OBJECTIVES:

Achieving market access in the Australian pharmaceutical market is challenging, as payers request greater certainty relating to clinical and cost effectiveness, as well as for budgetary constraints. Risk Sharing Arrangements (RSAs) are one method used by payers to increase certainty. The aim of this study was to analyse the use of RSAs in Australia between 2013 and 2021.

METHODS:

An analysis was conducted using the Market Access One Stop Shop (MAOSS) database to identify all Public Summary Documents (PSDs) for drugs recommended to be listed on the PBS which a pharmaceutical company proposed the use of an RSA, or where a RSA was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC).

RESULTS:

While the use of RSAs grew significantly from 3 in 2013 to 21 in 2016, the use of RSAs has stabilized since 2017, with 12 RSAs recommended in 2017 growing to 18 in 2021. Since 2016, approximately 1 in 3 recommended new drugs listed on the Pharmaceutical Benefits Scheme (PBS) may have an arranged RSA.

CONCLUSIONS:

The stabilization of growth in the use of RSAs indicates that the PBAC has reduced its reliance on RSAs, including in the oncology therapeutic area, and therefore the PBAC may have more confidence in either the provided clinical evidence within submissions, the analysis presented within the submissions or due to more realistic pricing negotiations. However, pharmaceutical companies need to be prepared to enter an RSA if there is identified uncertainty within their PBAC submissions to successfully gain PBS listing.