First Dual Inhibitor of Its Kind Is Expected to Have Some Impact in Psoriatic Arthritis

A recently approved treatment for psoriatic arthritis (PsA) brings a new mechanism of action to the therapeutic class. And while payers and rheumatologists varied in their expectations of what the drug’s impact on coverage of and prescribing for the class will be, almost half said they expect it to have at least some effect, according to a survey by Zitter Insights.

On Sept. 20, the FDA approved three more indications for UCB, Inc.’s Bimzelx (bimekizumab-bkzx) for the treatment of adults with active PsA, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation and adults with active ankylosing spondylitis. Two months later, on Nov. 20, the FDA gave the drug another approval, for the treatment of moderate-to severe hidradenitis suppurativa.

The agency first approved the humanized interleukin 17A (IL-17A) and IL-17F antagonist on Oct. 17, 2023, for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The latest approvals make the agent the first IL-17A and IL-17F inhibitor with FDA approval for the treatment of five chronic immune-mediated inflammatory diseases.

Dosing for PsA is 160 mg via subcutaneous injection every four weeks. For people with PsA and coexistent moderate-to-severe plaque psoriasis, dosing follows the latter condition’s dosage: 320 mg at weeks zero, four, eight, 12 and 16 and then every eight weeks. Drugs.com lists the wholesale acquisition cost (WAC) for one 160 mg/mL single-dose syringe or autoinjector as more than $7,962.

PsA symptoms include joint pain and stiffness, skin plaques and swollen toes and fingers. About 30% of people with psoriasis develop PsA.

Two other agents that inhibit IL-17A are approved for PsA, as well as other inflammatory conditions — Lilly’s Taltz (ixekizumab) and Novartis Pharmaceuticals Corp.’s Cosentyx (secukinumab) — but they do not inhibit IL-17F. Both are important cytokines that drive inflammatory processes.

For the Managed Care Biologics and Injectables Index: Q2 2023, from May 24, 2023, to June 30, 2023, Zitter Insights polled 34 commercial payers covering 117.0 million lives, 29 Medicare payers covering 43.3 million lives, 50 rheumatologists and 46 practice managers about their management and prescribing of PsA treatments, as well as about pipeline therapies.

AIS Health and Zitter Insights are both divisions of MMIT.

About half — 47% — of the payer respondents said that managing branded PsA treatments is a high priority, while the same percentage said their management of the agents is aggressive or very aggressive. Payers covering 71% of commercial lives and 71% of Medicare lives said they have average satisfaction with current treatments, but 64% of rheumatologists said they had high satisfaction with them.

In addition, 47% of payers and 56% of rheumatologists said that moderate unmet need exists in treating PsA. Fifty-four percent of rheumatologists said that people with the condition have a high level of disease burden compared with 36% of payers who rated it as high.

Rheumatologists said that socioeconomic status was the No. 1 social determinants of health factor impacting people’s ability to access health care services and therapy, followed by education and health literacy, and occupation and job security.

While 34% of rheumatologists said they expect Bimzelx to have a moderate impact on their treatment approach, meaning they expect it to change for a considerable portion of their patients, 16% said they anticipate it will have a high impact, resulting in a change for the majority of their patients. However, 44% said they think it will have some impact on their treatment approach, which will remain mostly unchanged except for certain patients.

Payers also varied in how much of an impact they said they expected the drug to have on their coverage of other available PsA therapies, with 44% saying they anticipate it will have some impact, with no change in coverage or tiering but potential changes to their utilization management criteria (see infographic).