early dialogues Early dialogues (ED): meetings between companies developing new health products and HTA bodies EUnetHTA and SEED projects: 20 pilots of EDs financed by European Commission Companies present their development plan and ask questions about choices for: Comparator Clinical endpoints: will they be appropriate criteria for evaluation by HTA bodies Others (populations, economic evaluation ) 13 From early dialogues to a better definition of criteria for HTA EDs are useful but not sufficient to determine HTA-relevant criteria To be complemented by: Disease specific guidelines New endpoints: Qualification process Avoiding the Lack of antidote case by: Preliminary debate on the pros and cons of the use of this criterion (and on its relative importance) At what stage: Early dialogues? During assessment by CHMP? Defining criteria and their relative importance: a sound of preliminary approach of MCDA? 14 7

8 From early dialogues to a better definition of criteria for HTA (Cont.) Defining criteria and their relative importance: a sound of preliminary approach of MCDA? Also valid for non clinical criteria Giens Annual Seminar 2014 Importance of non clinical criteria for assessment of medical devices (MDs) Patient capacity to take care of themselves - autonomy MD s usability Carers workload (eg parent of a child with Type 1 diabetes) Safety at work (nurses..) Healthcare access Healthcare organisation Societal impact How to implement this approach: Proposal of a combination of EUnetHTA core model and MCDA approach 15 Conclusion Need for better definition of criteria, their relative importance and how they will be analysed and combined to reach conclusions for the appraisal of Health technologies. Work to be done at national and international level Areas with a particular need: health technologies bringing significant non-clinical benefit Interest in the MCDA approach 16 8