ICER Publishes Final Evidence Report and Policy Recommendations on Tezepelumab for Severe Asthma

—Independent appraisal committee found that evidence is adequate to demonstrate a net health benefit of tezepelumab added to standard of care in individuals with severe asthma —

— Tezepelumab would achieve common thresholds for cost-effectiveness if priced between $9,000 – $12,100 per year —

— Recommendations for fair access include ensuring that all biologic options be available for patients with severe asthma due to variation in treatment response and common failure of first biologic therapy to achieve clinical goals —

BOSTON, December 16, 2021 – The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of tezepelumab (Amgen, AstraZeneca) for the treatment of severe asthma.

ICER’s report on these therapies was reviewed at the November 2021 public meeting of the Midwest CEPAC (Midwest CEPAC), one of ICER’s three independent evidence appraisal committees.

Downloads: Final Evidence Report | Report-at-a-Glance | Policy Recommendations

“ICER previously reviewed biologic therapies for moderate-to-severe asthma, and none of those available at that time were effective in patients without allergic or eosinophilic asthma,” said David Rind, MD, ICER’s Chief Medical Officer. “Tezepelumab has a new mechanism of action and does reduce exacerbations even for patients without eosinophilia who really have not had good options for treatment until now. For other asthma patients for whom biologics are available, tezepelumab is not clearly superior to those options, and it may be less effective at getting patients off oral steroids than dupilumab.”

Voting on Clinical Effectiveness and Contextual Considerations

For treating severe asthma, a majority (10-4) of panelists found that the evidence is adequate to demonstrate a net health benefit of tezepelumab added to standard of care when compared to standard of care alone.

For treating severe allergic asthma or severe eosinophilic asthma, a majority of panelists found that the evidence is not adequate to distinguish the net health benefit of tezepelumab from that of omalizumab (13-1) and dupilumab (14-0), respectively. 

For treating steroid-dependent asthma, a majority (10-4) of panelists found that the evidence is not adequate to distinguish a net health benefit of tezepelumab from that of dupilumab.

During their deliberations, panel members also weighed the therapy’s other potential benefits, disadvantages, and contextual considerations. For tezepelumab, voting highlighted the following as particularly important for payers and other policymakers to note:

The magnitude of the lifetime health burden of severe asthma.

Voting on Long-Term Value for Money

Consistent with ICER’s process, the Midwest CEPAC did not vote on long-term value for money because the manufacturer has not yet announced a price for tezepelumab.

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 HBPBs are price ranges 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)

Asthma scores 1.21 on ICER’s Health Improvement Distribution Index (HIDI), reflecting that it is 21% more prevalent among US Black adults than among the entire US adult population, and therefore any health gains from a broadly effective treatment will benefit a greater proportion of Black patients relative to their proportion of the overall population. 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.

Key Policy Recommendations:

ICER’s independent assessment of value informs the critical decisions that stakeholders across the US health system need to make around pricing and coverage. Following the voting session, a policy roundtable of experts — including clinical experts, patient advocates, representatives from US payers, and pharmaceutical manufacturers — convened to discuss the pricing implications and recommendations to ensure fair access.  Key recommendations stemming from the roundtable discussion include:

Manufacturers should set the price for new treatments for asthma in fair alignment with added benefits for patients and take steps necessary to include a more diverse patient population in clinical trials, including adequate number of patients with ethnic and racial backgrounds similar to the underlying population in the US with asthma. 
Payers will need to consider subpopulations of people with severe asthma when designing coverage policies for tezepelumab and other biologics.
All biologic options be available for patients with severe asthma due to variation in treatment response and common failure of first biologic therapy to achieve clinical goals. 

Biologic treatments for severe asthma are not easily interchangeable in an individual patient.  Clinical experts therefore advised it is not clinically reasonable to require patients with severe asthma to switch biologic therapies when they change insurance plans.

ICER’s detailed set of policy recommendations, including comprehensive considerations for establishing evidence-based prior authorization criteria, is available in the Final Evidence Report and in the standalone Policy Recommendations document.

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.