ustekinumab (unbranded Stelara) — CareFirst (Caremark)

Initial criteria

• Plaque psoriasis: member age ≥ 6 years; candidate for phototherapy or systemic therapy; has previously received a biologic or targeted synthetic drug indicated for moderate to severe plaque psoriasis OR meets any of the following: crucial body areas affected OR ≥ 10% BSA affected OR ≥ 3% BSA affected with inadequate response or intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, or acitretin) OR has a clinical reason to avoid those agents.
• Psoriatic arthritis: member age ≥ 6 years; previously received a biologic or targeted synthetic drug indicated for active psoriatic arthritis OR (mild to moderate disease with inadequate response, intolerance, or contraindication to methotrexate, leflunomide, or other conventional synthetic drugs such as sulfasalazine) OR presence of enthesitis OR severe disease.
• Crohn’s disease: treatment of moderately to severely active Crohn’s disease.
• Ulcerative colitis: treatment of moderately to severely active ulcerative colitis.
• Immune checkpoint inhibitor-related toxicity: treatment of diarrhea or colitis when member has experienced inadequate response, intolerance, or contraindication to infliximab or vedolizumab.
• For all indications: prescriber must be appropriate specialist (dermatologist, rheumatologist, gastroenterologist, hematologist, oncologist as applicable), member must have negative TB test within 12 months if biologic-naïve; treatment of active or latent TB as appropriate prior to initiation; cannot use concomitantly with another biologic or targeted synthetic for same indication.

Reauthorization criteria

• Plaque psoriasis: age ≥ 6 years; positive clinical response (low disease activity or improvement in signs/symptoms) such as reduction in BSA affected or improvement in itching, redness, flaking, scaling, burning, cracking, pain.
• Psoriatic arthritis: age ≥ 6 years; positive clinical response evidenced by improvement in number of swollen/tender joints, dactylitis, enthesitis, skin/nail involvement, functional status, or CRP.
• Crohn’s disease: positive clinical response or remission evidenced by improvement in abdominal pain, tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on imaging or endoscopy, or disease activity scores (e.g., CDAI).
• Ulcerative colitis: positive clinical response or remission evidenced by improvement in stool frequency, rectal bleeding, urgency of defecation, CRP, fecal calprotectin, mucosal appearance, or disease activity scores (e.g., UCEIS, Mayo score).
• Immune checkpoint inhibitor-related toxicity: must continue to meet initial coverage criteria.

Approval duration

12 months for psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis; 6 months for immune checkpoint inhibitor-related toxicity