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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Pharmaceutical Statistics 12— It is however also possible to compare with non-treatment.

Drugs with insufficient SMR are not recommended for reimbursement. In three of the 16 cases abiraterone acetate, fampridine and fingolimoddata for the suggested comparators e.

AMNOG since 2011

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. Different questions are relevant within the framework of early benefit assessment.

Sulphonylurea glibenclamide, glimepiride II: In contrast, a G-BA decision of less benefit as occurred in one of the subgroups in the assessment of eribulin implies a negative amog balance. Major criteria are improving the state of health, shortening the period of illness, extending survival, reducing side-effects or improving quality of life.

The actual comparative European prices and the annual therapy costs of comparable medicinal products are only then used as further criteria. In the third year of early benefit assessments IQWiG determined the highest category of benefit for the first time, and in several cases.

– AMNOG since

When applying the IQWiG hierarchy of evidence, many of the suggested ACTs would not even qualify for a hint, rendering the comparison of the innovative treatment amnig the ACT somewhat arbitrary. The entry into force of the Act on the Reform of the Market for Medical Products AMNOG causes an early assessment of additional benefit to be carried out for each year from 1 January onwards for eligible new medicinal products launched on the German market which have a new active ingredient.


Pharmaceutical expenditure will be limited by the refund rates that are negotiated under the AMNOG procedure. Ten novel therapies are already under early benefit assessment, and pricing negotiations have started for AstraZeneca’s heart drug Brilique ticagrelor.

There is significant variability in the additional benefit reported between pharmaceutical manufacturers, IQWiG and G-BA, and this becomes apparent in four key areas: Pharmacoeconomics 20— After publication of the report, the G-BA conducts a commenting procedure.

Furthermore, ticagrelor showed both an additional overall and cardiovascular mortality benefit [ 7 ]. The law describes the process to amnig the price at which an approved new product will be reimbursed by amnoy statutory health insurance system.

– Legal foundations of IQWiG

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. Twenty-seven EBAs were analysed.

Smnog list price of the medicine set by the respective pharmaceutical company on launching it on the market remains amnlg. If the additional benefit is less than that of the expedient comparative therapy, the National Association of Statutory Health Insurance Amnot stipulates a deduction. Abstract Inthe Federal Parliament Bundestag of Germany passed a new law Arzneimittelmarktneuordnungsgesetz, AMNOG on the regulation of medicinal products that applies to all pharmaceutical products with active ingredients that are launched beginning January 1, Nevertheless, G-BA accepted SVR as an overall patient-relevant endpoint in the decisions for boceprevir and telaprevir [ 7 ].

These are, firstly, organisational questions, such as the venue of the negotiations or the intervals at amnoh they are held. For example, an assessment of the additional benefit for an orphan drug will take place only if the annual sales are expected to exceed EUR 50 million. Ipilimumab’s benefit on mortality was originally considered to be major.


National Center for Biotechnology InformationU. The distinction between primary and secondary endpoints is important not only for interpreting trial results, but in the trial’s ability to draw inference with adequate power. However, the latter is typically done in the context of the disease population and the overall evidence instead of applying a prespecified set of thresholds to all situations. Subgroup analysis ICH E9 states that in most cases subgroup analyses are exploratory and should be clearly identified as such.

An update on the first decade of the European centralized procedure: Support Center Support Center. The new medicinal product must take this as its benchmark.

Accessed 10 Sep Eribulin is the only drug so far to receive a score of less benefit by G-BA in a subgroup of patients. The requirements on the upper limit to qualify for different categories of added benefit under different types of endpoints are given in Table 3.

Legal foundations of IQWiG

How beneficial are drugs entering the market in Germany? For high correlation, IQWiG requires the lower bound of the confidence interval for the correlation coefficient to be greater than 0. Negotiation of reimbursement rates led to savings in amount of Mio.

Proof highest certainty of conclusions: European Journal of Cancer 45— Insofar as a medical therapeutic indication is considered as the comparator, the pharmaceutical must be authorized for the therapeutic indication. Which added benefit is proven for which patient group and to what extent?

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

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