—  Tirzepatide has a novel dual GIP and GLP-1 receptor agonist mechanism of action and is seen as an add-on type 2 diabetes therapy; tirzepatide would achieve common thresholds for cost-effectiveness if priced between $5,500 – $5,700 per year —

— At the January 20 virtual meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate over tirzepatide’s comparative clinical effectiveness, other potential benefits, and long-term value for money —

BOSTON, January 6, 2022 – The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of  tirzepatide (Eli Lilly) for the treatment of type 2 diabetes.

“Tirzepatide is seen as an add-on therapy to metformin, like injectable semaglutide or empagliflozin,” said Jon Campbell, PhD, MS, ICER’s Senior Vice President for Health Economics. “It has a novel GIP and GLP-1 receptor agonist mechanism of action. When compared to injectable semaglutide in one head-to-head trial, tirzepatide showed a greater decrease in HbA1c levels and weight, as well as in triglycerides and blood pressure. The evidence suggests that tirzepatide may deliver important health benefits, but data are still limited on long-term cardiovascular and renal effects.”

This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC (New England CEPAC) on January 20, 2022. 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

The evidence provides high certainty that tirzepatide delivers at least a small net health benefit when added to background therapy, with the possibility of a substantial net health benefit (“B+”).

Tirzepatide is at least comparable to injectable semaglutide, with the potential of a small net health benefit (C+).

A lack of head-to-head data between tirzepatide and empagliflozin made it more difficult to assess clinical benefit. The evidence provides moderate certainty that tirzepatide is at least comparable to empagliflozin, with the possibility of delivering a more substantial net health benefit (C++).

Key Cost-Effectiveness Findings

Tirzepatide is not yet approved by the FDA, and its manufacturers have not yet announced what the treatment’s US price would be if approved. ICER’s health-benefit price benchmark (HBPB) range for tirzepatide is between $5,500 – $5,700 per year. This range factors in assumptions about long-term cardiovascular benefits that have not been directly demonstrated yet in clinical trials.

ICER’s HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.

Health Improvement Distribution Index (HIDI)

ICER’s Health Improvement Distribution Index (HIDI) findings are shown below for several populations. For example, type 2 diabetes scores 1.4 on the HIDI for American Indian/Alaska Native Americans, reflecting that type 2 diabetes is 40% more prevalent among American Indian/Alaska Native American adults than among the entire US adult population, and therefore any health gains from a broadly effective and accessible treatment will benefit a greater proportion of American Indian/Alaska Native American patients. Policymakers may choose to give special consideration to diseases that have a HIDI greater than 1, where equal access to effective treatments can reduce health disparities by producing proportionally greater improvement among the subpopulation of interest.

HIDI Findings:

  • American Indian/Alaska Native: 1.4
  • Hispanic: 1.2
  • Asian Indian: 1.2
  • Non-Hispanic Black: 1.1

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.