Which Risk Share Agreements are Available and are Those Applied In Global Reimbursement Decisions?

Abstract

Objectives: In response to greater health budget restrictions and the rise in costly new treatments, manufacturers and payers have increasing interest in performancebased risk-sharing arrangements (PBRSAs) that address uncertainty and accelerate access to medicines. Our objectives were to review guidelines for PBRSA implementation and the use of PBRSAs in the UK, Italy, and the Netherlands. MethOds: A non-systematic review was undertaken using PubMed to identify guidance on PBRSA implementation. Appropriate governmental and agency websites in the UK, Italy, and the Netherlands were also reviewed to identify PBRSA examples. Key considerations for PBRSA implementation and its historical application in the UK, Italy and the Netherlands were evaluated. Results: Several key considerations for PBRSA implementation were identified from published guidelines. The approach to PBRSA implementation varies between countries with regards to: evidence collection, governance, reporting, and evaluation. While PBRSAs have been applied in the UK, simple cost-sharing arrangements are now encouraged due to difficulties with the implementation and evaluation of PBRSAs. In Italy, AIFA makes extensive use of online monitoring registries to inform their PBRSAs. However, there is no established process for implementation. Currently, in the Netherlands all inpatient drugs with a budget impact > € 0.6 million and an unacceptable level of uncertainty can be granted access via coverage with evidence development arrangements. Both national and international registry data are used in the re-evaluation of reimbursement decisions. cOnclusiOns: The approach to PBRSA implementation varied across the three countries reviewed, although the objectives for their use were similar across the analysed countries. Manufacturers need to consider country-specific factors for implementation and key PBRSA considerations identified via our research offer guidance for applying PBRSAs in these markets.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 com...

Risk-Sharing Agreements in the EU: A Systematic Review of Major Trends

“…As an example of this, Briceno and Seoane-Vazquez [ 51 ] reviewed 207 NICE drug appraisals between September 2001 and September 2014 and determined that more than 45% of the appraisals published after 2010 included a confidential discount from the company to the NHS. This study highlighted that most high-cost drugs achieved a positive evaluation from NICE only if a simple discount was offered through a PAS [ 51 , 52 ]. Although the UK primarily preferred discounts, PBRSAs were also successful.…”

“…As a result, empirical evidence and validated success stories have been lacking in past years, and this has led to substantial debates about the sustainability of alternative pricing and reimbursement processes [ 7 , 22 ]. However, details of and results from RSAs that were originally not publically available are now beginning to emerge [ 52 , 65 ], enabling this study.…”