ICER’s analysis finds that Tezspire, which is under review at the FDA, provides clinical benefit for patients with severe asthma, but with increased costs to the healthcare system.
Tezspire (tezepelumab), a monoclonal antibody under review at the FDA to treat patients with asthma, would need to be priced at between $9,000 and $12,000 annually to meet standard thresholds for cost-effectiveness, according to a review by the Institute for Clinical and Economic Review (ICER).
But at an anticipated price of $28,000 per year, the therapy would exceed cost-effectiveness standards, and cost-effectiveness is only modestly improved when productivity and other effects are considered, according to the report.
Treatment with Tezspire results in gains of 1.09 quality adjusted life year and 1.12 equal value life year. The quality-adjusted life year (QALY) is the academic standard for measuring how well different kinds of medical treatments lengthen and/or improve patients’ lives. ICER uses this measure of cost effectiveness, as well as equal value life year (evLY), which measures any gains in length of life, regardless of the treatment’s ability to improve patients’ quality of life.
From a health system perspective and using a placeholder net price of approximately $28,000 per year, ICER estimates a cost of $430,000 per QALY gained and $422,000 per evLY gained.
“The base-case findings suggest that tezepelumab plus standard of care (SoC) provide clinical benefit in terms of gains in QALYs, LYs, and evLYs over SoC alone but do so with increased costs to the health system and society. For scenario analyses within the allergic and eosinophilic asthma populations, we find similar results to the base case,” ICER reviewers wrote.
Tezspire is being developed by AstraZeneca in collaboration with Amgen. The companies submitted a biologic license application to the FDA in July 2021, and the FDA granted Tezepelumab priority review. The Prescription Drug User Fee Act action date is set for the first quarter of 2022.
Tezspire is a potential first-in-class monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), a key cytokine that in allergic, eosinophilic and other airway inflammation associated with severe asthma. It is administered by subcutaneous injection every four weeks.
In data the companies released, Tezspire significantly improved exacerbation rate, its primary end point, and met secondary end points of improvements in lung function, asthma control and quality of life. ICER reviewers pointed that that although Tezspire improved symptom scores compared with placebo, these improvements were smaller than the minimal clinically important differences on the scales used.
ICER compared Tezspire with Xolair (omalizaub) for patients with allergic asthma and Dupixent (dupilumab) for patients with eosinophilic asthma. For patients with eosinophilic asthma, Tezspire’s improvement in annualized asthma exacerbation rate (AAER) was similar to that seen with Dupixent.
For patients with allergic, asthma Tezspire’s improvements in symptoms was similar to Xolair, although Tezspire achieved a higher improvement in the exacerbation rate.
ICER reviewers point out that symptom control, rather than exacerbation rate, remains a priorty for both physicians and patients.
Additionally, ICER reviewers noted the lack of data of Tezspire’s effect in subpopulations, specifically among Black patients. The CDC estimates that 25 million Americans have asthma. In the United States, asthma is more than twice as common among Black children as among White children and remains somewhat more common among Black adults. In one trial of Tezspire, only 92.5% of patients where White, and in another trial, only 5.8% of patients were Black.