New Cholesterol Drug's High Price May Not Be Worth It: Study

WEDNESDAY, Jan. 2, 2019 (HealthDay News) — Despite being slashed by half in recent months, the price tag for advanced cholesterol-fighting drugs is still too high to make them cost-effective, a new analysis has concluded.

In March, the manufacturer of alirocumab (Praluent) announced that it would cut the cost of the medication from $14,000 a year to $7,000.

But the price would have to fall even more, to around $900 to $2,000 a year, to make it as cost-effective as cholesterol-lowering drugs that have been around far longer, researchers reported.

“We do think these drugs are useful to patients, and cost is a major barrier to access at this point,” said lead researcher Dr. Dhruv Kazi. He is associate director of the Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center in Boston.

“Perhaps the right thing here is to acknowledge the efforts the manufacturers have made to respond to these pricing pressures,” Kazi said. “But I don’t think we’re there yet.”

The pricing dilemma stems from the fact that there already are very cheap and very effective cholesterol-lowering drugs on the market, Kazi said. Statins and ezetimibe both are available in generic form, and have years of safety and effectiveness data behind them.

“Your additional drugs have to work harder to be cost-effective,” Kazi said.

Praluent belongs to a new class of drugs called PCSK9 inhibitors. They work by boosting the liver’s ability to remove cholesterol from the bloodstream. The U.S. Food and Drug Administration approved Praluent in July 2015; a second drug in this class, evolocumab (Repatha), received approval in December 2017.

Regeneron Pharmaceuticals, maker of Praluent, said in a statement that it disagrees with the new cost analysis.

The company argues that researchers did not take into account clinical trial results showing the drug’s ability to ward off deaths and reduce cholesterol levels in hard-to-treat heart patients.

The American Heart Association acknowledged the usefulness of PCSK9 inhibitors in new cholesterol guidelines it released in November. The new guidelines recommend that the drugs be used alongside statins for certain high-risk heart patients who are having trouble lowering their levels.

But doctors and patients are still struggling to access these new drugs, and cost is the barrier, said Dr. Suzanne Steinbaum, director of Women’s Cardiovascular Prevention, Health and Wellness at Mount Sinai Hospital in New York City.

“I can’t get these medications covered by insurance. There are these amazing tools out there to help us, but unless we figure out insurance coverage and cost, it’s irrelevant,” Steinbaum said.

Kazi’s team did a cost-effectiveness analysis on Praluent based on results from the latest clinical trial of the drug, known as the ODYSSEY Outcomes trial.

The researchers said that its price would have to be reduced by 86 percent to be considered cost-effective for treating “bad” LDL cholesterol.

That amounts to an annual price tag of $874 to $2,311, depending on the drug regimen against which Praluent is being compared, the study authors concluded.

Such a cost cut would be “unprecedented” for biologic therapies in the U.S. market, they noted.

Results of this analysis were announced in March with release of the ODYSSEY trial results, prompting the subsequent price cut by Regeneron.

“We’re excited that having done this analysis in a timely manner might have contributed to this price reduction,” Kazi said.

Regeneron said its own analysis concluded that Praluent is cost-effective at a yearly price range of $6,319 to $9,346 for people with serious heart problems, and at $13,357 to $19,805 a year for heart patients whose cholesterol resists treatment by other medications.

“These results are well within the current price range paid for Praluent in the U.S., and aligned to our March announcement to lower the Praluent U.S. net price to between $4,500 and $8,000 to payers who would allow for more straightforward, affordable patient access,” the company’s statement said.

Ultimately, the market will decide whether the price is low enough, Kazi said.

“It’s important to measure how patients and doctors respond to these pricing changes,” Kazi added. “Are patients actually able to get the drug? Are they able to take the drug in the long run? Because it’s not helpful if people start the drug and then stop it because it’s expensive or out-of-pocket costs are too high.”

The analysis was published online Jan. 1 in the Annals of Internal Medicine.

More information

The American Heart Association has more about cholesterol.

