ustekinumab — CareFirst (Caremark)

Initial criteria

• Plaque psoriasis (PsO): Member age ≥ 6 years and has previously received a biologic or targeted synthetic drug (e.g., Sotyktu, Otezla) indicated for moderate to severe plaque psoriasis; OR member age ≥ 6 years with moderate to severe plaque psoriasis when any of the following criteria are met: crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) affected; OR at least 10% of body surface area (BSA) affected; OR at least 3% of BSA affected AND member has an inadequate response or intolerance to phototherapy or pharmacologic treatment with methotrexate, cyclosporine, or acitretin, OR clinical reason to avoid such pharmacologic treatments.
• Psoriatic arthritis (PsA): Member age ≥ 6 years and has previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Otezla) indicated for active PsA; OR member age ≥ 6 years for active PsA when any of the following criteria are met: mild to moderate disease with inadequate response, intolerance, or contraindication to methotrexate, leflunomide, or other csDMARDs (e.g., sulfasalazine); OR enthesitis; OR severe disease.
• Crohn’s disease (CD): Authorization may be granted for treatment of moderately to severely active Crohn’s disease.
• Ulcerative colitis (UC): Authorization may be granted for treatment of moderately to severely active ulcerative colitis.
• Immune checkpoint inhibitor-related toxicity: Authorization may be granted for treatment of immune checkpoint inhibitor-related diarrhea or colitis when the member has experienced an inadequate response, intolerance, or contraindication to infliximab or vedolizumab.
• For all indications: Documented negative tuberculosis (TB) test within 12 months prior to initiation if naïve to biologic or targeted synthetic drugs associated with increased TB risk, with appropriate management of any latent or active TB.
• For all indications: Requested medication not used concomitantly with any other biologic drug or targeted synthetic drug for the same indication.

Reauthorization criteria

• Plaque psoriasis (PsO): Member age ≥ 6 years using the medication for moderate to severe plaque psoriasis and achieves or maintains positive clinical response evidenced by low disease activity or improvement in signs and symptoms when either reduction in BSA affected or improvement in symptoms (itching, redness, flaking, scaling, burning, cracking, pain) documented.
• Psoriatic arthritis (PsA): Member age ≥ 6 years using the medication for PsA and achieves or maintains positive clinical response evidenced by low disease activity or improvement in signs and symptoms when any of the following improve: swollen or tender joints, dactylitis, enthesitis, skin/nail involvement, functional status, or CRP.
• Crohn’s disease (CD): Member using medication for moderately to severely active CD achieves or maintains remission OR positive clinical response evidenced by improvement in abdominal pain/tenderness, diarrhea, body weight, abdominal mass, hematocrit, mucosal appearance on imaging/endoscopy, or improvement in CDAI score.
• Ulcerative colitis (UC): Member using medication for moderately to severely active UC achieves or maintains remission OR positive clinical response evidenced by improvement in stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance on imaging/endoscopy, or improvement on UC scoring tools (UCEIS, Mayo score).
• Immune checkpoint inhibitor-related toxicity: Member requesting continuation must meet all initial coverage criteria.

Approval duration

12 months (6 months for immune checkpoint inhibitor-related toxicity)