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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However, the definition of BSC varied considerably. The number of healthcare systems that conduct health technology assessment HTA has steadily increased over the last decade. This refund rate may not lead to higher annual therapy costs than the expedient comparative therapy for medicinal products with no proven additional benefit.

The legislature has almost completely restricted an exclusion procedure based on a lack of economic viability. The advantage of this amno 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.

Price negotiations take place during the second phase. Flow chart covering benefit assessment and price negotiation according to the new German regulations since January ACT selection, subgroup definition, definition of patient-relevant endpoints mortality, morbidity and HRQoLand the impact amnob selected adverse events on benefit assessment.

Either the medicinal product is allocated to the fixed-rate arrangement, or negotiations are carried out with regard to manog refund rate in accordance with section b of Book Five of the Social Code. For high correlation, IQWiG requires the lower bound of the confidence interval for the correlation coefficient to be greater than 0.

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

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. In addition, some further aspects have to be taken into account when interpreting the results.


Furthermore, pharmaceutical companies will now be virtually free of the risk of their products not being eligible for refund by the statutory health insurance. 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. This means that the additional benefit is to be proven as a therapeutic wmnog within the meaning of the fixed-rate arrangement.

We prefer that the original choices of endpoints in a trial be used in IQWiG’s benefit assessment. The Act on the Reform of the Market for Medical Products Arzneimittelmarkt-Neuordnungsgesetz — AMNOG of 22 December aims to limit the cost of pharmaceuticals, which has risen considerably in recent years particularly in amng market segment which was previously exempt from reference prices.

Fewer adverse events compared with the ACT is considered an additional benefit of the new medicine.

Additional discussions on the use of formal criteria to check clinical relevance in randomized clinical trials as part of 20112 benefit assessment strategy is given by Vach and Gladstone For one thing, if amnoy are to be used, they should be chosen to reflect the indications and the patient populations.

Stable contributions for the community of insured parties are a major asset. Categorisation and balancing of adverse events was conducted within various assessments.

AMNOG – evaluation of new pharmaceutical – GKV-Spitzenverband

In Octoberone year after publication of the first early benefit assessment, IQWiG staff members published an analysis of the dossier assessments amng up to the end of June Composite endpoints that have been traditionally used as the primary endpoints in many large registration trials can now be questioned by IQWiG.

The refund rates which were negotiated apply from the first day of the 13th month after first being launched on the market. In both cases, the decisions did not seem to weigh adverse reaction data in a quantitative analysis.

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. Federal Ministry of Health The standard in an area of application does not necessarily have to be a medicinal product from the same class of active ingredients.


The anmog of two large outcome trials is especially unrealistic for a new indication on mortality or severe morbidity for an approved drug. Second, the margins are based on a relative risk measure. A lower confidence level could mitigate the increase in variance due to a reduction in the number of events in the two groups.

Insofar as a medical therapeutic indication is considered as the comparator, the pharmaceutical must be authorized for the therapeutic indication. We hope IQWiG would be open to such an addition.

Implementation of AMNOG: An industry perspective

The Federal Ministry of Health: We propose alternative approaches to address the requirements in some cases and invite other researchers to help develop solutions in other cases. Additionally, the study population that was used for indirect comparison included patients with lower degrees of disability than the values required for treatment with fampridine.

Accessed 10 Oct There are many pharmaceuticals on the established market which the pharmaceutical companies are marketing as an alleged innovation. The Federal Joint Committee decides within another three months after publication how the patient-relevant additional benefit of the new medicinal product is ambog be classified. We discuss these issues from an industry perspective.

Since the introduction of the German health care reform in Amongan early benefit assessment EBA is required for all new medicines. First, regulatory approvals for conditions with unmet amog needs may be based solely on single arm studies. The Board will determine the product price and the price will apply retroactively. All resolutions that are adopted, including the summary scientific and legal evaluation, the discussions, as well as the debate with the arguments put forward in the statement procedure, are retrievable on the Internet site of the Federal Joint Committee.

For example, PFS was not considered a relevant endpoint in the assessment of various oncology drugs e.