WASHINGTON, DC, United States (KaiserHealth) – For the first time, research shows that a pricey new medication called Repatha not only dramatically lowers LDL cholesterol, the “bad cholesterol,” it also reduces patients’ risk of dying or being hospitalized.
Repatha, a man-made antibody also known as evolocumab, cut the combined risk of heart attack, stroke and cardiovascular-related death in patients with heart disease by 20 percent, a finding that could lead more people to take the drug, according to a study presented Friday at a meeting of the American College of Cardiology.
Some doctors hailed the results as major progress against heart disease. In an editorial in The New England Journal of Medicine, Dr. Robin Dullaart, a researcher at the University of Groningen in the Netherlands, called it a landmark study.
Others said they expected more from the $14,000-a-year drug. It was approved in 2015 without evidence that it prevents heart attacks, simply because its cholesterol reductions were so dramatic and promising.
Doctors often recommend that people keep their LDL levels under 100 milligrams per deciliter, and that people at very high risk reduce their LDL under 70.
In the new study, patients with heart disease who combined Repatha with a statin, the most commonly used cholesterol medication, decreased their LDL from 92 milligrams per deciliter to 30. Doctors have rarely seen cholesterol levels that low. Many doctors wondered if such low levels would be dangerous, causing memory problems or dementia due to a lack of cholesterol, said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, who was not involved in the new research but has led clinical trials of PCSK9 inhibitors in the past.
The new study, which followed 27,000 patients for two years, found no safety risks.
While doctors said they were relieved that Repatha is safe, doctors such as David Rind said they had hoped the study would show that the injectable medication reduces heart attacks and other serious complications by 30 percent or more, given its success in early studies.
“This [result] is probably a little less than we had been hoping for,” said Rind, chief medical officer at the Boston-based Institute for Clinical and Economic Review, which evaluates drugs’ cost effectiveness. Rind also was not involved in the study.
The study’s author, Dr. Marc Sabatine, said the “compelling reductions” in heart attacks, strokes and death suggest doctors should treat cholesterol much more aggressively, aiming to lower LDL levels as much as possible. His study focused on patients with underlying heart disease, most of whom had already had a heart attack.
The standard treatment for cholesterol, other than diet and exercise, is a generic statin, which costs $250 a year. Statins can cut LDL levels by up to half and reduce heart attack risk by 25 percent, Nissen said.
Some doctors are less impressed with the new study, which was funded by Amgen, Repatha’s manufacturer.
Part of the problem, analysts say, is that the underlying idea – reaching into the community to help people navigate the social and economic factors that can influence health – goes beyond what hospitals have traditionally viewed as their mission. Despite the potential for long-term payoff, administrators tend to focus on the immediate questions: How many beds are full? What medical services are being provided? How are they doing with their operating budget?
“It’s a new world out there in terms of the hospital not being the center of the universe,” said Lawrence Massa, president of the Minnesota Hospital Association, the state’s hospital trade group, which has been tracking hospital response to the health assessment requirement.
Initially, they found the money nonprofit hospitals put toward “community needs” went up after the assessment requirement: from about $355 million in 2011 to $459 million in 2013, according to an analysis by the association. (The needs assessment requirement took effect in between, for the tax year starting after March 2012.) But the increase leveled off in 2014 – the most recent year for which data are available.
Massa’s conclusion: Caring for the health of people before they come into the hospital is unfamiliar territory. Not everyone took naturally to it. “We saw some communities that embraced this, and did a nice job. … In other communities, there’s been friction between public health and the acute setting – and lack of understanding.”
With continued time and sustained emphasis, that could have changed, said Sara Rosenbaum, a professor of health law and policy at George Washington University.
But now? Even if the community benefit requirements remain intact, she and others fear this accountability effort could take a hit. Repeal of the health care law is likely to create fresh financial challenges for hospitals. For instance, although the House GOP’s American Health Care Act would restore some of the uncompensated-care funding cuts hospitals absorbed under the ACA, the coverage changes proposed in Republicans’ plan could mean tens of millions more uninsured people.
That scenario, policy experts and trade groups say, would increase the amount of free care nonprofit hospitals provide, creating new budget pressures that could lead them to tamp down on efforts to promote community health work.
“We could be right back in a situation where there is a fair amount of charity care, and that could become a large component of how hospitals are justifying their nonprofit status,” said Ken Fawcett, a physician who runs a community health worker initiative at Spectrum Health in Grand Rapids, Mich.
Meanwhile, the health assessment’s impact has been evident at Boston-based Massachusetts General Hospital. There, administrators used it to devise an intervention strategy around drug abuse – partnering, for instance, with local schools and community organizations, and hiring former addicts to help patients navigate recovery.
“There’s no question the Affordable Care Act required us to bump up our game,” said Joan Quinlan, its vice president for community health. If people lose coverage, she added, hospitals will increasingly argue that’s enough reason for a tax break. It could stifle efforts to promote more substantial community benefit.
“If the ranks of the uninsured or underinsured grow, then charity care will increase. And the ability to do some of these more creative downstream efforts will be hampered,” she said. “There might be heightened awareness. But if there aren’t resources to address them, it’s going to be hard.”
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