- Sanofi SA and Regeneron Pharmaceutical Inc.'s Dupixent isn't a cost-effective option for treating moderate-to-severe atopic dermatitis, according to the U.K.'s National Institute for Health and Care Excellence (NICE).
- Dupixent demonstrated solid efficacy in the clinic, leading to a EU approval in September. Yet even with that profile, a price tag of £1,264.89 (about $1,800) for a pair of syringes each carrying 2 ml of the product has raised eyebrows.
- "The committee agreed that dupilumab is innovative and a step change in managing atopic dermatitis, and acknowledged the stigma that can be associated with the condition. However, it did not hear that there were any additional gains in health-related quality of life over those already included in the [quality-adjusted life year] calculations," NICE wrote in an draft guidance published April 3.
Sanofi is relying on its nascent immunology business to help offset declines in diabetes. Revenues for the French pharma's best-selling product Lantus (insulin glargine) fell 19% last year, and its follow-on offering Toujeo (insulin glargine) hasn't escaped headwinds in the ultra-competitive U.S. diabetes market.
To that end, Dupixent (atopic dermatitis) is already proving its value. Sanofi recorded net sales of €219 million ($237 million) for the drug in 2017, while partner Regeneron recorded $256 million. The bulk of those sales come from the U.S., but Sanofi noted that €2 million ($1.8 million) came from Dupixent's launch in Germany.
Consensus among analysts put peak annual sales for the drug at $3 billion. Uptake will be key to achieving blockbuster status, however, putting weight behind the opinions of groups like NICE.
In crafting its draft guidance, NICE acknowledged Dupixent's efficacy but had concerns about some of the data and analyses Sanofi submitted. Two of NICE's conclusions, for instance, were that Sanofi both overestimated the long-term costs of best supportive care and underestimated the cost of injection site reactions and accident and emergency visits related to Dupixent treatment.
"As the quality of life estimates were adjusted over time, more people having best supportive care were assumed to be 'non-responders," NICE wrote. "Hence, over time, more people, and eventually everyone having best supportive care were assumed to be ‘non-responders’ and incurred the higher resource use and costs associated with 'nonresponse' ..."
"The committee considered that this would have over-estimated the longer-term costs of best supportive care. Because of this, the committee reiterated that it is important to model objective and plausible assumptions about the decline in clinical effectiveness and quality of life benefits," NICE added.
In its own statement, Sanofi highlighted it has until April 24 before the consultation period for the draft guidance ends.
"Whilst this is disappointing news, it is only the first step in the NICE appraisal process and we are currently reviewing NICE’s recommendations and the details that led to this initial assessment," Jessamy Baird, director of patient access in the U.K. and Ireland for Sanofi, said in an April 3 statement.
"We appreciate there will be complexities when assessing the cost-effectiveness of such a new treatment approach and will be submitting a formal response to the draft NICE guidance in the next few weeks."