MMIT Reality Check on Psoriatic Arthritis (July 2022)

Payer Coverage:

A review of market access for psoriatic arthritis treatments shows that under the pharmacy benefit, about 73% of the lives under commercial formularies are covered with utilization management restrictions. Around 37% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 50% of the lives under commercial policies are covered with utilization management restrictions. Almost 61% of the lives under Medicare policies have access to at least one of the drugs without utilization management restrictions.

For about 41% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 43% of the lives require multiple steps. Around 77% of payer-controlled pharmacy benefit covered lives require prior authorization, with 37% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Additional Indication for Skyrizi

In January 2022, the FDA gave another indication to AbbVie Inc.’s Skyrizi (risankizumab-rzaa) to treat adults with active psoriatic arthritis. The agency first approved the interleukin-23 (IL-23) antagonist on April 23, 2019. Dosing is 150 mg via subcutaneous injection at weeks zero and four and then every 12 weeks thereafter. The wholesale acquisition cost for one 150 mg dose every three months is $17,013.

FDA Approves Yusimry

In December 2021, the FDA approved Coherus BioSciences, Inc.’s Yusimry (adalimumab-aqvh) for the treatment of adults with moderately to severely active rheumatoid arthritis, people at least 2 years old with juvenile idiopathic arthritis, adults with active psoriatic arthritis, adults with active ankylosing spondylitis, people at least 6 with moderately to severely active Crohn’s disease, adults with moderately to severely active ulcerative colitis and adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate. 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.

FDA Grants Another Indication for Rinvoq

In December 2021, the FDA approved another indication for AbbVie Inc.’s Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis 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. The recommended dose of the tablet is 15 mg once daily. Website Drugs.com lists the price of 30 15 mg tablets as more than $5,522.

Key Findings:

Market Events Drive Changes

In January 2022, the FDA gave another indication to AbbVie Inc.’s Skyrizi (risankizumab-rzaa) to treat adults with active psoriatic arthritis. In December 2021, the agency approved Coherus BioSciences, Inc.’s Yusimry (adalimumab-aqvh) for the treatment of adults with active psoriatic arthritis, among other conditions. 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 the same month, the FDA approved another indication for AbbVie’s Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) inhibitor. 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 psoriatic arthritis.

Competitive Market Landscape

New-to-market products will have to compete with a crowded market of recently approved biosimilars and their reference products, which currently occupy preferred status on most plans, as well as brand-only disease-modifying antirheumatic drugs (DMARDs).

Pharmacy, Medical Benefit Implications

Most products in this indication are injectables with coverage available under both the pharmacy and medical benefit. Oral and self-administered injectable agents are covered primarily via the pharmacy benefit, while provider-administered medications are covered under the medical benefit. Policies will require trial and failure or evidence of intolerance to conventional therapy and preferred biologics, usually Humira and Amgen Inc.’s Enbrel (etanercept). Policies with defined prior authorization criteria for biologic DMARDs will require a documented negative tuberculosis test.

Key Players in Market:

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