Fast Facts for Men (and Women) About High Cholesterol

MONDAY, Dec. 17, 2018 (HealthDay News) — High cholesterol, a serious risk factor for heart disease, can affect both men and women, and it’s common for cholesterol levels to rise with age. But it’s often a problem for men earlier in life than for women.

A study published in the Journal of the American College of Cardiology found that men with less-than-optimal aerobic fitness are at greater risk of developing high cholesterol in their early 30s, while men with higher aerobic fitness are likely to avoid this until their mid-40s.

This underscores the importance of a regular fitness program with cardio exercise. Just 150 minutes a week can lower your high cholesterol risk.

Fast Stats on Cholesterol:

  • Nearly one-third of U.S. adults have high levels of low-density lipoprotein (LDL, or bad) cholesterol and 31 million have high total cholesterol.
  • Less than half of adults with high LDL cholesterol are getting treatment and fewer than 30 percent have it under control.
  • High total cholesterol doubles heart disease risk.

Research also points to genetics as a factor in who might develop high cholesterol. More than 80 percent of the cholesterol circulating in your body is made by your liver, and doesn’t come from food.

That being said, you do want to avoid trans fats because trans fat does tend to raise cholesterol and increase heart disease risk.

Starting at age 20, you should know your cholesterol numbers. A simple blood test done after a 12-hour fast measures total cholesterol, LDL, and HDL — or the good cholesterol — that has protective benefits.

If you have high total or LDL cholesterol or high triglycerides, another blood fat, talk to your doctor about lifestyle changes and possibly medication to get your numbers in a safe zone.

More information

You can download a comprehensive pamphlet about high cholesterol from the U.S. National Heart, Lung, and Blood Institute.

Could Too Much 'Good' HDL Cholesterol Be Bad for Your Heart?

MONDAY, Aug. 27, 2018 (HealthDay News) — When it comes to protecting one’s heart, high-density lipoprotein cholesterol — or HDL — has long had a reputation of being the “good” cholesterol, compared to the “bad” cholesterol — LDL (low-density lipoprotein).

But new research suggests that there could be too much of a “good” thing. Very high blood levels of HDL cholesterol may actually be bad for you. The research linked it to a higher risk for heart attack, and even death, among patients who already had heart problems or who faced a higher risk of developing heart disease.

The findings are based on a roughly four-year tracking of cholesterol levels and heart disease among nearly 6,000 men and women.

“Historically, HDL cholesterol, or ‘good’ cholesterol, is thought to be protective at high levels for cardiovascular disease and death,” said study lead author Dr. Marc Allard-Ratick, who’s with Emory University School of Medicine in Atlanta. “However, our study demonstrates that this may not be the case and, in fact, higher levels may be harmful.”

The study was done as part of the Emory Cardiovascular Biobank. On average, the participants were 63 years old and about one-third were women. Their HDL levels ranged from a low of less than 30 mg/dL to a high of greater than 60 mg/dL of blood.

Over the course of the study, 13 percent of the patients had a heart attack or died from a cardiovascular cause.

At the study’s end, the researchers concluded that patients with HDL levels in the middle-range of the spectrum — meaning between 41 to 60 mg/dL of blood — fared the best, having the lowest risk for heart attack or death from heart disease.

In contrast, those with HDL readings below 41 or above 60 faced a markedly increased risk for both health outcomes, demonstrating what the researchers called a “U-shaped” risk pattern.

Specifically, patients with HDL levels exceeding 60 were found to have a 50 percent greater risk of heart disease death or heart attack, compared with those in the middle-range, the investigators reported.

The findings held up even after accounting for a patient’s history of diabetes, smoking, drinking and LDL levels. Race and gender also didn’t appear to affect the findings.

Dr. Gregg Fonarow is director of the Ahmanson-UCLA Cardiomyopathy Center and co-director of the UCLA Preventative Cardiology Program in Los Angeles. He said that “research from UCLA established more than two decades ago that HDL cholesterol could — in certain individuals (including those with very high levels of HDL) and in certain circumstances — be dysfunctional and pro-inflammatory,” and contribute to narrowing of the arteries.

“In others words, the so-called ‘good’ cholesterol in terms of cardiovascular risk could go ‘bad’ and be associated with excess risk,” added Fonarow, who was not part of the team behind the new study.

