About half of practicing endocrinologists recently polled by Medscape Medical News had not heard of Novo Nordisk’s investigational injectable once-weekly glucagonlike peptide-1 (GLP-1) receptor agonist, semaglutide. The US Food and Drug Administration (FDA) will soon decide whether or not to approve the drug.
In mid-October, an FDA advisory panel unanimously recommended approval of semaglutide in 0.5-mg and 1.0-mg doses. The drug is administered once weekly as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The FDA is due to make an approval decision by December 5.
If approved, semaglutide would become the third once-weekly injectable GLP-1 receptor agonist on the US market, joining extended-release exenatide (Bydureon, AstraZeneca) and dulaglutide (Trulicity, Eli Lilly). (Albiglutide [Tanzeum, GlaxoSmithKline], which is also a once-weekly injectable GLP-1 receptor agonist, is being withdrawn.)
Soon after the FDA panel’s recommendation, Medscape Medical News polled 74 US endocrinologists who see at least 30 type 2 diabetes patients each month regarding their knowledge of semaglutide and their view as to which patients they thought might benefit the most from the therapy.
Half had not heard of semaglutide, but 22% said they were very familiar with the product. Sixteen percent knew some basic information, and 8% had an understanding of the clinical trial data.
Obese, Poorly Controlled Ideal Candidates
Poll respondents were given a summary of the data from Novo Nordisk’s eight phase 3 trials (conducted under the SUSTAIN moniker), in which more than 8000 adults with type 2 diabetes participated. A post hoc analysis of the SUSTAIN 1-5 trials showed that a greater proportion of adults with type 2 diabetes achieved a clinically meaningful reduction in both HbA1c level and body weight with once-weekly semaglutide vs comparator treatments, which included placebo, sitagliptin, insulin glargine U100, or extended-release exenatide.
Significantly more of those who received semaglutide achieved the clinically meaningful composite endpoint of a reduction of >1% HbA1c and weight loss of >5% with 0.5-mg (25% to 35%) and 1.0-mg (38% to 56%) semaglutide vs all comparators (2% to 13%; P < .0001) in SUSTAIN 1-5. All semaglutide patients also met the secondary endpoint of weight loss. Novo Nordisk’s cardiovascular outcomes trial, SUSTAIN 6, demonstrated a cardiovascular risk reduction with the drug in comparison with placebo.
In light of these data, the respondents were asked their view of semaglutide’s importance in treating diabetes. Sixty-three percent said it was important or very important; about a quarter said it was moderately important.
A large number of the endocrinologists said they viewed the ideal patient for semaglutide therapy as someone who was overweight/obese and whose condition was poorly controlled with one or more oral agents. Patients who need postprandial glucose control were also seen as benefiting from semaglutide. Some clinicians also said that patients would have to have good renal function and have no other contraindications to semaglutide.
Anticipated Switch From Other GLP-1s
Ninety-two percent of the endocrinologists polled said they anticipated prescribing semaglutide. About half said they would prescribe it within the first month of the drug’s approval. About a third said they would wait 2 to 6 months before prescribing semaglutide, and 5% said they would not prescribe it until 7 to 9 months after approval. Nine percent of clinicians said they’d wait at least 9 months after approval.
Not every patient with type 2 diabetes would be prescribed semaglutide. The clinicians estimated that about 14% of their patients with type 2 diabetes would be given the therapy, with some being switched from other GLP-1 agents.
For instance, clinicians said that they anticipated the percentage of patients receiving the once-daily injectable liraglutide (Victoza, Novo Nordisk) would drop from 21% to 16%. About 9% of patients taking dulaglutide would be switched to semaglutide, the poll respondents indicated.
There would also be some drop-off in the use of exenatide and extended-release exenatide, prescribed at lower levels.
The efficacy profile and the once-weekly dosing schedule were given as the main reasons for prescribing semaglutide. Approximately a third of clinicians polled said that insurance coverage, the drug’s safety profile, or the mode of administration were also reasons to prescribe the therapy.
However, potential reimbursement problems were cited by at least two thirds of poll respondents as a concern. In addition, 58% said that they were concerned about possible step edit or prior authorization for semaglutide.
About a fifth were concerned about side effects that were seen in the pivotal trials or about the drug’s safety profile.
The respondents practiced in a variety of settings. The largest number ― 45% ― were in an office-based multispecialty group practice. Nineteen percent practiced at an office-based single-specialty group, 12% were solo office-based, 9% practiced at a hospital, 9% in an academic (nonhospital) setting, research, military, or government facility, and 5% in a healthcare organization.
Four percent were younger than 35, 46% were 35 to 44, and the remainder were 46 or older.
The Medscape Medical News survey was conducted from November 7 to November 14, 2017. Respondents who completed the survey received a $50 Amazon.com gift card.
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