Report: EMA’s system of comparing drugs is flawed
The European system of comparing drugs against placebo and not against a comparator is flawed, according to researchers at the London School of Economics, reported InPharm.
The LSE report argues pharmaceutical companies should show how their drugs compare to existing treatments before approval, so that only the most beneficial and safest therapies reach patients. It suggests this will ease the burden on countries’ scarce healthcare resources by ensuring only the best drugs are funded.
Currently, the European Medicines Agency (EMA) asks for a new drug to be compared only against a placebo, unless this is deemed unethical, rather than against a direct comparator.
The report’s authors—researchers at LSE and the European observatory on health systems and policies, said 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 warned.
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 has yet to set comparative assessments as the default evidence standard for market approval, the authors wrote.
While estimates suggest that comparative efficacy data are available for 50-70% of new molecular entities at the time of approval, the report argued that this varies across therapeutic areas, and often only a fraction of evidence is accessible at the time of market authorization.
A further challenge is that no particular type of study is ideal for assessing comparative efficacy, they added.
Despite these limitations, they believe “comparative efficacy evidence should have a formal role in drug licensing decisions.” The report called 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,” said 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 concluded.