Severe asthma is a high-cost category with an increasing number of therapies that treat the condition. To help stakeholders absorb datapoints and perceptions from all directions and synthesize those insights into a tangible strategy for severe asthma, Zitter Insights surveys a leading panel of pharmacy and therapeutics (P&T) decision makers at payers and integrated delivery networks. The Managed Care Biologics and Injectables Index combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading specialty brands.
Payers with more than half of commercial lives and those with more than a third of Medicare lives said that managing branded severe asthma therapies is an average priority for them. Commercial payers covering more than half of lives and Medicare payers with almost half of lives said they have an aggressive approach to managing those agents.
Almost all pulmonologists and payers with almost all lives said they are satisfied with the current medications for severe asthma. Payers representing more than half of lives and more than half of pulmonologists said there is moderate unmet need in the treatment of the condition. Almost all pulmonologists reported that patients have a high or very high disease burden.
During the year prior to the survey, Xolair (omalizumab) from Genentech USA, Inc., a Roche Group member, and Novartis Pharmaceuticals Corp. was the severe asthma agent pulmonologists prescribed most often, by almost one-third of respondents. That was followed by GSK’s Nucala (mepolizumab), Sanofi and Regeneron Pharmaceuticals, Inc.’s Dupixent (dupilumab), AstraZeneca’s Fasenra (benralizumab), the new agent Tezspire (tezepelumab-ekko) from Amgen Inc. and AstraZeneca and then Teva Pharmaceuticals USA, Inc.’s Cinqair (reslizumab).
On Dec. 17, 2021, the FDA approved Tezspire for the add-on maintenance treatment of severe asthma in people at least 12 years old. The agent is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine. It is the only biologic for severe asthma that does not have a phenotype or biomarker limitation within its label. Commercial and Medicare payers with more than four-fifths of lives had conducted a P&T review of Tezspire by the time of the survey. Among those who had yet to do so, payers with more than two-thirds of commercial lives and ones with almost all Medicare lives said they expect the new drug to have a moderate impact on products currently available to treat severe asthma. Almost one-third of pulmonologists said they expect Tezspire will have a moderate impact on their treatment of both new and current patients with severe asthma.
Social Determinants of Health
Among payers covering Medicare lives, the top social determinants of health initiatives for disadvantaged members with severe asthma are greater access to telehealth, educational content about healthy living and free or low-cost mental health services. Payers representing commercial lives said they prioritize services to assist in health/medicine language barriers, services to support health/medicine literacy and greater access to telehealth. Pulmonologists said they perceive socioeconomic status, followed by education and health literacy, as the top factors affecting the ability of people with severe asthma to access health care services.
Message: “Dupixent is now approved for children aged 6 to 11 years with uncontrolled asthma. This represents a population of about 75,000 in the U.S. The VOYAGE trial demonstrated a significant reduction in the annualized rate of exacerbations as compared to placebo. No new safety signals were found in this younger population.”
Payer Thoughts: “Dupixent’s expanded indication in asthma is unlikely to result in a significant increase in utilization, as atopic dermatitis remains the primary driver. We will continue to cover with prior authorization on specialty tier for all indications.”
FDA Approves Nucala Prefilled Syringe
On Jan. 24, 2022, the FDA approved a 40 mg prefilled syringe of GlaxoSmithKline plc’s Nucala (mepolizumab) as an add-on, maintenance treatment of children between the ages of 6 and 11 who have severe eosinophilic asthma. This will allow for in-home administration by a caregiver. The option to have a provider mix and administer the therapy in an office remains available.
New Drugs for Asthma, Kidney Disease, HIV Are On the Horizon
A new biologic for severe asthma, a drug for anemia related to chronic kidney disease (CKD) and a long-acting pre-exposure prophylaxis (PrEP) for HIV-1 are among the first-in-class therapies featured in OptumRx’s Q1 2022 Drug Pipeline Insights Report. In addition to these new drugs, the PBM also calls attention to the likelihood of more COVID-19 vaccines and treatments receiving full approval and additional uses in 2022.