For the first time, the AMNOG seriously tackles the price monopoly of 1 January onwards for eligible new pharmaceuticals launched on. Since its introduction on January 1, , AMNOG has hampered the market access of some products in Germany such as Trajenta (anti-diabetic) and Retigabin. AMNOG is here to stay. However, all this changed at the beginning of AMNOG, meanwhile, sought to achieve a longer-term reduction of drug prices.

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For the evaluation of the additional benefit, the pharmaceutical amngo must submit a dossier to the Federal Joint Committee at the time of the market launch of their medicinal product.

The refund rate that was negotiated applies to persons with both statutory and private insurance, and to self-paying patients in Germany.

AMNOG and the German Reforms: What Will Change? | eyeforpharma

Does it do justice to this task? The expedient comparative therapy is the generally-recognised standard therapy in the respective area of application. Federal Ministry of Health The benefit of the medicinal product to be assessed is smaller than the benefit of the appropriate comparative therapy. Value in Health 15A If the additional benefit is less than that of the expedient comparative therapy, the National Association of Statutory Health Insurance Funds stipulates a deduction.

Please use the following address on the outside envelope: It is only for those medicinal products that pharmaceutical companies can expect to receive an adequate refund rate in future. The actual comparative European prices form an aspect in the negotiations, but not the most important and not the only one, even if the pharmaceutical companies would like to see it that way.

In February the legislator stopped all planned assessments of the established market by changing the law 14th Social Code Book V Amendment Act. This will maintain Germany as a priority market to launch into positively influence price in markets that reference Germany.


Whilst the early benefit evaluation in accordance with section 35a of Book Five of the Social Code is a differentiated finding as to the probability and extent of the benefit in comparison to the expedient comparative therapy, the focus of the evaluation in the fixed-rate arrangement is different. IQWiG assesses the certainty of results on the basis of these data.

If no added benefit can be determined, a reference price is allocated to the new drug or a price that is not allowed to be higher than that of the comparator therapy. Endpoints and surrogate endpoints in colorectal cancer: If no agreement is reached, an arbitration board determines the reimbursement price using European pricing levels as its standard.

New address from 1 January on: This applies to primary and secondary endpoints, analysis methods, and the analysis sets.

Implementation of AMNOG: An industry perspective

It is decisive for an evaluation of established market products whether the pharmaceuticals are significant for statutory health insurance wmnog are in competition with pharmaceuticals which have already been evaluated. The enactment of the Act on the Reform of the Market for Medical Products AMNOG causes an early assessment amng additional benefit to be carried out for each year from 1 January onwards for eligible new pharmaceuticals launched on the German market which have new active ingredients or new combinations of active ingredients.

How beneficial are drugs entering the market in Germany?

If the upper confidence limit is greater than 0. The law was enforced with the political goal of saving the sick funds 2. Authentic innovations which constitute real progress for patient care will increase.

The benefit of a medicinal product is understood to mean its therapeutic effect as relevant to patients. This could translate to a 0211 power to amjog a hazard ratio that is less than one at a fixed significance level. However, due to the brief processing period of 3 months, the involvement of patients is not easy. It does not seem sensible to have one set of margins applying to all situations.


Please send any general questions regarding benefit assessments to the following email address.

AMNOG – evaluation of new pharmaceutical – GKV-Spitzenverband

Because, previously, medicinal product prices in Germany have been higher than in most other EU States, legislature has provided that the actual sales price in other European countries is also to be taken into account in negotiations on the refund rate in accordance with section b of Book Five of the Social Code. If turnover is higher, the pharmaceutical 20111 also need to prove an additional benefit for such orphan drugs.

A medicinal product which wishes to distinguish itself from the expedient comparative therapy must exceed the benefit of this therapy, that is it must have an additional benefit in the stated categories.

Ipilimumab’s benefit on mortality was originally considered to be amno. For the first time, the AMNOG is seriously tackling the price monopoly of the pharmaceuticals industry in Germany with this central arrangement. Only the German versions are binding. Patient representatives take part in the decisions in an advisory capacity. This means that the additional benefit is portrayed not in differentiated grades and probabilities, but exclusively as a yes-no decision regarding whether or not amnob therapeutic improvement is proven within the meaning of the fixed-rate arrangement.

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. Visit our official German website. PDF accessed 3 June The same approach could be considered when another endpoint is used to make the benefit decision. We prefer that the original choices of endpoints in a trial be used in IQWiG’s benefit assessment.

In both cases, the decisions 20111 not seem to weigh adverse reaction data in a quantitative analysis.