The history of medications to help people lose weight does not inspire a lot of confidence. Amphetamines, the fen-phen (fenfluramine-phentermine), sibutramine (sold under the brand name Meridia) — they helped people lose weight. But they also had dangerous, sometimes fatal, side effects.
But in June 2021, FDA approved the repurposing of a diabetes drug, semaglutide, as a weight-loss drug that Novo Nordisk is selling under the brand-name Wegovy.
And at the 2022 Pharmacy Benefit Management Institute (PBMI) Annual National Conference today in Orlando, Florida, a pharmacy benefits management (PBM) executive and Novo Nordisk executive said the good safety track record of semaglutide as a diabetes drug and the class of drugs to which it belongs, called glucagon-like peptide 1 (GLP-1) agonists, should be reassuring.
“Now that we are in the millions of patients on the product, it gives me confidence that it is not only effective (against diabetes) but also safe,” said David Skomo, RPh, chief operating officer for WellDyne.
Ryan Flugge, Pharm.D., a medical account associate director for Novo Nordisk, said the GLP-1 agonists have been used to treat diabetes for over a decade. “If there were safety concerns, we would have seen signals by now.” He added that the cardiovascular outcomes for the GLP-1 agonists when they have been used as diabetes medications have shown benefit, not harm, when it comes to cardiovascular disease.
Wegovy’s average wholesale price is $1,300 per month. It is unclear now whether payers will reap immediate savings from people losing weight and avoiding comorbidities or reducing the use of medications for obesity-related conditions such as a hypertension.
Skomo and Flugge both spoke about the growing proportion of people in the U.S. who are overweight or have obesity. Skomo, referencing data from the CDC, said the proportion of Americans who are obese has increased by 40% over the past 20 years and the proportion that is severely obese(a body-mass index [BMI] of 40 or more) has doubled.
Obesity needs to be a reframed as a progressive chronic disease that needs to be managed rather than a failure of self-control to exercise and eat a healthful diet, Skomo told the PBMI conference attendees.
“It is a chronic disease that they (people with obesity) struggle with and we have to think about it in that way,” Skomo said.
Skomo showed survey results showing that employers are interested in addressing obesity but look to wellness programs as the way to do so. He argued that PBMs can play a role now that Wegovy is on the marketand a wave of other diabetes drugs are also expected to be weight-loss indications from the FDA and be sold for that purpose.
PBMs should be putting these new weight-loss drugs on their formularies as preferred brands, Skomo said, and also encourage coverage by making them an opt-out choice for payers rather than opt-in. He also said PBMs should impose prior authorization rules to assuage payers concerns about misuse and ballooning costs. Skomo says uses the Wegovy’s FDA-approved label to set its prior authorization rules. The label says the drug is indicated for use in people who are obese (a BMI of 30 more ) or who are overweight a BMI of 27 or more who also have a health condition related to being heavy.