By Linda Carroll

(Reuters Health) – Patients at high risk for heart disease who cannot afford newer cholesterol-lowering medications are more likely to have heart attacks, strokes and other cardiovascular events within just one year compared to counterparts who were able to get the drugs, a new study suggests.

Clinical trials have shown that the new drugs, called PCSK9 inhibitors, can lower LDL-cholesterol significantly and also improve cardiovascular outcomes in people who don’t get enough benefit from statin drugs, which are the first-line treatment for high cholesterol.

The problem with the newer drugs is the cost. During the period covered by the new study, the cost of the PCSK9 inhibitors in the U.S. was in the range of $14,000 per year, according to the American Heart Association, which last fall encouraged drug companies to lower their prices to improve patient access. Even when patients have insurance, the out-of-pocket costs for these drugs can be prohibitive, earlier studies have shown.

“One of the most surprising things we saw in this study was a difference in risk in as little as 11.5 months of therapy,” said study coauthor Kelly Myers. “That means there is a beneficial effect in less than a year.”

Myers is chief technology officer at the FH Foundation, a non-profit research and advocacy organization focused on familial hypercholesterolemia, a genetic disease that causes high cholesterol levels.

To take a closer look at the impact of patients’ ability to get the new drugs, the researchers combed through healthcare claims data on 139,036 adults with hypercholesterolemia who were prescribed a PCSK9 inhibitor between August 2015 and December 2017.

When they analyzed the data, the researchers found that 88,770 patients (63.8%) had a history of atherosclerosis and 2,899 (2.1%) had a documented diagnosis of familial hypercholesterolemia. Insurers had rejected nearly two-thirds (61%) of the prescriptions, while 15% of patients had opted not to fill their prescriptions, presumably because of the out-of-pocket costs, the researchers said.

A comparison of the patients whose prescriptions had been rejected by insurers to those who had taken PCSK9 inhibitors for 338 days or more showed a 16% increase in risk of a cardiovascular event, such as a heart attack, a stroke, or cardiac bypass surgery over the course of 11.5 months, without the medication.

Similarly, a comparison of patients who never filled their prescriptions to those who had taken PCSK9 inhibitors for 338 days or more yielded a 21% increase in the risk of cardiovascular events over the same 11.5 month period, the authors reported in Circulation: Cardiovascular Quality and Outcomes.

“This real-world evidence highlights that over eighty thousand individuals being treated for cardiovascular disease or familial hypercholesterolemia had a significantly increased risk of heart attacks and strokes when their PCSK9 therapy prescription was rejected or unfilled,” Myers said. “Coverage decisions that do not take into consideration an individual’s high risk, especially for those with genetic conditions like FH, are a failure of our health system to prevent heart attacks, stroke and death.”

The new findings should spur further research, said Dr. Mary Ann McLaughlin, director of Cardiovascular Health and Wellness at Mount Sinai Heart and an associate professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City.

“We should take it as a baseline since there are things you can’t always quantify by just looking at a chart review and billing data,” McLaughlin said. “There could be legitimate reasons for some of the rejection of some of the prescriptions.”

An interesting finding is the 21% higher risk among those who received a prescription but did not fill it, McLaughlin said. “These patients may not be making other types of lifestyle changes, such as adhering to a healthy diet or maybe they are smoking. You can’t tell from this.”

It doesn’t matter how good a drug is, if a patient can’t afford it, said Dr. Albert Wu, an internist and professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health.

“The potential for this drug is being frustrated by our payment system which makes it difficult for patients to afford these and other new drugs,” Wu said.

SOURCE: http://bit.ly/2JP2ek9 Circulation: Cardiovascular Quality and Outcomes, online July 23, 2019.