Risk factors impact denials, wait times, discontinuations in biologic treatment for asthma
Key takeaways:
- There was an association between white race and denial for biologic treatment.
- Denials were more than twice as likely for dupilumab compared with omalizumab.
- Median time to approval was 34 days.
SAN DIEGO — Multiple risk factors were associated with denials and longer wait times for biologic treatment in moderate to severe asthma, as well as with discontinuations, according to a series of posters presented here.
These barriers can delay or prevent optimal care, Sunit P. Jariwala, MD, FAAAAI, professor, division of allergy/immunology, Albert Einstein College of Medicine, told Healio.
“Our earlier studies found that low-income NYC patients are more likely to experience delays in access to biologics, specifically due to time between approval and administration of medication,” Jariwala said. “Through these current studies, we sought to identify additional baseline factors that might contribute to biologics denials and increased wait times.”
Presented at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress, the study comprised patients treated for moderate to severe asthma at Montefiore Medical Center between 2017 and 2023.
“Biologics offer targeted treatments based on a patient’s asthma phenotype,” Jariwala said. “For moderate or severe persistent asthma patients who are refractory to other medications, such as preventive asthma inhalers, biologics have been shown to reduce asthma-related health care utilization such as asthma emergency department visits.”
In a cohort of 509 patients, 53 (10.4%) were denied biologic treatment. The researchers noted an association between white race and denial.
Treatment with dupilumab (Dupixent; Sanofi/Regeneron) was 2.41 times more likely than treatment with omalizumab (Xolair; Genentech/Novartis) to be denied (P = .022).
Other risk factors for denial included nasal polyps (OR = 2.79; P = .001), NSAID allergy (OR = 1.86; P = .041) and aspirin-exacerbated respiratory disease (OR = 2.34; P = .007). Age was associated with greater risk for denial as well (OR = 1.06; P = .004) in a multivariate regression model.
Among 395 patients with approved biologic treatment, the median time to approval was 34 days, which the researchers used to stratify times as shorter or longer. The patients with shorter times to approval were older, the researchers said.
Compared with approval times for omalizumab, approval times for mepolizumab (Nucala, GSK) were longer (OR = 1.76; P = .078). The most significant predictor for longer approval times was the number of steroid prescriptions (OR = 1.09) in the multivariate regression model.
Also, the researchers said that there were no associations between reduced times for approval and race, insurance type, the need for peer-to-peer review, types of clinical comorbidities, or number of office visits.
Further study found that 119 of 456 patients (26.1%) discontinued therapy, primarily because of lack of response (40%). Risks for discontinuation increased for patients with higher baseline eosinophil (P < .0001) and IgE (P = .003) levels. Risk factors also included older age (OR = 1.01; P = .033) and nasal polyps (OR = 2.27; P = .0002).
Patients with Medicare were more likely to discontinue treatment than patients with Medicaid (OR = 2.65; P = .002), as were patients on mepolizumab (OR = 2.3; P = .013) and benralizumab (Fasenra; AstraZeneca; OR = 2.26; P = .017) compared with those on omalizumab.
These factors may be useful in predicting denials, times to approval, and discontinuations in biologic treatment, the researchers said, but further studies may provide a better understanding of these risks and better guide increases in approvals and reductions in wait times.
Jariwala noted that specialty pharmacy-based interventions have value in reducing time to approval.
“As soon as the medication is ordered by the clinician, specialty pharmacy-based interventions navigate patients through the medication authorization, approval, appeal and delivery process,” Jariwala said. “This team also navigates renewals to ensure continuity of the medication for patients responding to therapy.”
Also, he said, increased physician awareness about the clinical value of biologics and referrals for evaluations related to biologics for patients with uncontrolled asthma may help as well.
Reference:
- Khan F, et al. Poster 723. Presented at: 2025 AAAAI/WAO Joint Congress; Feb. 28-March 3, 2025; San Diego.
- Jariwala S, et al. Poster 065. Presented at: 2025 AAAAI/WAO Joint Congress; Feb. 28-March 3, 2025; San Diego.
For more information:
Sunit P. Jariwala, MD, FAAAAI, can be reached at sjariwal@montefiore.org.