The AMNOG (Arzneimittelmarktneuordnungsgesetz) reforms that were passed in to law in November 2010 reduce the power of pharmaceutical companies to determine new drug prices. The Government expects to save the statutory health insurance system €2.2 billion ($3.09 billion) per year by implementing these reforms.[1]
The goal of the AMNOG is to have an early benefit assessment for new approved medications (including new combinations) or existing medications with a new application. Those with an active ingredient previously launched and now coming with a new therapeutic indication will need to submit a dossier within 3 months, if requested by the Federal Joint Committee (Gemeinsame Bundesausschuss; G-BA). This assessment is then used to determine the possible pricing for the product.
It is important to note that the G-BA may request an evaluation of benefit for drugs already marketed and if this request is made, the manufacturer has just 3 months to submit the necessary dossier. An additional example would be those therapies considered "important" or drugs competing with "Section 35a Drugs".
Manufacturers are still free to set the price of new products at launch but they must make a submission to the G-BA for rapid assessment using a standard template. The manufacturer provides information including:
The Institute for Quality and Efficiency in Healthcare (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen; IQWiG) will review this submission and provide the benefit assessment. For drugs that are not recognised as having additional value, reimbursement amounts are set at prices for a comparably effective drug (i.e. a reference price group is assigned) and/or a reimbursement cap (Festbeträg) is set. After at least 12 months has passed, the manufacturer may resubmit and request re-assessment if there is new evidence available e.g. further clinical data.
If additional benefit is demonstrated, it will be categorised according to the level of benefit and then the price will be negotiated between the manufacturer and the Federal Association of Statutory Health Insurance Funds (GKV-Spitzenverband; GKV-SV).
If there is no agreement, then the GKV-SV will implement arbitration (at which point the price of the product in other European markets becomes, in effect, a cap on the price in Germany) and consultation with the G-BA and IQWiG. The manufacturer may request cost-benefit evaluation of their product which is likely to be conducted by IQWiG. This evaluation will be based on economic assessment and the results of the evaluation will feed back to the negotiation between the GKV-SV and the manufacturer.
Drugs that treat orphan diseases will not be part of the "full" early benefit assessment and a quick review is not an option. A "small" dossier must be submitted for orphan drugs whereby additional benefit must be considered but no proof is needed. However, the extent of the additional benefit and therapeutic significance of the additional benefit must be quantified. There is no exemption from a 16% mandatory rebate. Orphan drugs are not exempt from price negotiations with the GKV Spitzenverband and the GKV will negotiate a price that reflects the level of additional benefit. Should the sales exceed gross revenues of more than €50 million in one year, the G-BA will demand submission of full value dossier to be supplied within three months of their request.[2] This dossier must include demonstrated additional benefit against a suitable comparative therapy.
For expert advice on European market access issues, please contact Nigel Seear, VP Europe in our London office. nigel.seear@bridgehead.com
References
[1] Fahrenkamp H. Changes in the German market for Pricing and Reimbursement of innovative Pharmaceuticals. Presentation at EMIG Quarterly Meeting. 9 May 2011. London, UK.
[2] VDA. AMNOG: Key Issues and Consequences. Published November 2010. Available at: http://www.vfa.de/en/latest-topics/amnog-key-issues-and-consequences.html. Accessed June 2011.
