PHP10 Australia's Rule of Rescue and the Life Saving Drugs Programme: Same-Same But Different?

Abstract

Medicines that are considered to be clinically effective but not cost-effective by the Pharmaceutical Benefits Advisory Committee (PBAC) may be reimbursed in Australia through two pathways: by meeting the ‘rule of rescue' (RoR) criteria to be listed on the Pharmaceutical Benefits Scheme, or being included on the life-saving drugs programme (LSDP). The criteria for the RoR and LSDP share some similarities, but the LSDP criteria are less subjective and more restrictive. We sought to analyse and compare outcomes for submissions that were considered under the RoR and LSDP from 2008 to 2011. Public Summary Documents of PBAC recommendations for 2008-2011 were reviewed to identify submissions that were considered for reimbursement citing the RoR or requested listing on the LSDP. Outcomes of the applications were analysed and Payer interviews were undertaken to better understand the factors influencing the funding decisions. During this period three submissions were considered under the RoR criteria, two in 2008 and one in 2009. None of these were approved for listing on the basis of the RoR, however two were accepted on the basis of high clinical need and high but acceptable cost-effectiveness ratio. No submission has requested consideration under the RoR, or been assessed under this criteria by the PBAC, since November 2009. In comparison, from 2008-2011, 4 new applications and 5 re-submissions requested listing on the LSDP and 3 of these were successful. Despite stricter criteria for the LSDP than the RoR, applications to the LSDP have had a better success rate. The RoR has not been used to justify a listing on the PBS for at least four years, perhaps indicating that these criteria are no longer favoured by the PBAC.