Topline Data On Obesity Drug Wegovy’s Impact On Cardiovascular Outcomes Won’t Necessarily Change Payer Coverage Policies

On August 8^th, Novo Nordisk posted topline data on the effects of its weight loss agent, Wegovy (semaglutide), which reduced major cardiovascular events by 20% in a much anticipated randomized controlled clinical trial named SELECT. The cardiovascular events avoided included cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, in trial participants who prior to the study had experienced a major adverse cardiovascular event but did not have diabetes. In the trial, semaglutide dosed at 2.4 mg and administered once-weekly sub-cutaneously, appeared to have a safety profile “in line” with previous clinical studies involving semaglutide.

Some commentators have said that this could change payers’ calculus regarding whether they will pay for obesity medications. However, it’s not as straightforward as it may appear at first glance. Besides waiting for the full presentation of data in a peer-reviewed journal or at a public academic or medical professional conference, payers will have a host of other criteria to evaluate when deciding if to cover and if so with which conditions of reimbursement.

For the SELECT trial, Novo Nordisk collected data from more than 17,600 participants, 72.5% of whom were male. The average age and body mass index were 61.6 and 33.3, respectively.

Approximately 76% of the participants had experienced a heart attack prior to the trial, 23% a stroke, and 9% had peripheral artery disease. There’s some overlap as some had multiple cardiovascular events. Furthermore, 24% were diagnosed with heart failure.

The trial started recruiting patients five years ago. Therefore, it can be presumed that the reported outcomes apply following up to five years of Wegovy usage.

On the face of it, the data released by Novo Nordisk could very well bolster the case for more widespread use and insurance coverage of Wegovy. But until more detailed information is made available about the trial data, payers probably won’t change their current restrictive formulary policies. Such data include a stratification of sub-populations, for example, into BMI ranges, a clearer picture of the adverse event profiles, and timing of the effects.

In addition, given that real-world data demonstrate dropout rates at one year as high as 68%, payers will want to know how the SELECT trial results translate to a real-world setting. Knowledge of determinants of patient adherence is important, especially in light of the fact that when weight loss agents are no longer taken people regain the weight they had lost. Multiple factors may contribute to non-adherence, including the adverse events profile.

Until now, payers have been reluctant to pay for obesity drugs, and have actually pulled back coverage in recent months, in part due to their worry about the cost-effectiveness of weight loss agents and the budgetary impact or financial exposure they face when they reimburse for large portions of the eligible population.

Indeed, according to a recent study of real-world integrated pharmacy and medical claims data, the annual cost of overall healthcare for patients on Wegovy or a similar drug versus a similar cohort of patients who weren’t prescribed a weight loss agent, were considerably higher, on average.

Nonetheless, an in-depth examination of the SELECT trial data may cause some payers to rethink coverage of weight loss agents such as Wegovy, at least for certain sub-populations of patients. For this, though, they would need more granular data to enable readjustment of cost-effectiveness and budgetary impact estimates. Also, most payers would probably wait until the Food and Drug Administration added reduction of cardiovascular risk to Wegovy’s label.

Hazarding an educated guess based on the emerging evidence, commercial payers may view Wegovy and other drugs in the new classes of weight loss agents as an adjunct (in conjunction with diet and exercise) for those with a high to very high BMI and a heart condition. And payers will continue to cover semaglutide- and tirzepatide-based products—as they do today—for patients with diabetes.

But caveats remain in place for the time being, specifically regarding the distinction between how commercial and public market payers approach coverage of obesity drugs of any kind. At present, Medicare doesn’t cover such medications. In order for Medicare to lift the prohibition on coverage, Congress would have to pass the Treat and Reduce Obesity Act. While there appears to be bipartisan support for passage of this piece of legislation, its enactment may still be several years away even if it’s passed by Congress sooner.

And then there is the problem of churn or enrollee turnover, often from year to year. This impacts the commercial and Medicaid spaces more than Medicare. The SELECT trial was a five year study. And this time frame presents payers in the U.S. with a dilemma. Supposing the positive outcomes took some time to come about, because of churn payers may not view the high upfront costs as an investment as it’s probable they won’t see a positive return. They’d essentially be paying for something which the next payer down the road would benefit from.

Finally, for payers there’s an equally important question, what about the effects of Wegovy on patients who don’t have the kind of serious underlying cardiovascular disease defined in the SELECT trial? In the real world, the vast majority of people seeking to take weight loss agents do not fit the characteristics of SELECT trial participants.

This may help to explain why it’s very likely payers will adopt intensive usage of indication restrictions, prior authorization, step edits and quantity limits as conditions of reimbursement. Here, step edit or fail first policies refer to only allowing for coverage of more expensive treatments if the patient has tried a cheaper alternative.

In sum, the initial data from the SELECT trial look good. But this may not necessarily change payer coverage policies with respect to weight loss agents, at least not in the short term. Payers will first need to assess a multitude of factors prior to making their decisions to cover and if so with which conditions of reimbursement.