CHARACTERISTICS OF MANAGED ACCESS AGREEMENTS FOR MEDICINES IN AUSTRALIA
Author(s)
Robinson MF, Roughead E
University of South Australia, Adelaide, Australia
Presentation Documents
The Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommends subsidy of a medicine for an indication (MIP) based on appraisal of the evidence for comparative clinical effectiveness, cost effectiveness and financial cost. PBAC advises what uncertainties exist in the evidence. Where uncertainties exist, the Australian Government uses a wide range of managed entry agreements (MEAs) to make medicines available in the national Pharmaceutical Benefits Scheme (PBS). OBJECTIVES: To describe the characteristics of all MEAs established by type of action, source of recommendation, and therapeutic area (ATC). METHODS: Extracted information for all MEAs implemented between January 2012 and May 2016. A typology for the type of action was developed. RESULTS: Eighty-six MIPs were PBS-listed with 171 MEAs. 74% of MIPs had two or more MEAs. 51% of MIPs provided additional health benefit (cost effective) and 49% the same benefit (cost minimised) over comparators. 51% of MIPs treated cancers or immune diseases (ATC L). PBAC recommended MEAs for 90% of MIPs. 82% of MEAs were simple financial agreements; of the 8 possible financial actions 33% were discounts, keeping the actual price confidential, and 43% required reimbursement if financial caps were exceeded. 13% of MEAs relied on performance measures linked to reimbursement; most of the 6 possible MEAs limiting subsidised continuation to patient response. Coverage with evidence development (CED) MEAs were least common (5%); 5 of the 8 CED required review of outcomes from clinical trials already underway. CONCLUSIONS: The Australian Government relies on financial agreements to manage access. There may be barriers to implementation of more complex MEAs. The PBAC is involved in implementing many MEAs through the evaluation and appraisal of evidence.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PHP282
Topic
Health Policy & Regulatory
Topic Subcategory
Risk-sharing Approaches
Disease
Multiple Diseases
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