Opzelura – NC Standard

Restricted Product(s):

• Opzelura (ruxolotinib) cream 1.5%

FDA Approved Use:

• For short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
• For the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older

Criteria for Approval of Restricted Product(s):

Initial Coverage

1. The patient is 12 years of age or older; AND
2. The patient has a diagnosis of mild-to-moderate atopic dermatitis; AND
   1. The patient's affected body surface area (BSA) is less than or equal to 20%; AND
   2. The patient has experienced a therapeutic failure or inadequate response to at least ONE medium- to high-potency topical corticosteroid; OR
      1. The patient has a clinical contraindication or intolerance to ALL topical corticosteroids; AND
   3. The patient has experienced a therapeutic failure or inadequate response to at least ONE topical calcineurin inhibitor; OR
      1. The patient has a clinical contraindication or intolerance to ALL topical calcineurin inhibitors; OR
3. The patient has a diagnosis of nonsegmental vitiligo; AND
   1. The patient's affected body surface area (BSA) is less than or equal to 10%; AND
   2. The patient has experienced a therapeutic failure or inadequate response to at least ONE medium- to high-potency topical corticosteroid; OR
      1. The patient has a clinical contraindication or intolerance to ALL topical corticosteroids; OR
      2. The prescriber has provided information indicating why the patient cannot use at least a medium-potency topical corticosteroid for the treatment of vitiligo; AND
   3. The patient has experienced a therapeutic failure or inadequate response to at least ONE topical calcineurin inhibitor; OR
      1. The patient has a clinical contraindication or intolerance to ALL topical calcineurin inhibitors; AND
4. The patient will not be using the requested agent in combination with other biologic immunomodulators, JAK inhibitors, or potent immunosuppressants; AND
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Continuation Coverage

1. The patient was approved through Blue Cross NC initial criteria for approval; OR
   1. The patient would have met initial criteria for approval at the time they started therapy; AND
2. The patient has a diagnosis of mild-to-moderate atopic dermatitis; AND
   1. The patient's affected body surface area (BSA) is less than or equal to 20%; AND
   2. The patient has demonstrated a positive clinical response while using the medication, as demonstrated by improved skin clearance
      (i.e., improved IGA-TS score, a reduction in itching, rashes, inflammation, or dryness/scaling, etc.); OR
3. The patient has a diagnosis of nonsegmental vitiligo; AND
   1. The patient's affected body surface area (BSA) is less than or equal to 10%; AND
   2. The patient has demonstrated a positive clinical response while using the medication, as demonstrated by a reduction in vitiligo patches or degree of depigmentation within patches (i.e., improved VASI or F-VASI score, etc.); AND
4. The patient will not be using the requested agent in combination with other biologic immunomodulators, JAK inhibitors, or potent immunosuppressants.

Duration of Approval: 365 days (1 year)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Quantity Limit Exception Criteria:

1. If the request is for Opzelura cream 1.5%, greater than 60g per 28 days:
   1. The patient has an affected body surface area (BSA) greater than 4%; AND
   2. The request does not exceed 240g per 28 days (one 60g tube per week); OR
2. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
3. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
4. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
5. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

March 2025: Criteria change: Created NC Standard policy. Essential no longer has step requirement through PDE-4 inhibitor. Updated QL to 60g per 28 days, and QL criteria to allow up to 240g per 28 days if member has BSA >4%.

April 2024: Criteria change: Created Enhanced and Net Results policy.

June 2023: Criteria change: Created Enhanced only policy. Removed step requirement through PDE-4 inhibitor.

January 2023: Criteria change: Expanded t/f topical corticosteroid to medium potency for both indications. Updated wording to require contraindication/intolerance to all products in each step requirement. Added criteria to allow prescribers to provide information if medium potency topical corticosteroid is inappropriate for vitiligo indication. Added BSA requirement. Added continuation criteria.

August 2022: Criteria update: Added expanded indication for nonsegmental vitiligo. Added clinical intolerance/contraindication criteria to t/f agents for atopic dermatitis indication.

October 2021: Original utilization management criteria issued.