AN ANALYSIS OF GERMAN G-BA ADDED BENEFIT ASSESSMENT DECISIONS USING THE WORLD HEALTH ORGANIZATION DALY FRAMEWORK

Author(s)

Loftus BM, Gustavsen G, Gaebler JA
Health Advances, Weston, MA, USA

OBJECTIVES: Since January 2011, the German G-BA has evaluated new drugs on their degree of added benefit versus a comparator therapy. We used disease-specific Disability Adjusted Life Years (DALYs), reported by the World Health Organization (WHO) as the sum of Years of Life Lost from mortality (YLL) plus Years Lost due to Disability (YLD), to help explain G-BA benefit assessment decisions.   METHODS: EMA-approved drugs (January 2010-June 2015) were identified from European Public Assessment Reports (EPARs) and cross-referenced with the G-BA website to create an analysis set of drugs that have received benefit assessment ratings. Drugs with EMA orphan-drug designation were excluded. We defined Added Benefit (AB) as drugs that received G-BA ratings of “considerable”, “low”, or “unquantifiable” benefit in any patient subgroup, and No Added Benefit (NAB) as drugs only receiving ratings of “no additional benefit” and “inferior”.  Using WHO-reported German 2012 DALYs, proportions of YLLs and YLDs for each drug’s lead indication were calculated: Drugs for diseases in which YLLs >75% of the DALY were defined as High Mortality Drugs (HMD); drugs for all other diseases were Low Mortality Drugs (LMD).  We then predicted the odds of receiving AB versus NAB based on this new metric. SPSS was used to perform Fisher’s exact test and to generate Odds Ratios (OR). Sensitivity analyses were performed on the %YLL threshold definition.  RESULTS: From 373 EPARs, we identified 73 non-orphan drugs receiving G-BA benefit assessment ratings, 58 of which had matched DALY data for the lead indication. Of these 58 drugs, 35 were indicated for HMDs while 23 had LMD indications.  30 of 35 (86%) HMDs received an AB rating while only 4 of 23 (17%) LMDs received an AB rating (p<0.001, OR: 28.6). CONCLUSIONS: Our analysis suggests that in Germany there may be a demonstrated and predictable bias for drugs for fatal diseases.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

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

Code

PHP244

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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