IMPACT OF THE GERMAN AMNOG EVALUATION ON DRUG PRICES- CORRELATION OF REBATE?

Author(s)

Neeser K*;Loeffler D;Schmidt E, Muller E LASER Analytica, Loerrach, Germany

OBJECTIVES: In January 2011 the new German law on the reorganization of the pharmaceutical market (AMNOG) came into force with the intention to reduce drug prices in Germany. Up to June 2013 44 dossiers completely evaluated and for 16 drugs (excluding orphan drugs) a price has been negotiated between the manufacturer and the National Association of Statutory Health Insurance Funds (GKV-SV). Since previous analyses have shown no correlation of negotiated price and the extent of clinical benefit, the underlying analysis aims to identify further parameters potentially influencing the reimbursed price of a new drug.  METHODS: Evaluated drugs with completed price negotiation between manufacturers and the GKV-SV were selected from the website of the Federal Joint Committee (G-BA). The manufacturer free price was analyzed for potential interactions with following parameters extracted from module 3 of the AMNOG dossier: number of eligible patients, annual drug cost of the evaluated intervention and appropriate comparator, and the final price as listed in the Lauer-Taxe (official German drug price index).  RESULTS: The 16 drugs, for which a negotiated reimbursement price was available, showed a minor (n=8), considerable (n=5), not quantifiable (n=2) or no additional clinical benefit (n=1).The investigated drug price was between 0,73 and 71 times the price of its appropriate comparator before entering negotiations. The negotiated price was between 0% and 56% lower compared to the price listed in the AMNOG dossier, regardless of the level of additional benefit. The number of eligible patients for each drug (141 to 214,000) tends to correlate with the negotiated rebate.  CONCLUSIONS: An additional benefit is necessary for a reimbursement beyond the reference group price. Despite the small number of observations it might be concluded, that the reimbursed price inversely correlates with disease incidence. The highest rebate on reimbursement price resulted from the decision of the arbitration board.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PHP122

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

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