{"id":108212,"date":"2025-10-31T16:39:17","date_gmt":"2025-10-31T16:39:17","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/108212\/"},"modified":"2025-10-31T16:39:17","modified_gmt":"2025-10-31T16:39:17","slug":"canadians-can-wait-years-to-get-drugs-regulators-have-already-deemed-safe-why","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/108212\/","title":{"rendered":"Canadians can wait years to get drugs regulators have already deemed safe. Why?"},"content":{"rendered":"<p class=\"c-article-body__text text-pr-5\">It was nearly two years ago when an oncologist first told Jas Velic that his best hope of surviving aggressive blood cancer was CAR-T therapy, a cutting-edge treatment that would genetically alter some of his own white blood cells to attack his cancer. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Unlike the punishing regimen of weekly chemotherapy keeping the 43-year-old father of two alive, CAR-T therapy is given as a single infusion.<\/p>\n<p class=\"c-article-body__text text-pr-5\">It also appears to be better than other drugs at controlling multiple myeloma, the type of cancer Mr. Velic has. The latest clinical trial results, <a href=\"https:\/\/ascopubs.org\/doi\/10.1200\/JCO-25-00760\" rel=\"nofollow noopener\" target=\"_blank\">reported<\/a> in June, showed that a third of patients facing certain death from advanced myeloma were free of detectable cancer five years after receiving CAR-T therapy, a stunning result for a disease considered incurable.<\/p>\n<p class=\"c-article-body__text text-pr-5\">In theory, CAR-T could have been available in Canada by the time Mr. Velic and his oncologist, Keith Stewart, the director of the Princess Margaret Cancer Centre in Toronto, first discussed it in December of 2023. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Ten months earlier, Health Canada had approved Carvykti, a version of CAR-T for multiple myeloma. A separate organization, Canada\u2019s Drug Agency, had already recommended provincial governments pay for it if they could get a steep discount from the manufacturer. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Even with the approvals, that last \u201cif\u201d meant Mr. Velic and other Canadian patients like him still had to wait for an indeterminate amount of time while another leg of Canada\u2019s complex drug-funding process played out.<\/p>\n<p class=\"c-article-body__text text-pr-5\">A third organization called the pan-Canadian Pharmaceutical Alliance (pCPA), which represents all of Canada\u2019s public insurance plans, negotiated behind closed doors with Johnson &amp; Johnson Innovative Medicine, formerly Janssen, over a discount for Carvykti. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Carvykti has a sticker price in Canada of $632,455 for a one-time infusion, making it one of the most expensive drugs in the world. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Those talks collapsed in September, after nearly two years. Now patients will have to wait even longer for Carvykti to come to Canada, if it comes at all. Meanwhile, the treatment is already publicly reimbursed in 13 other countries, including the United States, Spain and Belgium.<\/p>\n<p class=\"c-article-body__text text-pr-5\">CAR-T therapy was \u201chope for a normal life again one day,\u201d Tanja Velic, Mr. Velic\u2019s wife, said through tears. \u201cIt\u2019s just so disappointing to know that there is something available and proven to work and people across the world are getting it, but because of where we live, we\u2019re not able to access it.\u201d<\/p>\n<p>      Mr. Velic and his wife, Tanja, have grown frustrated at the lack of access to the CAR-T therapy they believe could improve his life.<\/p>\n<p>          Eduardo Lima\/The Globe and Mail<\/p>\n<p class=\"c-article-body__text text-pr-5\">The saga of Carvykti is an extreme example of an enduring problem that Prime Minister Mark Carney and Ontario Premier Doug Ford have both vowed to tackle. In Canada, it takes longer for new prescription drugs to run the gauntlet from regulatory approval to public reimbursement than in any other G7 country \u2013 <a href=\"https:\/\/www.canada.ca\/en\/patented-medicine-prices-review\/services\/npduis\/analytical-studies\/posters\/factors-delaying-2025poster.html\" rel=\"nofollow noopener\" target=\"_blank\">two-and-a-half years on average<\/a>.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Nobody feels those delays more acutely than Canadians with cancer, even though oncology drugs usually move through the system more swiftly than medications for other diseases. That\u2019s because time is a luxury many cancer patients don\u2019t have. