Opzelura — Blue Cross Blue Shield of Oklahoma
Atopic dermatitis (mild to moderate)
Initial criteria
- ONE of the following:
- A. Diagnosis of mild to moderate atopic dermatitis (AD) AND ALL of the following:
- 1. Body surface area (BSA) ≤ 20%
- 2. Patient is NOT immunocompromised
- 3. ONE of the following:
- A. Tried and had an inadequate response to at least a low-potency topical corticosteroid used in AD after ≥ 4 weeks OR
- B. Intolerance or hypersensitivity to a low-potency topical corticosteroid OR
- C. FDA-labeled contraindication to ALL topical corticosteroids used in AD
- 4. ONE of the following:
- A. Tried and had an inadequate response to a topical calcineurin inhibitor used in AD after ≥ 6 weeks OR
- B. Intolerance or hypersensitivity to a topical calcineurin inhibitor OR
- C. FDA-labeled contraindication to ALL topical calcineurin inhibitors used in AD
- 5. BOTH of the following:
- A. Currently treated with topical emollients and practicing good skin care
- B. Will continue emollient use and good skin care practices in combination with the requested agent
- OR
- B. Diagnosis of nonsegmental vitiligo AND ALL of the following:
- 1. Body surface area (BSA) ≤ 10%
- 2. ONE of the following:
- A. BOTH of the following:
- 1. ONE of the following:
- A. Prescriber stated patient has stage four advanced, metastatic cancer and agent is used to treat the cancer OR
- B. Documentation of stage four advanced, metastatic cancer and agent used for associated condition
- 2. Use consistent with best practices and FDA-approved or supported by evidence-based literature
- OR
- B. Vitiligo impacting areas OTHER THAN face, neck, axillary, or groin AND ONE of the following:
- 1. Tried and had inadequate response to at least a medium-potency topical corticosteroid after ≥ 2 weeks OR
- 2. Intolerance or hypersensitivity to a medium-potency topical corticosteroid OR
- 3. FDA-labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids
- OR
- C. Vitiligo on the face, neck, axillary, or groin AND ONE of the following:
- 1. Tried and had inadequate response to medium-potency topical corticosteroid after ≥ 2 weeks OR
- 2. Tried and had inadequate response to topical calcineurin inhibitor OR
- 3. Intolerance or hypersensitivity to medium-potency topical corticosteroid OR topical calcineurin inhibitor OR
- 4. FDA-labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids AND ALL topical calcineurin inhibitors
- OR
- C. Patient has another FDA-labeled indication for the requested agent
- AND
- If patient has an FDA-labeled indication, ONE of the following:
- A. Patient’s age is within FDA labeling for requested indication OR
- B. Support for age use is provided
- Prescriber is a specialist in dermatology or has consulted with one
- ONE of the following regarding concomitant use:
- A. Not used in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
- B. Used in combination AND BOTH of the following:
- 1. Prescribing information does not limit use with another immunomodulator
- 2. Support for combination use provided (e.g., clinical trials, guidelines)
- Patient has no FDA-labeled contraindications to the requested agent
Approval duration
3 months for atopic dermatitis; 6 months for nonsegmental vitiligo; 12 months for BCBSIL and BCBSTX