RECOMMENDATIONS IN CLINICAL GUIDELINES, ‘NO BENEFIT’ RATINGS, AND OPT-OUT DECISIONS IN GERMANY SINCE THE INTRODUCTION OF THE AMNOG LAW IN 2011- HOW DO THE PIECES FIT TOGETHER?

Author(s)

Staab TR1, Dintsios C2, Schulenburg J3, Ruof J1
1Roche Pharma, Grenzach-Wyhlen, Germany, 2Bayer Vital GmbH, Leverkusen, Germany, 3Leibniz University, Hanover, Germany

OBJECTIVES: Based on the pharmaceutical law (‘AMNOG’) that was introduced in Germany in 2011, the Federal Joint Committee (G-BA) is charged with the determination of the additional benefit of new medicines versus the available standard. This decision constitutes the basis for price negotiations between the statutory health insurance (GKV-SV) and the pharmaceutical companies. At any time the pharmaceutical companies may decide to withdraw their innovative drugs from the market. All withdrawals from the German market since 2011 were analysed with regards to the additional benefit granted by G-BA and recommendation status in clinical guidelines. METHODS: Withdrawals from the German pharmaceutical market that completed a benefit assessment between January 2011 and June 2016 were identified and categorised into opt-out decisions (prior to completion of first price negotiation) and supply termination (during or after further price negotiations). Respective medicines were reviewed with regards to recommendation status in clinical guidelines and G-BA’s benefit decision. RESULTS: Of 139 medications, 10 opt-outs and 12 supply terminations were identified. Twenty-one (95%) thereof received a ‘no benefit’ rating. Of the 12 terminations, 9 (75%) underwent the arbitration procedure. Most frequently (9 of 22), withdrawals concerned metabolic disorders. At the time of the benefit assessment, 19% of the withdrawn medicines were recommended specifically and 62% by therapeutic class in ≥1 relevant therapeutic guideline per indication. CONCLUSIONS: A ‘no benefit rating’ suggests that, based on available data, the new medicine does not provide additional benefit to patients. Yet, some of those medications are recommended in clinical guidelines. Our analysis indicates that new medicines with a ‘no benefit’ rating might still provide additional value to patients and health care systems which are not captured within the early benefit assessment.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PHP156

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

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