IS G-BA STRATEGICALLY DISCOUNTING THE BENEFIT ASSESSMENT OF RELATIVELY HIGH COST DRUGS?
Author(s)
Jaksa A, Daniel K, Bergemann R, Ho YS
Context Matters, Inc., New York, NY, USA
OBJECTIVES: Gemeinsame Bundesausschuss (G-BA) states that it assesses additional benefit strictly on clinical grounds, but it also requires that manufacturers submit drug and comparator costs. This raises the possibility that G-BA’s assessment might be influenced by price, possibly to provide leverage during subsequent price negotiations. This research tests the hypothesis that high cost drugs (relative to the comparator) are more likely to receive poor benefit assessments. METHODS: The following variables were collected from the Federal Gazette publication or the “Beschluss” document: additional benefit assessment, annual cost per patient of drug and comparator, and estimated target population. The Scottish Medicines Consortium (SMC) clinical rationale for the same drugs and indications were collected to control for clinical efficacy. After excluding orphan drugs, reviews using best supportive care comparators, and reviews without SMC reviews, 58 reviews remained for analysis. G-BA’s additional benefit assessments were ranked from least benefit to most. The influence of drug cost relative to the comparator on the G-BA assessment was estimated via an ordered logit model. The model also included controls for the (log) size of the target population and clinical efficacy (SMC’s clinical assessment). RESULTS: An increase in the cost difference between the drug and the comparator is estimated to result in a modest, statistically significant increase in the odds of receiving an additional benefit assessment greater than a “no additional benefit” assessment. CONCLUSIONS: Our results are inconsistent with the alternative hypothesis that G-BA is strategically discounting its assessment of relatively high cost drugs. The positive estimated relationship is consistent with manufacturers’ setting higher prices for more beneficial drugs (The data available provide no way to statistically account for this plausible source of endogeneity). Our results provide no support for rejecting the null hypothesis that G-BA assesses added benefit independently of drug cost.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PHP243
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases