Hostname: page-component-78c5997874-t5tsf Total loading time: 0 Render date: 2024-11-10T16:30:06.622Z Has data issue: false hasContentIssue false
  • English
  • Français

CHARACTERISTICS OF MANAGED ENTRY AGREEMENTS IN AUSTRALIA

Published online by Cambridge University Press:  26 December 2017

Maxine F. Robinson Open the ORCID record for Maxine F. Robinson [Opens in a new window] ,
Cathrine Mihalopoulos ,
Tracy Merlin Open the ORCID record for Tracy Merlin [Opens in a new window]  and
Elizabeth Roughead
Maxine F. Robinson
Affiliation:
Quality Use of Medicines and Pharmacy Research Centremaxinerobinson@mac.com
Cathrine Mihalopoulos
Affiliation:
Faculty of Health, Deakin University
Tracy Merlin
Affiliation:
Adelaide Health Technology Assessment
Elizabeth Roughead
Affiliation:
Quality Use of Medicines and Pharmacy Research Centre
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives: Australia relies on managed entry agreements (MEAs) for many medicines added to the national Pharmaceutical Benefits Scheme (PBS). Previous studies of Australian MEAs examined public domain documents and were not able to provide a comprehensive assessment of the types and operation of MEAs. This study used government documents approved for release to examine the implementation and administration of MEAs implemented January 2012 to May 2016.

Methods: We accessed documents for medicines with MEAs on the PBS between January 2012 and May 2016. Data were extracted on Anatomical Therapeutic Classification (ATC), type of MEA (financial, financial with outcomes, outcomes, and subcategories within each group), implementation and administration methods, source of MEA recommendation, and type of economic analysis.

Results: Of all medication indication pairs (MIPs) recommended for listing, one-third had MEAs implemented. Our study of eighty-seven MIPs had 170 MEAs in place. The Government's expert health technology assessment (HTA) committee recommended MEAs for 90 percent of the eighty-seven MIPs. A total of 81 percent of MEAs were simple financial agreements: the majority either discounts (32 percent) or reimbursement caps (43 percent). Outcome-based MEAs were least common (5 percent). Ninety-two percent of MEAs were implemented and operated through legal agreements. Approximately half of the MIPs were listed on the basis of accepted claims of cost-minimization. Forty-nine percent of medicines were in ATC L group.

Conclusion: Advice from HTA evaluations strongly influences the implementation of ways to manage uncertainties while providing access to medicines. The government relied primarily on simple financial agreements for the managed entry of medicines for which there were perceived risks.

Keywords

Managed entry agreementsPharmaceutical policyOutcome-based agreementsPerformance-based agreements
Type
Assessments
Information
International Journal of Technology Assessment in Health Care , Volume 34 , Issue 1 , 2018 , pp. 46 - 55
Copyright
Copyright © Cambridge University Press 2017 

