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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The list price of the medicine set by the respective pharmaceutical company on launching it on the market remains unchanged. Statistics in Medicine The early additional benefit evaluation is completed and published at the latest three months after the market launch of the medicinal product.

In andIQWiG therefore developed appropriate qmnog methods, newly organized procedures, and trained additional staff.

For one thing, if margins are to be used, they should be chosen to reflect the indications and the patient populations. These questions must be answered by the pharmaceutical company in the form of a dossier.

The sales prices communicated in the 15 countries are weighted according to their respective turnover and purchasing power using purchasing power parity. We will continue to monitor and analyze the upcoming developments and discussions in particular with a focus on the impact on small biotech- companies and orphan drug manufacturers.

The distinction between primary and secondary endpoints is important not only for interpreting trial results, but in the trial’s ability to draw inference with adequate power.


The dossier must prove an additional benefit of the pharmaceutical over the appropriate comparator specified by the G-BA. European Medicines Agency C requires an interaction zmnog. It should be understood that only the original German document is legally binding.

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.

If there are several indications, several comparative therapies may also be defined.

AMNOG – evaluation of new pharmaceutical

Germany is typically prioritized by the pharmaceutical industry: We understand products to be innovative which tangibly improve patient care. We invite our academic colleagues to conduct research to decide if this could be a viable alternative.

How beneficial are drugs entering the market in Germany? Subscribe Forgot your password? SinceICH E9 has been the primary reference for statistical principles amnoog clinical trials in support of marketing applications in Europe, Japan, and the Amnpg States. The comparator should belong to the appropriate therapy in the therapeutic indication according to the generally accepted state of medical knowledge.

Implementation of AMNOG: An industry perspective

It determines, for instance, the expedient comparative therapy and, after a statement procedure, issues a resolution on the additional benefit of new medicinal products that is relevant to patients. Certainty of conclusion on additional benefit The quality of the studies and data included in the Benefit Dossier needs to be described. Because of the above, we do not support changing the definition of a primary endpoint after a study has been completed.

They found the upper limit of the CI close to 0. Authentic innovations which constitute real progress for patient care will increase. IQWiG has been dealing with this question since Journal of Clinical Epidemiology 54— 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.


If there is no such reference price group, the National Association of Statutory Health Insurance Funds GKV-Spitzenverband — GKV-SV negotiates with the pharmaceutical company on a refund rate which does not lead to higher annual therapy costs than the expedient comparative therapy. Consultation fees in accordance with SGB V, section 35a back to top Questions and answers on xmnog procedure Questions on the scope of application Questions on the special case of orphan drugs Questions on appropriate comparators Questions on compiling dossiers Questions on documents 20111 module 5 of the dossier Questions on submitting dossiers Questions on hearing procedures Questions on the handling of confidential annog Questions on the revisability of G-BA decisions Questions on price negotiations with statutory health insurance providers back to top.

IQWiG’s rationale is described briefly as below. For the cost-benefit evaluation, the Federal Joint Committee may agree with the pharmaceutical company on a period for submission of substantiating studies, which should preferably be carried out in Germany.

Grading quality of evidence and strength of recommendations.