abstract: Access to anti-cancer drugs: Many evidence-based treatments are off-label and unfunded by the PBS - Australia

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.

Making Sense of the Debate Over Patient Access to Medical Information

Making Sense of the Debate Over Patient Access to Medical Information:

By John Lumpkin, MD

“When it comes to health care, information is power.”

This comment from U.S. Department of Health & Human Services Secretary Kathleen Sebelius has sparked a heated debate among doctors and patient advocates about the merits and drawbacks of giving patients easy access to their lab results, doctors’ notes and other personal medical information. A deliberation in this month’s issue of SGIM Forum, the newsletter of the Society of General Internal Medicine (SGIM), is emblematic of how doctors’ and patients’ views on transparency vary.
Internist Douglas P. Olson, MD says it’s too early to offer patients electronic access to their lab results or medical records and that without systemic changes it could actually undermine the patient-doctor relationship lists among his concerns the potential to confuse or worry patients; a lack of evidence showing the positive effect on healthcare safety and quality; and the increased demands on doctors’ time to respond to patient questions.
These concerns are valid and shared by many other doctors. In a recent survey by OpenNotes―a project supported by the Robert Wood Johnson Foundation’s Pioneer Portfolio that enables doctors to share their visit notes with patients online―doctors were asked about their expectations and attitudes toward sharing electronic medical notes. The survey was conducted before doctors engaged with OpenNotes. Responses revealed doctors were worried about the impact on workflow and weren’t convinced that it would make a difference to patients’ health.
In contrast, patients in the OpenNotes survey were almost uniformly enthusiastic about being offered access to their doctor’s notes online.

Doctors Are Cautious, Patients Enthusiastic About Sharing Medical Notes - Beth Israel Deaconess Medical Center