An April 24 letter from Vermont Sen. Bernie Sanders to the CEO of Novo Nordisk began with heartfelt thanks to the Danish drugmaker for inventing Ozempic and Wegovy, two drugs poised to improve the health of tens of millions of obese Americans. and similar diseases.
But the senator’s grateful tone quickly faded.
As important as these drugs are, they won’t do any good for the millions of patients who can’t afford them, Sanders wrote. “Furthermore, if prices for these products are not significantly reduced, they also have the potential to bankrupt Medicare, Medicaid and our entire health care system.”
It’s a sentiment that comes up regularly among people who are big fans of the drug and its close relatives, Mounjaro and Eli Lilly’s Zepbound. They all work by masquerading as a natural hormone called GLP-1 and tricking the body into slowing digestion and reducing blood sugar.
The medications help patients lose double-digit percentages of their body weight and keep it off—an average of 12.4% in the clinical trial for Wegovy and an average of 18% at the highest dose in the trial for Zepound. It is rare for insurance companies to cover GLP-1 drugs only for weight loss, and Medicare is prohibited by law from doing so. But as the pounds drop, so do the risks of serious problems like type 2 diabetes, hypertension, heart attacks and strokes, and medications can be covered to prevent these conditions.
“Obesity is a major public health crisis and for so long we haven’t had treatments that have really made a difference,” said Dr. Lauren Eberly, a cardiologist and health services researcher at the University of Pennsylvania. “These drugs can change the course of your disease and save your life.”
This makes these drugs extremely valuable. Unfortunately, they are also extremely expensive.
The sticker price for Ozempic, which the Food and Drug Administration approved to treat type 2 diabetes, is more than $12,600 a year. Wegovy, a higher-dose version approved for weight loss in people with obesity and as a way for overweight patients with cardiovascular disease to reduce their risk of heart attack and stroke, sells for nearly $17,600 a year.
Read more: “Miracle” weight loss drugs may have reduced health inequalities. Instead they got worse
Mounjaro and Zepbound mimic GLP-1 as well as a related hormone called glucose-dependent insulinotropic peptide, or GIP. Their list prices come to roughly $13,900 a year for Mounjaro, which is approved as a diabetes treatment, and about $13,800 a year for Zepbound, the weight-loss version.
Eberly said those prices are simply too high.
“We as a public health medical community — and the community at large — really need to advocate for increased affordability,” she said. “I think we’re overdue for a real reckoning on this.”
In the United States, the tab for these GLP-1 drugs is exorbitant almost any way you look at it.
In 2022, the prescription drug that accounted for the largest share of Medicare Part D spending was the blood thinner Eliquis. More than 3.5 million beneficiaries used it that year, at a cost of $15.2 billion, the U.S. Department of Health and Human Services says.
That total was more than double the amount spent on the next most expensive drug, the type 2 diabetes drug Trulicity, according to the Centers for Medicare and Medicaid Services, or CMS.
But $15.2 billion is practically a rounding error compared to the $268 billion price tag if Wegovy were given to all 19.7 million obese Medicare beneficiaries, researchers estimated in the New England Journal of Medicine.
Even if the drug were only prescribed to Medicare patients with a clinical diagnosis of obesity, the cost would exceed $135 billion. That’s more than the $130 billion Medicare will spend on all retail prescription drugs in 2022, according to CMS.
“This is a real budget situation for CMS,” said Melissa Barber, a public health economist who studies pharmaceutical policy at Yale School of Medicine. “They’re going to have to deal with that.”
No matter how expensive a drug is, it is “extremely unlikely” that Medicare would go bankrupt, a CMS spokesman said. Costs for the Medicare Part B and Part D programs reset each year, and if they go up, beneficiaries and the government share the burden of covering the difference, the spokesman said.
Sanders offered another perspective. A report released this month by the Senate Health, Education, Labor and Pensions Committee, which he chairs, noted that Americans are charged $1,349 for a 28-day supply of Wegovy, while the same amount of the drug goes for $186 in Denmark. $137 in Germany and $92 in the UK.
“Prices for these drugs are so high in the United States that everyone — whether they use the products or not — will likely be forced to bear the brunt of Novo Nordisk’s profit-maximizing strategy through higher premiums and taxes of insurance,” Sanders wrote. in his letter to the company.
The financial impact on Medicare is mitigated by a 2003 federal law that prevents the government’s health insurance program from covering weight-loss drugs. Drugs can be added to formularies if they are prescribed for another “medically accepted indication,” such as to treat type 2 diabetes or reduce heart risk, but patients can’t take them if their only medical problem is obesity.
