Preliminary ICER Review of Oral Semaglutide

The FDA approved the weekly subcutaneous injection of semaglutide on 12/5/17 for the treatment of Type 2 Diabetes. Oral semaglutidewould be the first oral GLP-1 receptor agonist if approved. Oral semaglutide is being reviewed by the FDA and EMA and has a PDUFA date on 9/20/2019.
 
ICER released a draft analysis of semaglutidein September 2019. In estimating the net health benefit of semaglutide, ICER found the drug would potentially, but inconclusively provide a net health benefit compared to liraglutide, had low certainty of a benefit compared to empagliflozin, had moderate certainty of a benefit compared to sitagliptin and had a high certainty of a substantial net benefit when added to background therapy. ICER based its economic analysis for semaglutide on the cost of injectable semaglutide. A discount off WAC was used for semaglutide for an estimated annual cost of $6,520. Annual discounted prices used for comparators included $1,505 for sitagliptin, $2,088 for empagliflozin and $5,342 for liraglutide. The final market price would change the QALY analysis. Using these estimated costs, ICER estimated the incremental cost-effectiveness ratios for oral semaglutide as $100,000/QALY compared to liraglutide, $80,000/QALY compared to sitagliptin,and $160,000 compared to background treatment alone. Empagliflozin was found to be more cost-effective than semaglutide. The final ICER report on semaglutide is expected to be published on 12/9/2019.
 
We provided a summary of the outcomes from the ten trial Phase III PIONEERtrials evaluating oral semaglutide for the treatment of type 2 diabetes in June of this year. Seven of the PIONEER trials have been published and The Pharmaceutical Pipeline Trackerhas links to PubMed abstracts and five more for a total of 12 semaglutide trials.  The Knowledgebase also provides more detail on the primary outcome from each of the PIONEER trials. A subscription provides 24/7 access to the data.