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Ontario Health Minister Sylvia Jones emphasized that reality when, on Oct. 7, she <a href=\"https:\/\/www.theglobeandmail.com\/canada\/article-ontario-cancer-drug-pilot-project-prices\/\" target=\"_self\" rel=\"nofollow noopener\" title=\"https:\/\/www.theglobeandmail.com\/canada\/article-ontario-cancer-drug-pilot-project-prices\/\">unveiled a three-year pilot project<\/a> designed to speed up access to some breakthrough cancer treatments included in an international collaboration of regulators called Project Orbis. <\/p>\n<p class=\"c-article-body__text text-pr-5\">The Ontario program will provide public funding for as many as 10 new oncology drugs per year at the start of price negotiations with pharmaceutical companies rather than at their conclusion. <\/p>\n<p class=\"c-article-body__text text-pr-5\">A few days before Ontario\u2019s announcement, the pCPA said it, too, would speed up price negotiations for select cancer drugs, possibly eliminating the need for Ontario\u2019s pilot project.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Earlier this year, Mr. Ford\u2019s government tried unsuccessfully to convince other Canadian jurisdictions to join the pilot. When they declined, Ms. Jones told her provincial and territorial counterparts in a letter in May that Ontario had decided to strike out on its own. <\/p>\n<p><a style=\"display:block\" href=\"https:\/\/www.theglobeandmail.com\/resizer\/v2\/5FVEC75OCFGHPLVRM4ZS7IOUVQ.JPG?auth=f632286cae3a33f3f313914dbb1198a0a2de533af6c19cd6c5ddb2b3b9aa8126&amp;width=600&amp;height=400&amp;quality=80&amp;smart=true\" aria-haspopup=\"true\" data-photo-viewer-index=\"0\" rel=\"nofollow noopener\" target=\"_blank\">Open this photo in gallery:<\/a><\/p>\n<p class=\"figcap-text\">Sylvia Jones, the Health Minister in Premier Doug Ford\u2019s cabinet, is seeking to speed up Ontarians\u2019 access to cancer drugs.Nathan Denette\/The Canadian Press<\/p>\n<p class=\"c-article-body__text text-pr-5\">Ms. Jones\u2019s letter, which her office shared with The Globe and Mail, does not specify what kept other provinces on the sidelines, other than \u201cjurisdictional concerns.\u201d Other provincial governments contacted by The Globe declined to explain their reluctance. <\/p>\n<p class=\"c-article-body__text text-pr-5\">But it could have something to do with the less-discussed advantages of Canada\u2019s system for adding new drugs to provincial, territorial and federal drug plans. It may be slower than some peer countries, with its multiple steps overseen by four different agencies, but it gets lower prices and reserves taxpayer dollars for drugs with the best evidence, pharmaceutical policy experts say. <\/p>\n<p class=\"c-article-body__text text-pr-5\">The pCPA, for instance, saved government drug plans nearly $4-billion in the last fiscal year alone through confidential discounts off the sticker price of brand-name drugs. The public plans represented by the pCPA collectively account for about 41 per cent of all prescription drug spending in Canada.<\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cThe pCPA process should be held up as a pretty awesome way that the provinces, when they work together, are able to do better things,\u201d said Mina Tadrous, a pharmaceutical policy researcher at the University of Toronto.<\/p>\n<p class=\"c-article-body__text text-pr-5\">And high-cost drugs are one of the major factors driving increases in public drug spending. Public plans spent $18.4-billion on prescription drugs in 2023, according to the Canadian Institute for Health Information, of which 45 per cent was spent on drugs that cost $10,000 a year or more.<\/p>\n<p class=\"c-article-body__text text-pr-5\">While the United States moves faster, it also pays much more for drugs. The average list price of a drug in the U.S. is more than three times that of the Canadian price, according to data from the Patented Medicine Prices Review Board.<\/p>\n<p><a style=\"display:block\" href=\"https:\/\/www.theglobeandmail.com\/resizer\/v2\/OJBYNJM7VNPX5OJZV7VPVVUEKM.jpg?auth=a6e376ef0102e9e95471cf8534e67b8cf810b0e8a9a5697ba5870b93b7c6490a&amp;width=600&amp;height=400&amp;quality=80&amp;smart=true\" aria-haspopup=\"true\" data-photo-viewer-index=\"1\" rel=\"nofollow noopener\" target=\"_blank\">Open this photo in gallery:<\/a><\/p>\n<p class=\"figcap-text\">Cancer cells come in many forms \u2013 the ones in blue are pancreatic \u2013 and drug makers can spend years targeting specific types.Min Yu\/Eli and Edythe Broad Center for Regenerative Medicine and Stem Cell Research at USC, USC Norris Comprehensive Cancer Center<\/p>\n<p class=\"c-article-body__text text-pr-5\">In the case of cancer drugs, judging their value and negotiating their prices is a minefield now more than ever. The latest oncology breakthroughs target ever-narrower subtypes of tumours, making them more like rare-disease drugs. Pharmaceutical companies generally charge more for drugs for rare diseases because they must turn a profit off fewer patients. