Opzelura — Blue Cross Blue Shield of New Mexico

Initial criteria

• For atopic dermatitis (AD): ALL of the following must be met:
• • Patient has mild to moderate AD AND affected body surface area (BSA) ≤ 20%
• • Patient is NOT immunocompromised
• • ONE of the following:
• – Tried and had inadequate response to at least a low-potency topical corticosteroid after ≥ 4 weeks OR
• – Intolerance or hypersensitivity to at least a low-potency topical corticosteroid OR
• – FDA-labeled contraindication to ALL topical corticosteroids used in AD
• • ONE of the following:
• – Tried and had inadequate response to a topical calcineurin inhibitor after ≥ 6 weeks OR
• – Intolerance or hypersensitivity to a topical calcineurin inhibitor OR
• – FDA-labeled contraindication to ALL topical calcineurin inhibitors used in AD
• • BOTH of the following:
• – Currently treated with topical emollients and practicing good skin care AND
• – Will continue topical emollients and good skin care practices in combination with the requested agent
• For nonsegmental vitiligo: ALL of the following must be met:
• • Affected BSA ≤ 10%
• • ONE of the following:
• – BOTH of the following:
• • Diagnosis of stage IV advanced metastatic cancer and requested agent used to treat the cancer OR an associated condition (documentation required)
• • Use consistent with best practices, supported by evidence-based literature, and FDA approved
• – Has vitiligo on areas OTHER THAN face, neck, axillary, groin AND ONE of the following:
• • Tried and had inadequate response to at least a medium-potency topical corticosteroid for ≥ 2 weeks OR
• • Intolerance or hypersensitivity to a medium-potency topical corticosteroid OR
• • FDA-labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids
• – Has vitiligo on face, neck, axillary, groin AND ONE of the following:
• • Tried and had inadequate response to at least a medium-potency topical corticosteroid for ≥ 2 weeks OR
• • Tried and had inadequate response to a topical calcineurin inhibitor OR
• • Intolerance or hypersensitivity to a medium-potency topical corticosteroid or topical calcineurin inhibitor OR
• • FDA-labeled contraindication to ALL medium-, high-, and super-potency corticosteroids AND ALL topical calcineurin inhibitors
• For patients with another FDA-labeled indication:
• • The indication must be FDA-labeled
• • ONE of the following:
• – Patient’s age is within FDA labeling OR
• – Support exists for use in patient’s age
• • Prescriber is a specialist in the diagnosis area or has consulted with one
• • ONE of the following regarding concomitant therapy:
• – Will NOT be used with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
• – If used with another immunomodulator, BOTH:
• • Prescribing information does NOT limit combination use AND
• • Supported by clinical trials, studies, or guidelines (documentation required)
• • Patient does NOT have any FDA-labeled contraindications to the requested agent
• For members residing in Ohio (fully insured or HIM Shop plans):
• • Patient has no FDA-labeled contraindications AND ONE of the following:
• – Has another FDA-labeled indication for the requested agent and route of administration OR
• – Has another indication supported in compendia for the agent and route OR
• – Prescriber submits TWO articles from major peer-reviewed medical journals supporting safety and efficacy (randomized, double-blind, placebo-controlled; case studies not acceptable)

Approval duration

3 months (AD); 6 months (vitiligo); 12 months (BCBSIL, BCBSTX, and Ohio)