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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Granting marketing authorisation to a drug implies a positive benefit-risk balance. No assessment along these social law criteria additional benefit is carried out on approval.

All resolutions that are adopted, including the summary scientific and legal evaluation, the discussions, as well as the debate with the arguments put forward in the statement procedure, are retrievable on the Internet site of the Federal Joint Committee.

The benefit of a medicinal 202 is understood to mean its therapeutic effect as relevant to patients. Accessed 29 Jun Here, the benefit in comparison to other medicinal products of a fixed-rate group takes on a major role in proving a therapeutic improvement.

The manufacturer may request an advice meeting with the G-BA in order to determine the appropriate comparative therapy ACT and address any other relevant questions.

Proof highest certainty of conclusions: Accessed 4 Jan Many of our comments relate to the scientific basis for making pricing and reimbursement decisions. However, such endpoints may be very valuable in detecting changes in morbidity before they become symptomatic for patients i. It issues directives for anog benefit catalog of the statutory health insurance funds and specifies measures for quality assurance in inpatient and outpatient areas of the healthcare system. Institute for Quality and Efficiency in Health Care suggested a major additional benefit in terms of efficacy.

Statistical Methods in Medical Research 17— The upper limit of the CI for such an endpoint needs to be 0. G-BA also reduced the total additional benefit score by one level due to the side-effect profile. Both total benefit scores and subgroup scores were included in the analysis.


When conducting benefit assessments, we prefer following prespecified rules to protect the integrity of the statistical inference. Combination of ACE-inhibitor lisinoprile or ramiprile or enalaprile and calcium-antagonist amlodipine or nitrendipine. During these 12 months, the manufacturer can set the price for the product. Fewer adverse events compared with the ACT is considered an additional benefit of the new medicine. On the rare occasions when a component of a composite endpoint is removed, we propose in Section 2.

AMNOG – evaluation of new pharmaceutical

Stable contributions for the community of insured parties among a major asset. If turnover is higher, the pharmaceutical companies need to prove an additional benefit for such orphan drugs too. Significant added benefit 3: 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.

Pharmaceutical Statistics 12— Additional discussions on the use of formal criteria to check clinical relevance in amnoy clinical trials as part of a benefit assessment strategy is given by Vach and Gladstone The Institute for Quality and Efficiency in Health Care IQWiG is an independent specialist scientific institution studying matters that are of fundamental significance for quality and efficiency within statutory health insurance according to the standards of evidence-based medicine.

Therefore, alternative methods of evidence generation have to be developed and applied that take into account clinical aspects, such as manageability and reversibility of adverse events.

One year on, and only ten new therapies have gone through anmog benefit assessment. Lack of data could also result in downgrading. The pharmaceutical company has a right to consult on the dossier with the Federal Joint Committee at an early date e.

For example, in oncology there is a focus on survival benefit 20122 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 accordance with the framework agreement, the refund rate is agreed in the event of an additional benefit by a supplement on the annual therapy costs of the expedient comparative therapy.

For example, PFS was not considered a relevant endpoint in the assessment of various oncology drugs e. Abstract 20012the 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, A framework to assess the value of application of formal criteria to check clinical relevance in RCTs as part of a benefit assessment strategy.


National Center for Biotechnology InformationU. The same approach could be considered when another endpoint is used to make the benefit decision. The endpoints in clinical trials differ across disease areas. The conclusions of IQWiG and G-BA on adverse events were sometimes related amnoy subgroup analyses belatacept, boceprevir, fingolimod and telaprevir [ 7 ].

It would be an exaggeration to portray this withdrawal of the pharmaceutical companies as a risk that Germany might no longer be supplied with modern medicinal products. wmnog

AMNOG – evaluation of new pharmaceutical – GKV-Spitzenverband

Patient representatives take part in the decisions in an advisory capacity. The assessment procedure is only complete with a formal decision by the G-BA on the annog benefit and on the extent of added benefit.

Open in a separate window. The Federal Joint Committee is the highest decision-making body of the joint self-government of physicians, dentists, psychotherapists, hospitals and health insurance funds in Germany. The comparative measure is the relative risk for an undesirable outcome between the new treatment and the comparator. Indication medium certainty of conclusions: The reduction in the confidence level should reflect the total number of events removed. Amno for multiple testing—when and how?

Similarly, SVR is a marker of hepatitis C manog that may detect changes in disease severity, even before they become symptomatic.

The G-BA reported no benefits on health-related quality of life. Eribulin is amnoh only drug so far to receive a score of less benefit by G-BA in a subgroup of patients. Received Oct 24; Accepted May The process consists of two phases.

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