The FDA recently expanded the indication of AbbVie Inc.’s Rinvoq (upadacitinib), making it the first oral treatment for Crohn’s disease. And while respondents to a Zitter Insights survey said the drug will somewhat lessen the unmet need in the treatment of the condition, they said that a moderate level of need still exists with the agent’s approval.
On May 18, the FDA expanded the label of Rinvoq to include the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) inhibitor. The agency initially approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. This is the seventh indication the drug has gotten across rheumatology, dermatology and gastroenterology.
Recommended induction dosing of the tablet for the most recent use is 45 mg once daily for 12 weeks, and then maintenance dosing is 15 mg once daily. The wholesale acquisition cost (WAC) for a 30-day supply of all three strengths — 15 mg, 30 mg and 45 mg — is $6,124.96.
The FDA noted that this is the first oral agent it has approved for this condition. All other available treatments are either subcutaneously injected or intravenously infused.
For the Managed Care Biologics and Injectables Index: Q3 2022, from Aug, 26 2022, to Sept. 30, 2022, Zitter Insights polled 36 commercial payers covering 121.9 million lives, 28 Medicare payers representing 40.2 million lives and 50 gastroenterologists about their management and prescribing of therapies to treat Crohn’s disease. Commercial payers covering 68% of lives said that managing branded treatments for Crohn’s is a high or very high priority for them, while payers representing 66% of Medicare beneficiaries said the same thing.
Both AIS Health and Zitter Insights are divisions of MMIT.
Almost half — 44% — of gastroenterologists said that Rinvoq’s approval will have some impact on their treatment of new patients, and 38% said it would have a moderate impact on their treatment of current patients.
Payers covering 40% of commercial beneficiaries said that Rinvoq’s approval for Crohn’s will have some impact on other drugs available to treat the condition, meaning that there will not be a change in coverage or tiering, but some agents’ utilization management criteria may change. Payers representing 33% of Medicare lives said they expect it to have a high impact, with some products likely not to be covered any longer and/or having greater use of utilization management criteria.
Commercial payers with 70% of lives said that people with Crohn’s disease will have an average disease burden with the availability of Rinvoq, while Medicare payers with 60% of beneficiaries classified the burden as high. Payers covering 85% of commercial lives, those with 99% of Medicare lives and 74% of gastroenterologists said there is still either moderate or high unmet need in treating Crohn’s once Rinvoq becomes available (see chart).
For more information on the Zitter Insights data, contact Jill Brown Kettler at firstname.lastname@example.org.