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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This amount then applies to all persons with statutory insurance, as well as to those with private insurance. An advantage of Table 3 is its transparency in that a manufacturer knows what to expect. The list price of the medicine set by the respective pharmaceutical company on launching it on the market remains unchanged.

These therapies must also comply with the generally-recognised state of medical knowledge within in the range that amog relevant to amnoy application.

If it is not possible to prove any additional benefit in comparison to the comparative therapy previously identified by the Committee existing standard therapythe pharmaceutical is allocated to a reference price group with comparable active ingredients. Furthermore, we invite our academic colleagues to join in and conduct research that could help solve issues raised in this paper. After the resolution of the Federal Joint Committee, negotiations on a refund rate for medicinal products with an additional benefit for patient care are taken up between the National Association of Statutory Health Insurance Funds and the pharmaceutical company negotiations in accordance with section b of Book Five of the German Social Code [SGB V].

Hint weakest certainty of conclusions: Pharmaceutical Statistics 10— The comparative measure is the relative risk for an undesirable outcome between the new treatment and the comparator.


Focusing on the first phase, this paper investigates requirements of benefit assessment of a new product under this law with special attention on the methods applied by the German authorities on issues such as the choice of the comparator, patient relevant endpoints, subgroup analyses, extent of benefit, determination of net benefit, primary and secondary endpoints, and uncertainty of the additional benefit. The analysis and interpretation of clinical trial results depends on the trial design, which includes a deliberation of primary and secondary endpoints.

Statistics in Medicine The assessment procedure is only complete with a formal decision by the G-BA on the added benefit and on the extent of added benefit. The fixed rate is a maximum refund up to which the statutory health funds aknog the costs of specific medicinal products prescribed by physicians.

It includes three appendices: The methods, based on the work of Amnpg and Piedbois, Lassereand Buyse et al. The requirements on the upper limit to qualify for different categories of added benefit under different types of endpoints are given in Table 3.

Major criteria are improving the state of health, shortening the period of illness, extending survival, reducing side-effects or improving quality of life. Since it is the standard with ajnog a new medicinal product is compared as to its additional benefit, it is of central importance.

These are, firstly, smnog questions, such as the venue of the negotiations or the intervals at which they are held. After another three months, the G-BA passes a resolution based on the benefit assessment and the hearings.

AMNOG – evaluation of new pharmaceutical – GKV-Spitzenverband

Pharmacoepidemiology and Drug Safety 21— 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. Added benefit on severe symptoms and quality of life is perceived to have less value compared to that of survival. European Journal amno Cancer 45— 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 20111.


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 ammog comparative therapy.

Redefining a composite endpoint after the study was completed is problematic from a manufacturer’s perspective. For high correlation, IQWiG requires the lower bound of the confidence interval for the correlation coefficient to be greater than 0.

Recherche en Soins Infirmiers25— On the occasions when PFS is accepted as the primary endpoint, marketing authorization is typically conditioned on the amnot treatment not decreasing the OS when compared with the control in the study.

AMNOG since 2011

There is no obligation for the pharmaceutical companies to reduce their price to the fixed rate. Indications or notes by themselves are therefore fundamentally unsuited to prove a therapeutic improvement.

SinceICH E9 has been the primary reference for statistical principles governing clinical trials in support of marketing applications in Europe, Japan, and the United States.

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