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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General Methods Version 4. The latter is the case if no suitable reference price group exists. If a treatment effect is found to be statistically significant at the prespecified significance level, the treatment is said to be efficacious. The quality of the studies and data included annog the Benefit Dossier needs to be described.

For example, an assessment of the additional benefit for an orphan drug will take place only if the annual sales are expected to exceed Amnov 50 million.

Implementation of AMNOG: An industry perspective

It is decisive for an evaluation of established market products whether the pharmaceuticals are significant for statutory health insurance or are in competition with pharmaceuticals which have already been evaluated. It describes clearly the standards for proof of additional benefit, for determining the appropriate comparator, and for the dossier submitted by the pharmaceutical company. By submitting our proposals, 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.

Value in Health 15A The situation is especially problematic when there is only one large registration trial. The Act hence obliges pharmaceutical companies to subject their new products to an early evaluation of their additional benefit, to be carried out by the Federal Joint Committee, after being launched on the market.

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 therapy.


This amount then applies to all persons with statutory insurance, as well as to those with private insurance. Validity of surrogate endpoints in oncology Version 1. Here you will find: 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, It completely revises pricing regulations for newly authorized pharmaceuticals and their reimbursement by statutory health insurance providers.

Pharmaceutical companies may submit the dossier to the G-BA in advance for the purpose of a check for formal completeness without regard todata contents. When conducting benefit assessments, we prefer following prespecified rules to protect the integrity of the statistical inference.

If several alternatives for the expedient comparative therapy are identified, the refund rate may not lead to higher annual therapy costs than those of the most economical alternative.

Where necessary, the G-BA will then give comments in writing to the company which additional documents or information is required. However, other medicinal products of the same fixed-rate group are available in such a case for patient care at the fixed rate or lower.

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.

Strong control over multiple endpoints: Pharmaceutical companies can send any questions they may have regarding the G-BA consultation procedure among the following email address: The Federal Joint Committee is the highest decision-making body of the joint self-government of physicians, dentists, psychotherapists, hospitals and health insurance funds in Germany.

Since it is the standard with which a new medicinal product is compared as to its additional benefit, it is of central importance. 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. The approach has been criticized by some researchers e.


Only the German versions are binding. The pharmaceutical company must send these documents, including all clinical trials it has commissioned or carried out, to the G-BA in electronic form no later than the day the pharmaceutical is first brought into circulation. These therapies must also comply with the generally-recognised state of medical knowledge within in the range that is relevant to the application.

AMNOG and the German Reforms: What Will Change? | eyeforpharma

Both statutory and private health insurers can presume in future that high 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.

Guideline on the evaluation of anticancer medicinal products zmnog man.

Process of early benefit assessment at the G-BA. Subgroup analysis ICH E9 states that in most cases subgroup analyses are exploratory and should be clearly identified as such.

Concerns that research results and innovations will pass Ammnog by are unfounded. Third, the margins are based on the expectation of two large studies. The process to determine reimbursement decisions under the new law consists of two phases and is described in Fig.

AMNOG – evaluation of new pharmaceutical

On the rare occasion when deviations from prespecified choices are necessary, we propose a general concept of adjusting the confidence level to construct confidence intervals for treatment effect on endpoints that do not have enough precision under the existing study design. Because of the above, we do not support changing the definition of a primary endpoint after a study has been completed.

They determined that 13 of the first 21 dossiers contained high-quality data on patient-relevant outcomes; these data allowed amnnog assessment of added benefit in at least one group of patients.