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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New response evaluation criteria in solid tumours: This refund rate may not lead to higher annual therapy costs than the expedient comparative therapy for medicinal products with no proven additional benefit.

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

We amnnog that the magnitude of an observed treatment effect is also important to regulators when judging whether an observed benefit is clinically meaningful or not. It takes its decisions on the basis of its Rules of Procedure. However, a considerable amount of experience has been gathered regarding the early part of the process, i.

For four new drugs azilsartan medoxomil, bromfenac, pitavastatin, regadenosonthe manufacturers did not submit a dossier, leading to a no additional benefit decision by the G-BA without an IQWiG evaluation [ 7 ].

– Legal foundations of IQWiG

The Board will determine the product price and the price will apply retroactively. There is also some debate over which endpoints should be considered anmog be relevant for patients. The assessment procedure is only complete with a formal decision by the G-BA on the added benefit and on the extent of added benefit.


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.

Safety endpoints such as adverse events may also be relevant.

Grading quality of evidence and strength of recommendations. Lack of data could also result in downgrading.

AMNOG – evaluation of new pharmaceutical

These questions must be answered by the pharmaceutical company in the form of a dossier. Because, previously, medicinal product prices in Germany have been higher than in most other EU States, legislature has provided that the actual sales price in other European countries is also to be taken into account in negotiations on the refund rate in accordance with section b of Book Five of the Social Code.

For example, in oncology there is a focus on survival benefit and measures of disease morbidity, such as progression-free or disease-free survival, while in virology, endpoints primarily address viral load and in rheumatology, clinical composite scores are the current standard.

In seven EBAs, there was evidence of an increased number or greater severity of adverse events, thus causing a greater negative outcome on the patient compared with the ACT. Recently, there has been a change to the rules in that Criterion 5 is used only for price negotiations, and not for determining the comparator.

Journal of the American College of Cardiology 52— All pharmaceutical companies can do this within four weeks of the publication of the resolution of the Federal Joint Committee. On the basis of the dossier, the Federal Joint Committee examines the additional benefit of the new medicinal product as described by the pharmaceutical company.

It is however also possible to compare with non-treatment. Whereas the studies presented by the manufacturer aamnog not accepted by IQWiG, G-BA decided to accept inclusion of the studies and concluded a significant amog benefit for belimumab [ 7 ]. Until the AMNOG procedure has been completed, the price set by the pharmaceutical company itself applies to the new pharmaceutical for one year. It may be assumed that G-BA would not consider a transient decrease in white blood cell count as patient relevant, whereas it would consider a symptomatic myocardial infarction to be patient relevant.


It also remains unclear under what circumstances a manufacturer may deviate from the assessment methodologies of IQWiG and G-BA, and to what extent benefit assessment will be penalised for such deviations. In the case of drugs for rare diseases orphan drugsthe approval of the drug is at the same time deemed to be proof of added benefit. Interview with Josef Hecken]. The sales prices communicated in the 15 countries are weighted according to their respective turnover and purchasing power using purchasing power parity.

AMNOG since 2011

Belimumab Institute for Quality and Efficiency in Health Care concluded no additional benefit, whereas G-BA concluded there was a significant additional benefit. Concerns that research results and innovations will pass Germany by are unfounded.

This article has been cited by other articles in PMC. Pharmaceutical companies will benefit from the new arrangements in the medium term.

This came as no surprise to Kowa, as statins have been reference priced since in Germany. Journal of Clinical Epidemiology 54— Who benefits from the refund rate negotiations? a,nog