Skip to main content
Log in

Access with Evidence Development Schemes

A Framework for Description and Evaluation

  • Conference Paper
  • Published:
PharmacoEconomics Aims and scope Submit manuscript

Abstract

There is an inevitable tension between robust reimbursement processes and providing speedy access to new and novel technologies, given uncertainties about key pieces of evidence and subsequent concerns regarding their overall efficiency. The public perception of these treatments as ‘breakthrough’, combined with substantial clinical pressure, has led to healthcare payers looking for schemes that allow the new technology to be made available to (some) patients, while (at least partially) protecting the principles of their reimbursement decision-making processes. Current literature on these schemes is almost completely descriptive and provides little help in planning future schemes. We propose a framework for evaluating current schemes and informing the design of future schemes. We examine the value of the framework using the UK Multiple Sclerosis Risk-Sharing Scheme as a case study.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1

Similar content being viewed by others

References

  1. Stafinski T, McCabe CJ, Menon D. Funding the unfundable: mechanisms for managing uncertainty in decisions on the introduction of new and innovative technologies into healthcare systems. Pharmacoeconomics 2010; 28 (2): 113–42

    Article  PubMed  Google Scholar 

  2. Tunis SR, Carino TV, Williams II RD, et al. Federal initiatives to support rapid learning about new technologies. Health Aff 2007; 26 (2): w140–9

    Article  Google Scholar 

  3. Chapman S, Reeve E, Rjaratnam G, et al. Setting up an outcomes guarantee for pharmaceuticals: new approach to risk sharing in primary care. BMJ 2003; 326: 707–9

    Article  PubMed  Google Scholar 

  4. Chalkido K, Lord J, Fischer A, et al. Evidence based decision making: when should we wait for more information? Health Aff 2008; 27 (6): 1642–53

    Article  Google Scholar 

  5. Department of Health. Health Service Circular HSC 2002/004. Cost effective provision of disease modifying therapies for people with multiple sclerosis. London: DoH, 2002 Feb

    Google Scholar 

  6. Claxton K. Exploring uncertainty in cost effectiveness models. Pharmacoeconomics 2009; 26 (9): 781–98

    Article  Google Scholar 

  7. Daniels N, Sabin JE. Accountability for reasonableness: an update. BMJ 2008; 337: 1850

    Article  Google Scholar 

  8. National Institute for Health and Clinical Excellence. Social value judgements: guidance to the Institutes Advisory Committees. 2nd ed. London: NICE, 2008

    Google Scholar 

  9. National Institute for Clinical Excellence. Full guidance on the use of beta interferon and glatiramer acetate for the treatment of multiple sclerosis. London: NICE, 2002: 1–25

    Google Scholar 

  10. Chilcott JB, McCabe C, Tappenden P, et al. Modelling the cost effectiveness of interferon beta and glatiramer acetate in the management of multiple sclerosis. BMJ 2003; 326 (7388): 522–7

    Article  PubMed  Google Scholar 

  11. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale. Neurology 1983; 33: 1444–52

    Article  PubMed  CAS  Google Scholar 

  12. Pickin DM, Cooper C, Nichol J, et al. The United Kingdom Multiple Sclerosis Risk Sharing Monitoring Study: early results and lessons for the future. BMC Neurol 2009 Jan 6; 9: 1

    Article  PubMed  Google Scholar 

  13. Hansard HC Deb 24 July 2002 vol 389 c1424W 1424W

  14. Hansard HC Deb 09 April 2003 vol 403 cc317-8W 317W

  15. Hansard HL Deb 09 June 2003 vol 649 cc9-11WA 10WA

  16. Hansard 5 Dec 2006 Column 383W [online]. Available from URL: http://www.parliament.the-stationery-office.co.uk/pa/cm200607/cmhansrd/cm061205/text/61205w0038.htm [Accessed 2009 Dec 10]

  17. Hansard HC Written Answers for 28 Oct 2008 (pt 0029)

  18. Brekinridge A, Walley T. Risk sharing and payment by results. Clin Pharmacol Ther 2008 May; 83 (5): 666–7

    Article  Google Scholar 

  19. Association of British Neurologists. Guidelines for treatment with interferon beta and glatiramer acetate in multiple sclerosis. London: ABN, 2001

    Google Scholar 

  20. Committee forMedicinal Products forHuman Use, European Medicines Agency. Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis. London: European Medicines Agency, 2006

    Google Scholar 

Download references

Acknowledgements

We acknowledge the valuable contributions of participants in the Banff Summit. No sources of funding were used to assist in the preparation of this article. The authors have received payments from many organizations that may be affected by AED schemes.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Christopher J. McCabe.

Rights and permissions

Reprints and permissions

About this article

Cite this article

McCabe, C.J., Stafinski, T., Edlin, R. et al. Access with Evidence Development Schemes. Pharmacoeconomics 28, 143–152 (2010). https://doi.org/10.2165/11530850-000000000-00000

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/11530850-000000000-00000

Keywords

Navigation