Questioning patient subgroups for benefit assessment: Challenging the german gemeinsamer bundesausschuss approach

Value in Health

Volumn 17, Issue 4, 2014, Pages 307-309

  Ruof, Jörg ^a,b   Dintsios, Charalabos Markos ^c,d   Schwartz, Friedrich Wilhelm ^b  

^a ROCHE INNOVATION CENTER MUNICH   (Germany)

^b HANNOVER MEDICAL SCHOOL   (Germany)

^c VFA DIE FORSCHENDEN PHARMA UNTERNEHMEN   (Germany)

^d HEINRICH HEINE UNIVERSITY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL EFFECTIVENESS; DECISION MAKING; EARLY BENEFIT ASSESSMENT; EVIDENCE BASED MEDICINE; GERMANY; HEALTH ASSESSMENT QUESTIONNAIRE; HEALTH CARE COST; HUMAN; MEDICAL INFORMATION; NOTE; PRIORITY JOURNAL; PUBLIC HEALTH SERVICE; REIMBURSEMENT;

COST CONTROL; EVIDENCE-BASED MEDICINE; GERMANY; HEALTH CARE COSTS; HEALTH CARE REFORM; HUMANS; NATIONAL HEALTH PROGRAMS; PRESCRIPTION DRUGS; REIMBURSEMENT MECHANISMS;

EID: 84903171301     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2014.05.001     Document Type: Article

References (24)

1. Federal Ministry of Health. The Act on the Reform of the Market for Medicinal Products (Gesetz zur Neuordnung des Arzneimittelmarktes - AMNOG). Available from: http://www.bmg.bund.de/ministerium/english-version/health/amnog. html. [Accessed November 22, 2013].
2. J. Ruof, F.W. Schwartz, J.M. Schulenburg, and C.M. Dintsios Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation Eur J Health Econ 2013 10.1007/s10198-013-0495-y. [Epub ahead of print]
3. IQWiG. General Methods 4.0. Available from: https://www.iqwig.de/ download/General-Methods-4-0.pdf. [Accessed November 22, 2013].
4. G-BA. Verfahrensordnung [in German]. Available from: http://www.g-ba.de/ institution/auftrag/Verfahrensordnung/. [Accessed June 12, 2013].
5. R. Rychlik Target patient populations: how does the regulatory and reimbursement view differ? Insights from the German IQWiG J Public Health 21 2013 109 114
6. D.L. Sackett, W.M. Rosenberg, and J.A. Gray et al. Evidence based medicine: what it is and what it isn't BMJ 312 1996 71 72
7. M. Sculpher Subgroups and heterogeneity in cost-effectiveness analysis Pharmacoeconomics 26 2008 799 806
8. G-BA. Format und Gliederung des Dossiers, einzureichende Unterlagen, Vorgaben für technische Standards (Modul 4) [in German]. Available from: http://www.g-ba.de/institution/themenschwerpunkte/arzneimittel/ nutzenbewertung35a/anlagen/. [Accessed December 10, 2013].
9. G-BA. Übersicht der Wirkstoffe [Overview of products]. Available from: http://www.g-ba.de/informationen/nutzenbewertung/. [Accessed November 22, 2013].
10. European Medicines Agency. Summary of product characteristics. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar- search.jsp&mid=WC0b01ac058001d124. [Accessed June 5, 2013].
11. P.B. Chapman, A. Hauschild, and C. Robert et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation N Engl J Med 364 2011 2507 2516
12. M. Petticrew, P. Tugwell, and E. Kristjansson et al. Damned if you do, damned if you don't: subgroup analysis and equity J Epidemiol Community Health 66 2012 95 98
13. P. Sleight Debate: subgroup analyses in clinical trials: fun to look at - but don't believe them! Curr Control Trials Cardiovasc Med 1 2000 25 27
14. J. van Gijn Extrapolation of trials data into practice: where is the limit? Cerebrovas Dis 5 1995 159 162
15. P.M. Rothwell Treating individuals 2 - subgroup analysis in randomised controlled trials: importance, indications, and interpretation Lancet 365 2005 176 186
16. S.F. Assmann, S.J. Pocock, L.E. Enos, and L.E. Kasten Subgroup analysis and other (mis)uses of baseline data in clinical trials Lancet 355 2000 1064 1069
17. L.A. Moye Rudiments of subgroup analyses Prog Cardiovasc Dis 54 2012 338 342
18. ICH harmonised tripartite guideline. Statistical principles for clinical trials - E9. Available from: http://www.ich.org/fileadmin/Public-Web-Site/ICH- Products/Guidelines/Efficacy/E9/Step4/E9-Guideline.pdf. [Accessed June 5, 2013].
19. Committee for Proprietary Medicinal Products Points to consider on multiplicity in clinical trials Biometrical J 43 2001 1039 1048
20. X. Sun, M. Briel, and J.W. Busse et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review BMJ 344 2012 e1553 e1562
21. European Medicines Agency. Early dialogue between regulators and health technology assessment bodies key to medicines development. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news-and-events/news/2013/11/ news-detail-001979.jsp&mid=WC0b01ac058004d5c1. [Accessed December 10, 2013].
22. Federal Ministry of Health. Der Deutsche Bundestag beschließt Vorschriften zur Verbesserung der Arzneimittelsicherheit und Arzneimittelversorgung [in German]. Available from: http://www.bmg.bund.de/ fileadmin/dateien/Pressemitteilungen/2012/2012-02/120628-PM-48-AMG-Novelle-BT-2- 3-Lesung-01.pdf. [Accessed June 5, 2013].
23. Federal Ministry of Education and Research. Aktionsplan Individualisierte Medizin - Ein neuer Weg in Forschung und Gesundheitsversorgung [in German]. Available from: http://www.bmbf.de/pub/BMBF-Aktionsplan-IndiMed.pdf. [Accessed June 3, 2013].
24. G. Gordon, J. Cairns, and D. Churchill et al. Evidence-based medicine: a new approach to teaching the practice of medicine JAMA 268 1992 2420 2425