ASSESSMENT OF ANTIDIABETIC DRUGS IN FRANCE- WHAT IS THE BASIS FOR A REIMBURSEMENT RECOMMENDATION?

Author(s)

Dumet AF, Chavade D, Busin C, Fernandez J, Galbraith M, Grande M, d'Andon A
the French National Authority for Health (HAS), Saint Denis la Plaine, France

OBJECTIVES:

The French National Authority for Health (HAS) is responsible for health technology assessment, providing opinions for reimbursement purposes on drugs. Recommendations for reimbursement are based on the Clinical Benefit (CB) score with a 4-point scale from insufficient (no reimbursement) to important (highest level of reimbursement). According to the French legislation, the CB takes into account 5 criteria: disease severity, treatment aim, efficacy/side effects ratio (ranked on a 4-point scale), the drug’s place in the therapeutic strategy and public health impact. We observed that antidiabetic drugs frequently have several CB scores as they’re assessed by (sub)indication and therefore aimed to identify criteria driving the CB appraisals for antidiabetic indications.

METHODS: A retrospective and descriptive study analysing of HAS appraisals for all new antidiabetic (sub)indications assessed between 2010 and 2015 was conducted. For each appraisal, information regarding CB criteria was collected.

RESULTS: The efficacy/side effects ranking was correlated to the CB score in 80% of the indications. When HAS concluded that the drug had no place in the therapeutic strategy, the CB was systematically insufficient. Other CB criteria were less decisive: severity of the disease was always important, treatment aims were always symptomatic and only one indication obtained a positive impact on public health.

CONCLUSIONS: The percentage of insufficient CB in antidiabetic drugs appears to be higher than for all drugs assessment. However, all of these drugs are available as they obtained a favorable opinion for reimbursement in other (sub)indications, questioning the rationale for such a precise assessment. CB appraisal appears to be mostly driven by the efficacy/side effects ratio and the drug’s place in therapeutic strategy.

Conference/Value in Health Info

2017-11, ISPOR Europe 2017, Glasgow, Scotland

Value in Health, Vol. 20, No. 9 (October 2017)

Code

PDB44

Topic

Economic Evaluation

Topic Subcategory

Cost/Cost of Illness/Resource Use Studies

Disease

Diabetes/Endocrine/Metabolic Disorders

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