New drugs often without new benefits

Many new drugs have no added benefit

22/05/2014

Questionable benefit of new medicines? Since the introduction of the Pharmaceutical Market Reform Act (AMNOG), new medicines must be evaluated, „the result of which forms the basis for the decision how much the statutory health insurance pays for a new drug with a new active substance“, reports the Federal Joint Committee (G-BA). Together with the Institute for Quality and Efficiency in Health Care (IQWiG), the G-B succeeds § 35a in the fifth Social Code the task of this benefit assessment.

„The method of early benefit assessment of pharmaceuticals - this can be said after three years of practice - is established and stable“, explained the chairman of the G-BA, Josef Hecken, at a symposium at the end of April. Since 2011, the G-BA claims to have „around 70 corresponding evaluation procedures have been completed.“ The previous balance is rather sobering. Only slightly more than one-fifth of the tested products have a significant added value, the news agency reports „dpa“ citing a preliminary balance sheet of the G-BA. Much of the evaluated remedies brought little or no benefit to the patients.

Only a few preparations with considerable added benefit
Of the 73 preparations that have been assessed based on the AMNOG since 2011, only 14 had a significant added benefit, according to the G-BA. 27 preparations, however, the examiners attested no additional benefit at all. For three preparations, without detailed evaluation, the respective maximum limits for billing with the health insurance funds have been determined, reports the news agency „dpa“. In addition, the examiners had found in 23 drugs a small and six drugs a non-determinable added value. According to G-BA Chairman Josef Hecken, the benefit assessment has already proved itself, even if „always potential for improvement“ show. It serves as a filter to identify 40 to 50 percent of products that have no or only an irrelevant added value, according to Hecken. Thus, the financial resources in the health system could be used much more effectively.

Criticism of the research-based pharmaceutical companies
On the part of the Association of Research-Based Pharmaceutical Companies (vfa), however, the benefit assessment by the G-BA is rated less positively. „So far, the umbrella association of statutory health insurance funds has used its dominant position of power in all procedural steps in order to reduce the reimbursement amounts of innovative medicines far below the European average“, so the criticism of the vfa chief executive Birgit Fischer. The intention of the policy, with the AMNOG „To strengthen patient innovation through a benefit assessment and efficient funding“, need „for success, other participation and decision-making structures.“ Stay here „the innovations in patient care on the track“, criticized Fischer.

Participate representatives of science in the benefit assessment
As a counterbalance to the health insurance companies, the vfa Executive Director called for the extension of the Subcommittee on Pharmaceuticals of the G-BA to include representatives of the scientific community. In their opinion, these would have to come from the regulatory authorities (Federal Institute for Drugs and Medical Devices, BfArM, Paul-Ehrlich-Institut, PEI) and from the medical expert groups (Association of Scientific Medical Societies, AWMF;, „who are directly familiar with the study design and the supply.“ The G-BA emphasized in its press release that he was responsible for „a constructive-critical dialogue with all participants“ ready stand. Thus, further adaptations of the procedure in AMNOG are conceivable, but the basic idea of ​​the benefit assessment remains unaffected. (Fp)