{"id":771240,"date":"2026-06-30T14:55:18","date_gmt":"2026-06-30T14:55:18","guid":{"rendered":"https:\/\/www.newsbeep.com\/ca\/771240\/"},"modified":"2026-06-30T14:55:18","modified_gmt":"2026-06-30T14:55:18","slug":"despite-approval-from-health-canada-delay-in-cancer-drug-funding-leaves-patients-in-limbo","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ca\/771240\/","title":{"rendered":"Despite approval from Health Canada, delay in cancer drug funding leaves patients in limbo"},"content":{"rendered":"

Open this photo in gallery:<\/a><\/p>\n

Alex Shved and his wife Agata Zieba, parents to two daughters under two years old, are appealing OHIP\u2019s 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<\/p>\n

Alex Shved has been e-mailing Ontario politicians and filing appeals at the speed of a man who knows he doesn\u2019t have time to waste. <\/p>\n

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. <\/p>\n

Despite Health Canada having approved a commercial version of TIL therapy called lifileucel last August, Mr. Shved can\u2019t get it. <\/p>\n

Ontario parents hope son\u2019s death can change Canada\u2019s approach to novel cancer treatments<\/a><\/p>\n

The treatment isn\u2019t available in Canada outside of clinical trials because it is still being reviewed for public funding. Mr. Shved applied to Ontario\u2019s 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\u2019t intended to be an interim funding mechanism for drugs that could, eventually, qualify for public coverage. <\/p>\n

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. <\/p>\n

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. <\/p>\n

\u201cMy number one priority is to be around as long as possible for my two girls and my wife,\u201d he said, \u201cso I will do whatever it takes to do that.\u201d<\/p>\n

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\u2019s multistage system for publicly funding new treatments. <\/p>\n

Elizabeth Stewart, 48 and Kevin Nash, 58, recently had their applications rejected by OHIP\u2019s out-of-country program for the same reasons cited in the cases of Mr. Shved and Evan Armit<\/a>, a 23-year-old elite hockey player and business student who died of melanoma last summer. <\/p>\n

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<\/a> for new prescription drugs to go from regulatory approval to public reimbursement in at least one province, longer than in any other G7 country. <\/p>\n

Defenders of Canada\u2019s 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. <\/p>\n

A new type of surgery is helping some cancer patients keep their fertility intact during treatment<\/a><\/p>\n

That\u2019s why some melanoma patients seeking TIL therapy are trying the workaround of OHIP\u2019s out-of-country program, even though that route is most often used to pay for procedures, not drugs.<\/p>\n

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. <\/p>\n

\u201cThere was not a single word, not a single sense of compassion or care,\u201d she said. \u201cIt was incredibly inhumane, given the circumstances.\u201d <\/p>\n

The office of Ontario Health Minister Sylvia Jones referred questions about TIL therapy and OHIP\u2019s out-of-country program to the Ministry of Health, which provided a written statement saying \u201cthere have been no instances of Ontario approving out-of-country funding for a drug while it was actively undergoing\u201d 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. <\/p>\n

The statement said that lifileucel is expected to enter pCPA negotiations \u201cimminently.\u201d <\/p>\n

But pricing negotiations for lifileucel are unlikely to begin until the end of the year at the earliest.<\/p>\n

First, the product needs a positive recommendation from Canada\u2019s Drug Agency, the organization that advises the provinces and territories on whether and how to cover new drugs.<\/p>\n

Although the agency accepts submissions from drug companies as early as six months before an anticipated Health Canada approval date, lifileucel\u2019s maker, California-based Iovance Biotherapeutics, didn\u2019t file until June 18 \u2013 about 10 months after Health Canada gave TIL therapy a green light. <\/p>\n

Erin Brophy, a spokeswoman for Canada\u2019s Drug Agency, said a draft recommendation on lifileucel is expected to be completed in November. <\/p>\n

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. <\/p>\n

In depth: Canadians can wait years to get drugs regulators have already deemed safe. Why?<\/a><\/p>\n

Asked about the delay in submitting to CDA, Iovance spokeswoman Jen Saunders said by e-mail that a \u201cfirst-of-its-kind individualized cell therapy like Amtagvi requires significant parallel preparation beyond the [Canada\u2019s 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.\u201d<\/p>\n

Made one batch at a time from a sample of a specific patient\u2019s 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. <\/p>\n

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. <\/p>\n

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. <\/p>\n

But those mechanisms work best with off-the-shelf drugs. <\/p>\n

\u201cI think cell therapies are particularly challenging because the drug product itself is so expensive and involves a lot of resources,\u201d said Marcus Butler, a medical oncologist and site lead for melanoma\/skin oncology at Princess Margaret Cancer Centre in Toronto. <\/p>\n

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. <\/p>\n

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. <\/p>\n

Five cancer drugs funded quickly through Ontario pilot project<\/a><\/p>\n

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\u2019s Health Services Appeal and Review Board (HSARB) the quasi-judicial tribunal that turned down Mr. Armit\u2019s appeal last summer.<\/p>\n

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<\/a> by Tribunal Watch Ontario. <\/p>\n

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. <\/p>\n

Mr. Shved, meanwhile, has filed an application for a judicial review of his OHIP out-of-country rejection. <\/p>\n

His hope is that a successful legal challenge \u201csets a precedent for all future out-of-country applications, so that many other people who are in my situation and Evan\u2019s situation and situations where they have other cancers can use the out-of-country program to get them the therapy that they desperately need.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"Open this photo in gallery: Alex Shved and his wife Agata Zieba, parents to two daughters under two…\n","protected":false},"author":2,"featured_media":771241,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[901,888,902,879,877,903,48,876,895,896,891,878,875,46,549,295,894,887,914,880,881,893,43,889,890,884,904,885,909,910,44,912,907,911,905,908,882,898,899,714,897,906,865,61,41,39,42,40,900,892,886,883,913],"class_list":["post-771240","post","type-post","status-publish","format-standard","has-post-thumbnail","category-headlines","tag-alberta","tag-arts-news","tag-bc","tag-breaking-news","tag-breaking-news-video","tag-british-columbia","tag-canada","tag-canada-news","tag-canada-sports","tag-canada-sports-news","tag-canada-trafficcanada-weather","tag-canadian-breaking-news","tag-canadian-news","tag-economy","tag-education","tag-environment","tag-federal-government","tag-foreign-news","tag-globe-and-mail","tag-globe-and-mail-breaking-news","tag-globe-and-mail-canada-news","tag-government","tag-headlines","tag-life-news","tag-lifestyle","tag-local-news","tag-manitoba","tag-national-news","tag-new-brunswick","tag-newfoundland-and-labrador","tag-news","tag-northwest-territories","tag-nova-scotia","tag-nunavut","tag-ontario","tag-pei","tag-photos","tag-political-news","tag-political-opinion","tag-politics","tag-politics-news","tag-quebec","tag-sports-news","tag-technology","tag-top-news","tag-top-stories","tag-topnews","tag-topstories","tag-travel","tag-trudeau","tag-us-news","tag-world-news","tag-yukon"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/771240","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/comments?post=771240"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/771240\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media\/771241"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media?parent=771240"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/categories?post=771240"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/tags?post=771240"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}