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
Presentation Documents
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