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Canada\u2019s health system, meanwhile, has competing priorities and a limited supply of cash for new drugs, including those for cancer, which are mostly delivered in hospitals and paid for out of the public purse. <\/p>\n<p class=\"c-article-body__text text-pr-5\">For Dr. Stewart of Princess Margaret, Canada\u2019s largest cancer centre, it is \u201cfrustrating\u201d and \u201cdisappointing\u201d that Carvykti won\u2019t be available in Canada for the foreseeable future. <\/p>\n<p class=\"c-article-body__text text-pr-5\">He said he understands the need to contain costs. However, he\u2019s less tolerant of the time it sometimes takes for Canada\u2019s system to reach a yay or nay on new drugs. \u201cIf the answer is no,\u201d Dr. Stewart said, \u201cthen it shouldn\u2019t take two years to come to that conclusion.\u201d<\/p>\n<p>The long journey<\/p>\n<p class=\"c-article-body__text text-pr-5\">When it comes to understanding why Canada takes longer than other wealthy countries to publicly cover new drugs, Carvykti is both an outlier and an explanation. <\/p>\n<p class=\"c-article-body__text text-pr-5\">It\u2019s an outlier in that the process for Carvykti took longer than normal and ended with a rare failure. It\u2019s an explanation in that such outliers raise the average time to public reimbursement for all drugs, making Canada\u2019s system look slower than is the case when new medications traverse the system smoothly.<\/p>\n<p class=\"c-article-body__text text-pr-5\">In a study published in June of 160 drugs added to public plans between 2018 and 2023, Dr. Tadrous of U of T and his co-authors found that, on average, 906 days elapsed between Health Canada green-lighting a drug and at least one province listing it. <\/p>\n<p class=\"c-article-body__text text-pr-5\">That is longer than the figure that Innovative Medicines Canada, the lobby group for brand-name drug makers, has been using in a public campaign arguing that \u201c<a href=\"https:\/\/innovativemedicines.ca\/browse-by\/access-to-medicine\/\" rel=\"nofollow noopener\" target=\"_blank\">two years is too long<\/a>\u201d for Canadians to wait for drugs to be covered by the public system. <\/p>\n<p class=\"c-article-body__text text-pr-5\">IMC says it <a href=\"https:\/\/innovativemedicines.ca\/browse-by\/access-to-medicine\/#lightbox-1\" rel=\"nofollow noopener\" target=\"_blank\">took 732 days<\/a>, on average, for a Health Canada-approved drug to be listed in provinces representing at least half the Canadian population between 2012 and 2021 \u2013 longer than in the United States, Germany, France, Australia, Japan, Italy and several other developed countries. <\/p>\n<p class=\"c-article-body__text text-pr-5\">But as Dr. Tadrous noted in his study, averages like these are skewed by outlier cases with unusual delays, some contributed to by drug makers themselves. (The study was co-authored by health economists at the Patented Medicine Prices Review Board, a federal agency that sets ceiling prices for brand-name drugs. It sits outside the pathway to public reimbursement.)<\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cSometimes for these really high-cost drugs for rare diseases, there\u2019s a bit of a standoff between the companies and the payers over concerns with the certainty of the evidence,\u201d Dr. Tadrous said, \u201cand that\u2019s where you kind of see some of these drag out.\u201d <\/p>\n<p><a style=\"display:block\" href=\"https:\/\/www.theglobeandmail.com\/resizer\/v2\/SKHMAMS4GRCFLDJKCAPDC3UXII.jpg?auth=f1d485a92b4a54d39e30d827abb950286c9d5e3a3755842375e1cd6666fa8622&amp;width=600&amp;height=400&amp;quality=80&amp;smart=true\" aria-haspopup=\"true\" data-photo-viewer-index=\"2\" rel=\"nofollow noopener\" target=\"_blank\">Open this photo in gallery:<\/a><\/p>\n<p class=\"figcap-text\">Health Canada\u2019s approval is a necessary step, but not the only or final one, for the makers of drugs like Carvykti.Sean Kilpatrick\/The Canadian Press<\/p>\n<p class=\"c-article-body__text text-pr-5\">The journey to public coverage of a new drug begins when Health Canada, the regulatory agency, authorizes it for sale in Canada. Health Canada <a href=\"https:\/\/dhpp.hpfb-dgpsa.ca\/review-documents\/resource\/SBD1684955300002\" rel=\"nofollow noopener\" target=\"_blank\">first approved Carvykti<\/a> on Feb.9, 2023, nearly a year after Janssen applied on March 4, 2022. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Health Canada has a target time of 300 calendar days to issue decisions on new drugs. Although 342 calendar days elapsed between Janssen\u2019s application and regulatory approval, Health Canada told The Globe the active review time was actually 199 days. <\/p>\n<p class=\"c-article-body__text text-pr-5\">That\u2019s mainly because Health Canada paused the clock three times at Janssen\u2019s request so the company could respond to requests for clarification, according to Joshua Coke, a Health Canada spokesman.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Carvykti is a complex product. CAR-T is a bespoke type of immunotherapy, versions of which are already publicly covered in Canada for some leukemias and lymphomas. