— Semaglutide as add-on therapy to metformin achieves commonly cited thresholds for cost-effectiveness but is less cost-effective than empagliflozin —

— New England CEPAC will deliberate on the treatment’s clinical efficacy, contextual considerations, and economic value at November 14 public meeting —

BOSTON, November 1, 2019 – The Institute for Clinical and Economic Review (ICER) today released an Evidence Report assessing the comparative clinical effectiveness and value of oral semaglutide (Rybelsus® Novo Nordisk), a GLP-1 receptor agonist for the treatment of Type 2 diabetes mellitus. This new therapy is an oral version of the injectable Ozempic® (Novo Nordisk), which was approved by the FDA in 2017. For this analysis, oral semaglutide was compared to background therapy with metformin alone, and to three competitors for add-on therapy: liraglutide (Victoza®, Novo Nordisk), sitagliptin (Januvia®, Merck), and empagliflozin (Jardiance®, Boehringer Ingelheim).

“SGLT-2 inhibitors and GLP-1 receptor agonists have become increasingly important therapies for Type 2 diabetes because they help with weight loss and reduce cardiovascular risk beyond that seen with other therapies,” said David Rind, MD, ICER’s Chief Medical Officer. “Patients seeking to use a GLP-1 agonist but wishing to avoid injection have had no oral options until oral semaglutide, which appears to have efficacy similar to the injectable GLP-1s. However, judging from the list price of oral semaglutide, its net price is likely to be much higher than that of competitor oral treatments, including the SGLT-2 inhibitors like empaglifozin that appear to have similar benefits with fewer common side effects.”

This Evidence Report will be reviewed at an upcoming public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) in Providence, Rhode Island on November 14, 2019. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.

Key Clinical Findings

ICER’s report concludes that the evidence is adequate to provide high certainty that oral semaglutide delivers a substantial net health benefit compared to ongoing background therapy with metformin alone. Semaglutide results in better control of blood sugar than the other options, and better weight reduction than any of the options except empagliflozin. The available evidence on these outcomes and on harms from treatment is judged as providing moderate certainty that semaglutide produces at least a small net health benefit compared to sitagliptin as an add-on therapy. However, compared to liraglutide, the evidence for an added benefit of oral semaglutide is judged to be promising but still inconclusive, and there is insufficient evidence to distinguish the net health benefit of oral semaglutide from that of empaglifozin.

Key Cost-Effectiveness Findings

When compared to background therapy alone, oral semaglutide’s annual estimated net price of $6,103 falls within ICER’s value-based price benchmark range of $6,000-$6,400 per year. At this estimated net price, oral semaglutide is also likely to reach commonly cited cost-effectiveness thresholds compared to liraglutide. There is substantial uncertainty about cost-effectiveness compared to sitagliptin, and oral semaglutide is unlikely to reach commonly cited thresholds compared with empagliflozin.

ICER’s value-based price benchmarks suggest a price range, net of any discounts and rebates, that aligns fairly with a treatment’s added benefits for patients over their lifetimes. The ranges reflect commonly cited cost-effectiveness thresholds of between $100,000 and $150,000 per Quality-Adjusted Life Year (QALY) gained. To reach alternative thresholds of between $100,000 and $150,000 per Life Year (LY) gained, oral semaglutide could be priced between $6,400-$7,100 per year.

At oral semaglutide’s estimated net price, approximately 7.1% of eligible patients could be treated in a given year before crossing ICER’s potential budget impact threshold of $819 million.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.