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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The threshold changes over time based on multiple considerations including inflation. We discuss these issues from an industry perspective.

Similarly, SVR is a marker of hepatitis C progression that may detect changes in disease severity, even before they become symptomatic. If the cost of treatment exceeds a yearly turnover limit of 50 million euros in statutory health insurance, then the orphan drug is subject 201 the regular procedure of early benefit assessment.

– Legal foundations of IQWiG

If 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. On the rare occasions when a component of a composite endpoint is removed, we propose in Section 2.

After a clinical benefit has been ascertained, the price is then determined through a complex negotiation process between the manufacturer and the decision makers.

Endpoints and surrogate endpoints in colorectal cancer: The number of healthcare systems that conduct health technology assessment HTA has steadily increased over the last decade.

The situation is especially problematic when there is only one large registration trial. 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 amnnog and benefits. The Board will determine the product price and the price will apply retroactively. These questions must amnlg answered by the pharmaceutical company in the form of a dossier.

However, other medicinal products of the same fixed-rate group are available in such a 212 for patient care at the fixed rate or lower. This is different from obtaining marketing authorization. Either the medicinal product ammog allocated to the fixed-rate arrangement, or negotiations are carried out with regard to a refund rate in accordance with section b of Book Five of the Social Code.


The methods, based amnlg the work of Buyse and Piedbois, Lassereand Buyse et al.

Implementation of AMNOG: An industry perspective

The actual comparative European prices form an aspect in the negotiations, but not the most important and not the only one, even if the pharmaceutical companies would like to see it that way.

Major criteria are improving the state of health, shortening the period of illness, extending survival, reducing side-effects or amnot quality of life. A methodological approach to determine minor, considerable and major treatment effets in the early benefit assessment of new drugs. The Federal Joint Committee 20122 within another three months after publication how amng patient-relevant additional benefit of the new medicinal product is to be classified.

A cost-benefit evaluation can be carried out section 35b of Book V of the Social Code. Eur J Health Econ. An ACT is used to determine the additional benefit of the new medication.

Those deemed to bring an incremental therapeutic benefit score ranging from 1 to 4 qualify for price negotiations, and may obtain a price premium over the appropriate therapeutic comparator. Abstract Objectives Since the introduction of the German health care reform in Januaryan early benefit assessment EBA is required for all new medicines.

In future, they will receive early-evaluated new, high-quality medicinal products which are better than the previous standard, for a suitable refund rate.

Until the AMNOG procedure has been completed, the price set by the pharmaceutical company itself applies to the new pharmaceutical for one year. These statutory stipulations are complied with by the Federal Joint Committee by submitting a separate dossier for medicinal products that are comparable with fixed-rate medicinal products in pharmacological and therapeutic terms Annex VI to the 5th Chapter of the Rules of Procedure of the Federal Joint Committee.

Verfahrensordnung des Gemeinsamen Bundesausschusses; 5. IQWiG assesses the certainty of results on the basis of these data. With AMNOG, the system is today common to all therapeutic areas, and entails a risk of low prices for novel therapies that fail to outdo established alternatives.


If a surrogate endpoint is used, its surrogacy for the clinical endpoint needs to be validated. Init took German authorities over nine months to issue their first assessment under the new pricing scheme. Accessed 13 Dec C requires an interaction test. Current Opinion in Oncology 20— Please review our privacy policy. The steps the Institute chooses to assess a specific medical intervention depend primarily on the research question posed and the available scientific evidence.

The chart below shows the added therapeutic benefit scores granted by IQWiG to new medicines so far.

AMNOG One Year On: How Will German Health Reform Impact Pharma Market Access in ?

Furthermore, we invite our academic colleagues to join in and conduct research that could help 20012 issues raised in this paper. We understand products to be innovative which tangibly improve patient care. Second, the margins are based on a relative risk measure.

Major added benefit over comparator 2: Determination of net benefit When a new treatment is associated 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. For amnof at the end of the arrows this evaluation leads to an up- and downgrade, respectively.

Since the AMNOG provisions came into force, legislature has presumed that a new medicinal product has a fictive benefit as a result of its approval under the law on medicinal products. This criterion applies to price negotiations aknog. In the latter case, the pharmaceutical company must pay the cost of the evaluation. The Federal Joint Committee deals with the arguments that have been put forward and then adopts its resolution.