PRELIMINARY ANALYSIS OF THE UNWRITTEN DECISION RULES BEHIND THE FRENCH TRANSPARENCY COMMISSION'S ASSESSMENT OF DRUGS

Author(s)

Toumi M1, Michel M2, Mraidi M3, Rahmouni A3, Duvillard R31University Claude Bernard Lyon 1, Lyon, France, 2University Paris Descartes, Paris, France, 3Creativ-Ceutical, Paris, France

OBJECTIVES: Our objective was to analyze the French HTA decision making process of the Transparency Commission (TC) and try to identify unwritten decision rules which influence a drug’s SMR and ASMR. METHODS: We analyzed the TC database for the years 2005 to 2010, looking at key points of the TC’s opinions listed within such as: SMR, ASMR, target population, public health impact, presence of alternatives, orphan drug status, prescription restriction etc. Using a bivariate analysis we compared drugs granted: insufficient SMR versus other SMR; ASMR V versus ASMR IV; ASMR IV versus ASMR I, II and III. RESULTS: We found that drugs granted an ASMR V more often had alternatives than drugs with an ASMR IV (89.74% vs. 69.82%, p<0.005), while prescription of drugs with an ASMR IV was more often restricted than for drugs with an ASMR V (p=0.01 for hospital-only prescription and p<0.005 for specialist prescription). The median target population for drugs with an ASMR IV was also smaller than for an ASMR V (15,000 vs. 97,250). On the other hand drugs with an ASMR IV more often had no public health impact than those with an ASMR I-III (55.70% vs. 22.13%, p<0.005). Drugs with a high ASMR had smaller median target population (3,400 vs. 15,000) although there was no difference in orphan drug status between the two groups (9.47% for ASMR IV vs. 14.07% for ASMR I-III, p=0.20). More drugs with ASMR I-III were paediatric medicines (30.04% vs. 14.79%, p<0.005). CONCLUSIONS: Further analyses are in progress using additional qualitative criteria extracted  from the TC’s opinions and using a multivariate analysis. Such information would be critical for the development of TC application dossier.

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

Value in Health, Vol. 14, No. 7 (November 2011)

Code

PHP115

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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