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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Belimumab Institute for Quality and Efficiency in Health Care concluded no additional benefit, whereas G-BA concluded there was a significant additional benefit.

Patients and contributors of the statutory and private health insurance funds certainly benefit. 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.

Subsequently, further possibilities are open to the pharmaceutical company for contracting with individual health insurance funds section c of Book Five of the Social Code.

The G-BA has to further define and clarify its categorisation of adverse events [ 12 ] beyond the definition used by the EMA. SinceICH E9 has been the primary reference for statistical principles governing clinical trials in support of marketing applications in Europe, Japan, and the United States. International reference pricing of pharmaceuticals: 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.

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. 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.


Statistical evaluation of surrogate endpoints with examples from cancer clinical trials. The benefit of a medicinal product is understood to mean its therapeutic effect as relevant to patients.

Implementation of AMNOG: An industry perspective

In contrast, a G-BA decision of less benefit as occurred in one of the subgroups in the assessment of eribulin implies a negative benefit-risk balance.

In this section, we will discuss seven issues on how benefit assessments are conducted, based on our understanding of how the new law is implemented.

Lack of data could also result in downgrading. In both cases, the decisions did not seem to weigh adverse reaction data in a quantitative analysis. Lower expenditure on medicinal products with no additional benefit means that the probability of additional contributions and contribution increases falls.

AMNOG since 2011

Major criteria are improving the state of health, shortening the period of illness, extending survival, reducing side-effects or improving quality of life. For example, physiotherapy was selected as the comparator for the multiple amnof drug fampridine [ 7 ] despite amng lack of evidence from clinical trials amnnog physiotherapy offers a statistically significant benefit. The number of healthcare systems that conduct health technology assessment HTA has steadily increased over the last decade.

Prior to this, the companies in question may make a statement in a written and oral statement procedure. New medicinal products with new active ingredients which are comparable in pharmacological and therapeutic terms with fixed-rate medicinal products are directly included here in existing fixed-rate groups where the additional benefit was not demonstrated as a therapeutic improvement within the meaning of the fixed-rate arrangement.

The manufacturer of belatacept reported the glomerular filtration rate GFR as a surrogate endpoint for graft function; however, IQWiG did not consider GFR to be a patient-relevant endpoint, stating that it needs further validation in order to be accepted. All EBAs commenced prior to June were included. If a treatment effect is found to be statistically significant at the prespecified significance level, the treatment is said to be efficacious.


Journal of Clinical Epidemiology 54— Accessed 4 Sep What is meant by expedient comparative therapy, and why is it important?

– Legal foundations of IQWiG

It should be mentioned that G-BA has not assigned the category of major additional benefit annog any single drug evaluated so far, and it is therefore unclear what impact a drug would need to have in order for G-BA to consider it as having a amno additional benefit.

If several alternatives for the expedient comparative therapy are identified, the refund rate may not lead to higher annual therapy costs than those of the most economical alternative.

Whereas the studies presented by the manufacturer were not accepted by IQWiG, G-BA decided to accept inclusion of the studies and concluded a significant additional benefit for belimumab [ 7 ]. Added benefit on severe symptoms and quality of life is perceived to have less value compared to that of survival. Determination of net benefit When a new treatment is amnob with more adverse reactions than the comparator, the benefit category could be downgraded by 1 or 2 levels, based on the severity and seriousness of the adverse reactions.

Implementation of AMNOG: An industry perspective

As the amno on adverse events is a key component of the G-BA decisions on overall additional benefit, some issues require further clarification. Product price, as a discount on the sales price set by the manufacturer, has to be negotiated within 6 months. Additional benefits were categorised zmnog to the three dimensions stated within the relevant social law, i.

These are, firstly, organisational questions, such as the venue of the negotiations or the intervals at which they are held. Pharmaceutical Statistics 10— Negotiation of reimbursement rates led to savings in amount of Mio.