Access to anti-cancer drugs: Many evidence-based treatments are off-label and unfunded by the PBS
ABSTRACT
Background:
The off-label use of a drug refers to a use outside the terms of its
approval by the Therapeutic Goods Administration's (TGA). It is also
possible to prescribe unlicensed drugs under the Therapeutic Goods
Administration's (TGA) Special Access Scheme. A high rate of off-label
prescribing has previously been reported in cancer. Our study aimed to
document the disparity between clincial evidence-based guidelines for
anti-cancer therapy, product approval, and funding status of these
agents within an academic tertiary/quaternary cancer centre.
Method:
All chemotherapy protocols approved for use in our specialist oncology
centre were assessed to determine if the drugs were off-label or
unlicensed for that indication based upon review of their current
product information. The Pharmaceutical Benefits Scheme (PBS) funding
status for each protocol was subsequently assessed.
Results:
A total of 448 protocols, containing 82 different drugs, across 15
tumour groups were identified. Overall, 189 (42.2%) of protocols were
off-label and 3 (0.7%) were unlicensed. This resulted in all 192
protocols being unfunded by the PBS. Of the 189 off-label protocols, 132
(69.9%) were based on established evidence-based treatment guidelines
and a further 39 (20.6%) were based upon phase II or III clinical trial
data.
Discussion: Over 90% of
off-label protocols are supported by established treatment guidelines or
published peer-reviewed research even though the medications are not
approved for that particular use by the TGA. However, these off-label
protocols are unfunded by the PBS: this results in a marked inequality
of access to appropriate medications for cancer patients across
Australia.
