Breakthrough heart drug gets approval
Patients eager to access medication that could significantly reduce cardiovascular deaths
Former soccer coach Alan Churchard would love to run around on the field again, or even just be able to climb the stairs at the stadium.
But the 71-year-old West Vancouver resident has heart failure that prevents him from playing sports or just kicking a ball with his grandson.
Heart failure, which affects more than 100,000 British Columbians, is a debilitating and life-threatening disease in which the heart cannot pump enough blood around the body. Symptoms such as breathlessness, fatigue and fluid retention can appear slowly and worsen over time.
However, a new drug approved by Health Canada last week could be a game-changer for Churchard.
“I’m quite excited,” he said. “I’m hoping it will help me, at least climb up the stairs again.”
Andrew Ignaszewski is one of B.C.’s top cardiologists. A year ago, he said Phase 3 clinical trials showed the new drug, now called Entresto, could reduce the number of cardiovascular deaths by more than 20 per cent.
The results were so staggering that the trial ended early after scientists realized it saved more lives than the current standard treatment — a generic drug called enalapril.
It is the first treatment in two decades to show a higher survival rate for patients.
Ignaszewski, head of cardiology at St. Paul’s Hospital, called Entresto a major advance in heart-failure treatment.
But a year later, patients like Churchard are stuck in an agonizing wait for a treatment that could not only save their lives, but also improve their quality of life. Churchard, who had his first heart attack in 1996 and was diagnosed with heart failure four years ago, had to stop taking one of his medications because it was making him tired, lethargic and impatient with family members. Now he takes different drugs, but must take more than 10 pills a day, and still he can’t play soccer, one of his greatest passions, or go for long walks with his wife.
Entresto is taken only twice a day, according to Ignaszewski, and is a well- tolerated medication.
He said Saturday that while it may be another year before Entresto is readily available in B.C., he will have samples soon and hopes to provide it to his patients most in need, including Churchard, in about a month.
“It creates less strain of the heart and makes it work better so you can do more. Your quality of life improves,” he said. “The biggest improvement in quality of life is in reduction of hospital admissions.”
With each visit to the hospital, a heart failure patient experiences a decline in health, and increased mortality, he said, adding that patients on Entresto are able to do more exercise.
“Their blood pressure is better, their kidney function is surprisingly better,” he said. “I am very excited for my heart failure patients. This is a big breakthrough.”
Although it’s not yet known how much the drug will cost in B.C. or whether it will be covered by Pharmacare, Entresto will be more expensive than enalapril.
The price of Entresto is expected to be $7.24 a day and it will be available to Canadians in December, said Patricia Tiramani, a spokeswoman for Novartis Pharmaceuticals Canada Inc.
Ignaszewski had expected the drug would be more expensive than enalapril, which costs about $1.50 a day. As a new drug, there is no generic version of Entresto. But, Ignaszewski said, in the future other companies may develop the drug, which could bring the price down.
Now that Health Canada has approved the drug, the national Common Drug Review will make a recommendation on whether it should be covered by provincial drug plans.
The review compares the new drug against similar drugs and decides whether it provides value for the money.
The B.C. Ministry of Health’s drug benefit council will then review the drug, likely in late February, or early March, to see if it should be covered by Pharmacare. It examines all the evidence about the drug’s efficacy, safety and cost-effectiveness, according to the ministry.
Ignaszewski said heart failure is responsible for nine per cent of all deaths in Canada and the second leading cause of hospitalization for patients over 65.
When the heart doesn’t pump enough blood, the body responds by producing hormones that constrict blood vessels, making it harder for the failing heart to function. The continued release of those hormones damages the heart, blood vessels and kidneys, he said.
The drug suppresses the damaging hormones, he said, while boosting one of the heart’s builtin protective mechanisms.