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Johnson &amp; Johnson makes tailored doses of Carvykti for individuals with myeloma by drawing their blood and genetically modifying their T-cells to attack myeloma cells. The modified cells, infused back into patients, multiply continuously but safely, like a living drug. <\/p>\n<p class=\"c-article-body__text text-pr-5\">CAR-T therapy has proven so beneficial that its inventors, one of whom did his foundational research in immunology at the University of Alberta, last year won a <a href=\"https:\/\/www.theglobeandmail.com\/canada\/article-2024-gairdner-awards\/\" rel=\"nofollow noopener\" target=\"_blank\">Canada Gairdner International Award<\/a>, often a prelude to the Nobel Prize. <\/p>\n<p>An exception to the rule <\/p>\n<p class=\"c-article-body__text text-pr-5\">Steve Romanowitch is one of the fortunate few Canadian multiple myeloma patients who didn\u2019t have to wait for CAR-T therapy.<\/p>\n<p class=\"c-article-body__text text-pr-5\">He was 51 when he was diagnosed in 2022. At the time, he was a busy coach for his hockey-mad teenage daughters and was working as a firefighter, a job that raised his cancer risk. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Overall survival rates for myeloma have increased dramatically in the last 20 years because of a burst of effective and expensive new therapies. When one fails, patients move on to the next best treatment, sometimes achieving remission for five or 10 years or longer. (This cascade has made multiple myeloma the cancer with the highest direct per-patient costs to the Canadian health care system, according to a <a href=\"https:\/\/cdn.cancer.ca\/-\/media\/files\/research\/cancer-statistics\/2024-statistics\/2024-special-report\/2024_pdf_en.pdf?rev=5e4571f0dc22433baf1abf21ae2874d3&amp;hash=AB563A419B8C8044B88F9EA1D4CC200A&amp;_gl=1*1xn9ty7*_gcl_au*NDgzMTUyMDcyLjE3NTkyNjMwMDU.\" rel=\"nofollow noopener\" target=\"_blank\">report<\/a> released last year by the Canadian Cancer Society.) <\/p>\n<p class=\"c-article-body__text text-pr-5\">Eventually, however, myeloma patients exhaust their options. Mr. Romanowitch ran out of roadway faster than most. He endured six lines of therapy, including two stem cell transplants, in just over a year before a doctor advised him to get his affairs in order. <\/p>\n<p class=\"c-article-body__text text-pr-5\">He and his wife, Suzanne, were discussing whether he wanted a formal firefighter\u2019s funeral when they decided it would be better if Mr. Romanowitch were alive to enjoy it. Nearly 300 people \u2013 firefighters, hockey families, dear old friends \u2013 came to support Mr. Romanowitch at a party in the parking lot and gymnasium of the Markham, Ont., church where he and Suzanne were married.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Not long after the party, Mr. Romanowitch and his wife made what they thought was a long-shot application to see if the Workplace Safety Insurance Board would pay for Mr. Romanowitch\u2019s last, best hope: CAR-T therapy in Buffalo, N.Y., where a cancer centre was already offering the treatment.<\/p>\n<p class=\"c-article-body__text text-pr-5\">The WSIB ultimately agreed to pay the approximately $800,000 cost for Mr. Romanowitch to receive CAR-T in the United States in April of 2024 because his myeloma was deemed a work-related cancer. No Canadian hospital was offering the complex therapy, even if WSIB was willing to foot the bill. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Mr. Romanowitch\u2019s cancer has been stable ever since.<\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cI\u2019m actually doing pretty darn good,\u201d Mr. Romanowitch said. \u201cI was happy that it was going to give me, theoretically, nine to 12 months. That was my hope, and we\u2019re past that now, and there\u2019s no real indication that things are going to change.\u201d<\/p>\n<p><a style=\"display:block\" href=\"https:\/\/www.theglobeandmail.com\/resizer\/v2\/LLVF67B4FVAV3MFOGKKBDLPC4Y.JPG?auth=133ecd4d8c0ded46f14190ac345bb967597f035df69590ea813b3d13666b08b9&amp;width=600&amp;height=400&amp;quality=80&amp;smart=true\" aria-haspopup=\"true\" data-photo-viewer-index=\"3\" rel=\"nofollow noopener\" target=\"_blank\">Open this photo in gallery:<\/a><\/p>\n<p class=\"figcap-text\">Mr. Romanowitch, relaxing with dog Griffin after the fundraising walk, is upbeat about his health since receiving a one-time infusion of CAR-T therapy.Alex Franklin\/The Globe and Mail<\/p>\n<p>Red tape or due diligence?<\/p>\n<p class=\"c-article-body__text text-pr-5\">Unlike Mr. Romanowitch, Mr. Velic, a contractor, had to wait for Carvykti to wind its way through the rest of Canada\u2019s system for adding new drugs to public drug plans. <\/p>\n<p class=\"c-article-body__text text-pr-5\">After Health Canada approval, new medications go before a committee of experts at Canada\u2019s Drug Agency, an independent organization that advises the federal, provincial and territorial drug plans outside of Quebec on whether and how to cover drugs and medical devices.