Cardiac surgeon and scientist Dr. Subodh Verma (left) and patient Richard Neilson at St. Michael’s Hospital on January 3. When Nielson suffered a heart attack in 2019, Dr. Verma performed double bypass surgery on Nielson’s heart, operating on Christmas Day. day.Sammy Corgan/Globe and Mail
Shortly after Richard Neilson survived a heart attack and double bypass surgery in 2019, his heart surgeon enrolled him in a clinical trial for a drug that researchers hope will reduce his risk of future heart attacks. I invited him.
That drug is semaglutide, now better known as Ozempic, a blockbuster type 2 diabetes treatment that has become a medical and cultural phenomenon because it allows people to easily lose weight.
Mr. Nielson, a 68-year-old Toronto truck driver, has lost 45 pounds from his 6-foot stature, but that doesn’t mean he didn’t care much about his body shape, and he didn’t want to worry about its potential cardiovascular benefits. I was excited and agreed to participate in the clinical trial. About one frame a year while shooting Wegovy. A high-dose version of semaglutide is sold for weight management and is manufactured by the same company as Ozempic.
“If it was just weight loss, I wouldn’t have worried about it,” Neilson said.
A clinical trial in which Neilson participated, called SELECT, paved the way for Health Canada’s decision in November to approve Wegovy to reduce the risk of heart attacks. For the first time, Canadian regulators have given the green light to a highly popular class of drugs known as glucagons. Peptide-1 (GLP-1) receptor agonists for conditions other than diabetes, overweight, and obesity.
Experts say this won’t be the last. Just before Christmas, the U.S. Food and Drug Administration approved a similar drug, tirzepatide, sold as Zepbound, to treat obstructive sleep apnea. GLP-1 drugs are being tested for dozens of other chronic diseases, including chronic kidney disease, nonalcoholic fatty liver disease, Alzheimer’s disease, and Parkinson’s disease.
The new and future potential of GLP-1 drugs poses a challenge for Canada’s cash-strapped public drug program, which has so far limited Ozempic to patients with diabetes. They declined to interview Wegoby because it is marketed as a weight management drug. That could change if Wegovy and its cousins, including tirzepatide, are approved and promoted as treatments for other chronic conditions that afflict millions of overweight and obese Canadians.
“This is going to be a big change,” said Mina Tadros, a professor of pharmaceutical policy and drug safety at the University of Toronto. Insurers around the world have traditionally balked at bundling the cost of weight loss drugs with cosmetic treatments such as Botox. The success of GLP-1 drugs is forcing payers to “rethink the paradigm,” he said.
“What’s lagging behind is real evidence. Much of it is hypothesis,” Dr. Tadros warned. “For the first time, we see signs that cardiovascular effects are no longer just a hypothesis.”
GLP-1 drugs manage blood sugar levels and help you lose weight by mimicking the GLP-1 hormone that your body naturally produces. Weekly injections slow stomach emptying, but appear to work most powerfully in the brain, where they suppress hunger cues. The main side effects are nausea and gastrointestinal upset.
some recent analysis Clinical trial data for GLP-1 therapeutics in cardiovascular and renal diseases suggest that the drugs may provide health benefits independent of weight loss, possibly because these drugs This is thought to suppress inflammation throughout the body.
“These are all completely new conversations,” says Daniel Drucker, a clinical scientist based in the Lunenfeld-Tannenbaum Institute at Mount Sinai Hospital in Toronto and one of the researchers who discovered the GLP-1 hormone. he said. “I address this exact point in every lecture. We need to change our mindset from making weight loss the primary goal for everyone. Improving is the primary goal for many people.”
Ozempic is already the best-selling drug in Canada, according to data provided to the Globe and Mail by life sciences analytics firm IQVIA.
About $2.3 billion worth of Ozempic was sold through Canadian retail pharmacies in the first 11 months of last year, more than twice as much as the next best-selling drug Stelara, which treats Crohn’s disease and other autoimmune diseases. (These numbers include markup and dispensing fees.)
The IQVIA data counts all payers, including non-diabetic Canadians who paid out of pocket to use Ozempic off-label to lose weight. Wegovy, which first went on the market in Canada last year, had sales of about $147 million from April to the end of November.
Novo Nordisk, which makes both versions of semaglutide, says a 28-day supply of the weekly injectable Wegoby sells for $388.64 in Canada, excluding pharmacy markups and dispensing fees.
Dr. Tadros and his colleagues study Last month, it was shown that the dollar value of all drug purchases in Canada, regardless of payer, increased by 13.7 per cent between 2022 and 2023. The rate of increase was so much higher than expected that at first Dr. Tadros thought he was a summer student consuming large quantities of drugs. I made a mistake in the number.
“All of this yearly growth is driven by semaglutide,” he said.
It is not yet clear how this increase will impact public drug programs. Report on prescription drug spending According to CIHI research, taxpayer spending on diabetes drugs containing GLP-1 reached $868 million that year, representing 24% of the total growth in public drug program spending nationwide.
Ozempic was the biggest driver of this increase, with public spending reaching $434 million in 2022, up from $265 million the previous year.
According to some, it is clear that ontario researchthat means many patients with diabetes, obesity, or heart disease who could benefit from GLP-1 drugs are not receiving them.
Neilson is among them. He stopped taking Wigovy about a year and a half ago when the SELECT trial ended because he couldn’t afford the drug on his truck driver’s salary. As a senior, he qualifies for Ontario’s drug benefit program, but the plan doesn’t cover Wegovy.
Subodh Verma, a professor of surgery and pharmacology at the University of Toronto who performed Neilson’s double bypass surgery at St. Michael’s Hospital in Toronto in 2019, believes Neilson could benefit from continuing to inject the drug. are.
“The medication has an intrinsic value that isn’t necessarily related to weight, and it’s actually protecting his heart. That’s why I need to get him back on the medication.” said Dr. Verma, who led the SELECT trial. We are also leading clinical trials for other GLP-1 drugs. (Both he and Dr. Drucker have disclosed that they have received honoraria from pharmaceutical companies, including Novo Nordisk, which helped introduce the SELECT participants for this story to the Globe.)
Some pharmaceutical companies offer trial extensions or bridge programs that cover drug costs after the trial ends, but Novo Nordisk does not do so in the case of SELECT, which enrolled more than 17,000 people. Not yet. The company did not provide a reason for the decision in response to written questions from the Globe.
“Novo Nordisk is working with federal and state governments, insurers, employers and patient advocacy groups to improve access to our medicines and advocate for the recognition of obesity as a chronic disease. ” said Kate Hanna, Senior Director of Communications. Novo Nordisk Canada responded via email.
Novo Nordisk’s advocacy efforts in Canada include resubmitting Wegoby to the Canadian Medicines Agency’s expert panel, which advises public drug plans on drug coverage. Predecessor agency of CDA Recommended not to refund Wegovy will be used for weight management in 2022, but it may be reconsidered now that Wegovy has been approved by Health Canada for cardiovascular disease. The CDA is expected to issue new recommendations later this year.
“The conversation that needs to be had is this is to protect the heart, not for cosmetic reasons,” Dr. Verma said.
