CurrentAvMedPolicy N/A

Opzelura

Prior authorization form and clinical criteria for coverage of topical ruxolitinib (Opzelura) through AvMed specialty pharmacy, including initial and reauthorization requirements, quantity limits, age limits, prescriber specialty, concomitant therapy exclusions, prior therapy trials, and documentation requirements.

Policy Summary

PayerAvMed

PolicyOpzelura

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the AvMed PA/step-edit request form and fax to 1-305-671-0200; authorization can be delayed if incomplete or illegible.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes — current document is a prior authorization/step-edit form with criteria and documentation requirements.

2Distinct age thresholds (>=2 yrs; >=12 yrs for vitiligo)

1Quantity limit

20/10BSA limits (eczema/general vs vitiligo)

Coverage Summary

Coverage stance: covered_with_criteria — topical ruxolitinib (Opzelura) is covered when all form criteria are met and required documentation is provided. Scope: prior authorization form and clinical criteria for specialty pharmacy dispensing through AvMed (provided by Proprium Rx) covering initial and reauthorization requirements, prescriber specialty, age limits, prior therapy trials, concomitant therapy exclusions, and documentation requirements. Specialty pharmacy dispensing: Medication is provided by Specialty Pharmacy - Proprium Rx. Quantity and other thresholds: quantity limit 1 tube (60 grams) per 28 days; age thresholds: ≥ 2 years for general eczema/dermatitis use and ≥ 12 years for vitiligo; Body Surface Area thresholds: initial eczema/general BSA ≤ 20% (member will NOT be applying to more than 20% BSA) and vitiligo BSA ≤ 10% (provider attests area impacted does NOT exceed 10% BSA).

Initial Therapy Criteria (Eczema / General)

Initial Authorization (6 months) - general

All criteria must be met for approval; documentation (labs, diagnostics, chart notes) must be provided.

ALL of the following

Prescribed by or in consultation with an allergist, dermatologist, or immunologist
Member is 2 years of age or older>= 2 years
Member is NOT immunocompromised
Medication will NOT be used in combination with other biologic disease-modifying antirheumatic drugs (e.g., Humira, Enbrel, Taltz, Stelara), JAK inhibitors (e.g., Xeljanz, Rinvoq, Olumiant), or potent immunosuppressants (e.g., azathioprine, cyclosporine)
Member will NOT be applying to more than 20% of Body Surface Area (BSA)<= 20%
Chart notes documenting BSA must be attached
Prior topical and other therapy trials (history of failure, contraindication, or intolerance to ALL listed therapies)
- 30 days (14 days for very high potency) of therapy with TWO topical corticosteroids in the past 180 days30 days (14 days for very high potency) within past 180 days
- ALL of the following
  - tacrolimus (Protopic) 0.1% or 0.03% ointment
  - pimecrolimus (Elidel) 1% cream
    requires prior authorization
- 30 days of therapy with Eucrisa (crisaborole) 2% ointment in the past 180 days30 days within past 180 days
  requires prior authorization

Initial Therapy Criteria (Vitiligo-specific)

Initial Authorization (6 months) - vitiligo-specific alternative initial block (appears later in form)

Alternate initial criteria for vitiligo indication (form lists separate initial blocks); all must be met.

ALL of the following

Prescribed by or in consultation with a dermatologist
Member has a diagnosis of non-segmental vitiligo
Member is 12 years of age or older>= 12 years
Medication will NOT be used in combination with other biologic disease-modifying antirheumatic drugs, JAK inhibitors, or potent immunosuppressants
Provider attests the area impacted by vitiligo does NOT exceed 10% of the member's Body Surface Area (BSA)<= 10%
Chart notes documenting BSA must be attached
Prior therapy trials for vitiligo (history of failure, contraindication, or intolerance to ALL listed therapies)
- 90 days of therapy with ONE high to very high potency topical corticosteroid unless lesions are on sensitive areas (face, anogenital area, skin folds)90 days
- ALL of the following
  - tacrolimus (Protopic) 0.1% or 0.03% ointment
  - pimecrolimus (Elidel) 1% cream
    requires prior authorization
- 90 days of phototherapy (UVB or PUVA)90 days

Continuation / Reauthorization Criteria (Eczema / Dermatitis)

Reauthorization (12 months) - eczema/dermatitis (general) reauthorization criteria

All criteria must be met for approval; documentation must be provided.

