Tremfya 200 mg — Blue Cross Blue Shield of Illinois

Initial criteria

• Has tried and had an inadequate response to two Step 1 agents for the requested indication after ≥3 months per agent and an intolerance or hypersensitivity to one Step 1 agent OR
• Has tried and had an inadequate response to one Step 1 agent for the requested indication after ≥3 months and an intolerance or hypersensitivity to two Step 1 agents OR
• Has an intolerance or hypersensitivity to three Step 1 agents OR
• Has an FDA labeled contraindication to all Step 1 agents for the requested indication OR
• All Step 1 agents are not clinically appropriate AND prescriber provided list of previously tried agents OR
• The patient is currently being treated with the requested agent and is stable on therapy [chart notes required] OR
• Required prerequisite biologic immunomodulator(s) discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
• Required prerequisite biologic immunomodulator(s) expected to be ineffective or unsafe due to clinical factors [chart notes required] OR
• Required prerequisite biologic immunomodulator(s) not in patient's best interest based on medical necessity [chart notes required] OR
• Patient has tried a drug in same class/mechanism as prerequisite which failed or caused an adverse event [chart notes required]
• For Omvoh in Crohn's disease or ulcerative colitis: received Omvoh IV induction therapy OR new and will receive Omvoh IV induction therapy
• For Entyvio in Crohn's disease or ulcerative colitis: received ≥2 doses of Entyvio IV therapy OR new and will receive ≥2 doses
• For Skyrizi in Crohn's disease or ulcerative colitis: received Skyrizi IV induction OR new and will receive Skyrizi IV induction
• For Zymfentra in Crohn's disease or ulcerative colitis: received infliximab IV induction OR new and will receive infliximab IV induction
• For Tremfya in ulcerative colitis: received Tremfya IV induction OR new and will receive Tremfya IV induction
• Patient age within FDA labeling OR supported for patient age
• For Cosentyx 300 mg: if plaque psoriasis (± psoriatic arthritis) dose 300 mg every 4 weeks OR
• For hidradenitis suppurativa: dose 300 mg every 4 weeks OR 300 mg every 2 weeks after inadequate response to 4-week regimen ≥3 months OR
• For active psoriatic arthritis or active ankylosing spondylitis: dose 300 mg every 4 weeks after inadequate response to Cosentyx 150 mg every 4 weeks ≥3 months
• For Tremfya 200 mg: diagnosis of Crohn's disease or ulcerative colitis
• For Omvoh 300 mg: diagnosis of Crohn's disease
• For Actemra in systemic sclerosis associated ILD: request is for Actemra syringe (ACTpen not approvable for SSc-ILD)
• For Kevzara in pJIA: patient weight ≥63 kg
• For atopic dermatitis: currently treated with topical emollients and good skin care AND will continue both
• Prescriber is or has consulted with an appropriate specialist
• Patient will not use agent concomitantly with another immunomodulatory agent OR combination use supported and not contraindicated
• Patient has no FDA labeled contraindications to requested agent
• If prescribing information requires latent TB testing, TB testing performed and treated if positive OR TB testing not required
• For Ohio members of Fully Insured or HIM Shop plan: no contraindications AND indication is FDA labeled, compendia supported, or supported by ≥2 peer-reviewed journal articles

Reauthorization criteria

• Not for use of Olumiant or Actemra in COVID-19 hospitalized adults
• Patient previously approved for the requested agent
• For atopic dermatitis: clinical benefit demonstrated AND will continue topical emollients/skin care
• For polymyalgia rheumatica: clinical benefit demonstrated AND if Kevzara, no neutropenia (ANC <1000/mm³), no thrombocytopenia (platelets <100,000/mm³), and no AST/ALT >3× ULN
• For all other diagnoses: clinical benefit demonstrated
• Prescriber is or has consulted with an appropriate specialist
• Patient will not use in prohibited combination OR combination use supported
• Requested agent eligible for continuation of therapy

Approval duration

12 months (Rinvoq for AD: 6 months; Siliq for PS: 16 weeks; Xeljanz/Xeljanz XR UC induction: 16 weeks)