The Food and Drug Administration granted additional cardiovascular approval to the weight loss medication Wegovy last month.
This provision grants specific Medicare recipients who meet the weight and significant cardiovascular risk criteria restricted access to the medication.
Medicare Part D Considers Weight Loss Drug Coverage
At this time, Medicare is legally prohibited from providing coverage for obesity medications. The imminent lifting of the prohibition by Congress is improbable. Furthermore, only 20% of state Medicaid agencies approve weight loss medication coverage.
Nevertheless, the inclusion of a cardiovascular indication for Wegovy (semaglutide), an obesity medication that was previously approved, last month, creates an opportunity for health plans participating in the Medicare Part D (outpatient) program to grant coverage.
Patients with preexisting chronic cardiovascular disease who are overweight or obese may now be eligible for coverage under these plans for Wegovy.
In addition, Medicaid plans will be required to include Wegovy on their inventories of reimbursed medications moving forward.
However, managed care plans and state Medicaid agencies may still mandate that patients undergo step revisions prior to receiving Wegovy for the cardiovascular indication. This may necessitate the exploration of more affordable alternatives prior to obtaining access to the product.
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Medicare’s Wegovy Coverage Decision
Wegovy is not required to be included on the formulary of Medicare plans because it does not belong to one of the six protected drug classes for which reimbursement is mandatory for all medications.
As a result, it is probable that plans will approach coverage with the same degree of caution as those observed in the commercial sector, where Wegovy is covered by fewer than 50% of insurers.
Furthermore, even if plans opt to reimburse, the eligibility criteria for beneficiaries will remain restricted, given that the specific subpopulation targeted by the cardiovascular indication does not accurately reflect the characteristics of the average overweight or obese Medicare beneficiary.
The FDA added the indication to the label of Wegovy on the basis of SELECT trial data.
Participants in the clinical trial were severely at risk for subsequent significant cardiovascular events due to their overweight or obesity.
For example, 82% have coronary heart disease, one-fourth have had a prior stroke, and over two-thirds have experienced a myocardial infarction.
Consequently, it is highly probable that plans will implement prior authorization protocols and other utilization management tools when they provide coverage for the product.
Due to the relatively small absolute risk reduction of 1.5% for significant cardiovascular events among SELECT trial participants, restrictions are also likely.
More specifically, significant adverse cardiac events transpired in 6.5% of patients receiving Wegovy and 8% of those receiving placebo during the SELECT trial.
This results in a number needed to treat of 67 in order to prevent a single severe cardiovascular event, which an insurer might not deem to be an especially attractive value proposition.
Therefore, even for the subpopulation at high risk, Wegovy treatment does not guarantee cost savings.
There was no statistically significant reduction in the risk of cardiovascular mortality associated with Wegovy.
However, a matter of concern for payers is the fact that a significant number of patients discontinue their obesity medications, resulting in weight regain once the regimen is resumed.
A recent peer-reviewed study indicates that at one year, only forty percent of obese patients who were taking semaglutide-based products remained persistent.
An additional real-world analysis that was published revealed a significantly reduced persistence rate of 28% after one year.
The inclusion of a cardiovascular indication will grant Medicare beneficiaries at risk access to the weight loss medication Wegovy.
However, Medicare plans that opt to cover Wegovy are anticipated to impose a series of rigorous coverage limitations.
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