The Institute for Clinical and Economic Review (ICER) has produced an evidence report declaring oral semaglutide, approved by the FDA in September as a treatment for type 2 diabetes (T2D) alternative to injectables, isn’t as cost effective as well-known empagliflozin.

What is Semaglutide and Why is it Important?

With a trade name of Rybelsus, semaglutide is a treatment for T2D made by Novo Nordisk. It is a glucagon-like peptide-1 (GLP-1) receptor agonist that patients can take in the form of a daily pill. The approval of oral semaglutide was deemed an important milestone as Novo Nordisk leadership has posited for years that the oral (pill form) option would offer patients who should be on this treatment but weren’t due to their hesitation or fear of injectable drugs.

Novo Nordisk existing injectable drugs include once-weekly semaglutide (Ozempic) and once-daily liraglutide.

What drugs did ICER Compare?

In this evidence report ICER compared clinical trial and cost data for oral semaglutide, liraglutide (another GLP-1 sold as Victoza by Novo Nordisk); empagliflozin (sold as Jardiance by a U.S. and German partners Eli Lilly and Boehringer Ingelheim) and sitagliptin (sold as Januvia by Merck).

Why didn’t ICER rate semaglutide highest in cost effectiveness?

Apparently analysts at ICER factored in price and adverse event risk (e.g. severity of events and likelihood of their occurrence) and consequently the newly approved oral semaglutide didn’t score as high as empagliflozin.

Adverse events with GLP-1 agonists

ICER noted that although GLP-1 agonists are increasing prescribed for patients who can’t achieve glycemic control prior insulin therapy as it also helps them lose weight. However due to many reporting gastrointestinal side effects and consequently titration till tolerable “a considerable portion of patients discontinued oral semaglutide due to adverse events, specifically gastrointestinal events.”

What is Empagliflozin?

Sold under the trade name Jardiance (and others), it is a medication used together with diet and exercise to treat T2D. It is less preferred than metformin and sulfonylureas—however it may be used together with other medications such as metformin or insulin. A sodium glucose co-transporter 2 (SGLT) inhibitor, the drug works by expelling excess glucose through urine  and there is evidence that it could contribute to reducing heart failure and renal decline. Common side effects include genitourinary tract infections.

Empagliflozin and liraglutide were listed as preferred drugs in their categories in the 2019 American College of Cardiology Expert Consensus Decision Pathway for T2D patients reported American Journal of Managed Care (AJMC)

Cost Comparison

Factoring in cost data (list prices, discounts, and net costs) ICER utilized SSR Health LLC. They compared pricing for oral semaglutide, empagliflozin, liraglutide and sitagliptin. The top contenders priced:

T2D DrugList PriceNet PriceComment
Oral semaglutide $772 $501 30 days (monthly cost
comparable with other
GLP-1s however more
expensive than other
oral therapies such as
empagliflozin);
empagliflozin
$492 $174 30 days.

ICER Critiques

ICER methodologies and assumptions have been critiqued from the biopharmaceutical industry and patient advocacy groups in regard to certain methodologies and at times what some purport to be controversial recommendations.

ICER’s influence is growing and hence increasingly will face criticism. ICER is a private, non-profit organization has no authority unlike some price analysis organizations in other countries (e.g. NICE in the UK). ICER can’t compel manufacturers to share data and hence at times must depend on its own data collection and modeling and doesn’t involve patients or the public notwithstanding a public comment period following drafts of analyses but frankly afford limited transparency.

Source: ICER

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