Cibinqo — Blue Cross Blue Shield of Illinois

Initial criteria

• The requested agent is eligible for continuation of therapy AND the prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR BOTH of the following:
• Diagnosis of moderate-to-severe atopic dermatitis (AD) AND BOTH of the following:
• – ONE of the following: at least 10% body surface area involvement OR involvement of difficult-to-treat sites (hands, feet, face, neck, scalp, genitals/groin, skin folds) OR EASI score ≥16 OR IGA score ≥3
• – ONE of the following: (A) BOTH of the following: (1) ONE of the following: tried and had inadequate response to ≥1 medium-potency topical corticosteroid for ≥4 weeks OR intolerance/hypersensitivity to ≥1 medium-potency corticosteroid OR FDA labeled contraindication to all medium-, high-, and super-potency topical corticosteroids AND (2) ONE of the following: tried and had inadequate response to ≥1 topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) for ≥6 weeks OR intolerance/hypersensitivity to ≥1 topical calcineurin inhibitor OR FDA labeled contraindication to all topical calcineurin inhibitors OR (B) patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for treatment of AD
• OR patient has another FDA labeled indication or compendia-supported indication for requested agent
• If patient has FDA labeled indication, ONE of the following applies: age within FDA labeling for indication OR support for use in patient’s age for indication
• If patient has AD, BOTH of the following: currently treated with topical emollients and good skin care AND will continue use of emollients and good skin care with requested agent
• Patient has been tested for latent tuberculosis and if positive has begun therapy for latent TB
• Prescriber is a specialist (e.g., dermatologist, allergist, immunologist) or has consulted with appropriate specialist
• ONE of the following: (A) Patient will NOT use requested agent with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) if combined therapy used, BOTH of the following: prescribing information does not limit use with another immunomodulatory agent AND support for combination therapy provided (clinical trials, phase III studies, or guidelines)
• Patient does NOT have any FDA labeled contraindications to requested agent
• For members in Ohio with fully insured or HIM Shop (SG) plan, approval also if patient has no contraindications AND ONE of the following: another FDA labeled indication OR compendia-supported indication OR two peer-reviewed journal articles supporting safe and effective use for proposed indication

Reauthorization criteria

• Patient previously approved for requested agent through plan’s Prior Authorization process
• Patient has had clinical benefit with requested agent
• If diagnosis is moderate-to-severe atopic dermatitis, patient will continue maintenance therapies (topical emollients, good skin care) with requested agent
• Prescriber is a specialist (e.g., dermatologist, allergist, immunologist) or has consulted with appropriate specialist
• ONE of the following: (A) Patient will NOT use requested agent with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) if combined therapy used, BOTH of the following: prescribing information does not limit use with another immunomodulatory agent AND support for combination therapy provided (clinical trials, phase III studies, or guidelines)
• Patient does NOT have any FDA labeled contraindications to requested agent

Approval duration

6–12 months (BCBSIL, BCBSMT, BCBSTX: 12 months; others: 6 months; renewal: 12 months)