WHICH RISK SHARE AGREEMENTS ARE AVAILABLE AND ARE THOSE APPLIED IN GLOBAL REIMBURSEMENT DECISIONS?
Author(s)
Walzer S1, Droeschel D1, Shannon R2
1MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 2Global Health Economic Projects, LLC, New York, NY, USA
OBJECTIVES: Risk Share Agreements (RSAs) are defined as agreements between a payer and a manufacturer where the price level is related to the actual future performance of the product. In the last years RSAs were introduced and applied in various jurisdictions. METHODS: RSAs in Australia, Canada, Italy, Spain, UK and the US were systematically searched for. They were clustered into the type of RSA per country and compared to each other. RESULTS: In Australia the main RSA types were annual sales caps, indication-wide caps, label caps, price-volume agreements, comparator rebates. The details of deeds of agreements/RSAs are generally not publicly available. In Canada the final formulary inclusion decisions are made by each province separately where confidential contracting with direct discounts are preferred. In Italy different contracting mechanisms evolved to payments-by-results in the last years with the AIFA patient registry supporting the implementation of RSAs. Even though payment-by-results was the main type of RSA, cost sharing, cost ceiling, risk sharing and combination types were accepted. In Spain contracting has become relevant with the introduction of dual pricing (list price vs reimbursed price). Combination RSA types (rebates, price-volume agreements, utilization cap, therapeutic positioning, pay-for-performance) were used at all levels whereas most regions have discount/rebate volume-based negotiations at hospital levels for high budget impact drugs. In the UK many recently launched high cost drugs achieved positive NICE guidance only if a patient access scheme was offered; with discount “only” schemes as the only one accepted by the NHS. In the US RSA are differently used to other markets mainly as coverage with evidence development type and not directly linked to the actual price. CONCLUSIONS: Currently RSAs are applied in different countries, however not in the same way and utilizing the same types for RSA with discounts as being the most relevant for payers.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PHP313
Topic
Health Policy & Regulatory
Topic Subcategory
Risk-sharing Approaches
Disease
Multiple Diseases