<\/p>\n<p class=\"c-article-body__text text-pr-5\">The agency performs health technology assessments, which judge the value of new medications, and are a common feature of the reimbursement process in many Western countries. The experts at Canada\u2019s Drug Agency ask questions such as: Is this new drug any better than existing drugs? Does it satisfy an unmet patient need? Is it worth paying for in a public medical system beset by competing demands? <\/p>\n<p class=\"c-article-body__text text-pr-5\">Quebec has its own agency, abbreviated in French as INESSS, which asks similar questions and sometimes makes conclusions different from those of its national counterpart. <\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cI know lots of people like to call it red tape or a barrier, but it\u2019s really due diligence,\u201d said Suzanne McGurn, president and CEO of Canada\u2019s Drug Agency. <\/p>\n<p><a style=\"display:block\" href=\"https:\/\/www.theglobeandmail.com\/resizer\/v2\/UJBVAZRZJJAXZO3ZMVDLZBN63I.jpg?auth=c734ddebdd98882b7d72bcd77ced9fa54ea988b4252ff535dd5e24335d48b6ee&amp;width=600&amp;height=400&amp;quality=80&amp;smart=true\" aria-haspopup=\"true\" data-photo-viewer-index=\"4\" rel=\"nofollow noopener\" target=\"_blank\">Open this photo in gallery:<\/a><\/p>\n<p class=\"figcap-text\">Pharmacies dispense medication to patients, but the prices paid for brand-new drugs are usually set out in deals made between insurance plans and the drug makers.Darryl Dyck\/The Canadian Press<\/p>\n<p class=\"c-article-body__text text-pr-5\">The agency\u2019s predecessor organization, the Canadian Agency for Drugs and Technologies in Health, posted a final recommendation on May 17, 2023, in favour of covering Carvykti, so long as the price was slashed by 72 to 80 per cent. <\/p>\n<p class=\"c-article-body__text text-pr-5\">That was a quick turnaround of just more than three months between Health Canada approval and the drug agency\u2019s final verdict, which was made possible because Janssen chose to file a submission to the expert committee in the fall of 2022, before Health Canada approval. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Every company has the option to file parallel submissions at the two agencies, but some decline to use it. Dr. Tadrous\u2019s study found that drug makers\u2019 reluctance to file early to Canada\u2019s Drug Agency was a significant factor in delays to reimbursement.<\/p>\n<p class=\"c-article-body__text text-pr-5\">If Canada\u2019s Drug Agency recommends public funding for a new medication, the next step is pricing negotiations, led by the pan-Canadian Pharmaceutical Alliance, an independent non-profit corporation that until late 2022 was housed inside the Ontario Ministry of Health. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Drug companies operating in Canada often point to the pCPA as the bottleneck they\u2019d most like to see cleared. The pCPA operates on a consensus model. All 13 provinces and territories, plus federal drug plans that cover special populations such as veterans, Inuit and members of First Nations, must agree on a price before a deal is inked. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Then, each jurisdiction still has to decide whether it can afford to add the new drug to its roster. That takes 3.3 months on average, according to Dr. Tadrous\u2019s study. On rare occasions, provinces decline, despite agreeing to a price at the pCPA table. <\/p>\n<p class=\"c-article-body__text text-pr-5\">But before pricing negotiations can even begin, the pCPA must pick up the case. Drug makers sometimes watch in dismay as files sit idle for months, said Arima Ventin, the head of market access and government affairs for AbbVie Canada. <\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cWe would encourage them to look for innovative pathways so that drugs aren\u2019t just waiting in the queue,\u201d she said. <\/p>\n<p><a style=\"display:block\" href=\"https:\/\/www.theglobeandmail.com\/resizer\/v2\/JSMTBTACWBIGPHEB7GTDZVKH3U.JPG?auth=13c36951b9c945d0ee0fe9232fe29f9517fec547a5d84d248ff674a8e61dc478&amp;width=600&amp;height=400&amp;quality=80&amp;smart=true\" aria-haspopup=\"true\" data-photo-viewer-index=\"5\" rel=\"nofollow noopener\" target=\"_blank\">Open this photo in gallery:<\/a><\/p>\n<p class=\"figcap-text\">Johnson &amp; Johnson Innovative Medicine (formerly Janssen), the maker of Carvykti, couldn\u2019t reach an agreement with the pan-Canadian Pharmaceutical Alliance. Pricing negotiations collapsed last month.Piroschka van de Wouw\/Reuters<\/p>\n<p class=\"c-article-body__text text-pr-5\">In the case of Carvykti, nearly seven months passed between Canada\u2019s Drug Agency posting its final report on May 17, 2023, and the pCPA issuing a letter of engagement to kick-start talks on Nov. 10, 2023.