Asthma is a chronic inflammatory disorder of the airways leading to recurring episodes of wheezing, breathlessness, chest tightness, and coughing, with episodes characterized by airflow obstruction within the lung that is reversible, either spontaneously or with treatment. Disease severity is classified based on frequency and severity of symptoms—i.e., intermittent, mild persistent, moderate persistent, or severe persistent. Patients with severe persistent disease—comprising about 20% of the total U.S. asthma population—have more-frequent and more-severe exacerbations, often despite treatment, and are the targets for several emerging agents that may better serve this costly asthma subpopulation.

Physicians typically treat asthma patients in a stepwise manner, according to Global Initiative for Asthma Management and Prevention (GINA) guidelines, with the goal of maintaining patients on minimal drug therapy to achieve disease control. However, the limits of existing treatments and physicians’ frequent need to go through several lines of maintenance therapy create significant market potential for treatments that better serve the patients with more severe, persistent disease.

Inhaled corticosteroid (ICS) therapy, commonly GlaxoSmithKline’s Flovent (fluticasone propionate), is the mainstay of treatment for persistent asthma. Physicians may add a long-acting beta2 agonist (LABA), either in a separate inhaler or as a LABA/ICS fixed-dose combination inhaler such as GlaxoSmithKline’s Advair (salmeterol/fluticasone propionate) to boost efficacy. Severe asthma uncontrolled by LABA/ICS therapy and/or a leukotriene inhibitor (Merck’s Singulair [montelukast, generics]) or theophylline may receive oral corticosteroids or Genentech/Novartis’s anti-immunoglobulin E (IgE) biologic, Xolair (omalizumab), the latter if the patient has severe and/or refractory symptoms, elevated IgE levels, and perennial allergen sensitization. Xolair is the only treatment option beyond oral corticosteroids for severe, refractory asthma. However, it is relatively expensive, requires closely monitored SC injection, and carries a black box warning regarding anaphylaxis risk.

The pipeline for asthma includes several key therapies, including emerging interleukin (IL)-5 antagonists for severe, refractory patients with eosinophilic asthma. Employing the results from our survey of 103 clinicians (51 allergists, 52 pulmonologists) and 30 managed care organization (MCO) pharmacy/medical directors, we analyze the dynamics that will limit or promote market access for new market entrants, including Boehringer Ingelheim/Pfizer’s long-acting antimuscarinic antagonist (LAMA) Spiriva, GlaxoSmithKline’s once-daily LABA/ICS FDC Breo, and three IL-5 antagonists—Cephalon’s Cinquil (reslizumab), GlaxoSmithKline’s Bosatria (mepolizumab), and MedImmune/BioWa’s benralizumab. These therapies may offer incremental gains in safety, efficacy, and/or convenience. We also expect the launch of biosimilar omalizumab and branded-generic and generic forms of leading therapies (e.g., Advair), which will launch at a discount to their existing branded formulations.

Questions Answered in This Report:

  • Explore clinicians’ and payers’ attitudes toward emerging therapies in asthma: What impact does the availability of Breo for COPD have on physician prescribing for asthma and what are the payers’ reimbursement strategy and utilization control measures for this drug? What are physician and payer perceptions of Bosatria, Cinquil, and benralizumab? What impact will tiering decisions by MCOs have on physician prescribing of key emerging asthma therapies? How will MCOs reimburse emerging asthma therapies at various price points? What are the preferred end points for clinical trials? What issues drive MCOs to reimburse a drug on a nonpreferred tier instead of a preferred tier? How do payers anticipate positioning Spiriva within their formularies? What restrictions are payers likely to impose on the prescribing of Spiriva? Do payers anticipate recommending Spiriva be used ahead of biologics in the treatment of asthma? What impact will any payer imposed restrictions have on physician prescribing of biologics in asthma?

  • Understand clinician and payer perspectives on the existing market for biologics serving severe asthma: What are the sizes of the severe asthmatic and the COPD-like asthmatic sub-populations? What are physician perceptions of Xolair and other currently marketed drugs prescribed for severe asthma? Which factors limit physician prescribing of Xolair and what role do reimbursement restrictions play on physicians’ prescribing of the drug? What has been the role of manufacturer-sponsored copay assistance programs on Xolair prescribing and what is the payers’ attitude toward such programs?

  • Assess clinicians and payer perspectives on future treatment trends: What current and future patient shares do physicians estimate for key emerging agents and Xolair? How will the availability of branded-generic salmeterol/fluticasone propionate and biosimilar omalizumab affect physician prescribing and tier positioning of currently marketed and emerging therapies?

Scope:

This U.S. Physician & Payer Forum investigates payer and physician dynamics that affect prescribing practices for asthma therapies in the United States. The report is based on a survey of 103 specialist physicians (51 allergists, 52 pulmonologists) and 30 pharmacy/medical directors at MCOs that offer commercial health insurance. We analyze current physician and payer insights and practices; perceptions of novel agents in the pipeline; uptake of emerging therapies for high asthma (with a focus on the moderate to severe asthmatics); and formulary decision making for current and emerging agents, including  Spiriva, Breo, Cinquil, Bosatria, benralizumab, biosimilar omalizumab, and branded-generic/generic LABA/ICS fixed-dose combinations.

Markets covered: United States

Primary research: Online survey of 103 specialists (51 allergists, 52 pulmonologists) and 30 MCO pharmacy/medical directors

Population segments: Total, diagnosed, and drug-treated active cases of asthma; active cases of asthma broken out by severity (intermittent, mild, moderate, severe); patients with severe, refractory asthma.

Author(s): Laurie DiModica, M.S.

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