Millions of Medicare Recipients Could Gain Access to Weight-Loss Drug

Tens of millions of obese or overweight sufferers with coronary heart situations insured beneath Medicare might achieve entry to a preferred weight-loss drug, a examine has discovered.

Novo Nordisk’s Wegovy, chemically referred to as semaglutide, was accepted by the U.S. Meals and Drug Administration final month for reducing the danger of stroke and coronary heart assault in obese or overweight adults who would not have diabetes.

The FDA’s approval of the brand new use for Wegovy probably opens up entry to the drug for 1 / 4 of individuals on Medicare who’re obese or overweight, based on a examine printed by the Kaiser Household Basis (KFF) on Wednesday. Medicare is prohibited by legislation from overlaying Wegovy and different medicine for weight reduction alone.

The examine discovered that an estimated 7 % of Medicare beneficiaries, or 3.6 million total, had established heart problems and have been overweight or obese in 2020, and so they could possibly be eligible for protection of Wegovy for its new indication. Amongst these sufferers, 1.9 million additionally had diabetes, the KFF examine stated, and will have been already been eligible for Medicare protection of Wegovy and Novo’s extensively used diabetes drug, Ozempic.

Each belong to a category of medicines known as GLP-1 agonists, which have been initially developed to deal with sort 2 diabetes, however are additionally extremely efficient weight-loss medicine.

As a result of Wegovy is a self-administered injectable drug, Medicare protection could be offered beneath drug plans administered by personal insurers, referred to as Half D.

The KFF examine stated that whereas some Half D plans have introduced they may start overlaying Wegovy in 2024, broader protection in 2025 could possibly be extra probably.

Many Half D plans could be reluctant to broaden protection now because of the excessive worth of the drug and the big quantity of sufferers eligible for it “since they can not modify their premiums mid-year to account for increased prices related to use of this drug,” the examine stated.

How the expanded protection of Wegovy will influence Medicare spending may even rely upon what number of Half D plans add protection for it and the extent to which the plans apply restrictions like prior authorization, how many individuals who qualify to take the drug use it and the negotiated costs paid by plans, the examine stated.

The U.S. Facilities for Medicare and Medicaid Companies (CMS) issued a memo final month indicating that Half D plans can cowl Wegovy now that it has a sign that’s not excluded from Medicare protection.

“CMS has issued steerage to Medicare Half D plans stating that anti-obesity medicines (AOMs) that obtain FDA approval for a further medically accepted indication could be thought of a Half D drug for that particular use,” a spokesperson for the federal company advised Newsweek final month. “Half D protection continues to be not obtainable for AOMs when used for continual weight administration in sufferers who would not have the extra medically accepted indication, until offered as a supplemental profit by the Half D plan.”

The company has been contacted for additional remark by way of e-mail.

The examine additionally famous that not all Medicare sufferers eligible to take Wegovy are prone to take it, as some could possibly be delay by the out-of-pocket prices—which could possibly be between $325 and $430 month-to-month, earlier than reaching the $2,000 annual cap—and the potential negative effects of the drug.

The FDA stated the prescribing data for Wegovy comprises a warning to well being concerning the threat of thyroid C-cell tumors and that the drug shouldn’t be utilized in sufferers with a private or household historical past of medullary thyroid carcinoma or in sufferers with a uncommon situation known as a number of endocrine neoplasia syndrome sort 2.

The drug additionally comprises warnings for irritation of the pancreas (pancreatitis), gallbladder issues (together with gallstones), low blood sugar, acute kidney damage, hypersensitivity reactions, diabetic retinopathy (harm to the retina), elevated coronary heart price and suicidal conduct or pondering.

A spokesperson for Novo Nordisk beforehand advised Newsweek that the corporate “is repeatedly performing surveillance of the info from ongoing medical trials and real-world use of its merchandise and collaborates intently with the authorities to make sure affected person security and satisfactory data to healthcare professionals.”