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Negotiations concluded without a deal 22 months later, on Sept. 18.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Complicating matters, Carvykti had received a second Health Canada approval during this time frame that allowed it to be used by patients who had failed on just one other drug, instead of three, which enlarged the pool of eligible patients and increased the potential budget impact for provinces. <\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cWe just could not come to a point that was suitable for both parties, which is really unfortunate,\u201d said Mauro Chies, the chief executive officer of the pCPA. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Alaine Grand, vice-president of market access for Carvykti-maker Johnson &amp; Johnson, said the company presented its best and final offer June 5. \u201cWe had been very transparent as to what our limitations were for a very long time through those negotiations,\u201d she said. \u201cWe didn\u2019t feel that anything that we were sharing with them should come as a surprise, and we were still waiting for a response from them 13 weeks later.\u201d <\/p>\n<p>      Mr. Velic points out the spot on his spine where his first myeloma-related pain appeared. Chemo brings its own discomforts: It can take days for the restlessness and nausea to subside.<\/p>\n<p>          Eduardo Lima\/The Globe and Mail<\/p>\n<p>Humans are \u2018not numbers on a spreadsheet\u2019<\/p>\n<p class=\"c-article-body__text text-pr-5\">While the pCPA and Johnson &amp; Johnson were wrangling over the price of Carvykti, Jas Velic was suffering the ravages of weekly chemotherapy, treatments that will continue indefinitely.<\/p>\n<p class=\"c-article-body__text text-pr-5\">The night after chemo is the worst. He usually spends it in the tub, hoping the warm water will soothe his pain and nausea. Ms. Velic sits with him all night in the bathroom of the Mississauga home they share with their 14-year-old son and 12-year-old daughter. <\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cIt\u2019s a lot of sleepless nights,\u201d Mr. Velic said. \u201cAfter a couple of days, I start feeling like myself. So we get back to life and everything\u2019s normal, and then I take the treatment again.\u201d <\/p>\n<p class=\"c-article-body__text text-pr-5\">Mr. Velic has been on chemotherapy nearly non-stop since he was diagnosed with multiple myeloma in January of 2023. He was 40 at the time, abnormally young to have a type of cancer that most often strikes senior citizens.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Multiple myeloma, which arises in the bone marrow, ate away at Mr. Velic\u2019s spine until the self-employed contractor could barely walk or sit upright. <\/p>\n<p class=\"c-article-body__text text-pr-5\">When the pain began, in the fall of 2022, Mr. Velic assumed he had simply pushed himself too hard at work. But his back ache worsened to the point that he visited a local emergency room. Doctors there sent him home with Tylenol 3s, nothing more. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Finally, a nurse friend who witnessed Mr. Velic\u2019s agony brought him and his wife to the ER of the Toronto hospital where she worked and demanded Mr. Velic be thoroughly examined. He was diagnosed with multiple myeloma and admitted to hospital that day. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Mr. Velic doesn\u2019t remember the doctors telling him how much time he had left, only that, \u201cwe just needed to act urgently if we wanted to stop the progression, or if we wanted to make any kind of change. They really, really wanted me on treatment pretty much the same day.\u201d<\/p>\n<p>Watch: In an interview, Jas and Tanja Velic speak about their struggles getting access to CAR-T.<\/p>\n<p class=\"c-article-body__text text-pr-5\">In the years that have passed since, he\u2019s been on dozens of medications to try to control his multiple myeloma and lessen the side effects of his weekly chemotherapy. The stem cell transplant he received in September of 2023 didn\u2019t work, prompting his discussion with Dr. Stewart about CAR-T in December of that year. (Dr. Stewart has received funding from pharmaceutical companies that make myeloma treatments, including Carvykti-maker Johnson &amp; Johnson.)<\/p>\n<p class=\"c-article-body__text text-pr-5\">Mr. Velic has been in limbo ever since. Now that pricing talks have ended without a deal, he and his wife are looking at selling their home and draining their savings to travel abroad for CAR-T therapy.<\/p>\n<p class=\"c-article-body__text text-pr-5\">They aren\u2019t sure they\u2019ll find the money. They know most Canadians wouldn\u2019t be able to, either. <\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cAccess to life-saving treatments should never be dictated by profit margins or political agendas,\u201d Ms. Velic said. \u201cThese are human lives \u2013 not numbers on a spreadsheet.