The European Journal of Health Economics

, Volume 7, Issue 2, pp 129–136 | Cite as

Outcomes research collaborations between third-party payers, academia, and pharmaceutical manufacturers

What can we learn from clinical research?
  • Hans-Georg Eichler
  • Sheldon X. Kong
  • Jean-Pierre Grégoire
Original Papers


Research collaborations between academic researchers, regulatory agencies, and pharmaceutical manufacturers have made the drug development process more efficient and have frequently supported the successful documentation of quality, safety, and efficacy of pharmaceuticals (the so-called three hurdles). Over recent years issues of drug cost, access, and utilization have moved to center stage, giving rise to a “fourth hurdle approval” process by third-party payers. This requires new forms of collaborative research among new players. This contribution highlights the need for a “triangular” relationship in the field of outcomes research between scientists in academia, third-party payer institutions, and pharmaceutical manufacturers. We discuss, and illustrate by case studies, how successful models of collaboration from the drug development process might be relevant to research activities related to the fourth hurdle. Case studies which may provide useful models for collaborative outcomes research include the “International Conference on Harmonization” process, the voluntary consultation procedures established by drug regulatory agencies, and the Quebec experience in database sharing.


Drug development collaboration Drug regulatory agencies Outcomes research Pharmaceutical manufacturers Third-party payment 


Conflict of interest:

No information supplied.


