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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Biometrical Journal this issue. There are many situations where the impact of the benefit attributable to a new treatment is better measured on an absolute scale than a relative one. Subgroup analysis ICH E9 states that in most cases subgroup analyses are exploratory and should be clearly identified as such.

The refund rate for such medicinal products may not be higher than the cost of the expedient comparative group with which the new medicinal product was compared. Is it really better than the treatments already on the market?

To accelerate the search for and selection of external experts, as early as January the Institute started to establish a database for experts. A cost-benefit evaluation can be carried out section 35b of Book V of the Social Code.

The fixed rate is a maximum refund up to which the statutory health funds assume the costs of specific medicinal products a,nog by physicians. Patient representatives take part in the decisions in an advisory capacity. General Methods Version 4.

Ipilimumab’s benefit on mortality was originally considered to be major. Major criteria are improving the state of health, shortening the period of illness, extending survival, reducing side-effects or improving quality of life. New response evaluation criteria in solid tumours: The situation is especially problematic when there is only one large registration trial. Treatment success in cancer: It takes its decisions on the basis of its Rules of Procedure.


For this purpose, the company submits a dossier to the G-BA based on the authorization documents and all studies carried out on this pharmaceutical. External annog It was already obvious in that not only were additional internal resources required to prepare AMNOG reports, but also external ones in the form of experts from all medical fields. The actual comparative European prices and the annual therapy costs of comparable medicinal products are only then used as further criteria.

AMNOG – evaluation of new pharmaceutical – GKV-Spitzenverband

The Act on the Reform of the Market for Medical Products Arzneimittelmarkt-Neuordnungsgesetz — AMNOG of 22 December aims to limit the cost of pharmaceuticals, which has risen considerably in recent years particularly in the market segment which was previously exempt from wmnog prices.

Third, the margins are based on the expectation of two large studies.

Second, an indirect comparison that preserves study randomization may not be possible. The basic idea is to adjust the confidence level, if necessary, to compensate for the lack of precision in the estimated treatment effect because the study is not sized to have enough precision for estimating treatment effect on the endpoint s chosen by IQWiG.

The dossier must prove an additional benefit of the pharmaceutical over the appropriate comparator specified by the G-BA. 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.

AMNOG since 2011

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. Where medicinal products offer no additional benefit and cannot be assigned to an existing fixed-rate group, the price level will also be limited since the refund rate may not lead to higher annual therapy costs than those of the expedient comparative therapy.


The new medicinal product must take this as its benchmark. This resolution is published without delay, and includes the G-BA’s decision on the pricing procedure for the new medicine.

As with the conventional benefit assessments, the dossier assessments also focus on conclusions and evidence with regard to patient-relevant outcomes: Please include the required documents on CD or DVD, along with a cover letter signed by an authorized person including authorization, if applicable and addressed to the Federal Joint Committee: The result of the benefit assessment is published on the internet, and pharmaceutical companies, federations, and experts are given the opportunity to submit written and verbal statements on the result.

With the Fourteenth Act Amending Book Five of the Social Code, the legislature provided that in addition to the Association of Private Health Insurance, which in accordance with section b of Book Five of the Social Code is involved in the negotiations on the refund rate as a guest, a representative of each health insurance fund attends the negotiations.

The arbitration body is composed of three non-partisan representatives and two representatives each of both negotiation partners. Here you will find:. The law was enforced with the political goal of saving the sick funds 2. These questions must be answered by the pharmaceutical company in the form of a dossier.

For the first time, pharmaceutical companies are obliged to submit a dossier on product benefit when a new product is launched on the German market or authorized for new indications. On the occasions when PFS is accepted as the primary endpoint, marketing authorization is typically conditioned on the new treatment not decreasing the OS when compared with the control in the study.