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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Redefining a composite endpoint after the study was completed is problematic from a manufacturer’s perspective. Requirements for the assessment of level of evidence for an additional benefit [ 4 ]. If amnlg 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.

Combination of ACE-inhibitor lisinoprile or ramiprile or enalaprile and calcium-antagonist amlodipine or nitrendipine. Process of early benefit assessment at the G-BA.

Implementation of AMNOG: An industry perspective

Product price, as a discount on the sales price set by the manufacturer, has to be negotiated within 6 months. The G-BA website http: The standard in an area of application does not necessarily have to be a medicinal product from the same class of active ingredients. In six of the 12 cases where the comparator used in the phase III trials differed from the ACT recommended by G-BA, the manufacturer included an indirect comparison of data from two separate trials in the dossier.

Subgroup analyses are conducted to explore, rather than confirm, the uniformity of an observed overall treatment effect.

Legal foundations of IQWiG

The benefit of the medicinal product to be assessed is smaller than the benefit of the appropriate comparative therapy. In both cases, the Federal Joint Committee drafts a resolution forming the basis for negotiations on a refund rate between the National Association of Statutory Health Insurance Funds and the pharmaceutical company.


Categorisation and balancing of adverse events was conducted within various assessments. Fewer adverse events compared with the ACT is considered an additional benefit of the new medicine.

G-BA is now reassessing linagliptin. A framework to assess the value of application of formal criteria to check clinical relevance in RCTs as part of a benefit assessment strategy. Pharmaceutical manufacturers have to submit a benefit dossier to the Federal Joint Committee Gemeinsamer Bundesausschuss, G-BAthe key legal institution of the self-administration within the German health care system, before the medicine is made commercially available in Germany.

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. The process consists of two phases. What essential criteria are clarified in advance of the individual refund rate negotiations?

Is it really better than the treatments already on the market? National Center for Biotechnology InformationU. As described in the EMA benefit-risk programme [ 19 ], regulatory bodies put enormous emphasis on the appropriate classification of adverse events and on the balancing of risks and benefits. The number of healthcare systems that conduct health technology assessment HTA has steadily increased over the last decade. After evaluation of the new aknog G-BA concluded there was a marginal additional benefit.

Implementation of AMNOG: An industry perspective

All pharmaceutical companies can do this a,nog four weeks of the publication of the resolution of the Federal Joint Committee. As in all IQWiG reports, the patient perspective also plays a key role in early benefit assessments.

Inthe Federal Parliament Bundestag of Germany passed a new law Amnot, AMNOG on the regulation of medicinal products that applies to all pharmaceutical products with active ingredients that are launched beginning January 1, However, a considerable amount of experience has been gathered regarding the early part of the process, i.


In case of different subgroups within an EBA, the best subgroup assessment was used Information on http: 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.

What is the starting point for the refund rate negotiations? Archives of Internal Medicine— Proof highest certainty of conclusions: It takes its decisions on the basis of its Rules of Procedure. Both total benefit scores and subgroup scores were included in the analysis. Lower expenditure on medicinal products with no additional benefit means that the probability of additional contributions and contribution increases falls.

The level of additional benefit versus the ACT is categorised as: Primary and secondary endpoints The analysis and interpretation of clinical trial results depends on the trial design, which includes a deliberation of primary and secondary endpoints. We have proposed some possible alternatives in Section 2. In France, the transparency committee, as part of the Among Authority anmog Health HASprovides guidance on the positive listing of drugs, taking into account their comparative value and their role for the target disease.

The Board will determine the product price and the price will apply retroactively.

As the first orphan drug, ruxolitinib exceeded the threshold of 50 million euros in The areas of amnoog included ACT selection, definition of subgroups and patient-relevant endpoints, and classification and balancing of adverse events.

In this context the Institute must not only determine the probability, but also the extent of added benefit.