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Access to anticancer drugs: many evidence‐based treatments are off‐label and unfunded by the Pharmaceutical Benefits Scheme
Author(s) -
Mellor J. D.,
Van Koeverden P.,
Yip S. W. K.,
Thakerar A.,
Kirsa S. W.,
Michael M.
Publication year - 2012
Publication title -
internal medicine journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.596
H-Index - 70
eISSN - 1445-5994
pISSN - 1444-0903
DOI - 10.1111/j.1445-5994.2012.02751.x
Subject(s) - medicine , off label use , protocol (science) , drug , pharmaceutical benefits scheme , clinical trial , food and drug administration , cancer drugs , pharmacology , intensive care medicine , alternative medicine , medical prescription , pathology
Background The off‐label use of a drug refers to a use outside the terms of its approval by the Therapeutic Goods Administration ( TGA ). It is also possible to prescribe unlicensed drugs under the TGA 's special access scheme. A high rate of off‐label prescribing has previously been reported in cancer. Our study aimed to document the disparity between evidence‐based clinical guidelines for anticancer therapy, product approval and funding status of these agents within an academic tertiary/quaternary cancer centre. Methods 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 on 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 was identified. Overall, 189 (42.2%) of protocols were off‐label, and three (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%) was based on phase II or III clinical trial data. Conclusion 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 A ustralia.