TIME RESTRICTIONS OF BENEFIT ASSESSMENTS FOR MEDICINAL PRODUCTS IN GERMANY – CURRENT EXPERIENCE

Author(s)

Fink C, Art J, Ecker T, Ecker C
Ecker + Ecker GmbH, Hamburg, Germany

OBJECTIVES: Resolutions on early benefit assessment can be granted with a time restriction, termed “limited”. As a consequence companies are required to resubmit their data later. The objective of the present study was to assess reasons for limitation. METHODS: The following three criteria are given for limiting a resolution: incomplete data on patient relevant endpoints, limited quality of evidence, and missing data can be provided at a later stage. Assessment was based on resolutions with limitations published until June 2016. For each resolution reasons for limitations were identified and requirements for a resubmission were captured using supporting documents (“Tragende Gruende”). RESULTS:

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PHP216

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Reimbursement & Access Policy

Disease

Multiple Diseases

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