Hostname: page-component-78c5997874-mlc7c Total loading time: 0 Render date: 2024-11-15T19:30:22.308Z Has data issue: false hasContentIssue false

Perspectives on the National Institute for Health and Clinical Excellence's recommendations to use health technologies only in research

Published online by Cambridge University Press:  21 July 2009

Irfan A. Dhalla
Affiliation:
University of Toronto and St. Michael's Hospital
Sarah Garner
Affiliation:
National Institute for Health and Clinical Excellence
Kalipso Chalkidou
Affiliation:
National Institute for Health and Clinical Excellence
Peter Littlejohns
Affiliation:
National Institute for Health and Clinical Excellence

Abstract

Background: The concept of using public funds to pay for healthcare interventions only when provided in the context of ongoing research is receiving increasing attention worldwide. Nevertheless, these decisions are often controversial and implementation can be problematic.

Objectives: The aim of this study was to investigate the views of United Kingdom stakeholders on the current arrangements for implementing “only in research” (OIR) decisions and to investigate how improvements might be made.

Methods: After an internal review of previous OIR decisions issued by the National Institute for Health and Clinical Excellence (NICE), deliberations by NICE's Citizens Council, and an international workshop convened by NICE and the United States Agency for Healthcare Research and Quality, thirteen key stakeholders and experts from academia, industry, government, and the National Health Service (NHS) were interviewed using a semistructured interview guide. Interview transcripts were subjected to a framework-based analysis using computer-assisted qualitative data analysis software.

Results: All interviewees endorsed the use of the OIR option. There was a high degree of consensus for several suggestions regarding how the use of the OIR option might be improved. For example, there was universal agreement that a formal process should be established to prioritize research needs arising from OIR decisions and that funds for publicly funded research projects should be channeled in a manner that would better motivate healthcare providers to participate in OIR-related research.

Conclusions: The findings of this study suggest several potential modifications of the OIR pathway in the United Kingdom and may also be helpful to health technology assessment agencies in other countries that already use or are considering using an OIR-like option to reduce the uncertainty inherent in health technology assessment.

