Another patient with a rare disease has come forward, saying the Ontario government’s new policy to deny funding for most out of country drugs that haven’t already been approved in Canada could mean she could die after she runs out of money to pay for her treatment. Toronto resident Holly Wardlow says she has already spent close to half a million dollars and wiped out her savings, paying for a drug that costs $78,000 a month for her rare liver cancer. The goal of this medication is to reduce the size of a cancerous tumour so it can be surgically removed. Wardlow, an anthropology professor at the University of Toronto, says she was devastated to learn she had been turned down by a public program designed to help patients in unusual and life-threatening circumstances. “It’s scary and it’s sad,” she said in an interview with CV News Toronto. “I feel like the Ontario government just told me to just go die already, that’s what it feels like.” When approached by CTV News, Ontario’s health ministry pointed to a policy announced last week that it would change regulation 552 of the Health Insurance Act to only fund drug treatments that have gone through provincial approvals. The province said allowing the old regulation to stand “could cost the Ontario Health Insurance Plan (OHIP) $5.2 billion each year and would create a back door for global pharmaceutical companies to avoid negotiating directly with the province to achieve more competitive pricing.” It wasn’t immediately clear how the $5.2 billion figure had been arrived at. The new policy was announced after another patient, Alex Schved, won a court battle seeking funding to receive tumour-infiltrating lymphocyte therapy in Florida at a cost of US$600,000. The Divisional Court found OHIP offered no basis for denying Schved coverage and ordered the government to reconsider his case. But with the new regulation, it appears that Schved will not be covered. READ MORE: Ontario narrows out-of-country drug funding rules after cancer patient court victory Wardlow has a rare NRG1 fusion cholangiocarcinoma. Only about five Ontarians a year get diagnosed with that form of the disease. Bizengri, which is the brand name for the drug known as zenocutuzumab, was approved under Health Canada’s Special Access Program for Wardlow’s treatment but has not received wider approvals. In order for that process to happen, the manufacturer, Partner Therapeutics (PTx), would need to submit an application to Health Canada. However in a letter to Wardlow, the company’s chief development officer, Pritesh Gandhi, said it had no plans to do that in at least two years. “At present, the scope of PTx’s development and regulatory activities for Bizengri is focused in the United States,” it said. Wardlow had done eight cycles of chemotherapy and immunotherapy, which did shrink the tumour somewhat but not enough to operate on it and remove it entirely. However, her doctors discovered that the cancer’s rare NRG1 mutation meant that it could be targeted with Bizengri. “Patients have a much better quality of life than chemotherapy and it’s more effective so it’s a really nice option,” said Dr. James Cleary, a medical oncologist at the Dana Farber Cancer Institute in Boston who studies the drug. Since Wardlow started taking the drug in April, she has seen a marked shrinking of her tumour and her side effects have all but disappeared, she said, but that can only last as long as she can pay for it. “So ultimately it is costing us about $78,000 a month. And we’ve been doing this since mid-April, and we’re running out. And I’m lucky my parents have paid for a dose. My brother has paid for a dose,” said Wardlow, who has started a crowdfunding page, which as of Sunday has raised just over $57,000 – almost enough for another month. It’s not clear what will happen after that. In Wardlow’s application to the Case by Case Review Program at Cancer Care Ontario, her doctor said she could live for “approximately one year.” With Bizengri, “a dramatic response could convert to curative intent surgery,” they wrote. “I hope they would see it through the lens that this is a rare disease and I think we have an obligation to also take care of people with rare disease, just like we have an obligation to take care of people with common cancers,” Cleary said. Wardlow says she has cried a lot thinking about death. She has a mantlepiece full of supportive cards from friends and family and a bracelet with the words “just keep swimming,” from the Pixar movie Finding Nemo. “I try to remind myself that I’ve had a really good life, that I have very close relationships with my family, that I wanted a career that could be kind of adventurous,” she said. “And I’ve had, I think, an important impact on the small part of my field where I can have an impact. I’ve been a good teacher to my students. I’ve travelled to places that are wonderful. So I’ve had a good life, and so I tried to remind myself just to be really happy about that.”
