AUSTRALIA SLOW ACCESS IN NEW CANCER DRUGS

SYDNEY — Australia has the highest age-standardized incidence of cancer in the world, with 1 in 2 Australians developing cancer in their lifetime. And yet, patients here are experiencing significant delays in accessing some of the latest cancer drugs.

A case in point is melanoma, of which Australia has the highest incidence in the world. Breakthrough therapies that have revolutionized melanoma treatment elsewhere are only just now being made available to patients in Australia, having only just recently been added to the national reimbursement scheme.

The revolutionary immunotherapy ipilimumab (Yervoy), which has extended the lives of some patients with metastatic melanoma for up to 10 years, was added to Australia's list of subsidized medicines only this summer, in July. This is more than a year after it was already reimbursed in other countries with nationwide healthcare schemes, such as Canada and Germany.

The other breakthrough in melanoma has been the discovery of targeted therapy for the 50% of melanoma patients that harbor aBRAF mutation, but Australian patients have only just gained access to their first BRAF inhibitor. Dabrafenib (Tafinlar), as well as a companion diagnostic test, was approved for reimbursement just last month.

In contrast, melanoma patients in other comparably wealthy countries have had access to the first BRAF inhibitor, vemurafenib (Zelboraf), for an extended time — since 2011 in the United States and 2012 in the United Kingdom. Vemurafenib has never made it onto the Australian list.

With these examples and more, concerns have increasingly been voiced in the Australian market about untimely patient access to new cancer drugs.

These concerns have been highlighted recently in a report from Medicines Australia, an umbrella group for the pharmaceutical industry. Released in July, the Access to Cancer Medicines in Australia report has been open for comments.

"While Australia has performed well in providing affordable and equitable patient access to medicines in the past," the report concludes, the system now faces significant challenges.

"There are a growing number of examples where Australian cancer patients are being unable to access oncology medicines or experiencing delays in access compared with their overseas counterparts, and compared with what is recommended in US and European evidence-based cancer treatment guidelines," the report notes.

Two-Step Process

In Australia, a new drug is first considered for approval (on the basis of safety and efficacy) by the Therapeutic Goods Administration, and then is considered for reimbursement (on the basis of clinical and cost effectiveness) by the Pharmaceutical Benefits Advisory Committee (PBAC). This committee advises the federal government on which drugs should be placed on the subsidized medicines list (the Pharmaceutical Benefits Scheme; PBS).

For drugs that are accepted for reimbursement, patients pay only a nominal fee per prescription — Aus$5.90 (US$5.50) per prescription (with a maximum payable of Aus$36.10 [US$33.69]).

However, if the drug is not listed on the PBS, then it is basically unavailable to patients, unless they are lucky enough to be able to pay privately or gain access through a compassionate-access program.

"Private medical insurance does not pay for chemotherapy in Australia," explained Christopher Steer, MBBS, FRACP, a medical oncologist at Border Medical Oncology in Wodonga, Victoria.

"So it is either out of the patient's pocket, the drug company's coffers, or the patient misses out," he toldMedscape Medical News.

There is a frustration among clinicians, who, for instance, hear about promising results with these new therapies at international meetings, and then are unable to use them in their own patients once they are home.

"This is a problem," commented Michael Boyer, MD, from the Sydney Cancer Centre, Royal Prince Alfred Hospital, Camperdown, New South Wales, "and it needs to be addressed."

"From an Australian perspective, I appreciate that the PBS has to balance many things. On the other hand, I don't think it's right that something that is regarded as a standard treatment around the world is not reimbursed by our payor of drugs here," he commented.

In his own specialist area of lung cancer, there are several drugs that are not reimbursed for first-line use: erlotinib (Tarceva), gefitinib (Iressa), and pemetrexed (Alimta). In contrast, all 3 are reimbursed in the United Kingdom, and pemetrexed has been since 2008.