Actemra — Blue Cross Blue Shield of Texas

Initial criteria

• Has tried and had an inadequate response to two Step 1 agents for the requested indication after at least a 3-month duration of therapy per agent and intolerance or hypersensitivity to one Step 1 agent OR has tried and had an inadequate response to one Step 1 agent after at least a 3-month duration and intolerance or hypersensitivity to two Step 1 agents OR has intolerance or hypersensitivity to three Step 1 agents OR the patient has an FDA labeled contraindication to all Step 1 agents OR all Step 1 agents are not clinically appropriate for the patient and prescriber provided list of previously tried agents OR the patient is currently being treated with the requested agent and is stable OR prerequisite biologic agent discontinued due to lack of efficacy, diminished effect, or adverse event OR required prerequisite expected to be ineffective, cause barrier, worsen comorbidity, or harm OR not in best interest based on medical necessity OR patient tried another drug in same class that was discontinued due to lack of efficacy or adverse event
• If Omvoh is requested for Crohn's disease or ulcerative colitis: patient has received or will receive Omvoh IV induction therapy
• If Entyvio is requested for Crohn's disease or ulcerative colitis: patient has received or will receive at least 2 doses of Entyvio IV therapy
• If Skyrizi is requested for Crohn's disease or ulcerative colitis: patient has received or will receive Skyrizi IV induction therapy
• If Zymfentra is requested for Crohn's disease or ulcerative colitis: patient has received or will receive an infliximab IV product for induction therapy
• If Tremfya is requested for ulcerative colitis: patient has received or will receive Tremfya IV induction therapy
• If patient has an FDA labeled indication: patient’s age is within FDA labeling OR supported for age
• If Cosentyx 300 mg is requested as maintenance dosing: for plaque psoriasis ± psoriatic arthritis and dose 300 mg every 4 weeks; OR for hidradenitis suppurativa, dose 300 mg every 4 weeks OR dose 300 mg every 2 weeks after inadequate response to 300 mg every 4 weeks ≥3 months; OR for psoriatic arthritis or ankylosing spondylitis, dose 300 mg every 4 weeks and prior inadequate response to 150 mg every 4 weeks ≥3 months
• If Tremfya 200 mg requested: diagnosis of Crohn's disease or ulcerative colitis
• If Omvoh 300 mg requested as maintenance dose: diagnosis of Crohn's disease
• If Actemra requested for systemic sclerosis associated interstitial lung disease: request is for Actemra syringe (not ACTpen)
• If Kevzara requested for polyarticular juvenile idiopathic arthritis: patient weighs ≥63 kg
• If diagnosis of moderate-to-severe atopic dermatitis: currently treated with topical emollients and good skin care and will continue those practices with requested agent
• Prescriber is a specialist or has consulted with one appropriate to diagnosis
• Requested agent will not be used concomitantly with other immunomodulators unless use is allowed and supported by evidence
• Patient does not have any FDA labeled contraindications to requested agent
• If required, patient tested for latent TB and has begun therapy if positive
• If member resides in Ohio and plan is Fully Insured or HIM Shop (SG): no FDA labeled contraindications and patient has another FDA labeled indication, compendia-supported indication, or two peer-reviewed journal articles supporting use

Reauthorization criteria

• Request is not for use of Olumiant or Actemra in treatment of COVID-19 in hospitalized adults requiring oxygen or ECMO
• Patient previously approved for requested agent through prior authorization
• For atopic dermatitis: patient has had clinical benefit and will continue maintenance therapies (topical emollients, good skin care)
• For polymyalgia rheumatica: patient has had clinical benefit and if Kevzara is requested, patient does not have neutropenia, thrombocytopenia, or AST/ALT elevations >3× ULN
• For other diagnoses: patient has had clinical benefit with requested agent
• Prescriber is or consulted with appropriate specialist
• Requested agent not used in combination with other immunomodulators unless permitted and supported by evidence
• Requested agent is eligible for continuation of therapy

Approval duration

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