AbbVie is counting on rising immunology star Rinvoq to defend its top line once Humira takes a plunge off the patent cliff in 2023, but a prominent drug pricing watchdog just raised concerns over the med's cost in an important use.
The Institute for Clinical and Economic Review (ICER) on Friday unveiled its draft evidence report on JAK inhibitors and monoclonal antibodies used to treat atopic dermatitis, otherwise known as eczema. Rinvoq isn't yet approved in atopic dermatitis, but ICER flagged its $64,300 list price as too expensive to justify considering its benefits in the indication.
At an annual wholesale acquisition cost (WAC) of $64,300, Rinvoq would need a hefty 44% to 77% discount to be cost-effective at various thresholds, ICER found. The drug’s net price per year is slightly lower at $63,400.
AbbVie didn't immediately respond to a request for comment.
For Rinvoq, the pricing pushback comes shortly after the FDA delayed its decision on the drug in moderate to severe atopic dermatitis by three months in response to concerns about the safety of the JAK inhibitor class. The regulator is now set to make its call in the third quarter.
For its report, ICER also reviewed Pfizer’s abrocitinib, Leo Pharma’s tralokinumab, Eli Lilly and Incyte’s Olumiant and Sanofi and Regeneron’s Dupixent. Only Dupixent is approved so far in the field, so the group used placeholder prices in many cases. AbbVie's Rinvoq, already approved in arthritis, carries the largest price tag of the group.
ICER figures Pfizer's abrocitinib would be cost-effective if it costs $37,500 per year at the $150,000 per QALY threshold. Leo Pharma's candidate tralokinumab would be cost-effective at $31,700 per year, ICER said. Olumiant is already roughly $2,000 below that threshold at a WAC of $29,000.
As for the leading player, Sanofi and Regeneron's Dupixent, ICER says its net price falls within its highest cost-effectiveness threshold.
Overall, Dupixent seems poised to keep its lead in atopic dermatitis, with ICER echoing some of the FDA’s same concerns about the long-term safety of JAK inhibitors. In moderate to severe disease, higher doses of Rinvoq or Pfizer’s abrocitinib “may be somewhat more effective” than Dupixent, the watchdog said. Olumiant—at the doses likely to be approved—and tralokinumab appear “somewhat less effective” than Dupixent, ICER said, but those comparisons come with “substantial uncertainty."
Aside from JAK safety concerns, ICER pointed out that it has limited long-term safety data on LEO’s IL-13 inhibitor tralokinumab. The group's safety concerns about Dupixent, which it raised back in 2017, have waned, thanks to “published data and widespread use in clinical practice.”
Overall, ICER concluded that the net health benefits for abrocitinib, Olumiant, Rinvoq and tralokinumab versus topical therapies were “promising but inconclusive." Abrocitinib and Rinvoq’s net health benefits versus Dupixent were deemed “insufficient,” while Olumiant and tralokinumab were “comparable or inferior” to Sanofi and Regeneron’s eczema superstar.
In the first three months of the year, AbbVie reported worldwide Rinvoq sales of $303 million. AbbVie is counting on the medicine and another next-gen immunology drug Skyrizi to generate $15 billion by 2025.
Dupixent, for its part, saw sales climb 45% to $1.27 billion in 2021’s first quarter, Sanofi said.