- The Institute for Clinical and Economic Review, an influential drug pricing organization, found all five of the major biological asthma treatments on the market to be overpriced, according to a draft report released Sept. 24.
- The analysis focused on Sanofi and Regeneron's Dupixent, Novartis and Genentech's Xolair, GlaxoSmithKline's Nucala, Teva's Cinqair and AstraZeneca's Fasenra.
- The report is open for public comments through Oct. 22. An ICER council will further review the report and comments on Nov. 29.
ICER reviewed each drug's clinical effectiveness and then calculated what value-based pricing would look like using quality-adjusted life years, or QALY, a commonly used value metric.
The organization set pricing thresholds for each drug for $50,000, $100,000 and $150,000 per QALY gained. None of the drugs would be cost-effective at their current prices, the report concluded.
Even to hit the highest threshold of $150,000 per QALY gained, all the drugs would have to slash their annual price by at least half.
|Drug||Annual price*||$150,000 per QALY price||% discount to meet ICER range|
*As determined by ICER
Using the report's numbers, Regeneron Pharmaceuticals' Dupixent (dupilumab) would require the largest discount from its current list price to meet the $150,000 per QALY threshold. The Food and Drug Administration is reviewing Dupixent as a treatment for moderate-to-severe asthma with a decision expected in October. Dupixent is currently approved for atopic dermatitis.
Investment bank Leerink spun the report in a Sept. 26 investor's note as positive for Regeneron.
Analyst Geoffrey Porges wrote the ICER report "provides new evidence aligned with our superiority thesis and above-consensus forecast for Dupixent (dupilumab) in asthma."
Porges' note focused on the subset of eosinophilic asthma patients, which are people who have a high count of a certain inflammation marker.
While the ICER draft showed Dupixent beat placebo in this subset by the largest amount out of the five, it could not conclude with any statistical significance that Regeneron's biologic was any better than the other four in its meta-analysis of clinical data.
"[T]here remained significant heterogeneity in the populations," the draft stated. "In addition, the results did not differ substantially from the estimates from the original trials, which was unexpected as analyses for several of the trials found substantially greater relative risk reductions for exacerbations in the subgroup of patients with high baseline eosinophil counts."
Due to those limitations, ICER concluded there was insufficient evidence to determine comparative clinical effectiveness between the drugs.
But with the absence of head-to-head trials for these biologics, there's a data vacuum leaving analysts to try and parcel out evidence to show one drug is more effective than competitors.
Leerink projects asthma sales to contribute $2.5 billion to Dupixent's peak revenues and predicted total peak product revenues at $7.5 billion, well above consensus sales of $5.4 billion.