- Novo Nordisk's oral semaglutide delivers fewer benefits to diabetics than Eli Lilly and Boehringer Ingelheim's pill Jardiance and, if priced similarly to its injectable form Ozempic, will be more expensive, the Institute for Clinical and Economic Review concluded in a draft report.
- Oral semaglutide was more effective in preventing cardiovascular complications of diabetes than Jardiance, Merck & Co.'s Januvia, or Novo's own once-daily injectable Victoza, but proved less effective in preventing congestive heart failure than the comparator drugs, ICER said.
- Oral semaglutide is due for approval from the Food and Drug Administration this month, after which the price will likely be announced and a more precise cost-effectiveness calculation can be completed.
Diabetes is a disease area that has been particularly under pressure in recent years thanks to competition between and within new drug classes.
The GLP-1 class, which features the daily injection Victoza (liraglutide) as well as the weekly injections Trulicity (dulaglutide) from Lilly and Ozempic (semaglutide) from Novo, is due to see some new competition from oral semaglutide. As an oral agent, Novo would have a unique marketing proposition to patients over the other products' periodic shots.
Payers will be keen to read ICER's findings as they prepare to negotiate with Novo over oral semaglutide's price.
As the drug isn't approved, Novo has not announced a price yet for its oral version. ICER decided to do a comparison, however, using the price of Ozempic, which contains the same active ingredient, as a reference.
To arrive at a net price reflective of rebates or discounts, ICER then discounted 35% from Ozempic's wholesale acquisition cost, or list price. At that level, oral semaglutide was estimated to cost $6,520 a year, compared with ICER's estimate of $1,505 for Januvia (sitagliptin), $2,088 for Jardiance (empagliflozin) or $5,342 for Victoza.
At those prices, oral semaglutide plus a background therapy like metformin is "dominated" — more costly and clinically less effective — by Jardiance, ICER calculated. Oral semaglutide plus background therapy resulted in 1.95 more quality-adjusted life years, or QALYs, a measurement of effectiveness, than background therapy alone, while Jardiance plus background therapy resulted in 1.99 more QALYs than background therapy alone.
This cost-effectiveness picture could change based on Novo's eventual price for oral semaglutide as well as discounts and rebates offered to payers. ICER calculated a deeper discount from the list price for Jardiance and Januvia in its analysis.
In addition, the clinical effectiveness calculation could change based on additional post-marketing research, such as additional cardiovascular outcomes study. Jardiance's key EMPA-REG Outcomes study followed patients for four years, while oral semaglutide's PIONEER 6 study watched for heart-related complications for less than two.
However, the analysis raises the question of whether the Denmark-based company believes its competition is GLP-1s like Trulicity or oral medications like Jardiance, and whether it would set its price accordingly. Jardiance is in a different drug class, called SGLT2 inhibitors.
Novo spokesman Michael Bachner said the company has been engaged with ICER on this draft document and said the company welcomes "this discussion because determining the value of innovation is vital to how healthcare will improve and be reimbursed."
The ICER draft will be reviewed and voted on by an advisory committee on Nov. 14 before a final draft is published on Dec. 9.