Can Targeting Patient Subpopulations Serve as a Market Access Lever?

The asthma market is dominated by a number of effective and well-established treatments, including inhaled and oral therapies, and it constitutes more than $10 billion in sales per year in the United States. However, the future outlook of the U.S. asthma market is going to be strongly influenced by a number of new entrants that will increase competition in the wider disease market but particularly in the moderate-to-severe segment. In particular, novel biological therapies in the pipeline may address unmet need for severe refractory patients, especially those who experience severe exacerbations, an underserved population with limited treatment options. Employing results from our survey of 104 clinicians (53 pulmonologists ,51 allergists) and 31 managed care organization (MCO) pharmacy/medical directors, we analyze the dynamics that will limit or promote market access for new market entrants, including GlaxoSmithKline’s mepolizumab, Cephalon/Teva’s reslizumab (Cinquil), AstraZeneca’s benralizumab, Roche/Chugai’s lebrikizumab, AstraZeneca’s tralokinumab, and Sanofi/Regeneron’s dupilumab.

Questions Answered in This Report:

  • Current perceptions and attitudes towards the severe, refractory asthma population: What percentage of patients treated with current asthma therapies remain uncontrolled despite treatment or are refractory to these agents? According to physicians, how are they currently prescribing Xolair, and what are the key reasons why eligible patients do not receive or discontinue treatment with this drug? What restrictions do MCO PDs/MDs currently impose on Xolair, and how will these change as new therapies begin to enter the market?

  • Emerging agents for severe, refractory asthma: What level of awareness do physicians have of emerging therapies, including mepolizumab, reslizumab (Cinquil), benralizumab, lebrikizumab, tralokinumab, and dupilumab? How do physicians rank these agents on their likelihood to prescribe them? Do payers expect to cover these agents on their formularies? Which characteristics of these drugs are most influential in future prescribing and formulary positioning decisions?

  • Dynamics of the U.S. reimbursement environment for severe, refractory asthma: What opinions do physicians and payers have about the requirement with several emerging biologics to perform a blood test to identify suitable patients? How would prescribing or formulary coverage be impacted for therapies requiring either a standard or proprietary diagnostic blood test? According to payers, at what price points will novel therapies gain favorable formulary status, and how will tier positioning affect relative line of therapy in prescribing? How will the potential launch of biosimilar versions of omalizumab impact the prescribing and formulary positioning of Xolair and the emerging biologics?

Scope:

This U.S. Physician & Payer Forum investigates payer and physician dynamics that affect prescribing practices for therapies for severe, refractory asthma in the United States. The report is based on a survey of 53 pulmonologists, 51 allergists, and 31 pharmacy/medical directors at MCOs that offer commercial health insurance. We analyze current physician and payer insights and practices; perceptions regarding biologics and biomarker screening tests; uptake of emerging biologics and biosimilar omalizumab for severe, refractory asthmatics; and formulary decision making for current and emerging agents, including Genentech/Novartis’s omalizumab (Xolair), GlaxoSmithKline’s mepolizumab, Cephalon/Teva’s reslizumab (Cinquil), AstraZeneca’s benralizumab, Roche/Chugai’s lebrikizumab, AstraZeneca’s tralokinumab, and Sanofi/Regeneron’s dupilumab.

- Markets covered: United States.

- Primary research: Online survey of 53 pulmonologists, 51 allergists, and 31 MCO pharmacy or medical directors.

- Epidemiology: Asthma.

- Population segments: Patients with severe, refractory disease.

Author(s): Eun-Jin Yang, Ph.D.

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