Novo Nordisk Launches Oral Semaglutide Rybelsus at $26/Day, Priced in Line with Injectable GLP-1 Therapies

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On September 20, Novo Nordisk’s Rybelsus (semaglutide, oral semaglutide tablets) received approval from the U.S. FDA to improve glycemic control in adults with type 2 diabetes, in conjunction with diet and exercise. As the first orally administered glucagon-like peptide-1 (GLP-1) receptor agonist approved globally, it is taken once daily. The approved therapeutic doses are 7 mg and 14 mg, and the drug will be launched in the United States in the fourth quarter.

Recently, Novo Nordisk disclosed the list price of Rybelsus—$26 per day for all strengths (7 mg, 14 mg), equivalent to $772 for 30 tablets, a price comparable to that of similar injectable products.

This disclosure ends a two-year debate over the pricing of oral semaglutide and “alleviates investor concerns that Novo Nordisk’s GLP-1 injectables would be forced to undergo significant price cuts.” Currently, the list price for Ozempic, its once-weekly subcutaneous injection formulation of semaglutide, is $770, while the older once-daily subcutaneous GLP-1 drug Victoza (liraglutide) carries a list price of $920. To avoid cannibalizing the company’s other products in the same class, Novo Nordisk executives had previously hinted that they “favor pricing similar to that of GLP-1 injectables.”

Although this list price may have sparked some market dissatisfaction, Jefferies analysts pointed out that it exceeds the consensus expectation among investors for discounts on the company’s GLP-1 injectables. However, the key data point for the launch of Rybelsus will be the net price after rebates provided by Novo Nordisk, a figure that the company will not disclose publicly.

To date, Novo Nordisk has reported receiving positive feedback from payers regarding the clinical profile of Rybelsus and its internally conducted cost-effectiveness studies. Given Novo Nordisk’s aim to position Rybelsus early in the treatment paradigm for type 2 diabetes patients who have failed metformin therapy, the company may offer payers greater discounts on Rybelsus than on Ozempic.

As the world’s first oral GLP-1 antidiabetic drug, Rybelsus is highly regarded by the industry for its commercial prospects. EvaluatePharma predicts that global sales of Rybelsus are expected to reach $3.325 billion in 2024.

In addition to pricing, another decisive factor determining the sales prospects of Rybelsus is whether it can successfully obtain a label claim for reducing cardiovascular (CV) risk in its product information. Currently, the applications for Rybelsus and Ozempic to reduce CV risk in adult patients with type 2 diabetes are under review by the U.S. FDA, with the review results expected in January 2020.

This application is based on the results of two cardiovascular (CV) outcome studies. These studies were conducted in adult patients with type 2 diabetes at high risk for CV events, evaluating the impact of adding semaglutide or placebo to standard care on the risk of CV events. Data from the PIONEER 6 study showed that, when added to standard care, oral semaglutide reduced the risk of major adverse cardiovascular events (MACE) by 21% compared with placebo, meeting the primary endpoint of non-inferiority, although the result was not statistically significant. However, regarding individual components of MACE, oral semaglutide significantly reduced the risk of cardiovascular death by 51% and all-cause mortality by 49% compared with placebo, while showing similar effects on non-fatal myocardial infarction and non-fatal stroke. Data from the SUSTAIN 6 study demonstrated that, when added to standard care, Ozempic significantly reduced the risk of the composite MACE endpoint by 26% compared with placebo.

In the two aforementioned studies, PIONEER 6 demonstrated non-inferiority rather than superiority, while SUSTAIN 6 did not include a superiority analysis. Therefore, it remains uncertain whether Rybelsus and Ozempic will secure cardiovascular indications by early next year. Novo Nordisk may need to await data from larger-scale cardiovascular outcomes trials (CVOTs), such as the SOUL trial involving 9,600 patients with Rybelsus, which was initiated earlier this year. Although this study is not scheduled for completion until 2024, interim analyses may provide an opportunity for an earlier victory. Regarding this trial, Novo Nordisk stated that patient enrollment is currently “progressing smoothly.”

Initiating the SOUL trial prior to the FDA’s cardiovascular labeling review decision appears to be a costly yet potentially necessary insurance strategy. According to estimates from EvaluatePharma Vision’s R&D cost model, the SOUL trial will cost approximately $300 million.

Reference Source:

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