Allard-Ratick acknowledged that other studies have revealed a similar HDL problem among people who do not otherwise face a high risk for heart disease. But he said the new study is the first to uncover the same concern among people who are already at high-risk for cardiovascular complications, even if “the mechanism behind this finding remains unclear.”

And, he said, one “surprising aspect of the study was that this association between high levels of HDL and increased risk of death or cardiovascular disease was seen more commonly in women compared to men.”

As to what might constitute a dangerous HDL threshold, Allard-Ratick said that the risk association “likely occurs at (HDL) levels exceeding 80 mg/dL, and perhaps even higher in women.”

Fonarow said a number of prior studies have found that when compared to those with more moderately high HDL levels, people with “very high” HDL levels — meaning a threshold of 90 mg/dL or more — appear to face a greater risk for heart disease.

So what should concerned patients do?

Allard-Ratick said that “as the cause of this finding remains unclear, the appropriate management is not known at this time. Patients with very high HDL cholesterol should continue to address other modifiable risk factors — such as high blood pressure, smoking and obesity — to reduce cardiovascular disease.”

The findings were presented Saturday at the European Society of Cardiology meeting, in Munich, Germany. Research presented at meetings should be considered preliminary until it has been published in a peer-reviewed medical journal.

More information

Learn more about cholesterol from the American Heart Association.

When 'Good' Cholesterol Is Bad for Older Women

FRIDAY, July 20, 2018 (HealthDay News) — HDL cholesterol may be known as the “good” kind, but a new study suggests high levels of it are not always a good thing for women after menopause.

The study, of nearly 1,400 postmenopausal women, found that those with higher HDL levels were more likely to show “plaques” in their carotid arteries. Those arteries supply blood to the brain, and plaque buildup there signals an increased risk of both stroke and heart disease.

The study did not look at women’s rates of heart attack or stroke. But experts said the findings add to evidence that when it comes to HDL, there can be too much of a good thing.

“We used to think, the higher the better,” said Dr. Karol Watson, director of the Women’s Heart Health Program at the University of California, Los Angeles. “But we’ve been re-thinking HDL in recent years.”

Watson, who was not connected to the study, is also a member of the American College of Cardiology’s Prevention of Cardiovascular Diseases Section Leadership Council.

She said “everyone agrees” that low HDL — below 40 mg/dL — is bad.

But studies have also found that very high HDL is linked to trouble, too. For example, a 2016 study of over 630,000 people found that women and men with very high HDL — above 90 mg/dL — were more likely to die (of non-cardiovascular causes) during the study period than those whose HDL was in the middle of the pack.

HDL is known as the “good” cholesterol because it does positive things, including clearing fat from the arteries and ushering it to the liver to be removed.

But, Watson said, research suggests that HDL function can go awry when its environment is not ideal — such as when a person is obese or has diabetes or other health conditions causing chronic inflammation in the blood vessels.

“HDL seems to be like a chameleon, changing based on its surroundings,” Watson explained.

That general idea may explain what was seen in this study, according to lead researcher Samar El Khoudary, an associate professor at the University of Pittsburgh’s School of Public Health.

During the menopause transition, she said, women see a sharp drop in estrogen, a heart-protecting hormone. They also go through changes in body fat distribution, blood fats and other metabolic processes; that might lead to chronic inflammation that could alter the quality of HDL particles.

So a higher HDL level is “not necessarily cardio-protective,” El Khoudary said. But, she added, it’s not necessarily bad, either.

It’s important to look at the whole picture, she said. If, for example, a woman is normal weight, exercises, and does not have heart risk factors like high LDL cholesterol (the “bad” kind) or diabetes, a high HDL is “probably not something to worry about,” El Khoudary said.

Watson agreed. On the other hand, she said, a high HDL level should not make women or their doctors complacent.

“Never ignore a high LDL level just because the HDL is high,” Watson said.

The bottom line, according to El Khoudary, is that women should pay even more attention to maintaining a healthy lifestyle as they go through menopause.

