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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This means that the additional benefit is to be proven as a therapeutic improvement within the meaning of the fixed-rate arrangement. If turnover is higher, the pharmaceutical companies need to prove an additional benefit amnnog such orphan drugs too.

What is the starting point for the refund rate negotiations? All EBAs commenced prior to June were included.

– AMNOG since

This refund rate may not lead to higher annual therapy costs than the expedient comparative therapy for medicinal products with no amnlg additional benefit.

Flu-like symptoms were improved by fingolimod, resulting in an elevated benefit score [ 7 ] Fig. Insofar as a nonmedicinal treatment is considered as the comparator, this must be deliverable within the framework of the statutory health insurance.

Placebo alone or add on to metformin, 2021 combination of metformin plus sulphonylurea or pioglitazone. For one thing, if margins are to be used, they should be chosen to reflect the indications and the patient populations.

AMNOG since 2011

They determined that 13 of the first 21 dossiers contained high-quality data on patient-relevant outcomes; these data allowed the assessment of added benefit in at least one group of patients. Sulphonylurea glibenclamide, glimepiride II: All pharmaceutical companies can do this within four weeks of the publication of the resolution of the Federal Joint Committee.


G-BA agreed with these seven decisions and, in addition, concluded that belatacept, belimumab and the amnov of Cannabis sativa had additional benefits on morbidity [ 7 ].


Hint weakest certainty of conclusions: The ajnog could also depend on a patient’s disease state prior to initiating a new treatment. However, such endpoints may be very valuable in detecting changes in morbidity before they become symptomatic for patients i. For products at the end of the arrows this evaluation leads to an up- and downgrade, respectively.

Whereas IQWiG uses a threshold concept to define the impact that leads to a major, significant or marginal additional benefit [ 16 ], G-BA did not use this concept for its decisions.

The chart below shows the added therapeutic benefit scores granted by IQWiG to new medicines so far. We invite our academic colleagues to conduct research to decide if this could be a viable alternative. The additional benefit of rilpivirine was based entirely on the reduction of neurological adverse events [ 212 ].

Amnpg 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. Other countries are already doing this. In case of different subgroups within an EBA, the best subgroup assessment was used Information on http: If it is not possible for an additional benefit to be proven as a therapeutic improvement for active ingredients which are eligible for the fixed rate, the active ingredients are directly assigned to the existing fixed-rate group.


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

The process consists of two phases. Second, an indirect comparison that preserves study randomization may not be possible. Federal Ministry of Health This creates a significant challenge for the manufacturer.

What essential criteria are clarified in advance of the individual refund rate negotiations? After publication of the report, the G-BA conducts a commenting procedure.

This evaluation does not influence the benefit level of the products before the gap. 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 ?

As for secondary endpoints, ICH E9 states that their predefinition in the protocol is also important. Statistical Methods in Medical Research 17— The AMNOG procedure can also be discontinued by the pharmaceutical company ammnog the market launch and benefit evaluation, so that no refund rate is brought about.

For this, the pharmaceutical company provides the National Zmnog of Statutory Health Insurance Funds with the individual prices of all medicinal product packages, not including value-added tax, which are received by the pharmaceutical company if the discounts which it voluntarily grants or which it has to grant are taken into account. Assessment of actual benefits of new drugs by the Transparency Committee.