THE IMPACT OF THE STUDY DESIGN SUBMITTED FOR THE EARLY BENEFIT ASSESSMENT ON THE PRICING FOR ONCOLOGIC DRUGS
Author(s)
Beinhauer I1, Dintsios C2
1University of Cologne, Köln, Germany, 2Heinrich Heine University of Düsseldorf, Düsseldorf, Germany
OBJECTIVES: Aim of this study was to analyse if the design of the clinical studies influences the price negotiations according to the German AMNOG law between the pharmaceutical companies and the National Association of Statutory Health Insurance Funds. The analysis was conducted for all Oncologic drugs that underwent the early benefit assessment since its introduction in 2011 and had negotiated prices up to September 2016. METHODS: It was differentiated between additive (new therapy in addition to baseline therapy) and substitutive study designs (baseline therapy is replaced through new therapy) with an added or no added benefit. The study design was analysed with the dossiers of the pharmaceutical companies submitted to the Federal Joint Committee. Subgroup specific costs were calculated as annual therapy costs with the German price databank (Lauertaxe) and compared with the costs of the comparative drugs to quantify price premiums (multiplicative and additive premiums). Further price influencing factors were analysed in univariate and multivariate regression analysis and the budget impact for the statutory health insurance was considered. RESULTS: For additive and substitutive study designs with an added benefit a premium was negotiated on the annual therapeutic costs of the comparative drug. The median and the mean of the premium of substitutive designs was higher than for additive designs, if the comparative therapy was different to best supportive care. The multiplicative premium for the substitutive design was 15,07 vs. 2,29 for the additive design. EU-Prices and the population size had a significant effect on the reimbursement price. CONCLUSIONS: The mean reimbursement prices are higher for substitutive designs than for additive designs. Since the number of cases was small for some categories (e.g. additive design and no additional benefit), further analyses should be performed, when more oncologic drugs passed the AMNOG.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PCN306
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Oncology