When positive results from three randomized trials of trastuzumab (Herceptin) in locally invasive breast cancer were released earlier this year, patients with early-stage, HER-2positive breast cancer in Canada were told they would have to wait: Their doctors couldn't prescribe the drug to them, their hospitals couldn't administer it, and their governments wouldn't pay for it.
"Everyone got caught by surprise on this one," said medical oncologist Brent Schacter, M.D., of Cancer Care Manitoba and chief executive officer of the Canadian Association of Provincial Cancer Agencies.
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When the preliminary trial resultswhich found that trastuzumab increases progression-free survival, time to first distant recurrence, and overall survival in women with localized invasive breast cancerwere presented at this year's annual meeting of the American Society for Clinical Oncology in May, the drug had been approved in Canada for use only in women with the metastatic form of the disease.
Almost at once, newspapers began running dramatic stories of women spending their life savings to obtain the drug in American clinics. Cancer advocacy groups criticized provincial governments for not providing the drug to the roughly 4,300 women a year who would need it. Oncologists suggested that delay meant lives would be lost.
"Usually, there's a little lead time," Schacter said, so that provincial and territorial cancer agencies can prepare budgets that take into account new drugs and new indications. Then, they can ask the governments they report to for the money. In this case, he said, the storm of public outrage broke before most provincial cancer agencies could even make their case.
Women began asking for the drug almost immediately after the ASCO meeting, said Heather Logan, R.N., director of cancer control policy for the Canadian Cancer Society, and "people were looking to get the drug in the hands of women." The cancer agencies "were really proactive," she said.
Some Canadian provincesQuebec, Nova Scotia, and Prince Edward Islandsaid they'd make the drug available on a case-by-case basis. Others fast-tracked the approval processBritish Columbia made a special allocation of Can $8 million (US $6.6 million) and Ontario followed suit within days.
Although there is no question that trastuzumab will ultimately be provided to the patients eligible for it, finance and health ministers across Canada are worried about what the estimated Can $125 million (US $103 million) cost for the country will do to their budgets.
"It's not a trivial amount," Logan said, but it has to be put into the context of preventing breast cancer from becoming metastatic, which is more expensive to treat and causes more pain and suffering, she added.
In addition to the up-front cost of the drug, there will also be the increased laboratory cost of testing patients for HER-2 overexpression; only patients with HER-2positive breast cancer will respond to the drug. That is likely to be forgotten in the rush, said Diponkar Banerjee, M.D., of Cancer Care British Columbia and president of the Canadian Association of Pathologists. His association fears the increase in use of new targeted therapies like trastuzumab with no increase in resources to test which patients are likely to respond to such drugs.
Typically, he said, pathology labs get a global budget, which isn't linked to the caseload. In the case of British Columbia, he said, the advent of global testing for HER-2 could have tripled or even quadrupled costs. In fact, it won't be that bad, Banerjee thinks, because British Columbia's laboratories have begun testing 50 or 100 tissue samples at a time, which speeds up the work and lessens the impact.
But that sort of innovation may not be possible next time, he says. "This is only the beginning of targeted therapies," Banerjee said. "They'll all have this little problem to solve."
The situation with trastuzumab illustrates what may be, at times, a weakness of Canada's single-payer health care system: It can't move as quickly as the free market. That said, Schacter argued that provincial cancer agencies reacted quickly and properly; immediately after the ASCO meeting, they began making the case for more money, and some provincial governments accepted that case swiftly.
It is expected that the drug will be available throughout the country before the year is over, but "the process doesn't necessarily move at the same speed in each province," Schacter said.
Schacter said the Canadian health care system is highly regulated, mainly because of its commitment to ensuring that no one is left without medical care. But that, in turn, sometimes means that bureaucracy trumps compassion.
"I think we're likely to get caught again, and for many of the same reasons," he said, unless governments at all levels find a way to eliminate some of the red tape.
In the final analysis, the uproar over trastuzumab "may not be a bad thing," said the Cancer Society's Logan. "It may force us to deal with these issues."
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