Health economics and outcomes research within drug development: Challenges and opportunities for reimbursement and market access within biopharma research

Drug Discovery Today

Volumn 17, Issue 11-12, 2012, Pages 615-622

  Van Nooten, Floortje ^a   Holmstrom, Stefan ^c   Green, Julia ^a   Wiklund, Ingela ^a   Odeyemi, Isaac A O ^b   Wilcox, Teresa K ^a  

^a UNITED BIOSOURCE CORPORATION   (United States)

^b ASTELLAS PHARMA EUROPE LTD   (United Kingdom)

^c Astellas Pharma Global Development   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

AUSTRALIA; CANADA; CLINICAL EFFECTIVENESS; COMMERCIAL PHENOMENA; COST EFFECTIVENESS ANALYSIS; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; FRANCE; GERMANY; HEALTH ECONOMICS; HUMAN; ITALY; NETHERLANDS; PHYSICAL ACTIVITY; POPULATION; QUALITY OF LIFE; REIMBURSEMENT; REVIEW; RISK BENEFIT ANALYSIS; SWEDEN; UNITED KINGDOM;

BIOPHARMACEUTICS; COMPARATIVE EFFECTIVENESS RESEARCH; COST-BENEFIT ANALYSIS; DRUG DISCOVERY; HUMANS; INSURANCE, HEALTH, REIMBURSEMENT; MARKETING; OUTCOME ASSESSMENT (HEALTH CARE); RANDOMIZED CONTROLLED TRIALS AS TOPIC; TECHNOLOGY ASSESSMENT, BIOMEDICAL;

EID: 84861617317     PISSN: 13596446     EISSN: 18785832     Source Type: Journal    
DOI: 10.1016/j.drudis.2012.01.021     Document Type: Review

References (31)

1. M.M. Goetghebeur Evidence and Value: Impact on DEcisionMaking - the EVIDEM framework and potential applications BMC Health Serv. Res. 8 2008 270
2. C.J. Jewell, and L.A. Bero Developing good taste in evidence: facilitators of and hindrances to evidence-informed health policymaking in state government Milbank Q. 86 2008 177 208
3. D.M. Eddy Clinical decision making: from theory to practice. Anatomy of a decision JAMA 263 1990 441 443
4. D. Eddy Reflections on science, judgment, and value in evidence-based decision making: a conversation with David Eddy by Sean R. Tunis Health Aff. (Millwood) 26 2007 W500 W515
5. P.J. Neumann Medicare's national coverage decisions for technologies, 1999-2007 Health Aff. (Millwood) 27 2008 1620 1631
6. PBAC Public Summary Document: Nicotinic Acid 2006
7. Scottish Medicines Consortium. (2010) Glucosamine sulphate 1,500 mg powder for oral solution (Glusartel®). SMC No. (647/10)
8. CADTH CEDAC Final Recommendation on Reconsideration and Reasons for Recommendation: Dabigatran Etexilate 2009
9. J.D. Chambers, and P.J. Neumann US healthcare reform: implications for health economics and outcomes research Expert Rev. Pharmacoecon. Outcomes Res. 10 2010 215 216
10. L. Annemans Making Innovative Drugs Accessible in the European Union: Recommendations from the Belgian EU Presidency 2010 ISPOR (accessed November 2010) http://www.ispor.org/congresses/prague1110/ReleasedPresentations/Lieven- Annemans-Slides.pdf
11. S. Morgan Towards a definition of pharmaceutical innovation Open Med. 2 2008 e4 e7
12. L.P. Garrison A flexible approach to evidentiary standards for comparative effectiveness research Health Aff. (Millwood) 29 2010 1812 1817
13. US Department of Health and Human Services Draft Definition, Prioritization Criteria, and Strategic Framework for Public Comment 2011
14. T. Lonngren Successes and challenges in drug development - a regulatory perspective Presentation given at 16th World Congress on Basic and Clinical Pharmacology Copenhagen, Denmark, 17-23, July 2010
15. National Institute for Health and Clinical Excellence (NICE) Technology Assessment (TA) Decision Table 2010
16. J.J. Carlson Linking payment to health outcomes: a taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers Health Policy 96 2010 179 190
17. J. Adamski Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers BMC Health Serv. Res. 10 2010 153
18. A.E. Wang Rx for Pharmaceutical Companies: Internal Collaboration is the Key to Improved Innovation 2003 IBM Institute for Business Value
19. PricewaterhouseCoopers Biotech Reinvented: Where Do You Go from Here? 2010
20. European Medicines Agency Road Map to 2015: The Agency's Contribution to Science, Medicines, Health. Draft for Public Consultation 2010
21. Tapestry Network Pilots of multi-stakeholder consultations in early-stage drug development, http://www.tapestrynetworks.com/documents/EHILN-multi- stakeholder%20pilots%20joint%20statement%20-%2010-19-10.pdf.
22. European Network for Health Technology Assessment (EUNETHTA) European Medicines Agency and EUnetHTA Joint Action Start Collaboration on European Public Assessment Report (EPAR) Contribution to Relative Effectiveness Assessments 2010 http://www.ema.europa.eu/docs/en-GB/document-library/Press- release/2010/02/WC500073909.pdf
23. European Network for Health Technology Assessment. (2011), http://www.ema.europa.eu/docs/en-GB/document-library/Press-release/2010/02/ WC500073909.pdf
24. Directorate-General for Health & Consumers Future developments for the European Collaboration on Health Technology Assessment Presentation given at EUnetHTA Conference Paris France, 20 November 2008
25. US Food and Drug Administration Memorandum of Understanding Between United States Food and Drug Administration and Centers for Medicare and Medicaid Services 2010 http://www.fda.gov/AboutFDA/PartnershipsCollaborations/ MemorandaofUnderstandingMOUs/DomesticMOUs/ucm217585.htm
26. H.G. Eichler Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers Nat. Rev. Drug Discov. 9 2010 277 291
27. R.L. Fleurence The critical role of observational evidence in comparative effectiveness research Health Aff. (Millwood) 29 2010 1826 1833
28. I. Kennedy Appraising the Value of Innovation and Other Benefits. A Short Study for NICE 2009 National Institute for Health and Clinical Excellence
29. C. Kopp What is a truly innovative drug? New definition from the International Society of Drug Bulletins Can. Fam. Physician 48 2002 1413 1415
30. International Society for Pharmacoeconomics and Outcomes Research. Global Health Care Systems Road Map, http://www.ispor.org/htaroadmaps/default.asp
31. D. Motola Therapeutic innovation in the European Union: analysis of the drugs approved by the EMEA between 1995 and 2003 Br. J. Clin. Pharmacol. 59 2005 475 478