RISK-SHARING AGREEMENTS IN AUSTRALIA- ATTITUDE TOWARDS RISK-SHARING ARRANGEMENTS WITH THE DEPARTMENT OF HEALTH FOR THE PBS-LISTING OF PHARMACEUTICALS

Author(s)

Makino K1, Tilden D2, Kamei M3, Shibata K4
1THEMA Consulting Pty. Ltd., Sydney, Australia, 2Thema Consulting, Sydney, Australia, 3Nihon University, Chiba, Japan, 4Showa University, Tokyo, Japan

OBJECTIVES: Conditional reimbursement approval for pharmaceuticals, for example, risk-sharing arrangement (RSA) involving price-volume agreement or various post-launch monitoring requirements, is becoming a standard practice in Australia, especially for novel treatments with high ICER and/or potentially significant budget impact. Uptake of RSAs are relatively slow in other jurisdictions. Efficient implementation of an RSA requires active involvement from all stakeholders, in particular, drug manufacturers and the decision makers. This study reports the findings from a survey of pricing and reimbursement experts in Australia to gain insight into their attitude/opinions of RSAs from their own personal experience. METHODS: Senior-level health economists and consultants were targeted. The survey included questions about responder’s demographics, the number and type of RSAs they have personally been involved with, and their experience and opinions about RSAs. A general overview of RSAs is also provided to better contextualise the survey findings. RESULTS: Ten experts participated on an anonymous basis. They in total have been involved in 403 submissions, and 56 RSAs of various types. Capped cost agreements were most frequently employed (>70% of all RSAs). ‘Hidden price’ is also frequently agreed. Respondents generally had positive attitude towards RSA (mean of 3 using a 1-5 scale) mainly because it can potentially benefit timeline and address global pricing issues. Concerns were however raised about the fact that the ‘risk’ is entirely borne by the industry in many cases and RSA has now become an integral element in the PBAC’s decision making process. CONCLUSIONS: RSA is generally well perceived among industry experts in Australia, whilst an increasing role of PBAC in defining clauses in the agreement is seen as a hurdle against productive involvement from the industry. The Australian model of RSA may offer a useful template for other jurisdictions.

Conference/Value in Health Info

2014-09, ISPOR Asia Pacific 2014, Beijing, China

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PHP103

Topic

Health Policy & Regulatory

Topic Subcategory

Risk-sharing Approaches

Disease

Multiple Diseases

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