Draft ICER Report Finds Some Benefit for 5 Biologics to Treat Severe Asthma

The Institute for Clinical and Economic Review (ICER) found enough evidence that biologics provide a benefit over the usual standard of care for patients with moderate to severe asthma, the organization said in a draft evidence report released Tuesday.

However, since biologics cost much more than other pharmaceutical treatments, ICER said the 5 drugs it reviewed did not meet its usual cost-effectiveness thresholds and that “higher value care is more likely to be achieved through careful patient selection and continued biologic therapy for only treatment responders.”

Read more about ICER's work.

Severe asthma is defined as asthma that requires either oral corticosteroids for more than half of the year or the combination of high-dose inhaled corticosteroids and a long-acting beta agonist or other controller medication (leukotriene inhibitor/theophylline) to maintain control. Uncontrolled asthma is defined by at least 1 of the following: frequent exacerbations, serious exacerbations, or airflow limitation.Five monoclonal antibodies were evaluated for the treatment of eosinopilic, or type 2, inflammatory phenotype of asthma. This type accounts for about half of all patients with asthma.

Two—omalizumab (Xolair, Genentech/Novartis) and mepolizumab (Nucala, GlaxoSmithKline)—were rated as having incremental benefit over standard treatment. Three—dupilumab (Dupixent, Sanofi/Regeneron), reslizumab (Cinqair, Teva), and benralizumab (Fasenra, AstraZeneca) were rated as comparable or better.

The review considered asthma-related outcomes, including:

• Symptom scale/quality of life
• Asthma control
• Clinically significant asthma exacerbations
• Asthma-related hospitalizations and emergency room visits
• Mortality
• Use of oral steroids including a reduction in dose for those on chronic oral steroids
• Forced expiratory volume in 1 second (FEV1)
• Absence from school
• Absence from work
• Adherence
• Harms (serious adverse events, injection site reactions, infections)

The biggest benefit from the biologics was seen in health-related quality of life, followed by reduce exacerbations reductions alone (with indirect mortality benefits), and lastly by reduced usage of chronic oral steroids.

The report found incremental cost-effectiveness findings that ranged from $205,000 quality-adjusted life years (QALYs) for omalizumab to $269,000/QALY for dupilumab. None of the biologics met ICER’s threshold of $150,000/QALY.

In its budgetary impact analysis, ICER made its assumption using dupilumab as an example, since the other drugs it reviewed have already been on the market. Dupilumab is currently under FDA review for use as an additional treatment in moderate to severe asthma. A decision on dupilumab, which would be the first drug to target the IL-4 and IL-13 pathways in type 2 asthma, is expected next month.

At dupilumab’s wholesale acquisition cost (WAC) and discounted WAC, 39% and 99% of the eligible population could be treated before the total budget impact exceeds the ICER annual budget impact threshold of $991 million. While the difference in the per patient budget impact is only approximately $2000 per year, the substantial difference in the percentage of eligible population that can be treated is due to the size of the patient population.

At its prices to reach the cost-effectiveness thresholds between $50,000 and $150,000 per QALY, the total population budget impact resulted in cost-savings and the entire population could be treated.

As part of its report, ICER surveyed coverage of the biologics in the Missouri Medicaid plan, regional commercial plans, as well as Aetna and Cigna. Generally, coverage of the drugs required 1 to 3 severe exacerbations in a 3- to 12-month period, despite the continued use of a moderate- to high-dose inhaled cortical steroid (ICS) and another controller therapy such as a long-acting beta agonist or leukotriene receptor antagonist.

For Medicaid, Missouri requires the first dose to be prescribed by a specialist and the patient to have symptoms uncontrolled with continued use of an ICS and another controller therapy. The state also requires that the patient have visited the emergency department for an asthma exacerbation in the past 45 days.

Of the 3 regional plans surveyed, none covered any of the biologics except for 1, which covered omalizumab.