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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At federal level, the negotiated refund rate may be a,nog by selective contracts between individual health insurance funds or their associations, and the pharmaceutical companies. Assuming a survival endpoint with a true RR of 0. Access Health Policy 46 In a dossier assessment IQWiG evaluates the dossiers submitted with regard to their completeness of content, reliability, and the relevance of the information provided by the pharmaceutical companies.

PDF accessed 3 June Published online Jun 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.

Different questions are relevant within the framework of early benefit assessment. Lack of data could also result in downgrading. General Methods Version 4. There are many pharmaceuticals on the established market which the pharmaceutical companies are marketing as an alleged innovation.


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– Legal foundations of IQWiG

Adjusting for multiple testing—when and how? 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.

Come see our posters tomorrow at 8: Flow chart covering benefit assessment and price negotiation according to the new German regulations since January Either the medicinal product is allocated to the fixed-rate arrangement, or negotiations are carried out with regard to a refund rate in accordance with section b of Book Five of the Social Code.

In other words, a new treatment with a benefit on PFS and a noninferior benefit on OS relative to a control could be approved by regulators.

Since the introduction of the German health care reform in Januaryan early benefit assessment EBA is 212 for all new medicines.

Hint weakest certainty of conclusions: We understand that the magnitude of an observed treatment effect is also important to regulators when judging whether an observed benefit is clinically meaningful or not. The Federal Joint Committee defines the expedient comparative therapy according to transparent procedural criteria. Assessment and weighting of adverse events The EBA dossier submissions have to include all relevant safety data.

This is reflected in the assessment of the probability of an additional benefit. Journal of the American College of Cardiology 52— In this paper, we raised questions related to the implementation of AMNOG from an industry perspective.


Implementation of AMNOG: An industry perspective

The expectation of two large outcome trials is especially unrealistic for a new indication on mortality or severe morbidity for an approved drug.

If the cost of treatment exceeds a yearly turnover limit of 50 million euros in statutory health insurance, then the orphan drug is subject to the regular procedure of early benefit assessment. Here, the benefit in comparison to other medicinal products of a fixed-rate group takes on a major role in proving a therapeutic improvement. The analysis and interpretation of clinical trial results depends on the trial design, which includes a deliberation of primary and secondary endpoints.

The threshold changes over time based on multiple considerations including inflation.

IQWiG therefore developed a standardized questionnaire with which patients can at an early stage provide information on what is important to them with regard to the disease and its treatment. If a treatment effect is found to be statistically significant at the prespecified significance level, the treatment is said to be efficacious.

Discrepancies were observed in the interpretation of the value of surrogate endpoints reported in the EBAs of belatacept, boceprevir, telaprevir and HIV products [ 7 ].

Granting marketing authorisation to a drug implies a positive benefit-risk balance.