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Factors influencing the outcomes of the AMNOG benefit assessment

  • Background: Since 2011, pharmaceutical companies have to proof the added benefit of new drugs in Germany. The benefit assessment is in relation to an “appropriate comparator therapy” (ACT) defined by the Federal Joint Committee (FJC). Based on the benefit assessment, a reimbursement price is negotiated. In order to proof added benefit, it is essential to provide evidence on patient-relevant outcomes from direct head-to-head comparisons with the ACT. Indirect treatment comparisons and evidence based on surrogate parameters are usually not sufficient. FJC often splits the indication into different subpopulations. Objective: The objective was to analyse whether factors beyond the clinical evidence have influence on the benefit assessment of the FJC. Methods: All benefit assessments between 2011 and 2015 were included in the analysis. The benefit for each drug was calculated by weighting the evidence grade, strength of evidence and size of subpopulations. Drugs were then clustered in high, low or no benefit. Univariate logistic regression was used to identify variables with potential influence (p<0.25). Those variables were included in a multivariate logistic regression model and variables with p>0.1 were excluded in a stepwise approach. Results: The final multivariate logistic regression identified that following variables increase the chance of getting a higher benefit: pharmacologically innovative drug, drugs in disease areas with high unmet medical need, drugs in oncology or infectious diseases, and drugs for which the FJC can split the assessment into subpopulations. Conclusions: The analysis identified variables beyond clinical evidence that influence the benefit assessment by the FJC and provided a better understanding of decision making by the FJC.
Metadaten
Author:Thomas Hammerschmidt
URN:urn:nbn:de:bvb:861-opus4-2291
Series (Serial Number):Rosenheimer Beiträge (1)
Document Type:Working Paper
Language:English
Publication Year:2017
Tag:AMNOG, HTA, benefit assessment, pharmaceuticals, Germany
GND Keyword:AMNOG; health technology assessment; pharmaceutical; benefit assessment; Germany
Page Number:16
faculties / departments:Fakultät für Angewandte Gesundheits- und Sozialwissenschaften
Dewey Decimal Classification:3 Sozialwissenschaften / 33 Wirtschaft
Licence (German):License LogoCreative Commons - Namensnennung-Keine kommerzielle Nutzung-Weitergabe unter gleichen Bedingungen