Australian health technology assessment of companion testing for cancer drugs.

Abstract

e17500 Background: Patients in Australia access oncology therapies and diagnostic tests through two universal tax funded schemes: the Pharmaceutical Benefits Scheme (PBS) and the Medical Benefits Scheme. Since 1993 health technology assessment (HTA) has been a mandatory requirement for listing new drugs on the PBS. In 2010 HTA of biomarker diagnostic tests have been performed in parallel with the dependant drug. Several cancer drugs have gone through this process since 2010. This study aims to review the process and outcome for these cancer drugs. Methods: The HTA companion testing process in Australia was sourced from Government websites. Public summary documents for all HTAs related to cancer drugs with a companion test were reviewed from 2010. Time from HTA initiation to approval was calculated and compared. Results: Eleven drugs have gone through the parallel diagnostic/drug HTA process since 2010 in five different tumor types (breast, colorectal, gastric, melanoma, NSCLC). Time to reimbursement approval for each of the drugs and companion tests are summarized in the Table. Conclusions: While targeted therapies should assist decision making and improve time to patient access, experience in Australia demonstrates that HTA of companion testing adds another layer of complexity to the overall cost-effectiveness assessment, with potential consequences being delay to patient access. Pharmaceutical companies need to take this into account when they plan late phase clinical trials as well as regulatory and reimbursement submissions. Drug Indication Biomarker Proportion with biomarker Reimbursement Panitumumab Colorectal KRAS 40% Initiated 22Jul12 Approved 5Apr13 Gefitinib NSCLC EGFR 10-20% Initiated 6Apr11 Deferred 1Aug13 Dabrafenib Melanoma BRAF 45.8% Initiated 22Sep11 Approved 1Aug13 Trastuzumab Gastric HER2 14-23% Initiated 21Apr11 Deferred 30Nov12 Vemurafenib Melanoma BRAF 45.8% Initiated 28Jun11 Deferred 2Aug12 Erlotinib NSCLC EGFR 10-20% Initiated 28Jun11 Deferred 1Aug13 Trastuzumab Breast HER2 15% Initiated N/A Approved 2Aug13 Afatinib NSCLC EGFR 10-20% Initiated May12 Deferred 1Aug13 Crizotinib NSCLC ALK 5% Initiated 28Nov11 Not assessed yet Cetuximab Colorectal KRAS 40% Initiated 7Jun13 Not assessed yet