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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In the latter case, the pharmaceutical company must pay the cost of the evaluation.

By submitting our aamnog, we are also inviting other statisticians who design and analyze clinical trials to join us in developing solutions to minimize the impact of the identified differences. This article has been cited by other articles in PMC. Third, the margins are based on the expectation of two large studies.

AMNOG – evaluation of new pharmaceutical

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. If you would like to have more information, please do not hesitate to contact us at cposchen partners4access.

Visit our official German website. 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, These questions must be answered by the pharmaceutical company in the form of a dossier. Journal of the American College of Cardiology 52— In particular it contains statements on the extent of additional benefit, patient groups eligible for treatment, requirements for quality-assured administration, and the cost of treatment with the pharmaceutical.


At federal level, the negotiated refund rate may be followed by selective contracts between individual health insurance funds or their associations, and the pharmaceutical companies.

We will continue to monitor and analyze the upcoming developments and discussions in particular with a smnog on the impact on small biotech- companies and orphan drug manufacturers. Only the German versions are binding.

Both statutory and private health insurers can presume in future that amng refund rates are indeed countered by a corresponding additional benefit for patient care, and that they do not have to finance spurious innovations which all too frequently are excessively expensive, as they used to have to. Since it is the standard with which a new medicinal product is compared as to its additional benefit, it is of central importance.

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.

Implementation of AMNOG: An industry perspective

We understand products to be innovative which tangibly improve patient care. On the basis of the dossier, the Federal Joint Committee examines the additional benefit of the new medicinal product as described by the pharmaceutical company. Additional benefit needs to be demonstrated in patient relevant endpoints such as mortality and morbidity. Other countries are already doing this. The starting point here is the proven additional benefit in comparison to the expedient comparative therapy.

For this, the pharmaceutical company provides the National Association of Statutory Health Insurance Funds with the individual prices of all amog product packages, not including value-added tax, which are received by the pharmaceutical company if the discounts which it voluntarily grants or which it has to grant are taken into account.


Implementation of AMNOG: An industry perspective

The Federal Joint Committee plays a major role through the early benefit evaluation. Documents will be accepted on 27, 28 and 31 December from 8: The actual comparative European prices and the annual therapy costs of comparable medicinal products are only then used as further criteria.

The sales prices communicated in the 15 countries are weighted according to their respective turnover and purchasing power using purchasing power parity. 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.

It manog the various AMNOG stipulations and its accompanying legal regulations, and summarizes them into a uniform set of rules. The still relatively new law applies to all pharmaceutical products with a new active ingredient that have anmog launched beginning January 1, Subscribe Forgot amnoy password?

AMNOG – evaluation of new pharmaceutical – GKV-Spitzenverband

For the evaluation of the additional benefit, the pharmaceutical companies must submit a dossier to the Federal Joint Committee at the time of the market launch of their medicinal product. The Federal Joint Committee has set up an overview manog the evaluation procedure on its website.

Process of early benefit assessment at the G-BA. If it is not possible for an additional benefit to be proven as a therapeutic improvement for active ingredients which are eligible for the fixed rate, the active ingredients are directly assigned to the existing fixed-rate group.

If a surrogate endpoint is used, its surrogacy for the clinical endpoint needs to be validated.