- The Food and Drug Administration on Friday approved Novo Nordisk's glucose-lowering pill Rybelsus, a new entry in the usually injectable glucagon-like peptide 1 drug class. Rybelsus has the same active ingredient, semaglutide, as Novo's weekly shot Ozempic.
- Rybelsus will cost $772.43 for a 30-day supply, or nearly $9,400 a year, a price point that the Danish drugmaker described as "competitive" within the GLP-1 category. The drug is more expensive, however, than other oral type 2 diabetes drugs like Eli Lilly's Jardiance or Merck & Co.'s Januvia.
- Diabetes drugs have been under particular price pressure, with Novo's daily GLP-1 Victoza and insulin Novolog both kicked off the Express Scripts formulary. Broadly, insulin makers continue to face fierce criticism for price increases that have made insulin prohibitive for low-income diabetics.
Converting injectable drugs into pills is a common biopharma strategy for expanding the number of patients willing to take a drug, as well as extending product life cycles. In the case of peptides and proteins like GLP-1s and insulin, the size of the therapeutic molecule is a challenge.
Novo was able to succeed with an oral formulation of semaglutide by increasing the frequency and volume of the dose and coupling it with drug delivery technology from Emisphere that allowed for gastrointestinal absorption.
"Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and the FDA welcomes the advancement of new therapeutic options that can make it easier for patients to control their condition," Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said in a statement Friday.
Novo's price signals the drugmaker is positioning Rybelsus to compete with injectable GLP-1 agents, rather than with oral drugs from other classes. Novo's competitors in the GLP-1 class include the daily shot Adlyxin (lixisenatide) from Sanofi and Lilly's weekly injection Trulicity (dulaglutide), which cost roughly $620 and $760 a month, respectively.
However, Novo may find that it also needs to take into account competition from glucose-lowering pills in other drug classes. These include products like Januvia (sitagliptin) and Jardiance (empagliflozin).
The Institute for Clinical and Economic Review, an independent group that analyzes drug costs, has looked at the cost-effectiveness of Rybelsus, assuming an annual price equal to Ozempic. In its draft analysis, the group used an assumed cost of more than $6,500 a year, compared with about $1,500 for Januvia and $2,100 for Jardiance.
At that price, Rybelsus plus standard background therapies was "dominated," or both more expensive and less effective, by Jardiance plus background therapies on a measure called a "quality adjusted life year," or QALY. It cost $100,000 per QALY more than Novo's Victoza (liraglutide) and $80,000 more than Januvia in the same scenario.
ICER's final draft of that analysis is due on Oct. 31, ahead of its Nov. 14 panel meeting on Rybelsus.