Siliq — Blue Cross Blue Shield of Montana

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 an intolerance or hypersensitivity to ONE Step 1 agent OR has tried and had an inadequate response to ONE Step 1 agent and intolerance or hypersensitivity to TWO Step 1 agents OR has intolerance or hypersensitivity to THREE Step 1 agents
• Has an FDA labeled contraindication to ALL Step 1 agents for the requested indication OR ALL of the Step 1 agents are not clinically appropriate and prescriber has provided a complete list of previously tried agents for the requested indication
• Patient is currently being treated with the requested agent and is stable on it OR required prerequisite biologic immunomodulator agent(s) discontinued due to lack of efficacy, diminished effect, or adverse event OR expected ineffective or medically inappropriate based on clinical characteristics OR not in best interest based on medical necessity OR patient tried another drug in same pharmacologic class that was discontinued due to lack of efficacy or adverse event
• Omvoh for Crohn's disease or ulcerative colitis: patient has received or will receive Omvoh IV for induction therapy
• Entyvio for Crohn's disease or ulcerative colitis: patient has received or will receive at least 2 doses of Entyvio IV therapy
• Skyrizi for Crohn's disease or ulcerative colitis: received or will receive Skyrizi IV for induction therapy
• Zymfentra for Crohn's disease or ulcerative colitis: received or will receive infliximab IV product for induction therapy
• Tremfya for ulcerative colitis: received or will receive Tremfya IV for induction therapy
• Patient’s age is within FDA labeling or has support for age and indication
• Cosentyx 300 mg maintenance dosing: moderate to severe plaque psoriasis with or without psoriatic arthritis at 300 mg every 4 weeks OR hidradenitis suppurativa at 300 mg every 4 weeks or 300 mg every 2 weeks after inadequate response to 3 months of 300 mg every 4 weeks OR psoriatic arthritis or ankylosing spondylitis at 300 mg every 4 weeks after inadequate response to 150 mg every 4 weeks for 3 months
• Tremfya 200 mg requested: diagnosis of Crohn's disease or ulcerative colitis
• Omvoh 300 mg requested as maintenance dosing: diagnosis of Crohn’s disease
• Actemra for systemic sclerosis associated interstitial lung disease: request is for Actemra syringe (ACTpen not approvable for SSc-ILD)
• Kevzara for polyarticular juvenile idiopathic arthritis: patient weighs ≥63 kg
• Moderate-to-severe atopic dermatitis: currently treated with topical emollients and good skin care and will continue them with requested agent
• Prescriber is a specialist or consulting specialist in the diagnosis area
• Requested agent not used in combination with another immunomodulatory agent unless prescribing information allows and support for combination therapy is provided
• No FDA labeled contraindications to requested agent
• If required, patient has been tested for latent TB and treated if positive or no TB testing required per labeling
• For Ohio fully insured or HIM Shop members: no contraindications AND (FDA labeled indication OR compendia-supported indication OR submission of two major peer-reviewed publications supporting use)

Reauthorization criteria

• Request is not for use of Olumiant or Actemra in COVID-19 hospitalized adults (not covered)
• Patient previously approved for requested agent through the plan’s prior authorization process
• For moderate to severe atopic dermatitis: had clinical benefit and will continue maintenance therapies (e.g., topical emollients, good skin care)
• For polymyalgia rheumatica: had clinical benefit AND, for Kevzara, no neutropenia, thrombocytopenia, or AST/ALT >3× ULN
• For other diagnoses: patient had clinical benefit with requested agent
• Prescriber is or has consulted with a specialist in the diagnosis area
• Requested agent not used in combination with another immunomodulatory agent unless allowed by prescribing information and supported for combo therapy
• Requested agent is eligible for continuation of therapy

Approval duration

12 months