Access to anticancer drugs: many evidence-based treatments are off-label and unfunded by the Pharmaceutical Benefits Scheme.
Intern Med J
; 42(11): 1224-9, 2012 Nov.
Article
en En
| MEDLINE
| ID: mdl-22372936
ABSTRACT
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 Australia.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Uso Fuera de lo Indicado
/
Accesibilidad a los Servicios de Salud
/
Seguro de Servicios Farmacéuticos
/
Neoplasias
/
Antineoplásicos
Tipo de estudio:
Guideline
/
Prognostic_studies
Límite:
Humans
País/Región como asunto:
Oceania
Idioma:
En
Revista:
Intern Med J
Asunto de la revista:
MEDICINA INTERNA
Año:
2012
Tipo del documento:
Article
País de afiliación:
Australia