\u201d <\/p>\n<p>      Johnson &amp; Johnson Innovative Medicine is based in Belgium, where this warehouse in Frameries is the largest wholesaler of medicines for 3,200 pharmacies nationwide. <\/p>\n<p>          Nicolas Tucat\/AFP via Getty Images<\/p>\n<p>Speeding up the process<\/p>\n<p class=\"c-article-body__text text-pr-5\">As Mr. Chies of the pCPA emphasized, Carvykti is an outlier. It\u2019s rare for pricing talks to fail. Only 8 per cent of pricing negotiations for cancer drugs concluded without an agreement as of the end of August, according to the pCPA. That timeline excludes the collapsed Carvykti talks. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Still, Mr. Chies and Ms. McGurn of Canada\u2019s Drug Agency are both keenly aware of the long-standing criticism that Canada takes too long to publicly reimburse new drugs.<\/p>\n<p class=\"c-article-body__text text-pr-5\">They say their organizations were already increasing the pace, even before Ontario tried to force the issue with its new pilot project. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Mr. Chies said the pCPA is picking up files sooner and concluding deals faster now that it\u2019s an independent agency with more staff. The median negotiation time for oncology drugs, including the time it takes for the pCPA to pick up a file, fell to 5.7 months in 2024, down from nine months in 2022 and just more than 8 months in 2023. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Nearly 40 people, most of them negotiators, work for the organization today, up from a peak of about 20 when it was housed inside the Ontario government.<\/p>\n<p class=\"c-article-body__text text-pr-5\">On Oct. 21, the pCPA released details of what it is calling the \u201cearly negotiation process,\u201d which would see price negotiation for Project Orbis cancer drugs start after Canada\u2019s Drug Agency had written a draft report on a drug, instead of starting when a final recommendation was issued. The pCPA said this would speed up negotiations by up to six months.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Canada\u2019s Drug Agency, too, is making strides. The agency has persuaded more drug makers to file to its expert committees early, before Health Canada approval. In 2024-2025, 76 per cent of submissions landed early, up from 68 per cent and 55 per cent in the two previous years. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Mr. Carney\u2019s Liberals included a promise in their spring campaign platform to speed up drug approvals. So far there haven\u2019t been many details of that effort, though Health Minister Marjorie Michel <a href=\"https:\/\/www.theglobeandmail.com\/business\/economy\/article-speeding-up-generic-drug-approval-timelines-priority-health-minister\/\" target=\"_self\" rel=\"nofollow noopener\" title=\"https:\/\/www.theglobeandmail.com\/business\/economy\/article-speeding-up-generic-drug-approval-timelines-priority-health-minister\/\">told The Globe<\/a> in August that the pledge lined up with the federal government\u2019s broader efforts to be more efficient. <\/p>\n<p><a style=\"display:block\" href=\"https:\/\/www.theglobeandmail.com\/resizer\/v2\/Z2O7S3STWZDSPGUKTPPZWFWZGA.JPG?auth=6c269b9b039ed1c44bf12fe51376b0eb86cadfbad794d2c015ed48753108ff00&amp;width=600&amp;height=400&amp;quality=80&amp;smart=true\" aria-haspopup=\"true\" data-photo-viewer-index=\"6\" rel=\"nofollow noopener\" target=\"_blank\">Open this photo in gallery:<\/a><\/p>\n<p class=\"figcap-text\">Federal Health Minister Marjorie Michel, joined by her provincial counterparts at a recent meeting of health ministers in Calgary, entered cabinet after an election where Mark Carney\u2019s Liberals promised more efficient drug approvals.Jeff McIntosh\/The Canadian Press<\/p>\n<p class=\"c-article-body__text text-pr-5\">Health Canada, Canada\u2019s Drug Agency and the pCPA have also been collaborating on a <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC12025630\/#B6-curroncol-32-00235\" rel=\"nofollow noopener\" target=\"_blank\">new temporary access pathway<\/a> for drugs with promising early evidence that results in more of the three organizations\u2019 work being performed concurrently, rather than consecutively. <\/p>\n<p class=\"c-article-body__text text-pr-5\">Two cancer drugs that plied the new pathway, Epkinly for lymphoma and Enhertu for gastric cancer, went from Health Canada conditional approval to publicly covered in at least one province in 306 and 117 days, respectively, faster than is typical for oncology drugs. <\/p>\n<p class=\"c-article-body__text text-pr-5\">The long-term goal, Ms. McGurn said, is for Health Canada and Canada\u2019s Drug Agency to render their verdicts on new drugs the same day, instead of eight months apart, the average lag identified in Dr. Tadrous\u2019s study. <\/p>\n<p class=\"c-article-body__text text-pr-5\">But that won\u2019t be possible unless more drug companies play ball: Dr. Tadrous found that late manufacturer submissions to Canada\u2019s Drug Agency accounted for 49 per cent of overall delays to public reimbursement between 2018 and 2023.