The Pharmaceuticals Market Reorganisation Act (Arzneimittelmarkt- Neuordnungsgesetz – AMNOG) of 22 December aims to limit the cost. The early benefit assessment, the core of AMNOG, brought new challenges for . an analysis of the dossier assessments completed up to the end of June The Act on the Reform of the Market for Medicinal Products (AMNOG) and the Regulation on the Benefit Assessment of Drugs (AM-NutzenV) form the legal basis.

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The latter includes stratification variable s in a stratified randomization. These are, firstly, organisational questions, such as the venue of the negotiations or the annog at which they are held.

Because of the above, we do not support changing the definition of a primary endpoint after a study has been completed. Expensive marketing for spurious innovations in place of research for real innovations will no longer be worthwhile for the pharmaceutical companies. Pharmaceutical expenditure will be limited by the refund rates that are negotiated under the AMNOG procedure. It is not an exception for a funding organisation to carry out remuneration negotiations on the object of the evaluations subsequently to the evaluation by the Federal Joint Committee, such as the National Association of Statutory Health Insurance Funds with the pharmaceutical company on medicinal products in the case of new active ingredients.

This is especially the case for conditional approvals. No assessment along these social law criteria additional benefit is carried out on approval. Physiotherapy according to German remedies regulations; OST for multiple sclerosis. The public is able to read here about all active ingredients for which the Federal Joint Committee is carrying out or has already completed an early additional benefit evaluation.


When a new treatment is associated with more adverse reactions than the comparator, the benefit category could be downgraded by 1 or 2 levels, based on the severity and seriousness of the adverse reactions. The cost-benefit evaluation however does not halt the negotiations on the refund rate or suspend the setting of a fixed rate.

In the latter case, the pharmaceutical company must pay the cost of the evaluation. Come see our posters tomorrow at 8: Belimumab Institute for Quality and Efficiency in Health Care concluded no additional benefit, whereas G-BA concluded there was a significant additional benefit.

Author information Article notes Copyright and License information Disclaimer. Accessed 4 Sep Either the medicinal product is allocated to the fixed-rate arrangement, or negotiations are carried out with regard to a refund amno in accordance with section b of Book Five xmnog the Social Code.

This will be ambog into consideration during price negotiations.

AMNOG since 2011

They found the upper limit of the CI close to 0. What is the relevance of the data presented? Within this period, firstly, the Federal Joint Committee adopts a resolution on the additional benefit of a new medicinal product, having carried out its evaluation. If several alternatives are determined for the expedient comparative therapy, the refund rate may not lead to higher annual therapy costs than those of the most economical alternative.

Negotiation of reimbursement rates led to savings in amount of Mio. Open in a separate window. Instead of using ICER, the German and French decision makers for pharmaceutical product reimbursement place their primary focus on determining the clinical benefit from ambog studies. C requires an interaction test. The Federal Joint Committee decides within another three months after publication how the patient-relevant additional benefit of the new medicinal product is to be classified.


For products at the end of the arrows this evaluation leads to an up- and downgrade, respectively. Abstract Inthe Federal Parliament Bundestag of Germany passed a new law Arzneimittelmarktneuordnungsgesetz, AMNOG on the regulation of medicinal products that applies to all pharmaceutical products with active ingredients that are launched beginning January 1, Conflict of interest F.

As in all IQWiG reports, the patient perspective also plays a key role in early benefit assessments. Kowa, however faces challenges, since Livazo has been incorporated into the reference-pricing system after it was found to bring no additional benefit compared with other statins. Open in a separate window.

AMNOG – evaluation of new pharmaceutical – GKV-Spitzenverband

Endpoints and surrogate endpoints in colorectal cancer: This article has been cited by other articles in PMC. Verfahrensordnung des Gemeinsamen Bundesausschusses; 5.

The refund rates which were negotiated apply from the first day of the 13th month after first being launched on the market. The Federal Ministry of Health: New medicinal products which are comparable in pharmacological and therapeutic terms with fixed-rate medicinal products are directly evaluated here in the context of a fixed rate.

Three manufacturers applied the amnig that had been suggested by G-BA even though relevant data were not available. Institute for Quality and Efficiency in Health Care concluded no additional benefit, whereas G-BA concluded there was a significant additional benefit.