Ontario drug funding decision leaves cancer patients disappointed, with few options

Sabrina Apitz-Grossman was told 13 months ago that she had about 12 to 18 months to live.

A rare form of cancer in the 31-year-old’s knee had metastasized, spreading to her lungs. She has undergone radiotherapy, chemotherapy and surgeries, though the synovial sarcoma couldn’t be fully removed.

Apitz-Grossman’s doctors are recommending a treatment approved in the United States but unavailable in Ontario. She needs it urgently but the Ontario Health Insurance Plan turned her down for out-of-country coverage. An appeal failed, as did an application under a Case-by-Case Review Program to get special permission for the treatment to be administered at the Princess Margaret Cancer Centre in Toronto.

She is still fighting.

“I so desperately would love to turn 32,” she said.

Apitz-Grossman and other Ontarians with Stage 4 cancer told by their doctors that they are good candidates for treatments unavailable in the province were buoyed last month when 37-year-old Alex Shved, in a similar situation, won a court challenge against his OHIP out-of-country denial.

But their hopes were dashed when Health Minister Sylvia Jones responded to the court ruling by changing the rules.

Drug treatments will now only be funded out of country if they are already funded within the province but access is temporarily unavailable or delayed, a set of circumstances some patients see as impossibly narrow. The government said it clarified in regulation what was already long-standing policy.

“We’re protecting Ontario patients and taxpayers from price gouging and protecting their access to life-saving medications that would otherwise only be available in the United States or overseas,” Jones wrote in a statement.

“This change supports a consistent, fair and transparent approach to funding decisions, protects the integrity of Ontario’s world-class drug approval process and will help avoid up to $5.2 billion in additional costs to Ontario’s health-care system every year.”

Framing the move as a cost-saving measure is not sitting right with Apitz-Grossman.

“Are we saying that we could save like 5,000 or more people’s lives, and they’re proud of themselves for not doing that?” she said. “Is this supposed to be good news that we’re not going to save those people, so that we can instead buy a couple more private jets?”

Ontario Premier Doug Ford came under fire earlier this year for a government purchase of a $29-million private jet and quickly returned it.

The treatment Apitz-Grossman is seeking, Tecelra, is a personalized therapy made from a patient’s own T-cells, a type of white blood cell. Nearly half of patients in Apitz-Grossman’s situation respond to the treatment, and among those who respond, there is a 90 per cent chance of survival after a year and 70 per cent after two years, according to her oncologist.

But the treatment is costly, at US$727,000, Apitz-Grossman said. She feels terrible guilt for seeking such a pricey treatment, she said, but she wants to live.

“There has never been a moment where I have thought to myself, ‘Gosh, I wish that patient who was in the ICU for weeks and who it cost hundreds of thousands of dollars to save, hadn’t been saved,'” Apitz-Grossman said.

The origin of Jones’ $5.2-billion figure was unclear in her press release, and a government official later explained that it would be the additional cost if the province entirely stopped negotiating prices with drug manufacturers for public coverage in Ontario.

OHIP’s reason for denying Apitz-Grossman, Shved and others out-of-country drug treatment funding is that routinely paying for such requests while drugs are undergoing review for funding in Ontario would “undermine the incentive structure that encourages manufacturers to participate in Canada’s drug review processes.”

Kevin Nash, 59, has metastatic melanoma and is seeking the same tumour-infiltrating lymphocyte therapy as Shved. Nash’s out-of-country application and subsequent appeal were also denied, and he does not believe the government’s reasoning.

“These companies make billions of dollars a year, not a billion, billions of dollars a year,” he said. “Do you think that they care one bit whether Kevin Nash goes to Buffalo for a treatment? That’s so preposterous.”

In Apitz-Grossman’s case, the manufacturer of Tecelra has said it has no plans to apply for approval in Canada. That means there is no review process in this case to undermine, she noted.

Holly Wardlow, 61, is in a similar boat, with the government denying coverage through its Case-by-Case Review Program for a medication to treat her rare form of liver cancer because the drug was “expected to be reviewed for public funding in Ontario.”

That’s despite the manufacturer submitting two letters telling the province it has no plans to apply for approval in Canada.

“We just thought, ‘Well, this doesn’t make any sense,'” Wardlow said.

“We provided evidence that there is not going to be a population-based review. This drug is never going to be approved in Canada, let alone Ontario, because the manufacturer is not going to make an application, and they have evidence of that. And yet they provided the same reason for denying funding.”

Wardlow and her husband have been paying $78,000 a month for her to receive infusions in Ontario every two weeks, and her tumour has been shrinking with almost no side-effects, she said.

Their savings have been depleted and they have now started a GoFundMe.

“I’m getting out there and trying to stay fit, partly because I can, and partly because the weather is beautiful, and partly because I’m thinking ahead that surgery may be possible in the future,” Wardlow said.