The history of drugs that help people lose weight does not inspire much confidence. Amphetamines, phen-phen (phenfluramine-phentermine), sibutramine (sold under the trade name Meridia) - they have helped people lose weight. But they also had dangerous, sometimes fatal, side effects.
But in June 2021, the FDA approved the repurposing of the diabetes drug, semaglutide, into a weight-loss drug, which Novo Nordisk sells under the brand name Wegovy.
At the Pharmacy Benefit Management Institute's (PBMI) 2022 annual national conference in Orlando, Florida, the head of pharmacy benefit management (PBM) and a Novo Nordisk executive said the good safety record of semaglutide as a diabetes drug and the class of drugs it belongs to, called glucagon-like peptide 1 (GLP-1) agonists, should be encouraging.
"Now that we have millions of patients taking this drug, it gives me confidence that it's not only effective (against diabetes) but also safe," said David Scomo, RPh, WellDyne's chief operating officer.
Ryan Flügge, Ph.D., associate director of medical customer service at Novo Nordisk, says GLP-1 agonists have been used to treat diabetes for more than a decade. "If there were safety concerns, we would have seen the signals by now." He added that the cardiovascular results of using GLP-1 agonists as diabetes drugs have shown benefit, not harm, when it comes to cardiovascular disease.
The average wholesale price of Wegovy is $1,300 per month. It is unclear now whether payers will get immediate savings from people losing weight and getting rid of comorbidities or reducing their use of medications to treat obesity-related conditions such as hypertension.
Scomo and Flügge talked about the growing proportion of people in the United States who are overweight or obese. Scomo, citing CDC data, said the proportion of obese Americans has increased by 40 percent in the past 20 years, and the proportion of severely obese people (body mass index [BMI] 40 or more) has doubled.
Obesity needs to be seen as a progressive chronic disease that needs to be treated, not as a failure to exercise and stick to a healthy diet on its own, Skomo told PBMI conference attendees.
"It's a chronic disease that they (obese people) struggle with, and that's how we have to think about it," Scomo said.
Skomo showed survey results showing that employers are interested in addressing obesity but see wellness programs as a way to do so. He argued that PBMs could play a role now that Wegovy is on the market, and a number of other diabetes drugs are also expected to receive a weight-loss indication from the FDA and be marketed for that purpose.
According to Skomo, PBMs should include these new weight-loss drugs on their formularies as preferred brands, and encourage their coverage by making them a payer choice rather than optional. He also thinks PBMs should institute pre-authorization rules to allay payers' fears of abuse and rising costs. Scomo says it uses an FDA-approved Wegovy label to establish prior authorization rules. The label states that the drug is indicated for people who are obese (BMI 30 or greater) or overweight (BMI 27 or greater) who also have a health condition related to being overweight.
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