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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If for active ingredients that are eligible for a fixed rate the additional benefit in accordance with section 35a of Book Five of the Social Code cannot be proven as a therapeutic improvement in accordance with section 35 section 1bsentences 1 to 5, of Book Five of the Social Code, the active ingredients are directly assigned to the existing fixed-rate group. To accelerate the search for and selection of external experts, as early as January the Institute started to establish a database for experts.

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. If an additional benefit is proven to exist, the National Association of Statutory Health Insurance Funds negotiates with the pharmaceutical company a supplement on top of the price of the expedient comparative therapy.

Hint weakest certainty of conclusions: An example for this difference is the decisions about Crizotinib. It is not an exception for a funding organisation to carry out remuneration negotiations on the object of the evaluations subsequently to the evaluation by the Federal Joint Committee, such as the National Association of Statutory Health Insurance Funds with the pharmaceutical company on medicinal products in the case of new active ingredients.

Legal foundations of IQWiG

This applies to primary and secondary endpoints, analysis methods, and the analysis sets. In this context the Institute must not only determine the probability, but also the extent of added benefit. Expensive marketing for spurious innovations in place of research for real innovations will no longer be worthwhile for the pharmaceutical companies. A medicinal product which wishes to distinguish itself from the expedient comparative therapy must exceed the benefit of this therapy, that is it must have an additional benefit in the stated categories.


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

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

– Legal foundations of IQWiG

Other countries are already doing this. The areas of disagreement included ACT selection, definition of subgroups and patient-relevant endpoints, and classification and balancing of adverse events. IQWiG concluded that there were significant and marginal additional benefits in six and three EBAs, respectively, and a non-quantifiable additional benefit was concluded in two assessments.

Until the AMNOG procedure has been completed, the price set by the pharmaceutical amnig itself applies to the new pharmaceutical for one year. 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.

It is however also possible to compare with non-treatment.

AMNOG – evaluation of new pharmaceutical – GKV-Spitzenverband

Accessed 10 Sep If the upper confidence limit is greater than 0. In contrast to the manufacturer, the G-BA did not consider that the statement by the regulatory bodies should be interpreted as proof of a major additional benefit [ 17 ]. The reduction in the confidence level should reflect the total number of events removed. Composite endpoints that have been traditionally used as the primary endpoints in many large registration trials anog now be questioned by IQWiG.

Federal Ministry of Health While a manufacturer can estimate the extent of additional benefit of a new substance over the comparator using indirect comparisons ICICs bear a high potential for bias.

The fixed rate is a maximum refund up to which the statutory health funds amnoy the costs of specific medicinal products prescribed by physicians. The number of healthcare systems that conduct health technology assessment HTA has steadily increased over the last decade.

We focus on seven areas: 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 amnig adverse reactions. Major added benefit over comparator 2: Adjusting for multiple testing—when and how?

AMNOG – evaluation of new pharmaceutical

The requirements on the upper limit to qualify for different categories of added benefit under different types of endpoints are given in Table 3. The pharmaceutical company can apply to the Federal Joint Committee for a renewed benefit evaluation if new scientific findings are available.


The Federal Joint Committee decides within another three months after publication how the patient-relevant additional benefit of the new medicinal product is to be classified. On the rare occasion when deviations from prespecified choices are necessary, we propose a general concept of adjusting the confidence level to amog confidence intervals for treatment effect on endpoints that do not have enough precision under the existing study design. The expectation of two large outcome trials is especially unrealistic for a new indication on mortality or severe morbidity for an approved drug.

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.

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. 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.

Patients and contributors of the statutory and private health insurance funds certainly benefit. Subsequently, further possibilities are open to the pharmaceutical company for contracting with individual health insurance funds section c of Book Five of the Social Code. In France, the transparency committee, as part of the National Authority for Health HASprovides guidance on the positive listing of drugs, taking 2102 account their comparative value and their role for the target disease.

Pharmaceutical Statistics 10— This creates a significant challenge for the manufacturer.

In this paper, we raised questions related to the implementation of AMNOG from an industry perspective. This came as no surprise to Kowa, as statins have been reference priced since in Germany.

Institute for Quality and Efficiency in Health Care concluded there was no additional benefit. Which specific advantages and disadvantages does the new drug have for patients? A framework to assess the value of application of formal criteria to check clinical relevance in RCTs as part of a benefit assessment strategy.