So, if I turn out to be wrong about what I say below, I will post a retraction/apology. We’ll see…
As you know, I’ve applied twice to Ontario’s Case-by-Case Review Program to get funding for my zenocutuzumab treatment. And I’ve been denied both times. The first time, the reason provided was that the drug was “ineligible for funding” because it was “expected to be reviewed for public funding in Ontario and will undergo a population-based review.“ So, we provided a letter from the drug manufacturer saying they had no intention of applying for approval in Canada, so there could be no Ontario review. Reason for denial invalidated; therefore, request granted. Right? But no. Despite having this letter right in front of them, they gave the same reason for denial the second time around. So, of course, I appealed, and we are waiting for the response.
In the meantime, about 50 of our friends and colleagues emailed their MPPs (Members of Provincial Parliament) to express concern about the denials. And a bunch of them heard back, and forwarded us the responses from their various MPPs. And the responses invariably said that they had been told by the Ontario Ministry of Health that my request couldn’t be approved because zenocutuzumab is not approved by Health Canada.
So, we dutifully emailed these MPPs to correct them and let them know that the Ministry was giving them inaccurate information. Because the policy clearly states: (1) the program is “for patients who have rare clinical circumstances that are immediately life threatening, and who require treatment with an unfunded drug because there is no other satisfactory and/or funded treatment” (unfunded here means that possibly the drug has been approved by Health Canada, and possibly not, but either way it has not been adopted and funded by a province) and (2) “The drug must be available on the Canadian market…or the Applicant must provide evidence…that approval to import the drug has been obtained through Health Canada’s Special Access Programme.” In other words, no, it is not a requirement that the drug is approved and available in Canada, as long as the applicant has received permission from Health Canada to have the drug imported (and this permission requires evidence of the drug’s safety and efficacy through clinical trial data). I have this permission through the Special Access Program.
Meanwhile, there is the recent case of Alex Shved. Alex is an Ontario resident who has melanoma, and applied to Ontario’s Out of Country program, asking for funding so that he could travel to the US to receive TIL therapy (tumour infiltrating lymphocyte therapy). He was denied, and appealed, and denied, and then took it to court. The judges found that the government had not made its case for denial and instructed them to go back and make a different decision. One of the 3 judges was of the opinion that they should just approve the request and let Alex get his treatment. Instead, the government changed the rules and now says it will only approve requests where the treatment in question is already approved, funded, and in use in Ontario.
They called this a “clarification” of the policy rather than the egregious change in policy it actually is. And apparently they had been applying this standard for a while without telling anyone. I would point out that the whole point of this policy is to enable patients to receive treatments that aren’t available in Canada and can only be administered elsewhere. TIL therapy is not available here. Their “clarification” means that the only approvals they will give are for cases in which an approved and funded drug in Ontario is experiencing a temporary shortage. This just about never happens, and so the “clarification” means that they won’t have any applications. My assessment is that they want to get rid of the program, but they don’t dare because of possible political and public pushback, and so they have essentially gutted it.
I’ll admit, I naively thought, “that’s terrible, a travesty, but they can’t do that in my case because the Case by Case Review Program (different from the program Alex applied to) explicitly says that the drugs do not have to be approved by Health Canada, let alone funded in Ontario.” And so far there has not been a press release from the Ministry of Health “clarifying” the Case by Case Review Program.
However… I thought back to all those MPPs who were told by the Ministry that my case could not be approved because the drug was not approved in Canada…. Again, I had naively thought, “some bozo in the Ministry is confused about the policy and providing incorrect information.” And then I learned that there was another cancer patient in Ontario who was denied, was given the same reason I was given about the “anticipated Ontario review,” like me got a letter from the drug manufacturer (different drug, different manufacturer) saying they were not going to apply for approval in Canada because of Canada’s small market, and, like me, was denied again and given that same bullshit reason. She is now going to court about the denial.
So, this was making me mighty suspicious. I just want to say again that there is nothing in the Case by Case Review policy that requires Health Canada or Ontario approval or funding of the drug in question. In fact, the original intent of the policy is specifically to help patients like me who need a treatment that is not available in Canada, but the drug can be shipped to Canada. I would also add that there is nothing in the form you receive when you are denied that allows the government to check a box saying “ineligible for funding because drug is not approved by Health Canada.” This box (reason for denial) does not exist.
Meanwhile, I was interviewed a few weeks back by a CTV reporter (the story should air soon, and I’ll provide a link to it). He thought my situation would make a good human interest story, but, like me, he couldn’t wrap his head around the government’s reason for denying my request. It made no sense (I sent him the denial form letter and the letter from the drug manufacturer). And so he repeatedly contacted people in the Ministry of Health to ask them to explain, and finally yesterday he told me he was sorry to be the bearer of bad news, but the real reason for the denial is a change in policy, and that the government had not wanted to share that information with him, but finally did.
Again, I kind of naively thought to myself, “maybe this reporter is confusing the two policies, or maybe someone in the Ministry is. Maybe this has nothing to do with the program I’ve applied to.” And then I woke up at 3am today, sat bolt upright, and thought, “Of course he’s not confusing them. Of course they are changing this policy too so that they don’t have to approve anyone’s request.” The reporter didn’t specify exactly what the change in policy is, but my suspicion is that they are changing it (have already changed it) so that, like the Out of Country policy, only drugs that are already approved, funded, and in use in Ontario will qualify. Or maybe it will be a little broader, and they will say that only drugs approved by Health Canada qualify. We’ll see.
If this turns out to be true, I want to point out that (1) this won’t just be a “clarification” of existing policy; it will be a new policy created behind closed doors that violates both the letter and intent of the existing policy, (2) the new policy will likely mean that no one will be approved, and then no one will bother to apply, and so again the government will have de facto gotten rid of a life-saving program by gutting it, (3) the government created and has been implementing this new policy without telling anyone (I don’t know for how long) — without telling patients, oncologists, or hospitals. Which is underhanded and duplicitous as fuck, and (4) people will die. People in my situation will die. My death will probably be hastened because of the new policy unless I can get a lawyer who can successfully argue that I should be grandfathered in to the old policy.
Like I said, if it turns out I’m wrong about this, I’ll say so. But if I’m right, I’m hoping that any Ontario residents reading this will email their MPPs and complain vociferously. More soon.
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