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. Ferrario, A, Kanavos, P. Managed entry agreements for pharmaceuticals: The European experience. European Commission EaI. http://eprints.lse.ac.uk/id/eprint/50513 (accessed November 22, 2017).Google Scholar
2. Garrison, L, Towse, A, Briggs, A, et al. Performance-based rish sharing arrangements - Good practices for design, implementation, and evaluation: Report of the ISPOR Good Practices for Performance-Based Risk-Sharing Arrangements Task Force. Value Health. 2013;16: 703–719.CrossRefGoogle Scholar
3. Klemp, M, Fronsdal, K, Facey, K. What principles should govern the use of managed entry agreements? Int J Technol Assess Health Care. 2011;27:77–83.CrossRefGoogle ScholarPubMed
4. Australian Government. About the PBS. [updated 1 July 2015]. http://www.pbs.gov.au/info/about-the-pbs (accessed November 22, 2017).Google Scholar
5. Parliamentary Library. Pharmaceutical benefits scheme budget review 2015–16: Commonwealth of Australia. [updated May 2015]. http://www.aph.gov.au/About_Parliament/Parliamentary_Departments/Parliamentary_Library/pubs/rp/BudgetReview201516/PBS (accessed November 22, 2017).Google Scholar
6. Australian Health Department. New breast & lung cancer drugs available from today. [updated July 1, 2015]. http://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2015-ley083.htm (accessed November 22, 2017).Google Scholar
7. Australian Government. PBAC Guidelines for submissions: Commonwealth of Australia. http://www.pbac.pbs.gov.au/ (accessed November 22, 2017).Google Scholar
8. Moberg, J, Alonso-Coello, P, Oxman, A. GRADE Evidence to Decision (EtD) Frameworks Guidance. The GRADE Working Group 2015 May 2015. Report No. 1.1. https://ietd.epistemonikos.org/#/help/guidance (accessed July 13, 2016).Google Scholar
9. Carlson, JJ, Garrison, LP Jr, Sullivan, SD. Paying for outcomes: Innovative coverage and reimursement schemes for pharmaceuticals. J Manag Care Pharm. 2009;15:683–687.Google ScholarPubMed
10. Carlson, J, Sullivan, S, Garrison, L, Neumann, P, Veenstra, D. Linking payment to health outcomes: A taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers. J Health Policy. 2010;96:179–190.CrossRefGoogle ScholarPubMed
11. Towse, A, Garrison, L. Can't get no satisfaction: Will pay for permformance help? Pharmacoeconomics. 2010;28:93–102.CrossRefGoogle ScholarPubMed
12. Australian Government. Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme. Department of Health; 2016. Report No. 1.0. http://www.pbs.gov.au/info/industry/listing/listing-steps (accessed November 22, 2017).Google Scholar
13. Makino, K, Tilden, D, Kamei, M, Shibata, K. Risk-Sharing agreements in Australia: Attitude towards risk-sharing arrangements with the Department of Health for the PBS listing of pharmaceuticals. Value Health. 2014;17:A801.CrossRefGoogle Scholar
14. Ferrario, A, Kanavos, P. Dealing with uncertainty and high prices of new medicines; A comparative analysis of the use of managed entry agreements in Belgium, England, the Netherlands and Sweden. Soc Sci Med. 2015;124:39–47.CrossRefGoogle ScholarPubMed
15. Jaroslawski, S, Toumi, M. Market access agreements for pharmaceuticals in Europe: Diversity of approaches and underlying concepts. BMC Health Serv Res. 2011;11:259–266.CrossRefGoogle ScholarPubMed
16. Walker, S, Sculpher, M, Claxton, K, Palmer, S. Coverage with evidence development, only in research, risk sharing, or patient access scheme? A framework for coverage decisions. Value Health. 2012;15:570–579.CrossRefGoogle ScholarPubMed
17. McCabe, C, Stafinski, T, Edlin, R, Menon, D. Access with evience development schemes: A framework for descriptions and evaluation. Pharmacoeconomics. 2010;28:143–152.CrossRefGoogle Scholar
18. Coulton, L, Annemans, L, Javier, J, Brown, R, Keskinaslan, A, eds. Risk-sharing schemes worldwide: A landscape analysis of health outcomes-based reimbursement agreements. ISPOR 4th Asia-Pacific Conference; 2010; Phuket, Thailand.Google Scholar
19. Vitry, A, Roughead, E. Managed entry agreements for pharmaceuticals in Australia. Health Policy. 2014;117:345–452.CrossRefGoogle ScholarPubMed
20. Lu, C, Lupton, C, Ralowsky, S, Babar, Z-U-D, Ross-Degnan, D, Wagner, A. Patient access schemes in Asia-pacific markets:current experience and future potential. J Pharm Policy Pract. 2015;8:6.CrossRefGoogle ScholarPubMed
21. Robertson, J, Walkom, E, Henry, D. Transparency in pricing arrangements for medicines listed on the Australian Pharmaceutical Benefits Scheme. Aust Health Rev. 2009;33:192–199.CrossRefGoogle ScholarPubMed
22. Commonwealth of Australia. Availability of new innovative and specialist cancer drugs in Australia. The Senate, Committee CAR. [updated September 17, 2015]. http://www.roche-australia.com/content/dam/roche_australia/en_AU/policy/2015-02%20Senate%20Inquiry.pdf (accessed November 22, 2017).Google Scholar
23. WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Methodology [updated December 15, 2016]. https://www.whocc.no (accessed November 22, 2017).Google Scholar
24. Drummond, M, Sculpher, M, Torrance, G, O'Brien, B, Stoddart, G. Methods for the economic evaluation of health care programmes. 3rd ed. New York: Oxford University Press; 2005.CrossRefGoogle Scholar
25. Australian Government. PBS text files. www.pbs.gov.au/info/publication/schedule/archive (accessed November 22, 2017).Google Scholar
