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Novo diabetes pill is cost-effective at price of injectable drug, ICER finds

Novo Nordisk A/S' oral formulation of diabetes drug semaglutide appeared to be cost-effective compared with two marketed medicines for the condition, although its price has yet to be set, the Institute for Clinical and Economic Review said in a draft report.

In the U.S. pricing watchdog's Sept. 11 report, ICER had "moderate certainty" that oral semaglutide, currently being reviewed for regulatory approval in type 2 diabetes, led to greater reductions in patients' glucose levels and body weight than Novo Nordisk's injectable medicine liraglutide, sold as Victoza.

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ICER also compared oral semaglutide to Eli Lilly and Co. and Boehringer Ingelheim GmbH's Jardiance, or oral empagliflozin, concluding that Novo's experimental therapy was more effective in lowering and controlling blood glucose.

Similar results were reported when ICER compared semaglutide with Merck & Co. Inc.'s Januvia, or oral sitagliptin.

Novo Nordisk also makes injectable semaglutide, marketed as Ozempic. Whether oral and injectable formulations of semaglutide have the same benefits is unclear, ICER said.

Oral semaglutide's price is not yet available, so ICER used the net price of Ozempic as a placeholder. The placeholder net price per year for oral semaglutide would be $6,520.02, ICER said, the most expensive among the type 2 diabetes treatments.

Oral semaglutide seemed cost-effective at that price compared with Victoza and Januvia, although ICER said it could not be certain that it provided more value than Jardiance based on the data reviewed.

Semaglutide generally caused a higher instance of adverse events, such as gastrointestinal side effects, ICER said. Assuming the drug is approved, patients taking semaglutide might be more inclined to discontinue treatment compared to other diabetes drug options because of such side effects, the watchdog noted.

Overall, ICER emphasized its low confidence in comparisons suggesting semaglutide may be superior to other type 2 diabetes drugs, citing indirect evidence concerning semaglutide's effects on diseases of large and small blood vessels stemming from diabetes. Both oral and injectable semaglutide may actually increase rates of diabetic retinopathy, a microvascular condition that damages blood vessels in the eye. Novo Nordisk has an ongoing five-year trial specifically evaluating possible effects of injectable semaglutide on diabetic eye disease.

In addition, semaglutide's effects on major adverse cardiovascular events were uncertain. While semaglutide appeared to reduce these compared to the other diabetes drugs, ICER noted that the differences were not statistically significant.

Because of oral semaglutide's relatively higher clinical benefit, the drug was determined to be more cost-effective than Januvia and Victoza. According to ICER's initial model, though, Jardiance was less expensive and more cost-effective than oral semaglutide.

"All of these incremental value estimates are coupled with high levels of uncertainty," ICER said. "Based on the current clinical evidence, with limited follow-up, and without knowing the eventual price for oral semaglutide, we are unable to draw conclusions on its cost-effectiveness with any certainty."

ICER will accept comments on the draft report until Oct. 8 and expects to publish a final evidence report on Oct. 31. The report will be the focus of an advisory council meeting Nov. 14.