Authorization and Benefit Assessment: IQWiG calls for a change
In an article published in the BMJ (British Medical Journal) on July 10th 2019 the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) utilizes the internationally accepted platform in order to point out shortcomings in the approval of drug products – without keeping a low profile.
In comparison to other EU countries, the IQWiG is as German authority known to focus strictly on robust evidence during the early benefit assessment of drug products. This has been reinforced in the BMJ article.
Besides the fact that only a few recently approved drug products are truly innovative and can demonstrate a benefit in comparison to existing alternatives, there is a large number of HTA procedures (125 of 216 drugs entering the German market) that were based on insufficient evidence. Moreover, the institute criticizes that often requested post-approval evidence is not submitted in line with the requirements. The institute additionally highlighted the thereof resulting missing information basis necessary for an informed decision-making to guarantee a high-quality health care.
Overall, the IQWiG directly accused the pharmaceutical companies to waste money by investing in pipelines which focus on finding the next-best Me-too product without realizing a true improvement in health care.
As a consequence, the following requests are made to the competent authorities involved in the market authorization and HTA procedure of drug products, which should ideally work together on European level:
- Low tolerance with regard to accelerated approval procedures and enforcement of robust evidence based on longitudinal, adequately large, randomized, controlled Phase III trials.
- Enforcement of the obligation to conduct and provide post-approval evidence: active controlled studies which are used during HTA procedures.
- Clear distinction between marginal and relevant outcomes as basis for a targeted benefit assessment, as already initiated for Oncology products.
- In the long-term, Policymakers should play a proactive role in the R&D processes and define focus areas for the industry based on public health needs.
- Implementation of new models for R&D activities as e.g. benefit-oriented Public Private Partnerships, "Pay for Patents" or Open Source Models.
As SKC is actively involved in several benefit assessments and price negotiations in Germany we notice changes in regulatory procedures and possible differences in the benefit assessment by the IQWiG firsthand. In case you would like to receive further information or are interested in working with SKC, we are looking forward to your request.
Written by Univ.-Prof. Dr. med. Matthias P. Schönermark, Geschäftsführender Gesellschafter und Fenja Presuhn, M.A. Medizinmanagement
Akehurst RL, Abadie E, Renaudin N et al. Variation in the Health Technology Assessment and Reimbursement Processes in Europe. Value in Health 2017, 20(1),67-76.
Wieseler B, McGauran N, Kaiser T. New drugs: where did we go wrong and what can we do better? BMJ 2019; 366,l4340.