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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The fixed rate is a maximum refund up to which the statutory health funds assume the costs of specific medicinal products prescribed by physicians. Grading quality of evidence and strength of recommendations. One of the tenets amnlg statistical principles in ICH E9 is prespecification.

Twenty-seven EBAs were analysed. Does it do justice to this task? Author information Article notes Copyright and License information Disclaimer.

We believe this is one area where we especially need our academic colleagues to join in and conduct research to provide more insight amnoy the choice of the comparative measure, thresholds to define benefit categories, one study against two studies, and how decisions on these issues will impact the design and analysis of registration trials.

The analysis and interpretation of clinical trial results depends on the trial design, which includes a deliberation of primary and secondary endpoints.

Open in a separate window. G-BA agreed with these seven decisions and, in addition, concluded that belatacept, belimumab and the extract of Cannabis amnov had additional benefits on morbidity [ 7 ]. A medicinal product which wishes to distinguish itself from the expedient comparative therapy must exceed the benefit of this therapy, that is it must amnkg an additional benefit in the stated categories. Study populations were divided into subgroups more frequently by IQWiG than by the manufacturers.

A lower confidence level could mitigate the increase in variance due to a reduction in the number of events in the two groups.

The refund rates which were negotiated apply from the first day of the 13th month after first anog launched on the market. This came anmog no surprise to Kowa, as statins have been reference priced since in Germany.

Therefore, reducing the number of events in the groups by removing a component from the composite endpoint leads to a larger variance for the log hazard ratio estimate and a wider confidence interval for the log hazard ratio.


AMNOG – evaluation of new pharmaceutical

We invite our academic colleagues to conduct research to decide if this could be a viable alternative. Once this sales threshold is exceeded, orphan drugs are assessed as conventional drugs [ 6 ]. For medicinal products with no proven additional benefit, the National Association of Statutory Health Insurance Funds negotiates a refund rate with the pharmaceutical company in accordance with section b of Book Five of the Social Code.

Sadly for the industry, first outcomes confirm the G-BA’s tough approach towards innovation, and show how difficult it is to succeed in the delicate task of selecting an appropriate comparator. Unlike in most European countries, statutory health insurance previously had to accept any price that was demanded for new products, regardless of whether or not the active ingredient was a gain for patients.

So far, only very few ammog products have passed through the full AMNOG process, including 2021 negotiations. An example for this difference is the decisions about Crizotinib.

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

When conducting benefit assessments, we prefer following prespecified rules to protect the integrity of the statistical inference. If the cost of treatment exceeds a yearly turnover limit of xmnog million euros in statutory health insurance, then the orphan drug is subject to the regular procedure of early benefit assessment. For medicinal products which cannot be directly included in the fixed-rate arrangement, the National Association of Statutory Health Insurance Funds then negotiates with the pharmaceutical company on a refund rate.

It is hoped that discrepancies concerning the comparators used for phase III qmnog studies and benefit assessments, as well as discrepancies regarding the selection of patient-relevant endpoints, will diminish over time as a result of this initiative.

Institute for Quality and Efficiency in Health Care suggested a major additional benefit in terms of smnog. AMNOG requires subgroup analyses for age, gender and other possible effect modifiers.

Primary and secondary endpoints Ammog analysis and interpretation of clinical trial results depends on the trial design, which includes a deliberation of primary and secondary endpoints. The advantage of this approach is that, even with a lower confidence level, the point estimate for the additional benefit still needs to be of a certain magnitude for the confidence interval to meet the efficacy requirements.


After evaluation of the new data G-BA concluded there was a marginal additional benefit. Assessment and weighting of adverse events The Amhog dossier submissions have to include all relevant safety data. Published online Jun Balancing benefit and risk is a key feature of the EMA review process. This actual sales price includes statutory and voluntary discounts. What essential criteria are clarified in advance of the individual refund rate negotiations?

This evaluation does not influence the benefit level of the products before the gap. An ACT is used to determine the additional benefit amog the new medication. Guideline on the evaluation of anticancer medicinal products in man.

AMNOG – evaluation of new pharmaceutical – GKV-Spitzenverband

When a new treatment is associated with more adverse reactions than the comparator, the benefit category could be downgraded by 1 or 2 levels, based on the severity and seriousness of the adverse reactions. Where medicinal products offer no additional benefit and cannot be assigned to an existing fixed-rate amngo, the price level will also be limited since the refund rate may not lead to higher annual therapy costs than those of the expedient comparative therapy.

This will be taken into consideration during price negotiations. The legislature has almost completely restricted an exclusion procedure based on a lack of economic viability.

In the third year of early benefit assessments IQWiG determined the highest category of benefit for the first time, and in several cases. A framework to assess the value of application of formal criteria to check clinical relevance in RCTs as part of a benefit assessment strategy.

Adjusting for multiple testing—when and how? 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.

When it comes to approval, however, only effectiveness, quality and safety are examined and the market launch is regulated by weighing up benefits and risks.