Med Decis Making - Early benefit assessment of pharmaceuticals in Germany: manufacturers' expectations versus the Federal Joint Committee's decisions.


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CKGROUND: Since 2011, when the German Pharmaceutical Market Restructuring Act (AMNOG) came into effect, newly licensed pharmaceuticals must demonstrate an added benefit over a comparator treatment to be reimbursed at a value greater than the reference price. Evidence submitted by manufacturers is assessed by the Institute for Quality and Efficiency in Health Care (IQWiG) and subsequently appraised by the German Federal Joint Committee (FJC) as part of so-called early benefit assessments (EBA). This study aims to explain the decisions made, clarify the roles of the parties (manufacturers, IQWiG, FJC) involved, and guide manufacturers in developing future submissions by analyzing 42 EBAs concluded since January 2011.METHODS: We developed a variable list representing the essential components of the EBA: the rating decisions of manufacturers, IQWiG, and the FJC regarding each pharmaceutical's added benefit; the characteristics of the pharmaceutical; the characteristics of the EBA process; the types of evidence submitted; the methods used to generate evidence; and the pharmaceutical's maximum possible budget impact. We used Cohen's kappa to analyze agreement between the rating decisions of the different parties. The chi-square test and bivariate regression were used to identify associations between components of the EBA process and the rating decisions of the FJC.RESULTS: We observed a low level of agreement between manufacturers and the FJC (kappa = 0.21; 95% CI 0.107-0.31) and a substantial level of agreement between IQWiG and the FJC (kappa = 0.64; 95% CI 0.451-0.827) in their rating decisions. The characteristics of the EBA process--for example, duration of the process (P = 0.357), participation in the official hearing (P = 0.227), and the pharmaceutical's budget impact (P = 0.725)--did not have a significant effect on the rating decisions of the FJC. There was, however, an association between the type of evidence submitted and the FJC's rating decision when the manufacturer's dossier reported outcomes related to morbidity (P = 0.009) or adverse events (P < 0.001) but not mortality (P = 0.718) or quality of life (P = 0.783).CONCLUSIONS: While the FJC tends to disagree with the rating of benefit by manufacturers, it softens IQWiG's decisions, potentially to make the final outcome more acceptable. Concerns voiced that the FJC might be exceeding its statutory authority by taking cost or procedural considerations into account appear to be unfounded. Choosing appropriate evidence to submit for each endpoint remains a challenge, as submission of health outcomes evidently influences decisions.

Resumo Limpo

ckground sinc german pharmaceut market restructur act amnog came effect newli licens pharmaceut must demonstr ad benefit compar treatment reimburs valu greater refer price evid submit manufactur assess institut qualiti effici health care iqwig subsequ apprais german feder joint committe fjc part socal earli benefit assess eba studi aim explain decis made clarifi role parti manufactur iqwig fjc involv guid manufactur develop futur submiss analyz eba conclud sinc januari method develop variabl list repres essenti compon eba rate decis manufactur iqwig fjc regard pharmaceut ad benefit characterist pharmaceut characterist eba process type evid submit method use generat evid pharmaceut maximum possibl budget impact use cohen kappa analyz agreement rate decis differ parti chisquar test bivari regress use identifi associ compon eba process rate decis fjcresult observ low level agreement manufactur fjc kappa ci substanti level agreement iqwig fjc kappa ci rate decis characterist eba processfor exampl durat process p particip offici hear p pharmaceut budget impact p signific effect rate decis fjc howev associ type evid submit fjcs rate decis manufactur dossier report outcom relat morbid p advers event p mortal p qualiti life p conclus fjc tend disagre rate benefit manufactur soften iqwig decis potenti make final outcom accept concern voic fjc might exceed statutori author take cost procedur consider account appear unfound choos appropri evid submit endpoint remain challeng submiss health outcom evid influenc decis

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