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Tezepelumab, which is being currently reviewed by the FDA, provides small improvements in daily symptoms and quality of life but is only modestly cost-effectiveness at the anticipated price, according to the cost-effectiveness group's calculations.
The health benefit of AstraZeneca’s tezepelumab when added to standard of care therapy for severe asthma is comparable or better than standard care alone, but estimated costs could exceed standard cost-effectiveness measures, according to a draft analysis from the Institute for Clinical and Economic Review (ICER), the independent cost effectiveness and drug pricing group in Boston.,
Asthma affects about 25 million people in the United States, according to the CDC, and about 10% of patients have severe asthma. The condition leads to about 1.6 million emergency room visits, 180,000 hospitalizations, and 3,500 deaths each year in the United States. The societal costs are estimated to be $81.9 billion, including missed days from work and school, medical costs, and mortality.
Tezepelumab is a potential first-in-class therapy for severe asthma. It is a monoclonal antibody that inhibits the action of TSLP, an epithelial cytokine that plays a critical part in the inflammation associated with severe asthma. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles, and it has been correlated with disease severity.
AstraZeneca submitted a biologics license application (BLA) for tezepelumab to the FDA in July 2021 and the regulatory agency granted the therapy priority review. The Prescription Drug User Fee Act (PDUFA) date — the date by which the FDA is supposed to make a decision on the application — is in the early part of 2022.
The filing was based on results from the PATHFINDER clinical trials, including results from the pivotal NAVIGATOR phase III trial. In that trial, tezepelumab demonstrated superiority across the primary and key secondary end point in a broad population of patients with uncontrolled asthma while receiving treatment with medium- or high-dose inhaled corticosteroids.
ICER compared tezepelumab with Genentech’s Xolair (omalizumab) for patients with allergic asthma and Sanofi’s Dupixent (dupilumab) for patients with eosinophilic asthma. Reviewers also compared the efficacy of tezepelumab and Dupixent in patients dependent on chronic oral corticosteroids.
ICER reviewers found that for patients with eosinophilic asthma, improvements in symptom scores and reductions in annualized asthma exacerbation rate (AAER) were similar to the results seen with Dupixent. For patients with allergic asthma, improvements in symptoms were similar to those seen in older trials of Xolair while reductions in AAER were somewhat greater than with Xolair.
In a separate randomized trial of tezepelumab in patients with steroid-dependent asthma, patients treated with tezepelumab were not more likely to reduce their oral corticosteroid dose than placebo.
According to ICER findings, treatment with tezepelumab results in gains of 1.09 quality-adjusted life years (QALY) and 1.12 equal value life years (evLYs). From a health system perspective and using a placeholder price of about $27,860 per year, reviewers estimated a cost of $430,000 per QALY gained and $422,000 per evLY gained, which would exceed usual cost-effectiveness thresholds.
ICER reviewers also pointed out that trials for tezepelumab didn’t enroll enough Black patients to adequately assess how well the medication works in the Black Americans, which suffers disproportionately fromsevere asthma is more prevalent in this population.
ICER will be taking public comment on the draft analysis through Oct. 14, 2021, and a virtual meeting on the report is scheduled for Nov. 19, 2021.