26. Australian Government. PBAC Outcomes Australia: Department of Health; [updated April 22, 2016]. http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes (accessed November 22, 2017).Google Scholar
27. Turkstra, E, Comans, T, Gordon, L, Scuffham, P. ISPOR global health care systems road map: Australia – Pharmaceutical. [updated February 20, 2017]. https://www.ispor.org/HTARoadMaps/Australia_Pharm.asp (accessed November 22, 2017).Google Scholar
28. Toumi, M, Jaroslawski, S. Patient access schemes in UK are driven by health technology assessment. Value Health. 2011;13:A246.CrossRefGoogle Scholar
29. Toumi, M, Jaroslawski, S, Sawada, T, Kornfeld, A. The use of surrogate and patient-relevant endpoints in outcomes-based market access agreements: Current debate. Applied Health Econ Health Policy. 2017;15:5–11.CrossRefGoogle ScholarPubMed
30. Fagnani, F, Pham, T, Claudepierre, P, et al. Modeling of the clinical and economic impact of a risk-sharing agreement supporting a treat-to-target strategy in the management of patients with rheumatoid arthritis in France. J Med Econ. 2016;19:812–821.CrossRefGoogle ScholarPubMed
31. Jaroslawski, S, Toumi, M. Design of patient access schemes in the UK. Appl Health Econ Health Policy. 2011;9:209–215.CrossRefGoogle ScholarPubMed
32. Lu, C, Williams, K, March, L, Sansom, L, Bertouch, J. Access to high cost drugs in Australia. BMJ. 2004;329:415–416.CrossRefGoogle ScholarPubMed
33. Australian Government. The Pharmaceutical Benefits Scheme A-Z medicine listing. [updated 1 July 1, 2016]. http://www.pbs.gov.au/browse/medicine-listing (accessed November 22, 2017).Google Scholar
34. Australian Government. Deeds of Agreement. [updated September 23, 2013]. http://www.pbs.gov.au/info/industry/listing/elements/deeds-agreement/b-background (accessed November 22, 2017).Google Scholar
35. Espin, J, Rovira, J, Garcia, L. Experiences and impact of European risk-sharing schemes focusing on oncology medicines. Granada, Spain: Andalusian School of Public Health; 2011.Google Scholar
36. Edmonds, D, Dumbrell, D, Primrose, J, Birkett, D, Demirian, V. Development of an Australian Drug Utilization Database: A report from the Drug Utilization Subcommittee of the Pharmaceutical Benefits Advisory Committee. Pharmacoeconomics. 1993;3:427–432.CrossRefGoogle Scholar
37. Briggs, A, Ritchie, K, Fenwick, E, Chalkidou, K, Littlejohn, P. Access with evidence development in the UK: Past experience, current initiatives and future potential. Pharmacoeconomics. 2010;28:163–170.CrossRefGoogle ScholarPubMed
38. van de Vooren, K, Curto, A, Freemantle, N, Garattini, L. Market-access agreements for anti-cancer drugs. J R Soc Med. 2015;108:166–170.CrossRefGoogle ScholarPubMed
39. Williamson, S. Patient access schemes for high-cost cancer medicines. Lancet Oncol. 2010;11:111–112.CrossRefGoogle ScholarPubMed
40. Conter H. Financial risk-sharing agreements: Using options to make marginal benefits cost effective. J Clin Oncol. 2016;34 (Suppl):41.CrossRefGoogle Scholar
41. Garrison, L, Carlson, J, Bajaj, P, et al. Private sector risk-sharing agreements in the United States: Trends, barriers and prospects. Am J Manag Care. 2015;21:632–640.Google ScholarPubMed
42. Maguire, P, Gibson, E. Patient access schemes within the UK: A retrospective analysis. Value Health. 2015;18:A335–A766.CrossRefGoogle Scholar
43. Tettamanti, A, Urbinati, D, Noble, M. Market access entry agreements in the Italian market between January 2006 and April 2015. Value Health. 2015;18:A334–A766.CrossRefGoogle Scholar
44. Atkinson, W. The impact of CED on private payers. Biotechnol Healthc. 2007;4:24–30.Google ScholarPubMed
45. Lu, C, Williams, K, Day, R. Access to tumour necrosis factor inhibitors for rheumatoid arthritis treatment under the Australian Pharmaceutical Benefits Scheme: Are we on target? Intern Med J. 2006;36: 19–27.CrossRefGoogle ScholarPubMed
46. Garattini, L, Curto, A, van de Vooren, K. Italian risk-sharing agreements on drugs: Are they worthwhile? Eur J Health Econ. 2015;16:1–3.CrossRefGoogle ScholarPubMed
47. Australian Government. Review of Pharmaceutical Benefits Scheme Anti-dementia Drugs to Treat Alzheimers Disease: Department of Health. [updated May 28, 2012]. http://www.pbs.gov.au/info/reviews/anti-dementia-drugs (accessed November 22, 2017).Google Scholar
48. Australian Government. PBAC Review of bDMARDs for the treatment of severe active rheumatoid arthritis: Department of Health. [updated Februrary 19, 2010]. http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2009-12/pbac-psd-bdmards-dec09 (accessed November 22, 2017).Google Scholar
49. Bishop, D, Lexchin, J. Politics and its intersection with coverage with evidence development: A qualitative anlaysis from expert interviews. BMC Health Serv Res. 2013;13:88–98.CrossRefGoogle Scholar
50. Government, Australian. Framework for the introduction of a Managed Entry Scheme for submissions to the Pharmaceutical Benefits Advisory Committee. [updated February 23, 2011]. http://www.pbs.gov.au/info/publication/factsheets/shared/framework-for-introduction-of-managed-entry-scheme-for-PBAC-submissions (accessed November 22, 2017).Google Scholar
51. Australian Government. Access to Medicines Working Group (AMWG) Communique: Department of Health. [updated September 8, 2016]. http://www.pbs.gov.au/info/general/amwg-files/amwg-april-2016 (accessed November 22, 2017).Google Scholar