ICER: Initial Evidence Shows a Wide Range of Estimates for Cost-effectiveness of Tirzepatide

Lilly’s tirzepatide, when added to background therapy to treat patients with type 2 diabetes, scored slightly lower in an evaluation of quality-adjusted life year (QALY) when compared with Ozempic (semaglutide). But tirzepatide scored higher for QALY when compared with Jardiance (empagliflozin), according to a draft evidence report issued by The Institute for Clinical and Economic Review (ICER).

Tirzepatide is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single novel molecule. GIP is a hormone that may complement the effects of GLP-1. Trial results published in The Lancet found that tirzepatide reduces A1C and body weight across all three doses of tirzepatide compared with insulin glargine.

Eli Lilly announced last month that it had submitted applications to both the FDA and the European Medicines Agency for tirzepatide as a treatment for adults with type 2 diabetes.

In the ICER analysis, reviewers compared the clinical and cost-effectiveness of tirzepatide added to background therapy compared with background therapy alone, or Novo Nordisk’s Ozempic or Jardiance from Boehringer Ingelheim and Eli Lilly when added on to background therapy. The background therapy was metformin and/or sulfonylureas or thiazolidinediones. Metformin is recommended as first-line therapy for type 2 diabetes.

For an initial look at the cost-effectiveness of tirzepatide, ICER used a placeholder price equal to Ozempic, which is a once-weekly injectable GLP-1. The wholesale acquisition cost (WAC) of Ozempic is $851.60 for four doses administered once a week for four weeks, and, with discounts, ICER indicates this is $4,643.50 annually.

Of the known drug costs, Ozempic had the highest lifetime drug costs at $30,000. For total lifetime costs, including background treatment costs and costs of cardiovascular and renal complications, Ozempic had the highest costs at about $289,000, followed by tirzepatide ($284,000), Jardiance ($264,000), and background therapy ($263,000).

Based on this initial analysis, ICER estimated that Ozempic produced the highest QALYs. Treatment with tirzepatide and Ozempic produced higher QALYs than background therapy alone.

The quality-adjusted life year is the academic standard for measuring how well different kinds of medical treatments lengthen and/or improve patients’ lives. ICER uses this as a measure of cost effectiveness.

ICER, however, does not provide health benefit price benchmarks as part of draft reports. The organization is now taking comments through Dec. 8, 2021, and will incorporate those in an updated document, which will be the subject of a public meeting on Jan. 20, 2022.

In terms of clinical evidence, ICER judged the net health benefits of tirzepatide to be incremental or better than background therapy alone. ICER determined tirzepatide to have comparable or incremental net health benefits when compared with Ozempic. The two therapies were part of head-to-head comparison in the SURPASS-2 trial. Tirzepatide showed greater reduction in HbA1c and weight as well as in triglycerides and blood pressure. But the tirzepatide group had a greater incidence of gastrointestinal side effects, injection-site reactions, severe adverse events, and discontinuation.

There were no head-to-head trials done with tirzepatide and Jardiance, and ICER conducted a network meta-analysis, which demonstrated that tirzepatide had a greater decrease in HbA1c and weight loss.

ICER reviewers pointed out that both Ozempic and Jardiance have demonstrated improvement in cardiovascular outcomes. An assessment for tirzepatide could not be made because the cardiovascular outcomes trial for tirzepatide is ongoing. However, ICER conducted a meta-analysis of cardiovascular events for safety across the SURPASS trials of tirzepatide, which showed no increase in cardiovascular events and a trend toward cardiovascular benefit.