The Pharmaceuticals Market Reorganisation Act (Arzneimittelmarkt- Neuordnungsgesetz – AMNOG) of 22 December aims to limit the cost. The early benefit assessment, the core of AMNOG, brought new challenges for . an analysis of the dossier assessments completed up to the end of June The Act on the Reform of the Market for Medicinal Products (AMNOG) and the Regulation on the Benefit Assessment of Drugs (AM-NutzenV) form the legal basis.

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Requirements for the assessment of level of evidence for an additional benefit [ 4 ].

Proof highest certainty of conclusions: Whereas IQWiG uses a threshold concept to define the impact that leads to a major, significant or marginal additional benefit [ 16 ], G-BA did not use this concept for its decisions.

However, the definition of BSC varied considerably. While these endpoints have become established and recognised by the regulatory bodies, they are not necessarily accepted by HTA bodies. For example, PFS was not considered a relevant 20112 in the assessment of various oncology drugs e. For this, the pharmaceutical company provides the National Association of Statutory Health Insurance Funds with the individual prices of all medicinal 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.

Pharmaceutical expenditure will be limited by the refund rates that are negotiated under the AMNOG procedure. The expedient comparative therapy is the generally-recognised standard therapy in the respective area of application. If amnoy are several indications, several comparative therapies may also be defined. Results Twenty-seven EBAs were analysed. An alignment of regulatory and G-BA approaches therefore seems critical to provide patients with a clear understanding of the benefit-risk ratio.

Process of early benefit assessment at the G-BA. Insofar as a ammog therapeutic indication is considered as the comparator, the pharmaceutical must be authorized for the therapeutic indication. The pharmaceutical company can apply to the Federal Joint Committee for a renewed benefit evaluation if new scientific findings are available.


AMNOG One Year On: How Will German Health Reform Impact Pharma Market Access in 2012?

Accessed 10 Oct Therefore, alternative methods of evidence generation have to be developed and applied 201 take into account clinical aspects, such as manageability and reversibility of adverse events.

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 amnogg ingredients that are launched beginning January 1, The definition of an innovative medicine according to AMNOG includes additional benefit for patients in comparison with existing treatments.

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.

An advantage of Table 3 amnoog its transparency in that a manufacturer knows what to expect. In this context the Institute must not only determine the probability, but also the extent of added benefit.

AMNOG – evaluation of new pharmaceutical

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. Prior to this, the companies in question may make a statement in a written and oral statement procedure. If no agreement can be reached within six months on a refund rate between the National Association of Statutory Health Insurance Funds and the pharmaceutical company, the proceedings go to arbitration.

There is significant variability in the additional benefit reported between pharmaceutical manufacturers, IQWiG and G-BA, and this becomes apparent in four key areas: The aim of our investigation was to analyse manog outcomes 18 month after introducing the new legislation and to identify critical areas that require further discussion and development. Accordingly, in the early benefit evaluation, new medicinal products that are comparable in pharmacological and therapeutic terms with fixed-rate medicinal products are directly evaluated within a fixed-rate context section 35a subsection 1sentence 4, of Book Five of the Social Code.


See our research from… https: Whilst the early amnnog 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.

Combination of ACE-inhibitor lisinoprile or ramiprile or enalaprile and calcium-antagonist amlodipine or nitrendipine.

AMNOG One Year On: How Will German Health Reform Impact Pharma Market Access in ?

The hope remains, however, that increased experience [ 21 ] and earlier interaction between manufacturers, regulatory authorities, and HTA authorities, may encourage more streamlined and integrated regulatory and HTA programmes. The situation is especially problematic when there is among one large registration trial. The Act hence obliges pharmaceutical companies to subject their new products to an early evaluation of their additional benefit by the Federal Joint Committee Gemeinsamer Bundesausschuss — G-BA after being launched on the market.

Balancing benefit and risk is a key feature of the EMA review process. This ambog sales price includes statutory amnpg voluntary discounts. One of the tenets of statistical principles in ICH E9 is prespecification. If there is no expedient comparative therapy with medicinal products, non-drug therapies can also be considered if they are eligible as benefits under statutory health insurance.

This criterion applies to price negotiations only.