<\/p>\n<p class=\"c-article-body__text text-pr-5\">Bettina Hamelin, the president and CEO of the pharmaceutical lobby group Innovative Medicines Canada, said the companies she represents are eager to take advantage of any parallel processes, although Canadian branches are sometimes at the mercy of their global headquarters when it comes to timing. <\/p>\n<p class=\"c-article-body__text text-pr-5\">For now, though, a fundamental challenge remains. New drugs, including breakthroughs for incurable cancer, must run a gauntlet of four distinct organizations (Health Canada, Canada\u2019s Drug Agency, INESSS in Quebec and the pan-Canadian Pharmaceutical Alliance) and fourteen different jurisdictions (Ottawa, plus 10 provinces and three territories) before they\u2019re covered for all Canadians. <\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cCompare that with the U.S., where a drug is listed as soon as the FDA has made a decision on the safety and efficacy of the medicine,\u201d Ms. Hamelin said. \u201cAmericans have access on day one and Canadians have access two and a half years later on average, which is problematic when it\u2019s a cancer drug that could save a life.\u201d<\/p>\n<p class=\"c-article-body__text text-pr-5\">Mr. Velic feels that disparity deep in his marrow, where cancer still threatens his life. <\/p>\n<p class=\"c-article-body__text text-pr-5\">\u201cPeople in the States with their Medicare are getting Car-T,\u201d he said. \u201cSeventy and 80-year-olds are getting it. It\u2019s hard to watch.\u201d <\/p>\n<p><a style=\"display:block\" href=\"https:\/\/www.theglobeandmail.com\/resizer\/v2\/5QVT5KFIAZH37IQS7AUBHOMCBY.JPG?auth=9f759c67bfce778aaba73ab083688d3c0a1f9472f53fceb1b78a6b4095955591&amp;width=600&amp;height=400&amp;quality=80&amp;smart=true\" aria-haspopup=\"true\" data-photo-viewer-index=\"7\" rel=\"nofollow noopener\" target=\"_blank\">Open this photo in gallery:<\/a><\/p>\n<p class=\"figcap-text\">Eduardo Lima\/The Globe and Mail<\/p>\n<p>Cancer in Canada: More from The Globe and MailThe Decibel podcast<\/p>\n<p class=\"c-article-body__text text-pr-5 font-pratt\">Around the world, people under 50 are increasingly likely to <a href=\"https:\/\/www.theglobeandmail.com\/canada\/article-gen-x-and-millennials-see-rising-rates-of-cancer\/\" target=\"_blank\" rel=\"nofollow noopener\">get a cancer diagnosis.<\/a> Reporter Kelly Grant looked at how millennials and Gen Xers are dealing with that in Canada, and <a href=\"https:\/\/www.theglobeandmail.com\/podcasts\/the-decibel\/article-why-more-young-people-are-getting-cancer\/\" target=\"_blank\" rel=\"nofollow noopener\">spoke with The Decibel<\/a> about her findings. <a href=\"https:\/\/pod.link\/thedecibel\" target=\"_blank\" rel=\"nofollow noopener\">Subscribe for more episodes.<\/a><\/p>\n<p>First Person<\/p>\n<p class=\"c-article-body__text mv-16 l-inset text-pb-8\" data-sophi-feature=\"interstitial\"><a href=\"https:\/\/www.theglobeandmail.com\/life\/first-person\/article-battle-cancer-family-gift-illness-career\/\" rel=\"nofollow noopener\" target=\"_blank\">V\u00e9ronique Grigg: My battle with cancer taught me that a supportive family is a gift, not a given<\/a><\/p>\n<p class=\"c-article-body__text mv-16 l-inset text-pb-8\" data-sophi-feature=\"interstitial\"><a href=\"https:\/\/www.theglobeandmail.com\/life\/first-person\/article-hair-loss-chemo-cancer-first-person\/\" rel=\"nofollow noopener\" target=\"_blank\">Elisabeth Kroeker Bach: When I lost my hair during chemo, I chose colour over sorrow<\/a><\/p>\n<p class=\"c-article-body__text mv-16 l-inset text-pb-8\" data-sophi-feature=\"interstitial\"><a href=\"https:\/\/www.theglobeandmail.com\/life\/first-person\/article-when-my-son-had-cancer-i-had-to-learn-that-i-could-walk-by-his-side\/\" rel=\"nofollow noopener\" target=\"_blank\">When my son had cancer I had to learn that I could walk by his side but not in his shoes<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"It was nearly two years ago when an oncologist first told Jas Velic that his best hope of&hellip;\n","protected":false},"author":2,"featured_media":108213,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[697,163,85,46,482],"class_list":{"0":"post-108212","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-appwebview","9":"tag-health","10":"tag-il","11":"tag-israel","12":"tag-medication"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/108212","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=108212"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/108212\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/108213"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=108212"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=108212"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=108212"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}