MMIT Reality Check on Ulcerative Colitis (August 2022)

Payer Coverage:

A review of market access for ulcerative colitis treatments shows that under the pharmacy benefit, about 64% of the lives under commercial formularies are covered with utilization management restrictions. Around 34% of the lives under Medicare formularies are not covered for at least one of the drugs.

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Under the medical benefit, about 62% of the lives under commercial policies are covered with utilization management restrictions. Almost 47% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

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For about 25% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 35% of the lives require multiple steps. Around 85% of payer-controlled pharmacy benefit covered lives require prior authorization, with 29% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

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Trends:

FDA Approves Additional Indication for Rinvoq

In March 2022, the FDA gave another indication to AbbVie Inc.’s Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) blocker. The agency initially approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. The recommended starting dose for the tablet is 45 mg once daily for eight weeks, followed by a maintenance dose of 15 mg once daily. The wholesale acquisition cost for a 30-day supply is $5,671.26.

FDA’s Rinvoq Approval Brings New Ulcerative Colitis Option

The FDA recently gave an additional indication to AbbVie Inc.’s Rinvoq (upadacitinib) in ulcerative colitis, broadening that therapeutic class even more. And while a study revealed some concerns around another agent with a similar mechanism of action, payers and gastroenterologists last year expressed interest in Rinvoq over other late-stage pipeline agents.

Researchers Examine CF, UC/Crohn’s Adherence, Say Specialty Pharmacies ‘Could Help Reduce Medical Burden’

Two recent studies of specialty-drug treated conditions examined the impact of adherence on hospitalizations and medical costs. Findings of the studies — one on cystic fibrosis (CF) and the other on ulcerative colitis (UC)/Crohn’s disease — from AllianceRx Walgreens Prime (which changed its name to AllianceRx Walgreens Pharmacy in late June) demonstrate the importance of specialty pharmacy interventions in helping keep patients adherent to therapy.

Key Findings:

Market Events Drive Changes

In March 2022, the FDA gave another indication to AbbVie Inc.’s Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) blocker. In December 2021, the agency approved Coherus BioSciences, Inc.’s Yusimry (adalimumab-aqvh) for the treatment of adults with moderately to severely active ulcerative colitis, among other indications. It is the seventh biosimilar of AbbVie’s Humira (adalimumab) that the agency has approved. Coherus says it will launch Yusimry on or after July 1, 2023. In October 2021, Janssen Biotech, Inc., a division of Johnson & Johnson, made an unbranded infliximab — the same product as its Remicade but with a wholesale acquisition price 59% lower — available for multiple indications, including ulcerative colitis.

Competitive Market Landscape

New-to-market products should expect stiff competition due to the number of originator biologics and biosimilars currently available and more expected in the pipeline. With most products demonstrating similar clinical efficacy, with the exception of anti-tumor necrosis factor (TNF) agents, which stand out as preferred biologics in clinical guidelines, costs to patients will be a determining factor for prescriber and patient choice; therefore, contracting remains extremely important for market success.

Pharmacy, Medical Benefit Implications

Most products in this indication are injectables with coverage available under the pharmacy and medical benefits. Oral and self-administered injectable products are covered primarily via the pharmacy benefit, while provider-administered products are covered under the medical benefit.
Partial coverage is available for originator products and biosimilars with a prior authorization. Initial coverage requirements often include a recent trial and failure of conventional therapy, such as corticosteroids and immunomodulators at their maximum doses. Policies typically require prescribing be done by or in consultation with a specialist and may require documentation of proven clinical response for reauthorization.

Key Players in Market:

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AIS Health Staff

AIS Health Staff

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