The weight loss drug Wegovy secured a supplemental cardiovascular indication from the Food and Drug Administration last month. This allows for limited access to the drug for certain Medicare beneficiaries who fulfill weight and major cardiovascular risk criteria.
Currently, Medicare is prohibited by law from covering medications for obesity. Congress is unlikely to lift the prohibition any time soon. And merely 20% of state Medicaid agencies permit coverage of weight loss drugs.
However, because a cardiovascular indication to prevent heart attacks or strokes was added last month to an already approved obesity drug, Wegovy (semaglutide), this paves the way for coverage by health plans operating in the Medicare Part D (outpatient) program. These plans may now cover Wegovy for patients who are overweight or obese and have preexisting (severe) cardiovascular disease.
Furthermore, going forward Medicaid plans will be obligated to place Wegovy on their lists of drugs which they reimburse. But state Medicaid agencies and managed care plans can still require patients to undergo step edits before they can obtain Wegovy for the cardiovascular indication. This means they may have to try cheaper alternatives before being able to access the product.
Medicare plans don’t have to include Wegovy on formulary as it does not fall under one of the six protected drug classes in which all medicines must be reimbursed. Therefore it’s likely plans will make similarly cautious decisions about coverage to the ones being made in the commercial sector where less than 50% of insurers cover Wegovy.
Also, the numbers of beneficiaries eligible for coverage will be limited, even when plans decide to reimburse, as the narrowly defined sub-population with the cardiovascular indication isn’t representative of the typical Medicare beneficiary who is overweight or obese. The FDA based its decision to add the indication to Wegovy’s label on SELECT trial data. Clinical trial participants were overweight or obese and at severe risk for subsequent major cardiovascular events. For example, more than two-thirds had a previous heart attack, one-fourth a prior stroke and 82% have coronary heart disease. Accordingly, when plans cover the product, it’s very likely they will institute prior authorization protocols as well as other utilization management tools.
Restrictions are also probable because the absolute risk reduction of 1.5% of significant cardiovascular events among SELECT trial participants was relatively small. Namely, during the SELECT trial major adverse cardiac events occurred in 6.5% of patients on Wegovy and 8% of those on placebo. This translates into a number needed to treat of 67 to avoid one severe cardiovascular event, which may not be considered a particularly good value proposition from an insurer’s perspective. So even for the sub-population at severe risk, taking Wegovy will not necessarily lead to cost savings. What’s more, the data didn’t show Wegovy decreased the risk of cardiovascular death by a statistically significant margin.
Moreover, what may concern payers is that many patients don’t stay on their obesity medications, which then leads to weight rebound once they come off. A recently published peer-reviewed study shows that only 40% of obese patients taking semaglutide-based products were persistent at one year. And another released real-world analysis demonstrated considerably lower persistence of 28% at the end of one year.
Adding a cardiovascular indication will allow access by at risk Medicare beneficiaries to the weight loss drug Wegovy. But it’s expected that Medicare plans that decide to pay for Wegovy will implement a set of stringent coverage restrictions.