Rep. Brad Wenstrup (R-Ohio) has introduced a bill that would repeal that 2003 ban. Although Law on Treatment and Reduction of Obesity has 97 co-sponsors from both sides of the line, its financial implications have made it difficult to muster the votes needed to advance the legislation, he said.
Indeed, Phillip Swagel, director of the Congressional Budget Office, said last month that if the goal was to provide weight-loss drugs without increasing the deficit, their net cost would have to fall by a factor of 10 just to “entered the park. .”
Read more: How to pay for Ozempic and other promising medications
Dr. Caroline Apovian, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital in Boston, is concerned that the budget potential of Wegovy and Zepbound has made private health insurers afraid to cover them.
“No insurance company will be able to afford to give these life-saving drugs to the 42% of Americans with obesity,” she said. “So we have to do something.”
It is not clear what exactly it should be.
One possibility is for the federal government to ask Novo Nordisk and Eli Lilly to discount their GLP-1 drugs. The Inflation Reduction Act empowers Medicare to negotiate lower prices for 10 drugs each year, and researchers at the Congressional Budget Office expect at least some GLP-1s to be on the list “within the next several years.”
Private insurers are free to seek their own deals, and the similarities between Novo Nordisk and Eli Lilly’s drugs give insurers a lot of negotiating power, said John Cawley, a health economist at Cornell.
“They need to be more effective against each other,” Cawley said. “They might say, ‘We’re only going to cover one of these. Which do you want to be, the one we cover or the one we don’t?’”
There is reason to think that drugmakers could afford to offer significant discounts if they were so inclined.
Novo Nordisk charges Americans $968.52 for a 28-day supply of Ozempic, regardless of whether the dose of the active ingredient semaglutide is 0.5, 1 or 2 milligrams per injection pen. Likewise, Wegovy costs $1,349.02 every 28 days, regardless of whether the weekly injections contain 0.25, 0.5, 1, 1.7, or 2.4 mg of semaglutide.
However, a 2022 report in the journal Obesity estimated that a weekly dose of 2.4 mg of semaglutide could be made for “about $40” per month.
Barber is part of a team that also looked at how much it would cost to manufacture various diabetes drugs using methods designed to keep prices low. Her group calculated that a 30-day supply of an injectable drug with 0.77 milligrams of semaglutide could be produced for as little as 89 cents, a total that includes a 10% profit. Even with higher costs and a 50% profit, the drug could be made for $4.73 a month, the team reported in March in JAMA Network Open.
“They can be very affordable,” Barber said.
A spokeswoman for Novo Nordisk said the company was not aware of the assay used in the study, but it recognizes the need to find ways to make its products more affordable. She also said the company is reviewing the report from Sanders’ Senate committee and noted that “75% of our gross sales in the U.S. go to rebates and rebates reimbursed to insurance companies and other payers.”
Representatives from Eli Lilly would not comment on the cost of its drugs.
If manufacturers don’t agree to lower prices voluntarily, the federal government can take stronger action. The Inflation Reduction Act puts a cap of $35 a month on what seniors with Medicare Part D plans must pay for insulin. Congress could also set a cap on the prices of GLP-1 drugs, though that would be “a last resort,” said Lawrence Gostin, an authority on public health law at Georgetown University.
Read more: New beauty regime: Lose weight with Ozempic, tighten with cosmetic surgery
Drug rationing is another way to keep costs under control, health economists say. High sticker prices limit access to drugs, often making income a determining factor in deciding who can and should get them. But there are other ways to prioritize patients.
A person at a “healthy weight” — defined as a body mass index between 18.5 and 24.9 — incurs an average of about $2,780 a year in health care costs. That figure rises to $2,781 for a person with a BMI of 30 or higher, according to the 2024 edition of the “Handbook of Obesity.”
Most of these added costs are concentrated among people at the higher end of the BMI curve. Someone with a BMI between 35 and 39.9 requires an average of $3,336 in additional health care costs per year, while a person with a BMI of 40 or higher needs an additional $6,493 for medical care.
“If your goal is to target interventions to reduce health care costs, you would want to target people with more extreme or morbid obesity,” said Cawley, who co-wrote the handbook’s chapter on the economic cost of obesity.
Even if all else fails, prices will fall over a period of years as new drugs win FDA approval and make the market more competitive, economists said. And once generic versions become available, prices will drop. This is what happened to expensive drugs for hepatitis C and HIV.
“Eventually things become general,” Wenstrup said. “They still do the same thing, but it costs less.”
This story originally appeared in the Los Angeles Times.
#Millions #Americans #drugs #Ozempic #bankrupt #health #system
Image Source : www.yahoo.com