On the research end, she said, doctors need more precise measures of HDL function — not just HDL cholesterol level.

El Khoudary’s team also measured the study participants’ levels of HDL “particles” — which carry HDL cholesterol through the blood.

Overall, women with a greater number of “small” HDL particles had a lower risk of plaque buildup. Meanwhile, “large” particles showed a more complicated relationship: When women were just past menopause, those particles were tied to a heightened risk of artery narrowing. But among relatively older women, high numbers of large particles were linked to healthier-looking arteries.

If that all sounds complicated, that’s because it is.

For now, Watson said, no one knows whether measuring HDL particles is useful. “Until we understand more, we can’t do anything with that information,” she said.

How high is “too high” when it comes to HDL? There is no known cutoff, Watson said. In general, she added, there seems to be an HDL “sweet spot” of around 60 to less than 80 mg/dL.

But again, Watson said, you have to look at the whole person: If someone has risk factors for heart disease, a higher HDL number may be misleading.

El Khoudary recently received funding from the U.S. National Institute on Aging to expand on this research.

The findings were published online July 19 in the journal Arteriosclerosis, Thrombosis, and Vascular Biology.

More information

The American Heart Association has a primer on blood cholesterol.

High Cholesterol Tied to Better Brain Health in Those Over 85

MONDAY, March 5, 2018 (HealthDay News) — In a seemingly counterintuitive finding, new research suggests that high cholesterol is associated with a reduced risk of mental decline in the elderly.

People aged 85 to 94 with good brain function whose cholesterol was above normal had a 32 percent lower risk for mental decline over the next 10 years compared with people aged 75 to 84, who had a 50 percent higher risk of developing dementia, researchers found.

“It’s not so much that cholesterol suddenly becomes good for you if you can make it to 85,” said lead researcher Jeremy Silverman. He’s a professor of psychiatry at the Icahn School of Medicine at Mount Sinai in New York City.

“It’s such that people who are making it who remain alive and who have high cholesterol are more likely to carry other factors that protect them against the bad effects of cholesterol,” he explained.

Silverman cautioned that these findings don’t mean that if you’re 85 you should increase your cholesterol in hope of warding off dementia or Alzheimer’s disease. Plus, the study did not find a cause-and-effect relationship.

“Overall, high cholesterol was associated with a bad cognitive [mental] decline, but when we look only at people who were in good cognitive health at 85, a rising cholesterol was associated with a better outcome,” Silverman said.

For young and middle-aged people, it’s important to keep your cholesterol low, he noted. “There are many studies that show it is a risk factor for cognitive decline in people through their mid-70s,” he said.

The researchers also found that using statins was associated with protection against mental decline overall. But as people got older and older, the protective effects of statins were reduced, Silverman said.

“We don’t think that having a high cholesterol becomes a good thing — it’s just that you’re likely to be the kind of person for whom cholesterol doesn’t matter,” he explained.

Silverman doesn’t think that cholesterol itself is protective against mental decline, but that other factors protect against the bad effects of cholesterol.

This study adds a trait that can be looked at in the quest to find factors that promote successful mental aging, Silverman suggested. “We can focus specifically on those old people with high cholesterol and look for factors that protect them from cognitive decline,” he said.

One specialist thinks the study shows the link between heart health and brain health.

According to Keith Fargo, director of scientific programs and outreach at the Alzheimer’s Association, “Heart health factors are powerful influencers of a person’s cognition as they age.”

Fargo stressed that keeping cholesterol low as one ages is important in protecting against mental decline.

“But once people start getting to a certain age, things get a little trickier,” he said. “There is very likely a group of people who have some unknown protective factor that allows them to live to a ripe old age without cognitive decline,” Fargo said.

“These people are different in some way from your average individual,” he pointed out.

For the study, Silverman and James Schmeidler, an assistant professor of clinical psychiatry, also at Mount Sinai in New York City, collected data on nearly 1,900 people who took part in the Framingham Heart Study, an ongoing study on residents of Framingham, Mass.

The report was published online March 5 in the journal Alzheimer’s & Dementia.

More information

The U.S. National Institute on Aging has more on the aging brain.