Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Two years AMNOG and early benefit assessment pursuant to § 35a SGB V - a critical review from the manufacturer´s point of view

Simon Schmidmeier (Abschlußjahr: 2013)

Summary
Language: German

On 1 January 2011 the early benefit assessment pursuant to § 35a SGB V of reimbursable medicinal products with new active substances was introduced in Germany within the framework of the law on the reorganization of the pharmaceutical market in the statutory health insurance called the AMNOG.
After demonstrating the safety, therapeutic efficacy and pharmaceutical quality of a medicinal product through the marketing authorization procedure this is the so-called "fourth hurdle": at first, after the grant of the marketing authorization, the pharmaceutical company is committed to provide evidence of the benefit of a new drug, in particular the extent and likelihood of the additional benefit compared to the appropriate comparator therapy. Only then, in a second step, the company can negotiate an adequate refund with the statutory and private health insurance in Germany.
Following the submission of a dossier containing detailed information on the patient-relevant benefit and the costs of the therapy, the Federal Joint Committee (G-BA) arranges the early benefit assessment which is usually conducted by the Institute for Quality and Efficiency in Health Care (IQWiG). The G-BA then will take a decision on the extent of the additional benefit and its therapeutic significance which is determined on the basis of clinical comparative studies with a focus on the endpoints mortality, morbidity, quality of life and adverse drug reactions.
Previously, the access to the social insurance system was not regulated in Germany. Each authorised and prescribed drug had to be reimbursed by the statutory health insurance, regardless of any potential additional benefit. However, the former privilege of pharmaceutical companies to determine the prices on the German market themselves to cover the high costs of research and development is a thing of the past after the introduction of the AMNOG and the early benefit assessment. The free pricing is now restricted to the first year after launch. Within this maximum of twelve months, a decision must be taken on the additional benefit and an appropriate refund amount must be negotiated.
The process of the early benefit assessment has been in place for over two years now. By late 2012, 43 procedures had been started and 29 of these were also completed.
In practice, the compilation of the dossier is a major challenge for pharmaceutical companies due to the complexity of the process and resource management. The methods for the evaluation of the dossier and for the process of taking decisions on the extent of the additional benefit do not appear to be transparent and comprehensible. Based on a critical review after two years this thesis demonstrates how the process is executed, which results were obtained, and which problems and obstacles have been encountered by the pharmaceutical industry.

Pages: 63
Annexes: 1, Pages: 14