IQWIG VERSUS THE G-BA – FREQUENCY OF DIVERGENT OPINIONS IN GERMANY AND THEIR IMPACT ON GLOBAL PRICING

Author(s)

Macaulay R1, Mohamoud Z1, Schmidt B2
1PAREXEL, London, UK, 2Regulatory Benefits, Munich, Germany

OBJECTIVES: Since 2011, under the Pharmaceutical Market Restructuring Act (AMNOG), new pharmacological therapies in Germany are subject to an early benefit assessment (EBA) upon launch. The Institute for Quality and Efficiency in Health Care (IQWiG) usually conducts an initial assessment, followed by the Federal Joint Committee (G-BA) issuing a final verdict. If a newly approved drug is not deemed to offer an additional benefit over available therapies, it is not granted premium-pricing, instead being subject to reference pricing. This research assesses how the G-BA’s assessments differ from IQWiG’s. METHODS: All EBA resolutions were extracted from the English-language G-BA website alongside corresponding IQWiG press releases (01/01/2012-01/13/2017) and key information compared. For extracted outcome data, the focus was the subgroup of greatest additional benefit. RESULTS: Of 100 identified G-BA and IQWiG EBA assessments, 68% (68/100) did not differ in their additional benefit. The G-BA concluded on an additional benefit where IQWiG deemed none in 10% (10/100) of cases, G-BA and IQWiG both agreed that additional benefit was offered but differed in its extent in 20% (20/100; 15 cases: G-BA’s rating was lower, 5 cases: G-BA’s was higher). In the 2 cases where IQWiG’s verdict was ‘lesser benefit’, the G-BA ultimately concluded no additional benefit was proven. As for the level of certainty with which additional benefit was demonstrated, in 85% (39/46) the G-BA’s verdict matched IQWiG’s assessment; in 4% (2/46) of cases, the G-BA’s certainty rating was higher, in 11% (5/46) it was lower. CONCLUSIONS: Even after an unfavourable IQWiG assessment, companies should fully engage with the EBA consultation process, as the G-BA has frequently shown the flexibility to deviate from IQWiG’s initial assessment. As many countries use external reference pricing for price-setting and Germany is one of the most frequently referenced countries, this has global revenue implications.

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Value in Health, Vol. 20, No. 5 (May 2017)

Code

PHP289

Topic

Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment

Topic Subcategory

Approval & Labeling, Coverage with Evidence Development & Adaptive Pathways, Decision & Deliberative Processes, Health Care Research, Health Disparities & Equity, Prescribing Behavior, Pricing Policy & Schemes, Reimbursement & Access Policy, Risk-sharing Approaches, Treatment Patterns and Guidelines

Disease

Multiple Diseases

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