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Alex Shved and his wife Agata Zieba, parents to two daughters under two years old, are appealing OHIP’s decision to deny Shved’s out-of-country coverage that would allow him to access tumour-infiltrating lymphocyte (TIL) therapy in the U.S. The couple is seen at their home in Toronto, on June 18.Galit Rodan/The Globe and Mail
Alex Shved has been e-mailing Ontario politicians and filing appeals at the speed of a man who knows he doesn’t have time to waste.
The 37-year-old Etobicoke father of two young daughters is desperate to access tumour-infiltrating lymphocyte, or TIL, therapy, a bespoke treatment for metastatic melanoma that would be made from the cells of one of his own tumours.
Despite Health Canada having approved a commercial version of TIL therapy called lifileucel last August, Mr. Shved can’t get it.
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The treatment isn’t available in Canada outside of clinical trials because it is still being reviewed for public funding. Mr. Shved applied to Ontario’s out-of-country prior approval program to see if the province would pay for him to be treated in the United States but he was rejected because the program isn’t intended to be an interim funding mechanism for drugs that could, eventually, qualify for public coverage.
That gap leaves Mr. Shved and patients like him with limited options: Find about $1.5-million to pay for TIL therapy in the U.S., or take the matter to court while also bombarding politicians with e-mails asking for help.
Mr. Shved, who works in finance, has chosen the latter, hoping that a judicial review of his OHIP out-of-country rejection will change the system and, perhaps, save his life.
“My number one priority is to be around as long as possible for my two girls and my wife,” he said, “so I will do whatever it takes to do that.”
Mr. Shved is one of three Ontario melanoma patients who spoke to The Globe and Mail about the fear and frustration inherent in waiting to access Health-Canada approved TIL-therapy as it crawls through the country’s multistage system for publicly funding new treatments.
Elizabeth Stewart, 48 and Kevin Nash, 58, recently had their applications rejected by OHIP’s out-of-country program for the same reasons cited in the cases of Mr. Shved and Evan Armit, a 23-year-old elite hockey player and business student who died of melanoma last summer.
Patients seeking TIL therapy right now are far from alone in facing a long wait for a treatment that has already been authorized by Health Canada. In Canada, it takes two-and-a-half years on average for new prescription drugs to go from regulatory approval to public reimbursement in at least one province, longer than in any other G7 country.
Defenders of Canada’s approach say the due diligence that happens in the interim reserves tax dollars for the best medications and lowers drug prices through negotiated confidential discount deals. But the process can drag on too long for cancer patients who may only have months to live.
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That’s why some melanoma patients seeking TIL therapy are trying the workaround of OHIP’s out-of-country program, even though that route is most often used to pay for procedures, not drugs.
Ms. Stewart, a triathlete, mother to a 13-year-old boy and professional fundraiser who spent nearly a decade of her career soliciting donations for her local hospital in Guelph, learned that OHIP had rejected her application for out-of-country TIL coverage via a form letter earlier this month.
“There was not a single word, not a single sense of compassion or care,” she said. “It was incredibly inhumane, given the circumstances.”
The office of Ontario Health Minister Sylvia Jones referred questions about TIL therapy and OHIP’s out-of-country program to the Ministry of Health, which provided a written statement saying “there have been no instances of Ontario approving out-of-country funding for a drug while it was actively undergoing” negotiations led by the pan-Canadian Pharmaceutical Alliance (pCPA,) the organization that hammers out confidential pricing deals with pharmaceutical companies on behalf of public drug plans.
The statement said that lifileucel is expected to enter pCPA negotiations “imminently.”
But pricing negotiations for lifileucel are unlikely to begin until the end of the year at the earliest.
First, the product needs a positive recommendation from Canada’s Drug Agency, the organization that advises the provinces and territories on whether and how to cover new drugs.
Although the agency accepts submissions from drug companies as early as six months before an anticipated Health Canada approval date, lifileucel’s maker, California-based Iovance Biotherapeutics, didn’t file until June 18 – about 10 months after Health Canada gave TIL therapy a green light.
Erin Brophy, a spokeswoman for Canada’s Drug Agency, said a draft recommendation on lifileucel is expected to be completed in November.
Lifileucel, sold under the brand name Amtagvi, has a sticker price in the U.S. of US$515,000 for a one-time infusion, not including the cost of staying in an American hospital, usually for a few weeks.
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Asked about the delay in submitting to CDA, Iovance spokeswoman Jen Saunders said by e-mail that a “first-of-its-kind individualized cell therapy like Amtagvi requires significant parallel preparation beyond the [Canada’s Drug Agency] submission, including authorizing and qualifying treatment centres. We are coordinating urgently to align these various moving parts to offer Amtagvi in Canada as quickly as possible.”
Made one batch at a time from a sample of a specific patient’s tumour, TIL therapy is infused as a single treatment to seek and destroy melanoma cells after recipients undergo high-dose chemotherapy to wipe out their existing immune cells.
The customized nature of the treatment makes it a poor fit for some of the existing ways Canadians access new oncology drugs while waiting for public funding.
Pharmaceutical companies sometimes give away drugs through compassionate access programs. As well, Ontario has a pilot program that has started paying for nine new cancer drugs at the outset of pCPA pricing negotiations rather than at their conclusion.
But those mechanisms work best with off-the-shelf drugs.
“I think cell therapies are particularly challenging because the drug product itself is so expensive and involves a lot of resources,” said Marcus Butler, a medical oncologist and site lead for melanoma/skin oncology at Princess Margaret Cancer Centre in Toronto.
Dr. Butler also noted that TIL therapy is not a cure or an easy treatment to take. But he said it is an option when other treatments have stopped working for patients with aggressive melanoma.
About one-third of participants in the small trial that led to FDA and Health Canada approval of lifileucel had some reduction in the size of their tumours.
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Mr. Shved, Ms. Stewart and Mr. Nash, a father of three who lives in Haliburton and received his OHIP out-of-country rejection for TIL therapy in March, just want a chance to try. All three are appealing their rejections to Ontario’s Health Services Appeal and Review Board (HSARB) the quasi-judicial tribunal that turned down Mr. Armit’s appeal last summer.
If history is any guide, their chances of winning at HSARB are slim. The success rate for applicants at the tribunal since 2023 is less than 1 per cent, according to an analysis by Tribunal Watch Ontario.
Ms. Stewart is hoping to raise $1.7-million through a GoFundMe drive to receive TIL therapy in Florida. More than $500,000 has been donated so far.
Mr. Shved, meanwhile, has filed an application for a judicial review of his OHIP out-of-country rejection.
His hope is that a successful legal challenge “sets a precedent for all future out-of-country applications, so that many other people who are in my situation and Evan’s situation and situations where they have other cancers can use the out-of-country program to get them the therapy that they desperately need.”