Type 2 diabetes mellitus (T2DM) is a condition where cells do not respond adequately to insulin and so there are high glucose (sugar) levels. In the United States approximately 30 million individuals have diabetes mellitus (DM), of whom 95% have T2DM. Patients with DM are at increased risk for damage to larger and smaller blood vessels, which can lead to many complications including heart attacks, strokes, blindness, kidney failure, and infections and amputations of limbs. Control of glucose levels can reduce many of these complications, and some newer drugs for diabetes seem to reduce these complications even beyond just controlling blood glucose.

Oral GLP-1 semaglutide achieved commonly cited thresholds for cost-effectiveness but is less cost-effective than SGLT-2 competitor empagliflozin. The independent appraisal committee voted that oral semaglutide provides a superior net health benefit over background therapy alone, achieves intermediate long-term value for money, and may be an attractive alternative for patients who would prefer an oral treatment; however, the large potential short-term budget impact associated with treating even a small percentage of eligible US patients lead ICER to issue an Access and Affordability Alert.

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Interventions of Interest:

  • oral semaglutide (Rybelsus®, Novo Nordisk)
  • liraglutide (Victoza®, Novo Nordisk)
  • sitagliptin (Januvia®, Merck)
  • empagliflozin (Jardiance®, Boehringer Ingelheim).

Final Documents

Below you will find the final documents from the assessment review process:

“People with Type 2 diabetes who would like to use a GLP-1 receptor agonist have had no oral options until oral semaglutide, which appears to have similar efficacy to that of the injectable GLP-1s. However, oral semaglutide’s estimated net price is much higher than that of the oral SGLT-2 inhibitors like empagliflozin that appear to have similar benefits with fewer common side effects, making SGLT-2 inhibitors a more cost-effective ‘next’ therapy for many people with T2DM. Many patients may require multiple therapies, and clinical experts at our public meeting felt that a large percentage of the eligible patient population that could have benefited from GLP-1 therapy but avoided it because of the need for injections would be interested in trying an oral GLP-1; this could potentially create short-term budgetary challenges for the US health care system.”