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Many new drugs have no added benefit
Questionable benefits of new drugs? Since the introduction of the Act on the Reorganization of the Pharmaceutical Market (AMNOG), new medicinal products have to undergo an assessment, "the result of which forms the basis for deciding how much statutory health insurance pays for a new medicinal product with a new active ingredient," reports the Federal Joint Committee (G-BA ). Together with the Institute for Quality and Efficiency in Health Care (IQWiG), the G-B is responsible for the task of this benefit assessment in accordance with Section 35a of the fifth Social Code.
"The procedure for the early benefit assessment of medicinal products - this can be said after three years of practice - is established and stable", said the G-BA chairman, Josef Hecken, at a specialist conference at the end of April. According to its own statements, the G-BA has completed “around 70 corresponding assessment procedures since 2011.” The previous balance sheet is rather sobering. Only a little more than a fifth of the products examined have a significant added benefit, reports the news agency "dpa", citing a preliminary balance sheet from the G-BA. The majority of the medicinal products evaluated brought little or no benefit to patients.
Only a few preparations with significant additional benefit According to the G-BA, only 14 of the 73 preparations that have been evaluated based on the AMNOG since 2011 had a significant additional benefit. However, the investigators found that 27 preparations had no added benefit at all. Corresponding maximum limits for billing with the health insurance companies have been set for three preparations without detailed evaluation, reports the news agency "dpa". In addition, the investigators found a small added value for 23 drugs and an indefinable one for six drugs. In the view of G-BA chairman Josef Hecken, the benefit assessment has already proven itself, even if "there is always room for improvement". It serves as a filter to identify the 40 to 50 percent of products that have no or only an irrelevant additional benefit, says Hecken. This would also allow the financial resources in the health system to be used much more effectively.
Criticism of research-based pharmaceutical companies The Association of Research-based Pharmaceutical Companies (vfa), however, judges the benefit assessment by the G-BA to be less positive. "So far, the umbrella organization of statutory health insurers has used its dominant power in all procedural steps to pull the reimbursement amounts for innovative medicines well below the European average," said vfa chief executive Birgit Fischer. Politicians' intention with AMNOG "to strengthen innovations for patients through a benefit assessment and efficient financing" would require "other participation and decision-making structures for success." So far, "innovations in patient care have been left behind," criticized Fischer .
Involving representatives of science in the benefit assessment As a counterweight to the health insurance companies, the vfa managing director called for the G-BA's subcommittee on pharmaceuticals to be expanded to include representatives of science. In their opinion, these should come from the regulatory authorities (Federal Institute for Drugs and Medical Devices, BfArM; Paul Ehrlich Institute, PEI) and from medical circles (Working Group of Scientific Medical Societies, AWMF; affected specialist societies), “which are directly involved with the Understand the study concept and the care. ”In its press release, the G-BA emphasized that it was ready for“ a constructive-critical dialogue with everyone involved ”. Further adjustments to the procedure in the AMNOG are quite conceivable, however the basic idea of the benefit assessment remains unaffected. (fp)
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