MMIT Reality Check on Psoriasis (4Q2023)

Payer Coverage:

A review of market access for psoriasis treatments shows that under the pharmacy benefit, about 63% of the lives under commercial formularies are covered with utilization management restrictions. Around 38% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 47% of the lives under commercial policies are covered with utilization management restrictions. Almost 48% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 28% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, 41% require multiple steps. Around 86% of payer-controlled pharmacy benefit covered lives require prior authorization, with 48% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Approves Bimzelx

In October 2023, the FDA approved UCB’s Bimzelx (bimekizumab-bkzx) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is the only interleukin 17A and IL-17F inhibitor that the agency has approved for psoriasis. Dosing is 320 mg via two 160 mg subcutaneous injections at weeks zero, four, eight, 12 and 16, and then every eight weeks. The company says the drug should be available about one month after approval.

FDA Grants Abrilada Interchangeability Status

In October 2023, the FDA granted interchangeability status to Pfizer Inc.’s Abrilada (adalimumab-afzb), a biosimilar of AbbVie Inc.’s Humira (adalimumab). The designation applies to all of Abrilada’s FDA-approved indications, which include the treatment of certain people with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. Dosing is based on the indication. It is the second Humira biosimilar to gain the interchangeable designation, following Boehringer Ingelheim’s Cyltezo and a recently launched unbranded version of that drug, adalimumab-adbm. Abrilada launched in late October with a wholesale acquisition cost 5% below Humira’s, and then later in the year, Pfizer will launch Abrilada with a WAC 60% below Humira’s. The drug currently is approved as a citrate-free, low-concentration formulation as a single-dose prefilled pen, a single-dose prefilled glass syringe and a single-dose glass vial for institutional use.

FDA Expands Zoryve Label

In October 2023, the FDA expanded the label of Arcutis Biotherapeutics, Inc.’s Zoryve (roflumilast) to include the treatment of plaque psoriasis, including intertriginous areas, in children ages 6 to 11 years old. The agency initially approved the phosphodiesterase 4 inhibitor on July 29, 2022. The cream should be applied once daily to affected areas. Drugs.com lists the price of one 60-gram tube as more than $878.

Key Findings:

Market Events Drive Changes

In October 2023, the FDA expanded the label of Arcutis Biotherapeutics, Inc.’s Zoryve (roflumilast) to include the treatment of plaque psoriasis, including intertriginous areas, in children ages 6 to 11 years old. In the same month, the agency also approved UCB’s Bimzelx (bimekizumab-bkzx) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is the only interleukin 17A and IL-17F inhibitor that the agency has approved for psoriasis. Multiple biosimilars of AbbVie Inc.’s Humira (adalimumab) launched in 2023: Amgen Inc.’s Amjevita (adalimumab-atto), Biocon Biologics Limited’s Hulio (adalimumab-fkjp), Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), Novartis Pharmaceuticals Corp.’s Hyrimoz (adalimumab-adaz), Celltrion USA’s Yuflyma (adalimumab-aaty), Fresenius Kabi’s Idacio (adalimumab-aacf), Coherus BioSciences, Inc.’s Yusimry (adalimumab-aqvh), Organon & Co.’s Hadlima (adalimumab-bwwd) and Pfizer Inc.’s Abrilada (adalimumab-afzb).

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 limited head-to-head studies showing significant effectiveness of one biologic over another, lower copays will make products more appealing to patients; therefore, contracting remains extremely important for market success.

Pharmacy, Medical Benefit Implications

Many products are covered under both the medical and pharmacy benefits, with even infusions covered under the pharmacy benefit. Coverage is available for originator products and biosimilars with a prior authorization. Initial coverage requirements often include recent trial and failure of conventional therapy and phototherapy. Some policies require a specific affected Body Surface Area (BSA) and a minimum severity classification.

Key Players in Market:

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