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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 [email protected]
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
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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 

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