New antibody-based treatments are better than traditional drugs for moderate to severe asthma, but they still cost too much, a U.S. drug cost watchdog says. More than 50% too much, in fact.
In a new draft report (PDF), the Institute for Clinical and Economic Review (ICER) evaluated five biologic drugs in inflammatory or allergic asthma: GlaxoSmithKline’s Nucala; Teva’s Cinqair; Roche and Novartis’ Xolair; AstraZeneca’s Fasenra; and Sanofi and Regeneron’s Dupixent.
After looking at the clinical data on the range of drugs, ICER conceded that, as compared with placebo, these biologics significantly reduce the number of exacerbations each year. And they improve health-related quality of life based on a 32-item patient questionnaire. However, what ICER really cares about—as it always does—is whether those benefits are worth the price, and its conclusion isn't as sunny.
The organization's number crunching found the drugs’ costs ranged from $313,000 to $464,000 per additional quality-adjusted life year (QALY) gained, a common benchmark for assessing cost-effectiveness. Xolair was at the low end of that range, with Dupixent at the high end. The upshot? These drugs need discounts of 50% to 68% off their list prices to meet the organization’s usual cost-effectiveness threshold of $150,000 per QALY.
Does this mean Dupixent will become the poster child of ICER’s next target in its fight against high drug costs? Not necessarily, said Leerink analyst Geoffrey Porges in a Wednesday note to investors.
ICER used Dupixent solely for its budget impact analysis because it “would take market share from one or more drugs” if it's approved as an add-on therapy for asthma as expected next month. ICER aimed to determine whether using the drug would pose too big a burden on healthcare budgets, using $991 million per year as its standard limit.
Based on a 5% discount off the wholesale acquisition price—and including the added costs of switching patients to Dupixent—ICER estimated that almost all of the 1.3 million eligible moderate-to-severe asthma patients could be treated with the Sanofi-Regeneron drug over five years without busting the healthcare budget threshold.
“The analysis […] suggests that Regeneron and Sanofi will have a strong pharmacoeconomic package to present to payers in order to gain preferred status on formulary tiers before IL-5s and [Xolair], especially if the manufacturers are willing to offer an incremental 5-10% discount to further reduce the budget impact for such a large patient population,” wrote Porges in the memo.
Porges also noted that ICER ran a subgroup analysis for patients with high eosinophils counts in their blood. Nucala, Cinqair and Fasenra have all been approved for severe eosinophilic asthma, and both Dupixent and Xolair had delivered greater efficacy in these patients. In its analysis, ICER said Dupixent appears to be better than other therapies, but “the differences are not significant.”
Porges predicted a new approval in asthma could add $2.5 billion to Dupixent’s peak revenue, in line with Bernstein analyst Ronny Gal’s previous projection, but above consensus. ICER is taking public comments for the draft report until Oct. 22.