Comparative Efficacy Proposed for European Drug Approval

Superiority, equivalence, inferiority of new drugs should be compared with existing therapies

WEDNESDAY, Sept. 7 (HealthDay News) -- New drugs should be compared with existing treatments instead of placebo before their approval in Europe, according to a report published online Sept. 6 in the BMJ.

Corinna Sorenson, M.P.H., M.H.S.A., from the London School of Economics and Political Science, and colleagues discussed the current requirements, availability, and methodological tools for comparative efficacy evidence in Europe for the approval of new drugs.

The authors reported that the current European policy of comparing the benefits and risks of a new drug against a placebo (with comparisons with existing therapies required only when placebo use is deemed unethical), does not allow health care decision makers to determine whether a new drug is superior, equivalent, or inferior to its existing alternatives. The availability of comparative efficacy varies across therapeutic areas, and only a fraction of evidence is accessible at market authorization. The European Medicines Agency (EMA) encourages pre-market studies to establish comparative efficacy and risk, but has not made it a compulsory evidentiary standard for market approval. The EMA recommends randomized controlled trials for new drugs with safety or inferiority concerns. The authors suggest non-inferiority studies when alternative treatment options exist. They recommend open dialogue and agreement between the EMA, manufacturers, payers, and governments on the licensing and reimbursement requirements, and suggest that data on the efficacy, effectiveness, and safety of new drugs should be made publically available.

"Comparative efficacy evidence should have a formal role in drug licensing decisions," the authors write.

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