G Glaeske1. 1. Gesundheit, Pflege, Alterssicherung, SOCIUM, Universität Bremen, Mary-Somerville-Str. 5, 28359, Bremen, Deutschland. gglaeske@uni-bremen.de.
Abstract
BACKGROUND: Since the Pharmaceutical Market Restructuring Act (Arzneimittelmarktneuordnungsgesetz-AMNOG) went into effect on 1 January 2011, new medicinal products provided under statutory health insurance have to undergo an early benefit assessment, prepared on the basis of scientific dossiers drawn up by the German Institute for Quality and Cost Effectiveness in the Health Care Sector (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen-IQWiG) and adopted by the Federal Joint Committee (Gemeinsamer Bundesausschuss-G-BA). These assessments, in which the additional benefit of a product is compared with existing standard therapy and ultimately has a bearing on price negotiations with the pharmaceutical companies, are carried out on the basis of clinical trial data presented by the latter. Results so far, however, show that the IQWIG's and the G-BA's assessments often vary, although both bodies have the same documentation. Such differences can also be observed on an international level. OBJECTIVES: Using selected examples, the differences in the assessments of new pharmaceuticals are presented and reasons for national and international deviations are discussed. CURRENT DATA: As yet, no systematic comparative analysis has been made of assessments of medicinal products by the respective institutions. For this reason, it was not possible to make a systematic selection of pharmaceuticals, and the cases were instead selected according to available information. CONCLUSIONS: An overview of the results shows that the diverging assessments-both national and international-are not always scientifically justifiable, but rather appear to be influenced by the-not always transparent-framework parameters of the respective health system. Assessments are always shaped by certain perspectives on the data and results under scrutiny. It would undoubtedly be worthwhile to evaluate these influences to gain a better understanding of the reasons for national and international discrepancies in the assessment of additional therapeutic value of new pharmaceutical products.
BACKGROUND: Since the Pharmaceutical Market Restructuring Act (Arzneimittelmarktneuordnungsgesetz-AMNOG) went into effect on 1 January 2011, new medicinal products provided under statutory health insurance have to undergo an early benefit assessment, prepared on the basis of scientific dossiers drawn up by the German Institute for Quality and Cost Effectiveness in the Health Care Sector (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen-IQWiG) and adopted by the Federal Joint Committee (Gemeinsamer Bundesausschuss-G-BA). These assessments, in which the additional benefit of a product is compared with existing standard therapy and ultimately has a bearing on price negotiations with the pharmaceutical companies, are carried out on the basis of clinical trial data presented by the latter. Results so far, however, show that the IQWIG's and the G-BA's assessments often vary, although both bodies have the same documentation. Such differences can also be observed on an international level. OBJECTIVES: Using selected examples, the differences in the assessments of new pharmaceuticals are presented and reasons for national and international deviations are discussed. CURRENT DATA: As yet, no systematic comparative analysis has been made of assessments of medicinal products by the respective institutions. For this reason, it was not possible to make a systematic selection of pharmaceuticals, and the cases were instead selected according to available information. CONCLUSIONS: An overview of the results shows that the diverging assessments-both national and international-are not always scientifically justifiable, but rather appear to be influenced by the-not always transparent-framework parameters of the respective health system. Assessments are always shaped by certain perspectives on the data and results under scrutiny. It would undoubtedly be worthwhile to evaluate these influences to gain a better understanding of the reasons for national and international discrepancies in the assessment of additional therapeutic value of new pharmaceutical products.
Keywords:
Drug utilization review; Evaluation, pharmacological; Germany; New drug approval; Pharmaceutical Market Restructuring Act (AMNOG)