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EMA should compare 'like-for-like' when assessing new drugs

Published on 07/09/11 at 10:25am
EMA headquarters: Currently the regulator only asks for a new drug to be compared against a placebo

The European system of comparing drugs against placebo and not against a comparator is flawed, according to a new LSE report.

It argues pharma companies should show how their drugs compare to existing treatments before approval, so that only the most beneficial and safest therapies reach patients.

The report suggests this will ease the burden on coountries’ scarce healthcare resources by ensuring only the best drugs are funded.

Currently the European Medicines Agency only asks for a new drug to be compared against a placebo, unless this is deemed unethical, rather than against a direct comparator.

The authors of the report – researchers at the London School of Economics and the European observatory on health systems and policies, say this does not allow patients, clinicians, and other healthcare decision makers, to determine whether a new drug is superior, equivalent or inferior to its existing alternatives.

This can result in “the widespread use of potentially less efficacious and unsafe drugs”, they warn.

A number of studies have also questioned the true added value offered by new, and often more expensive, drugs compared with existing treatments.

The EMA has encouraged such ‘pre-market’ studies to establish comparative efficacy and risk, but the regulator has yet to set comparative assessments as the default evidence standard for market approval, write the authors.

While estimates suggest that comparative efficacy data are available for 50-70% of new molecular entities at the time of approval, the report argue that this varies across therapeutic areas and that often only a fraction of evidence is accessible at the time of market authorisation.

A further challenge is that no particular type of study is ideal for assessing comparative efficacy, they add.

Despite these limitations, they believe that “comparative efficacy evidence should have a formal role in drug licensing decisions”.

They call for open dialogue between regulators, drugmakers and government agencies “to achieve better congruence between licensing and reimbursement requirements”, and better public access to comparative data on the effectiveness and safety of new drugs.

“Numerous promising medicines have been developed and many more are on the way to initial clinical trials,” say the authors.

“With this success comes an equally important additional need – to develop a systematic approach to evaluate the risks and benefits of these new therapies in the context of existing alternatives.

“An important initial step is to support a formal role for comparative efficacy evidence in drug licensing,” they conclude.

Ben Adams

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