Type
General Essays
Copyright
Copyright © Cambridge University Press 2009

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. Brown, P, Brunnhuber, K, Chalkidou, K, et al. Health research: How to formulate research recommendations. BMJ. 2006;333:804.CrossRefGoogle Scholar
2. Chalkidou, K, Hoy, A, Littlejohns, P. Making a decision to wait for more evidence: When the National Institute for Health and Clinical Excellence recommends a technology only in the context of research. J R Soc Med. 2007;100:453460.CrossRefGoogle ScholarPubMed
3. Chalkidou, K, Walley, T, Culyer, A, Littlejohns, P, Hoy, A. Evidence-informed evidence-making. J Health Serv Res Policy. 2008;13:167173.CrossRefGoogle ScholarPubMed
4. Chalmers, I. Addressing uncertainties about the effects of treatments offered to NHS patients: Whose responsibility? J R Soc Med. 2007;100:440441.CrossRefGoogle ScholarPubMed
5. Claxton, KP, Sculpher, MJ. Using value of information analysis to prioritise health research: Some lessons from recent UK experience. Pharmacoeconomics. 2006;24:1055.CrossRefGoogle ScholarPubMed
6. Cooksey, D. A review of UK health research funding. Norwich: Her Majesty's Stationery Office; 2006.Google Scholar
7 Department of Health. Faster access to modern treatment: How NICE appraisal will work. London: Department of Health; 1999.Google Scholar
8. Department of Health. High quality care for all: NHS Next Stage Review final report. London: Department of Health; 2008.Google Scholar
9. Goeree, R, Levin, L. Building bridges between academic research and policy formulation: The PRUFE Framework-an integral part of Ontario's evidence-based HTPA process. Pharmacoeconomics. 2006;24:1143.CrossRefGoogle ScholarPubMed
10. Higginbottom, GM. Sampling issues in qualitative research. Nurse Res. 2004;12:719.CrossRefGoogle ScholarPubMed
11. House of Commons Health Committee. National Institute for Health and Clinical Excellence: First report of session 2007–08. London: The Stationery Office Limited; 2007.Google Scholar
12 Kesselheim, AS, Fischer, MA, Avorn, J. The rise and fall of Natrecor for congestive heart failure: Implications for drug policy. Health Aff (Millwood). 2006;25:10951102.CrossRefGoogle ScholarPubMed
13. Levin, L, Goeree, R, Sikich, N, et al. Establishing a comprehensive continuum from an evidentiary base to policy development for health technologies: The Ontario experience. Int J Technol Assess Health Care. 2007;23:299309.CrossRefGoogle ScholarPubMed
14. Lyratzopoulos, G, Patrick, H, Campbell, B. Registers needed for new interventional procedures. Lancet. 2008;371:17341736.CrossRefGoogle ScholarPubMed
15. Mays, N, Pope, C. Qualitative research in health care: Assessing quality in qualitative research. BMJ. 2000;320:50.CrossRefGoogle Scholar
16. National Institute for Health and Clinical Excellence. Rituximab for the treatment of relapsed or refractory stage III or IV follicular non-Hodgkin's lymphoma. NICE technology appraisal guidance 137. London: National Institute for Health and Clinical Excellence; 2008.Google Scholar
17. National Institute for Health and Clinical Excellence. Computerised cognitive behaviour therapy for depression and anxiety. Technology appraisal 97. London: National Institute for Health and Clinical Excellence; 2006.Google Scholar
18. National Institute for Health and Clinical Excellence. Irinotecan, oxaliplatin and raltitrexed for the treatment of advanced colorectal cancer. Technology appraisal 93. London: National Institute for Health and Clinical Excellence; 2005.Google Scholar
19. National Institute for Health and Clinical Excellence. Docetaxel for the adjuvant treatment of early node-positive breast cancer. NICE technology appraisal guidance 109. London: National Institute for Health and Clinical Excellence; 2006.Google Scholar
20. National Institute for Health and Clinical Excellence. Guidance on the use of taxanes for the treatment of breast cancer. Technology appraisal guidance – No. 30. London: National Institute for Health and Clinical Excellence; 2001.Google Scholar
21. National Institute for Health and Clinical Excellence. Guidance on the use of liquid-based cytology for cervical screening. Technology appraisal 69. London: National Institute for Health and Clinical Excellence; 2003.Google Scholar
22. National Institute for Health and Clinical Excellence. Consultancy services business plan. National Institute of Health and Clinical Excellence. http://www.nice.org.uk/media/F14/0A/ITEM5ConsultancyServicesBusinessPlanMain.pdf (accessed August 13, 2008).Google Scholar
23. National Institute for Health and Clinical Excellence. Guide to the methods of technology appraisal. London: National Institute for Health and Clinical Excellence; 2008.Google Scholar
24. National Institute for Health and Clinical Excellence. Laparascopic surgery for colorectal cancer. NICE technology appraisal guidance 105. London: National Institute for Health and Clinical Excellence; 2006.Google Scholar
25. National Institute for Health and Clinical Excellence. Managing uncertainty in healthcare: Report of a meeting organised by NICE and AHRQ. National Institute of Health and Clinical Excellence. http://www.nice.org.uk/media/A1A/E6/NICEAHRQWorkshopReportFINAL.pdf (accessed August 12, 2008).Google Scholar
26. NICE Citizens Council. Only in research. National Institute of Health and Clinical Excellence. http://www.nice.org.uk/media/129/29/OIRReport300407.pdf (accessed August 13, 2008).Google Scholar
27. NIHR Health Technology Assessment Programme. Annual Report 2007. NIHR Health Technology Assessment Programme. http://www.ncchta.org/publicationspdfs/Annualreports/AnnualReport2007Web.pdf (accessed August 13, 2008).CrossRefGoogle Scholar
28. Palmer, S, Smith, PC. Incorporating option values into the economic evaluation of health care technologies. J Health Econ. 2000;19:755766.CrossRefGoogle ScholarPubMed
29. Pope, C, Ziebland, S, Mays, N. Analysing qualitative data. In: Pope, C, Mays, N, eds. Qualitative research in health care. 3rd ed. Oxford: Blackwell Publishing; 2006.CrossRefGoogle Scholar
30. Raftery, J. Review of NICE's recommendations,1999–2005. BMJ. 2006;332:12661268.CrossRefGoogle ScholarPubMed
31. Rawlins, M. In pursuit of quality: The National Institute for Clinical Excellence. Lancet. 1999; 353:10791082.CrossRefGoogle ScholarPubMed
32. Rawson, NS, West, R, Appel, WC. Could conditional release of new drugs provide the information required to study drug effectiveness? A discussion paper. Can J Clin Pharmacol. 2000;7:185190.Google ScholarPubMed
33. Ritchie, J, Spencer, L. Qualitative data analysis for applied policy research. In: Bryman, A, Burgess, RG, eds. Analyzing qualitative data. London: Routledge; 1994.Google Scholar
34. Sauerland, S, Maegele, M. A CRASH landing in severe head injury. Lancet. 2004;364:12911292.CrossRefGoogle ScholarPubMed
35. Topol, EJ. Failing the public health—Rofecoxib, Merck, and the FDA. N Engl J Med. 2004;351:17071709.CrossRefGoogle ScholarPubMed
36. Tunis, SR, Pearson, SD. Coverage options for promising technologies: Medicare's ‘Coverage With Evidence Development’. Health Aff (Millwood). 2006;25:12181230.CrossRefGoogle ScholarPubMed
37. Vinck, I, Neyt, M, Thiry, N, Louagie, M, Ramaekers, D. Introduction of emerging medical devices on the market: A new procedure in Belgium. Int J Technol Assess Health Care. 2007;23:449454.CrossRefGoogle Scholar