We must revise drug regulatory framework at EU and national levels

Author: Louise Prime

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The outcome of the current drug development processes and policies in Europe is insufficient and we need combined action at both European Union (EU) and national levels to define public health goals, revise the legal and regulatory framework and focus on the needs of patients, researchers have claimed. Their analysis*, published in The BMJ, revealed that there is no evidence of added benefit over existing therapies for most new drugs entering the German healthcare system following approval by the European Medicines Agency (EMA).

The three researchers are all from the Institute for Quality and Efficiency in Health Care (IQWiG), in Germany, which by law must investigate the added benefit of new drugs compared with standard care. The Federal Joint Committee (G-BA), the main decision-making body within the German statutory health insurance system, is responsible for the assessment procedure and ultimately decides on the added benefit (or otherwise). However, a new drug is permitted to stay on the market even if the G-BA concludes that it has no added benefit.

Between 2011 and 2017, IQWiG assessed 216 drugs entering the German market following regulatory approval – 152 new molecular entities and 64 drugs granted a new indication. Given that the EMA had approved almost all of these drugs for use throughout Europe, the study authors explained, their results also reflect the outcome of European drug development processes and policies.

They reported that for the 216 assessments they analysed, the G-BA’s decision was as follows: no added benefit 115 (53%); major added benefit one (<1%); considerable added benefit 55 (25%); minor added benefit 33 (15%); non-quantifiable added benefit 12 (6%); less benefit none (0%). They discovered that the situation was especially bad in particular therapeutic areas: in psychiatry/neurology and diabetes, added benefit was shown in just 6% (1/18) and 17% (4/24) of assessments, respectively.

The researchers addressed the question of “me-too drugs”. They found that several new drugs in oncology and infectious diseases, although they did have an added benefit, had the same mode of action and so did not represent “real innovation”. They said: “For instance, the IQWiG analysis showed that in Germany 12 of 48 successful assessments (25%) in oncology were for PD-1 or PD-L1 inhibitors. The various drugs that showed added benefit in hepatitis C all use one of the three types of direct antiviral action or a combination thereof.”

They added that there is evidence to suggest that many of the investigated drugs are of added benefit only for particular subgroups of patients. Furthermore, they said, promised post-marketing studies often do not happen; and globally, regulators do little to sanction non-compliant companies.

They argued that in order to increase innovation manufacturers should be required to submit comparative data at the point of drug approval, and payers could then set reimbursement and pricing at levels that reward relevant outcomes for patients.

They concluded: “Combined action at EU and national levels is required to revise the legal and regulatory framework, introduce new drug development models, and focus on the needs of patients.”

*Wieseler B, McGauran N, Kaiser T. New drugs: where did we go wrong and what can we do better? BMJ 2019; 366 :l4340. doi:10.1136/bmj.l4340 (Published 10 July 2019)


Editorial team, Wilmington Healthcare

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