The weight-loss drug Wegoby secured additional cardiovascular disease indications from the Food and Drug Administration last month. This would limit access to medications for certain Medicare beneficiaries who meet weight and major cardiovascular risk criteria.

Currently, Medicare is prohibited by law from covering obesity medications. Congress is unlikely to lift the ban anytime soon. And only 20% of state Medicaid agencies allow weight loss drugs.

However, last month, the already approved obesity drug Wegovy (semaglutide) was added with a cardiovascular indication to prevent heart attacks and strokes, which means that medical care administered under the Medicare Part D (outpatient) program The path to insurance coverage has been opened. These plans may cover his Wegovy for patients who are overweight or obese and have pre-existing (severe) cardiovascular disease.

Additionally, future Medicaid plans will be required to include Wegoby on the list of reimbursable drugs. However, state Medicaid agencies and managed care plans may require patients to undergo rolling edits before obtaining Wegovy for cardiovascular disease. This means you may have to try cheaper alternatives before accessing the product.

Medicare plans do not need to include Wegovy in their prescriptions because it does not fall into one of the six protected drug classes for which all drugs must be reimbursed. Careful decisions on insurance coverage are therefore likely to be made, similar to those made in the commercial sector, where less than 50% of insurance companies cover his Wegovy.

Additionally, because the narrow subpopulation with cardiovascular disease indications is not representative of typical Medicare beneficiaries who are overweight or obese, even if plans decide to reimburse, the number of beneficiaries eligible for coverage is is limited. The FDA made the decision to add an indication to Wegovy’s label based on the SELECT trial data. Participants in the clinical trial were overweight or obese and at significant risk for subsequent major cardiovascular events. For example, more than two-thirds have had a previous heart attack, one-quarter have had a previous stroke, and 82% have coronary heart disease. Therefore, if a plan covers that product, it is very likely that pre-authorization protocols and other usage management tools will be instituted.

A potential limitation may be the relatively small absolute risk reduction of 1.5% for major cardiovascular events in SELECT trial participants. During the SELECT trial, major cardiac adverse events occurred in 6.5% of patients receiving Wegovy and 8% of patients receiving placebo. This means that 67 treatments would be required to avert her one serious cardiovascular event, which may not be a particularly good value proposition from an insurance company’s perspective. I don’t know. Therefore, even for subpopulations at serious risk, using Wegovy does not necessarily result in cost savings. Furthermore, the data did not show that Wegovy reduced the risk of cardiovascular death by a statistically significant margin.

Additionally, payers are concerned that many patients do not continue taking their obesity drugs and gain weight back when they stop taking the drugs. A recently published peer-reviewed study showed that only 40% of obese patients taking semaglutide-based products continued to take them for 1 year. And another published real-world analysis demonstrated a much lower persistence rate of 28% after one year.

Adding a cardiovascular disease indication would make the weight-loss drug Wegovy available to at-risk Medicare beneficiaries. However, Medicare plans that determine payments to Wegovy are expected to introduce a series of strict coverage limits.