The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report and Report-at-a-Glance 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 (T2DM). This new therapy is an oral version of the injectable Ozempic® (Novo Nordisk), which was approved by the FDA in 2017. For this analysis, adding 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). ICER’s report on these therapies was reviewed at the November 2019 public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC), one of ICER’s three independent evidence appraisal committees.
“People with Type 2 diabetes who would like to use a GLP-1 receptor agonist have had no oral options until oral semaglutide, which appears to have similar efficacy to that of the injectable GLP-1s,” said David Rind, MD, ICER’s Chief Medical Officer. “However, oral semaglutide’s estimated net price is much higher than that of the oral SGLT-2 inhibitors like empagliflozin that appear to have similar benefits with fewer common side effects, making SGLT-2 inhibitors a more cost-effective ‘next’ therapy for many people with T2DM. Many patients may require multiple therapies, and clinical experts at our public meeting felt that a large percentage of the eligible patient population that could have benefited from GLP-1 therapy but avoided it because of the need for injections would be interested in trying an oral GLP-1; this could potentially create short-term budgetary challenges for the US health care system.”
During the meeting, CEPAC members unanimously voted that the evidence was adequate to demonstrate that adding oral semaglutide to ongoing background therapy provides a positive net health benefit, and that this benefit is superior to that provided by adding sitagliptin. However, a majority of the CEPAC found that the evidence did not adequately demonstrate that the net health benefit of adding oral semaglutide was superior to that of adding liraglutide, nor did the evidence adequately distinguish the net health benefit of adding oral semaglutide from that provided by adding empagliflozin.
To read the full press release, click here.
To read the final evidence report, click here.