Abstract
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.
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.
| Original language | English |
|---|---|
| Pages (from-to) | e17500-e17500 |
| Number of pages | 1 |
| Journal | Journal of Clinical Oncology |
| Volume | 32 |
| Issue number | 15 (supplement) |
| DOIs | |
| Publication status | Published - 20 May 2014 |
| Externally published | Yes |
| Event | 2014 ASCO Annual Meeting - Chicago, United States Duration: 30 May 2014 → 3 Jun 2014 |
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
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