  1. 1.
    Liberati A, Magrini N (2003) Information from drug companies and opinion leaders. BMJ 326:1156–1157CrossRefPubMedGoogle Scholar
  2. 2.
    Morgan S, Barer M, Evans R (2000) Health economists meet the fourth tempter: drug dependency and scientific discourse. Health Econ 9:659–667CrossRefPubMedGoogle Scholar
  3. 3.
    Crowley WF, Sherwood L, Salber P, Scheinberg D, Slavkin H, Tilson H, Reece EA, Catanese V, Johnson SB, Dobs A, Genel M, Korn A, Reame N, Bonow R, Grebb J, Rimoin D (2004) Clinical research in the United States at a crossroads: proposal for a novel public-private partnership to establish a National Clinical Research Enterprise. JAMA 291:1120–1126CrossRefPubMedGoogle Scholar
  4. 4.
    Anis AH, Gagnon Y (2000) Using economic evaluations to make formulary coverage decisions. Pharmacoeconomics 18:55–62CrossRefPubMedGoogle Scholar
  5. 5.
    Edmonds P, Glynn D, Oglialoro C (2000) Access to important new medicines. Eur Business J 12:146–157Google Scholar
  6. 6.
    Sudlow CLM, Counsell CE (2003) Problems with UK government’s risk sharing scheme for assessing drugs for multiple sclerosis. BMJ 326:388–392CrossRefPubMedGoogle Scholar
  7. 7.
    Lee SJ, Earle CC, Weeks JC (2000) Outcomes research in oncology: history, conceptual framework, and trends in the literature. J Natl Cancer Inst 92:195–204CrossRefPubMedGoogle Scholar
  8. 8.
    Epstein RS, Sherwood LM (1996) From outcomes research to disease management: a guide for the perplexed. Ann Intern Med 124:832–837PubMedGoogle Scholar
  9. 9.
    Anderson C (1994) Measuring what works in health care. Science 263:1080–1082PubMedGoogle Scholar
  10. 10.
    Lipscomb J, Snyder CF (2002) The outcomes of cancer outcomes research: focusing on the National Cancer Institute’s quality-of-care initiative. Med Care 40 [Suppl]:III-3–III-10Google Scholar
  11. 11.
    Mauch RP (2001) Pharmaceutical industry and payer partnerships to manage costs and improve quality. Manag Care 10 [Suppl 9]:2–4Google Scholar
  12. 12.
    Motheral B, Brooks J, Clark MA, Crown WH, Davey P, Hutchins D, Martin BC, Stang P (2003) A checklist for retrospective database studies—report of the ISPOR task force on retrospective databases. Value Health 6:90–97CrossRefPubMedGoogle Scholar
  13. 13.
    Kong SX, Wertheimer AI (1998) Outcomes research: collaboration among academic researchers, managed care organizations, and pharmaceutical manufacturers. Am J Manag Care 4:28–34PubMedGoogle Scholar
  14. 14.
    Williams GH, Wara DW, Carbone P (1997) Funding for patient-oriented research. Critical strain on a fundamental linchpin. JAMA 278:227–231Google Scholar
  15. 15.
    Stokes DE (1997) Pasteur’s quadrant. Basic science and technological Innovation. Brookings.Google Scholar
  16. 16.
    Holton G, Sonnert G (1999) A vision of Jeffersonian science. Issues in science and Technololgy.
  17. 17.
    Maynard A, Kanavos P (2000) Health economics: an evolving paradigm. Health Econ 9:183–190CrossRefPubMedGoogle Scholar
  18. 18.
    Neumann P, Sandberg EA, Bell CM, Stone PW, Chapman RH (2000) Are pharmaceuticals cost-effective? A review of the evidence. Health Aff (Millwood) 19:92–109Google Scholar
  19. 19.
    DiMasi JA (2002) The value of improving the productivity of the drug development process. Faster times and better decisions. Pharmacoeconomics 20 [Suppl 3]:1–10Google Scholar
  20. 20.
    Maynard A, Bloor K, Freemantle N (2004) Challenges for the National Institute for Clinical Excellence. BMJ 329:227–229CrossRefPubMedGoogle Scholar
  21. 21.
    Kassirer JP, Angell M (1994) The journal’s policy on cost-effectiveness analyses. N Engl J Med 331:669–670CrossRefPubMedGoogle Scholar
  22. 22.
    Smith R (2002) New BMJ policy on economic evaluations. BMJ 325:1124CrossRefPubMedGoogle Scholar
  23. 23.
    Academy of Managed Care Pharmacy (2202) A format for submission of clinical and economic data in support of formulary consideration by health care systems in the United States, version 2.0.
  24. 24.
    Frantz S (2004) Calls for full disclosure of clinical trials. Nat Rev Drug Discov 3:635–636CrossRefPubMedGoogle Scholar
  25. 25.
    De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJPM, Schroeder TV, Sox HC, Van Der Weyden MB (2004) Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Can Med Assoc J. 171:606-60-7Google Scholar
  26. 26.
    Goldstein WC (2001) Pharmaceutical industry and payer partnerships: legal update. Manag Care 10 [Suppl 9]:5–6Google Scholar
  27. 27.
    Jefferson T, Demicheli V (2002) Quality of economic evaluations in health care. It is time for action to ensure higher methodological quality. BMJ 324:313–314CrossRefPubMedGoogle Scholar
  28. 28.
    World Health Organization (2002) World Health report 2002. World Health Organization: GenevaGoogle Scholar
  29. 29.
    Russell LB, Gold MR, Siegel JE, Daniels N, Weinstein MC (1996) The role of cost-effectiveness analysis in health and medicine. JAMA 276:1172–1177CrossRefPubMedGoogle Scholar
  30. 30.
    Borst-Eilers E (2000) Availability of pharmaceutical drugs. Lancet 356:S6CrossRefPubMedGoogle Scholar
  31. 31.
    Rothermich EA, Brod MI, Schonfeld WH, Rowland CR, Gomez-Mancilla B (2002) Prospective study designs in outcomes research. Pharmacoeconomics 20:715–725CrossRefPubMedGoogle Scholar
  32. 32.
    Dendukuri N, Blais L, LeLorier J (2002) Inhaled corticosteroids and the risk of diabetes among the elderly. Br J Clin Pharmacol 54:59–64CrossRefPubMedGoogle Scholar
  33. 33.
    Gregoire JP, Moisan J, Chabot I, Gaudet M (2000) Appropriateness of omeprazole prescribing in Quebec’s senior population. Can J Gastroenterology 8:676–680Google Scholar
  34. 34.
    Blais R, Gregoire JP, Rouleau R, Cartier A, Bouchard J, Boulet LP (2001) Comite de revue de l’utilisation des medicaments. Ambulatory use of inhaled beta(2)-agonists for the treatment of asthma in Quebec: a population-based utilization review. Chest 119:1316–1321CrossRefPubMedGoogle Scholar
  35. 35.
    Rahme E, Marentette MA, Kong SX, Lelorier J (2002) Use of NSAIDs, COX-2 inhibitors, and acetaminophen and associated coprescriptions of gastroprotective agents in an elderly population. Arthritis Rheum 47:595–602CrossRefPubMedGoogle Scholar
  36. 36.
    Tamblyn R, Laprise R, Hanley JA, Abrahamowicz M, Scott S, Mayo N, Hurley J, Grad R, Latimer E, Perreault R, McLeod P, Huang A, Larochelle P, Mallet L (2001) Adverse events associated with prescription drug cost-sharing among poor and elderly persons. JAMA 285:421–429CrossRefPubMedGoogle Scholar

Copyright information

© Springer Medizin Verlag 2006

Authors and Affiliations

  • Hans-Georg Eichler
    • 1
    • 4
  • Sheldon X. Kong
    • 2
  • Jean-Pierre Grégoire
    • 3
  1. 1.Department of Clinical PharmacologyMedical University of ViennaViennaAustria
  2. 2.Outcomes ResearchMerck & Co., Inc.Whitehouse StationUSA
  3. 3.Faculty of Pharmacy and Population Health Research UnitLaval UniversityQuebec CityCanada
  4. 4.Department of Clinical PharmacologyMedical University of Vienna, Allgemeines KrankenhausViennaAustria

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