ALL of the following

Documentation of positive clinical response to therapy (e.g., reduced BSA involvement, severity, itch)
Chart notes must be submitted
Medication will NOT be prescribed concurrently with biologic disease-modifying antirheumatic drugs, JAK inhibitors, or potent immunosuppressants
Member has NOT experienced serious treatment-related adverse events (e.g., serious infections, lymphoma or other malignancies, non-melanoma skin cancer, MACE, thrombosis, thrombocytopenia, anemia, neutropenia, or lipid elevations)
Prescribed by or in consultation with a dermatologist

Continuation / Reauthorization Criteria (Vitiligo)

Reauthorization (12 months) - vitiligo reauthorization criteria

All criteria must be met for approval; documentation must be provided.

ALL of the following

Documentation of positive clinical response to therapy (e.g., re-pigmentation)
Chart notes must be submitted
Medication will NOT be prescribed concurrently with biologic disease-modifying antirheumatic drugs, JAK inhibitors, or potent immunosuppressants
Member has NOT experienced serious treatment-related adverse events (e.g., serious infections, lymphoma or other malignancies, non-melanoma skin cancer, MACE, thrombosis, thrombocytopenia, anemia, neutropenia, or lipid elevations)

Concomitant Therapy Exclusions & Safety Notes

The form repeatedly excludes concurrent use with other potent immunomodulators: the medication must NOT be used in combination with other biologic disease‑modifying antirheumatic drugs (examples listed: Humira, Enbrel, Taltz, Stelara), JAK inhibitors (examples listed: Xeljanz, Rinvoq, Olumiant), or potent immunosuppressants (examples listed: azathioprine, cyclosporine). Members must also be NOT immunocompromised to meet initial criteria. The reauthorization criteria require that the member has NOT experienced serious treatment‑related adverse events, including: serious infections; lymphoma or other malignancies; non‑melanoma skin cancer; major adverse cardiovascular events (MACE); thrombosis; thrombocytopenia, anemia, or neutropenia; or lipid elevations.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prescriber must complete and sign the AvMed PA/step-edit request form and fax to 1-305-671-0200; authorization can be delayed if incomplete or illegible.

Documentation Required

Attach chart notes verifying trials and BSA

Chart notes documenting BSA, prior therapy trials, contraindications or intolerances, and clinical response must be attached; prior therapies will be verified via pharmacy claims or submitted chart notes.

Billing Rule

Specialty pharmacy dispensing

Medication is provided by Specialty Pharmacy - Proprium Rx.

Denial Risk

Denial risk for initiating with samples

Use of samples to initiate therapy does not meet step edit/preauthorization criteria and may lead to denial.

Prior Authorization

Prior authorization required for some comparators

Pimecrolimus (Elidel) and Eucrisa (crisaborole) require prior authorization when used as prerequisite therapies.

Background & Definitions

Form background: This is a pharmacy prior authorization/step‑edit request for topical ruxolitinib (Opzelura). The prescribing physician must sign the form (preprinted stamps not valid) and complete member/prescriber/drug information; incomplete or illegible submissions can delay authorization. The form requires documentation of prior therapies and Body Surface Area, and prior therapies may need separate prior authorizations and will be verified via pharmacy claims or submitted chart notes.

BSABody Surface Area

MACEMajor Adverse Cardiovascular Events

OpenPayer

Opzelura

Coverage Summary

Initial Therapy Criteria (Eczema / General)

Initial Therapy Criteria (Vitiligo-specific)

Continuation / Reauthorization Criteria (Eczema / Dermatitis)

Continuation / Reauthorization Criteria (Vitiligo)

Concomitant Therapy Exclusions & Safety Notes

Applicable Codes & Limits

Provider Actions & Requirements

Background & Definitions

Revision History