Currently, the majority of patients with persistent asthma
successfully control their disease through the use of more-conventional inhaled
agents. However, there remains a subset of patients whose disease remains
uncontrolled despite full compliance with a multi-drug regimen that includes
medium- or high-dose inhaled corticosteroid plus a long-acting beta2
agonist or unacceptable doses of oral corticosteroids. These patients have
severe, refractory asthma, and to date, their only treatment option has been Xolair
(Genentech/Novartis’s omalizumab), an IgE inhibitor launched in the United
States in 2003. In the late-stage pipeline for severe asthma are three novel
biologic agents and Spiriva (Boehringer Ingelheim/Pfizer’s tiotropium), which
we expect to help fulfill the unmet need in this population. The entrance of
these therapies will lead to the development of a more complex marketplace for
severe, refractory disease, one that will require physicians and payers alike
to make key decisions about which treatments to prescribe or reimburse over
others. In this report, which is based on our survey of 100 pulmonologists and
28 managed care organization (MCO) pharmacy or medical directors, we examine
the dynamics that will limit or promote market access of new therapies for
severe, refractory asthma.
Questions Answered in This Report:
Current perceptions and attitudes toward the severe,
refractory asthma population:
What are pulmonologists’ estimates of the
size and need of this population? What are their current prescribing practices
regarding Xolair? How will their prescribing change as new therapies enter the
market? What utilization restrictions do payers place on Xolair? To what extent
do these controls for severe, refractory agents influence prescribing?
Emerging agents for severe, refractory asthma:
How are the
efficacy and safety profiles of the emerging therapies perceived? How will the
safety and efficacy profiles of the emerging agents set them apart from each
other and from current therapies? Which characteristics of these drugs are most
influential in future prescribing and formulary positioning decisions? What
utilization controls will be placed on the new agents, and how will those
controls affect physician prescribing? How will the potential launch of
biosimilar versions of omalizumab affect the prescribing and formulary
positioning of the emerging biologics?
Dynamics of the U.S. reimbursement environment for severe,
What are payers’ expectations regarding the safety and
efficacy of the emerging agents? What are their expectations regarding patient
screening for optimal prescribing of the emerging biologics? At what price
points will novel therapies gain favorable formulary status? How will tier
positioning and utilization controls affect relative line of therapy in
prescribing and patient share? What clinical trial end points are payers
looking for in pivotal trials? Will head-to-head trials be necessary, and if
so, what comparators are preferred?
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 100 pulmonologists and 28 pharmacy/medical directors at MCOs that
offer commercial health insurance. We analyze current physician and payer
insights and practices; their perceptions of biologics and Spiriva in the
pipeline; the likely uptake of emerging therapies for severe, refractory asthma;
and formulary decision making for current and emerging agents, including
Genentech/Novartis’s omalizumab (Xolair), Cephalon/Teva’s reslizumab (Cinquil),
GlaxoSmithKline’s mepolizumab (Bosatria), Genentech’s lebrikizumab, and
Boehringer Ingelheim/Pfizer’s tiotropium (Spiriva).
Markets covered: United States.
Primary research: Online survey of 100 pulmonologists and
28 MCO pharmacy or medical directors.
Population segments: Patients with severe, refractory asthma.