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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It would be an exaggeration to portray this withdrawal of the pharmaceutical companies as a risk that Germany might no longer be supplied with modern medicinal products. The benefit of the medicinal product to be assessed is smaller than the benefit of the appropriate comparative therapy.

– AMNOG since

Nevertheless, G-BA accepted SVR as an overall patient-relevant endpoint amhog the decisions for boceprevir and telaprevir [ 7 ]. Why are some pharmaceutical companies not marketing their medicinal products in Germany? Product price, as a discount on the sales price set by the manufacturer, has to be negotiated within 6 months.

Accessed 10 Sep They found the upper limit of the CI close to 0. Subgroup analyses are conducted to explore, rather than confirm, the uniformity of an observed overall treatment effect.

Received Oct 24; Accepted May The list price of the medicine set by the respective pharmaceutical company on launching it on the market remains unchanged. Who benefits from the refund rate negotiations?

Institute for Quality and Efficiency in Health Care concluded no ammnog benefit, whereas G-BA concluded there was a significant additional benefit. In Octoberone year after publication of amng first early benefit assessment, IQWiG staff members published an analysis of the dossier amnlg completed up to the end of June The latter includes stratification variable s in a stratified randomization. Accessed 10 Aug The manufacturer may request an advice meeting with the G-BA in order to determine the appropriate comparative therapy ACT and address any other relevant questions.


In accordance with the framework agreement, the refund rate is agreed in the event of an additional benefit by a supplement on the annual therapy costs of the expedient comparative therapy. Patient representatives take part in the decisions in an advisory capacity. Open in a separate window.

As for secondary endpoints, ICH E9 states that their predefinition in the protocol is also important. Eur J Health Econ. Until the AMNOG procedure has been completed, the price set by the pharmaceutical company itself applies to the new pharmaceutical for one year. Because of the above, we do not support changing the definition of a amnof endpoint after a study has been completed.

It does not seem sensible to have one among of margins applying to all situations. If for active ingredients that are eligible for a fixed rate the additional benefit in accordance with section 35a of Book Five of the Social Code cannot be proven as a therapeutic improvement in accordance with section 35 section 1bsentences 1 to 5, of Amnlg Five of the Social Code, the active ingredients are directly assigned to the existing fixed-rate group.

The areas amjog disagreement included ACT selection, definition of subgroups and patient-relevant endpoints, and classification and balancing of adverse events. AMNOG itself is vague on the quantitative definition of an additional benefit.

In addition, some further aspects have to be taken into ammog when interpreting the results. Insofar as a medical therapeutic indication is considered as the comparator, the pharmaceutical must be authorized for the therapeutic indication. Treatment success in cancer: If there is no expedient comparative therapy with medicinal products, non-drug therapies can also be considered if they are eligible as benefits under statutory health insurance.


These are new pharmaceuticals to which patent protection, specialists speak of confidentiality protection, applies. All available information on adverse events has to be included in the dossier [ 34 ].

AMNOG – evaluation of new pharmaceutical – GKV-Spitzenverband

Skin and soft-tissue infections, community-acquired pneumonia. However, the latter is typically done in the context of the disease population and the overall evidence instead of applying a prespecified set of thresholds to all situations.

Subsequently, further possibilities are open to the pharmaceutical company for contracting with individual health insurance funds section c of Book Five of the Social Code. These also stipulate that the expedient comparative therapy which in each case was determined by the resolution of the Federal Joint Committee, and its annual therapy cost, are considered to be the most important aspects.

G-BA is now reassessing linagliptin a According to the German classification scheme: A methodological approach to determine minor, considerable and major treatment effets in the early benefit assessment of new drugs.

AMNOG One Year On: How Will German Health Reform Impact Pharma Market Access in 2012?

ACT selection, subgroup definition, definition of patient-relevant endpoints mortality, morbidity and HRQoLand the impact of selected adverse events on benefit assessment.

Since the AMNOG provisions came into force, legislature has presumed that a new medicinal product has a fictive benefit as a result amnlg its approval under the law on medicinal products. Composite endpoints that have been traditionally used as the primary endpoints in many large registration trials can now be questioned by IQWiG.

What is the relevance of the data presented?

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