Tragically Hip frontman Gord Downie was diagnosed with glioblastoma in December, 2015, and he dies from the brain cancer in October, 2017.Chris Wattie/Reuters
Glioblastoma, the brain cancer that killed legendary Tragically Hip frontman Gord Downie, has one of the poorest survival rates of any cancer.
There have been two significant treatment advances in the past decade or so: Temozolomide, a chemotherapy drug that manages to cross the blood-brain barrier, and a device known as Optune, which delivers electromagnetic “tumour treatment fields” to slow tumour growth. The treatments can be used together to extend the survival of glioblastoma patients.
But the Optune device, which has a list price of $27,000 a month, is rarely used in Canada because the treatment is not funded by any provincial health plan.
That’s not the worst of it though. The real frustration is that health authorities haven’t made an actual decision on funding the treatment or not. Rather, they have just dithered for years.
This is sadly typical of Canada’s broken drug-approval process – a slow, multistep approach that leaves patients and providers alike puzzled about coverage, especially for drugs and devices for rare conditions like glioblastoma.
The timeline tells a grim tale. Optune and its innovative approach was approved by the U.S. regulator, the Food and Drug Administration, way back in 2011, based on small studies.
In 2017, a relatively large study involving 695 patients showed positive, if modest, results. Patients treated with Optune in addition to temozolomide survived an additional couple of months compared to those treated with the chemotherapy drug alone. (Glioblastoma patients also undergo surgery and radiation.)
The longer-term results of the study showed that patients treated with Optune had a five-year survival rate that was more than double that of those who had chemotherapy alone – 13 per cent versus 5 per cent.
Again, these results are modest but those extra months and years matter to people living with an incurable cancer, who generally only live, on average, about one year after diagnosis.
(About 1,500 Canadians are diagnosed annually with glioblastoma. The most famous among them, Mr. Downie, was diagnosed in December, 2015, and died in October, 2017.)
Health Canada approved the Optune device in 2022, the first new glioblastoma treatment in a dozen years.
But approval is just a first step. Experts must then review drugs and devices and offer recommendations to provinces on whether or not they should be funded.
The Institut national d’excellence en santé et en services sociaux in Quebec (INESSS) reviewed Optune in the fall of 2023. Its expert panel said Optune had “clinically and statistically significant benefits, mostly on survival.” But it said the cost was high, and the inability of some cancer centres around Quebec to use the technology was deemed to create equity issues, so it recommended the device not be funded.
In February, 2024, a similar panel appointed by Canada’s Drug Agency recommended that Optune be “reimbursed, with conditions.” It cited improved survival but said the price suggested by the manufacturer was too high and “does not represent good value for the health system.” The CDA panel said that over three years, about 232 patients would be eligible for the treatment, and that would cost $76-million.
Public drug plans spend $17.4-billion a year in Canada. Many funding decisions are relatively easy, but the tough ones go to INESSS/CDA for review. Only one in four of those drugs ever gets to patients, even after a positive recommendation.
The sticking point is often price.
There are two agencies that assist governments with price negotiations, the pan-Canadian Pharmaceutical Alliance, and the Canadian Association of Provincial Cancer Agencies. But neither the pCPA or the CAPCA is tackling the Optune file, so negotiations now have to occur province by province. That’s inefficient to say the least.
There are 17 patients waiting for treatment via the Optune device in Quebec, 14 in Ontario and a handful in the rest of the country. Recently, a number of Quebec patients have gone public with their frustrations, and that’s understandable.
More than anything, they deserve a clear answer on whether the treatment will be covered or not. They shouldn’t have to beg.
A number of countries, such as France and Sweden, pay for Optune. Others, like Britain, do not. But at least the rules are clear.
Of course, governments have a right to refuse to fund everything. What they don’t have is a right to string people along with indecision.
Optune is no miracle treatment. But its years-long saga is a reminder that we need to do better.
When your life hangs in the balance, the last thing you need is bureaucratic dithering, robbing you of hope.