EFFICIENCY ASSESSMENTS OF PHARMACEUTICALS AND MEDICAL DEVICES IN FRANCE- A 2 YEARS UPDATE

Author(s)

Chevalier J, Delaitre C, Chicoye A
MAPI Group, Paris, France

OBJECTIVES: Since October 2013, companies are requested to submit a cost-effectiveness analysis when applying to reimbursement for pharmaceuticals or medical devices and claiming from a major to a moderate additional medical benefit versus comparators (ASMR/ASA/ASR I-III).  Efficiency appraisals are published after completion of the procedure and prices made public. They include critics of the methodology classified as minor, important and/or major limitations. Our aim is to present an analysis of these appraisals. METHODS: Results of appraisals in terms of ICERs and limitations will be presented along with the medical assessment (target population, therapeutic area, SMR/ASMR) and the annual treatment price. Limitations will also be detailed. RESULTS: As May 2015, a cost/effectiveness analysis was required for 28 pharmaceuticals and 1 medical device. Five (alemtuzumab, dolutegravir, riociguat, sofosbuvir, trastuzumab emtasine) have been published. They concern different therapeutic areas (pneumology, infectiology, oncology, neurology) and target populations (from 1,000 patients in CTEPH to 130,000 in hepatitis C). ASMR granted vary from IV to II, with one medicine granted a negative SMR. Efficiency has been assessed either for the full indication of the market authorization or only a restricted one. The ICERs varied from less than € 20,000 to almost € 200,000/QALY at companies requested prices, with treatment cost varying from € 6,000 to € 60,000. In case of major limitations, efficiency is not assessed, with negative impact on the following price negotiations. In case of important limitations, results have to be cautiously interpreted. CONCLUSIONS: These 5 published assessments provide key learnings about the French HTA body’s expectations. More evidence impact on the price negotiation is expected with upcoming assessments to be published and through ICERs calculation with published prices.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PHP301

Topic

Health Policy & Regulatory

Topic Subcategory

Approval & Labeling

Disease

Multiple Diseases

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