RISK SHARE AGREEMENTS (RSA), PRODUCT LISTING AGREEMENTS (PLA) OR PATIENT ACCESS SCHEMES (PAS) - ALL THE SAME OR DIFFERENT?

Author(s)

Kim H1, Harrison JP2, Moshyk A3, Liew D4
1University of Melbourne, Parkville, Australia, 2Bristol-Myers Squibb, Uxbridge, UK, 3Bristol-Myers Squibb, Saint-Laurent, QC, Canada, 4Monash University, Melbourne, Australia

OBJECTIVES: Australia, Canada and the UK are ‘mature’ health technology assessment (HTA) markets that allow special (undisclosed) arrangements between sponsors and payers so that drugs can be conditionally listed on reimbursement schedules but with limitation of economic uncertainty for payers. These agreements are called risk share agreements (RSA) in Australia, product listing agreements (PLA) in Canada and patient access schemes (PAS) in the UK. However, it is not clear what differences, if any, exist in these arrangements across the 3 markets This qualitative study sought to compare special arrangements between drug sponsors and payers in Australia, Canada and the UK.  METHODS: This is a qualitative review of publicly available information and the expert opinion from Australia, Canada and the UK. Experts were selected from industry and academia. RESULTS: All three countries allow simple agreements like a list price versus a net price. Complex arrangements, which may seek to address clinical as well as financial uncertainty, are also known to occur, but in the UK are usually by exception. Furthermore, in the UK, arrangements are proposed by sponsors and generally require approval by the relevant bodies prior to first consideration by the decision maker. In Canada, recommendations for PLAs are made by HTA agencies and negotiations take place after the HTA reviews. In Australia, RSAs can be proposed by either sponsors or payers. Implementation of agreements also vary between countries. In Australia, because drugs are funded by the federal government, implementation of RSAs occurs centrally. In the UK and Canada, local payers implement the agreements. CONCLUSIONS: Special arrangements in Australia, Canada and the UK serve a common purpose but there are important differences among the 3 countries which may lead to different benefits and barriers in implementation. Detailed information on agreements were limited due to the confidential nature of these agreements.

Conference/Value in Health Info

2016-09, ISPOR Asia Pacific 2016, Singapore

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PCN59

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy, Risk-sharing Approaches

Disease

Diabetes/Endocrine/Metabolic Disorders, Musculoskeletal Disorders, Oncology, Systemic Disorders/Conditions

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