GUIDELINES IN GERMAN EARLY BENEFIT ASSESSMENT – WHICH GUIDELINES ARE CONSIDERED BY FEDERAL JOINT COMMITTEE FOR DETERMINING THE APPROPRIATE COMPARATOR?

Author(s)

Scheler E, Stratil A, Roxlau T, Bonduelle D
IQVIA Commercial GmbH & Co. OHG, Munich, Germany

OBJECTIVES: To 1) evaluate how often Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) considers evidence in guidelines, 2) determine therapeutic areas where the majority of considered guidelines were exclusively non‑German, and 3) explore reasons for G-BA for not considering any guidelines when determining the appropriate comparator for German early benefit assessment. METHODS: All completed German early benefit assessments with procedure start date between 01/07/2014 and 01/06/2017 were selected. Documents necessary for analysis were retrieved from the G-BA website. Frequency of assessments in which G-BA considered German guidelines, non-German guidelines exclusively, and no guidelines at all were determined. Therapeutic areas wherein G-BA considered non-German guidelines exclusively in >50% of cases were identified. Reasons for not considering any guidelines were explored. RESULTS: Of 137 relevant assessments, the G-BA referred to German guidelines in 42% of cases when determining the appropriate comparator for early benefit assessment, while in 31% exclusively non‑German guidelines were considered. For the following therapeutic areas, this was the case in >50% for eye diseases (80%), diseases of respiratory system (63%), cardiovascular diseases (60%), and diseases of blood and blood forming organs (60%). In 27%, the G-BA referred to no guidelines at all. Of these, 24% corresponded to pharmaceuticals with orphan drug designation and one diagnostic tool, while 3% corresponded to regular pharmaceuticals. G-BA’s main reason to not consider any guidelines for regular pharmaceuticals was that no relevant guidelines were detected during the systematic guideline search. This might be due to low incidence/prevalence diseases in combination with very narrow drug indications. CONCLUSIONS: G-BA considers German guidelines where available. The therapeutic field with the highest proportion of G-BA considering exclusively non-German guidelines is eye diseases. G‑BA’s main reasons for considering no guidelines are orphan designations and failure to identify relevant guidelines, possibly due to low disease incidence/prevalence.

Conference/Value in Health Info

2018-11, ISPOR Europe 2018, Barcelona, Spain

Value in Health, Vol. 21, S3 (October 2018)

Code

PHP278

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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