— Tezepelumab reduces asthma exacerbations, but there is uncertainty about long-term safety as with all new biologic therapies; tezepelumab would achieve common thresholds for cost-effectiveness if priced between $9,000 – $12,100 per year —

— At the November 19 virtual meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate over tezepelumab’s comparative clinical effectiveness, other potential benefits, and long-term value for money —

BOSTON, November 4, 2021 – The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of tezepelumab (Amgen, AstraZeneca) for the treatment of severe asthma.

“ICER previously reviewed biologic therapies for moderate-to-severe asthma, and none of these were effective in patients with allergic nor eosinophilic asthma,” said David Rind, MD, ICER’s Chief Medical Officer. “Tezepelumab has a new mechanism of action and does reduce exacerbations even in patients without eosinophilia who really have not had good options for treatment until now. In other asthma patients for whom biologics are available, tezepelumab is not clearly superior to those options, and it appears to be less effective in getting patients off oral steroids than dupilumab. Additionally, there remains a large unmet need for therapies that substantially improve daily quality of life in patients with severe asthma.”

This Evidence Report will be reviewed at a virtual public meeting of Midwest CEPAC (Midwest CEPAC) on November 19, 2021. The Midwest 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

For the treatment of severe uncontrolled asthma, the evidence provides high certainty that tezepelumab is at least comparable to standard of care alone (without biologics), with the possibility of delivering either a small or substantial net health benefit (“C++”). This evidence rating balances the benefits of tezepelumab in reducing exacerbations with uncertainties about long-term safety.

For patients with allergic asthma, the evidence is insufficient (“I”) to compare tezepelumab with omalizumab.

Dupilumab has substantially more evidence on long-term safety. In the absence of head-to-head trials, the evidence is insufficient (“I”) to compare tezepelumab with dupilumab for the treatment of eosinophilic asthma. Given the somewhat limited data available from the tezepelumab trial, for patients with steroid-dependent asthma, the evidence provides high certainty that tezepelumab at best provides a net health benefit comparable to dupilumab, with the possibility that tezepelumab may be inferior (“C-”).

Key Cost-Effectiveness Findings

Tezepelumab 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 tezepelumab is between $9,000-$12,100 per year.

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.

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