Promising new cholesterol medicine raises drug cost questions

CTV National News: Big price tag for medical gain Avis Favaro has more on the research backing up a Canadian medical pioneer's new way of lowering cholesterol.

A medication that takes a new approach to lowering cholesterol – and that was developed in part thanks to a key Canadian discovery – appears to cut the risk of a heart attack and other heart events by as much as 20 per cent, a large new study has found. But with a high price tag, it remains to be seen who will be able to afford the drug.

The medication is called evolocumab and is sold as Repatha. It’s from a class of cholesterol medications called PCSK9 inhibitors that were only approved for use in Canada in 2015.

Repatha is designed for patients who have very high cholesterol due to genetics, or who have had a heart attack or stroke and for whom traditional cholesterol drugs, called statins, aren’t working.

They were developed thanks to the work of a team of researchers from Montreal who discovered that the PCSK9 enzyme is a powerful regulator of LDL, or bad cholesterol, in the blood

In the new study, published Friday in the New England Journal of Medicine and presented at the American College of Cardiology conference, researchers tested the drug on more than 27,500 people who had high LDL despite also taking statins.

They found that for every 200 patients treated with monthly Repatha injections for roughly two years, three fewer people would suffer a heart attack, stroke or heart-related death.

The drug cut by 20 per cent the combined risk of having either a heart attack, stroke or a heart-related death, found the study. It also cut the risk of hospitalization for chest pain or the need for angioplasty (an artery-opening procedure) by 15 per cent.

The study was funded by Amgen, the drug company that makes evolocumab.

Those are impressive findings, says Dr. Robert A. Hegele of the Robarts Research Institute in London, Ont.

Hegele has been studying PCSK9 inhibitors for several years and says while it has been known for some time that the drugs reduce cholesterol levels, there’s been doubt about whether they actually cut the risk of heart attacks and deaths.

“The drugs worked well, and lowered cholesterol to levels we have never seen before and lower cholesterol,” he told CTV News.

“Now we have more confidence that not only are we are helping on the biochemistry reports numbers, but also helping keep patients out of emergency rooms and cardiac operating theatres.”

The study could have extended for five years to allow researchers to get a full picture of the effects – and side effects – of the drug. But the study was terminated after only two years because the placebo group was at a disadvantage and having a higher rate of cardiac events.

Perry Colangeli, a 51-year-old from Calgary has been taking evolocumab as part of the study. He’d already had two heart attacks and a triple bypass but was told that even with the maximum dose of statins, his cholesterol remained stubbornly high.

“It makes you scared, with lots of anxiety, knowing you had a heart attack and the statins are supposed to help people but aren’t doing it. It caused me a lot of worries,” he said.

But since starting on evolocumab, Colangeli’s angina has improved, and he doesn’t need his nitroglycerin patches as often. Most importantly, he feels better, he says, and his doctors recently informed him that his cholesterol is now better than normal.

“I am so happy, so glad all the time. The stress is off,” he says.

But what does cause him stress is wondering whether he will be able to afford the drug.

While statins are available as cheap generics, evolocumab and other PCSK9 inhibitors cost about $7,500 a year. That’s because they are biologics, genetically-engineered molecules that are both expensive and time-consuming to produce.

Katherine Boothe, who studies pharmacare and drug pricing at McMaster University in Hamilton, Ont. says if these drugs are recommended for large groups of patients, a lot of provinces are going to struggle to afford them.

“My first thought is that even if the drug is really effective, the price has to come down in order to offer benefit …to the health care system,” she told CTV News.

“Public drug plans will really struggle to come to grips with the new ways to negotiate these prices and to afford these kinds of advances.”

Meanwhile, another study is underway to test a similar drug called Praluent, and see whether it too lowers heart risks. That study is due to wrap up later this year.

With a report from CTV medical specialist Avis Favaro and producer Elizabeth St. Philip