CurrentNeighborhood Health Plan of Rhode IslandPolicy 1254-F

Protopic (tacrolimus) step therapy and prior authorization criteria

Defines step therapy, age limits, FDA indications, compendial uses, and prior authorization requirements for Protopic (tacrolimus) ointment formulations for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyProtopic (tacrolimus) step therapy and prior authorization criteria

Policy CodePolicy 1254-F

Change TypeNo material change

Effective DateFeb 21, 2023

Next Review Date

Key ActionObtain prior authorization and document required prior therapy (>=14-day medium or higher potency topical corticosteroid) and clinical response as specified.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

0.03% & 0.1%Strengths referenced

>=16Min age for 0.1%

Under 2FDA contraindication

Topical steroid trialRequired prior treatment

Coverage Criteria

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Coverage decision tree

Covered with prior authorization when the following criteria structure is met (logical operators preserved):

Requested formulation: Request is for Protopic (tacrolimus) 0.03% ointment OR Protopic (tacrolimus) 0.1% ointment

Formulations listed in document

Age and indication for 0.1%: Patient is 16 years of age or older AND the requested drug is being prescribed for psoriasis on the face, genitals, or skin folds

Applies to 0.1% per document

Vitiligo criteria: If prescribed for vitiligo on the head or neck: (A) initial therapy OR (B) continuation of therapy with maintained positive clinical response (meaningful repigmentation)

Documented response required for continuation

Atopic dermatitis (short-term, non-continuous chronic) initial therapy: Requested drug is prescribed for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis (eczema) AND the request is NOT for continuation of therapy

Matches FDA indication

Atopic dermatitis continuation: Request is for continuation of therapy AND the patient has achieved or maintained a positive clinical response as evidenced by improvement or resolution of signs/symptoms (erythema, edema, xerosis, erosions, excoriations, oozing/crusting, lichenification, or pruritus)

Continuation requires documented clinical benefit

Sensitive area or prior corticosteroid failure: Requested drug will be covered when used on sensitive skin areas (face, genitals, or skin folds) OR the patient has experienced inadequate response, intolerance, or contraindication to at least one first-line agent (medium or higher potency topical corticosteroid)

Alternative pathway to coverage

Pediatric under 2 years: Patients less than 2 years of age (compendial uses noted) — document references use but FDA label does not indicate under 2 years

Compendial mention; FDA label contraindicates under 2 years per other sections

Requests for Protopic that do not meet the policy definition of short-term, non-continuous chronic treatment of moderate to severe atopic dermatitis, or requests that are for continuation of therapy without documented positive clinical response, may not meet coverage criteria and will require prior authorization review.

The FDA indication states the drug is for second-line, short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in patients who have failed or cannot use other topical prescription treatments; requests outside that scope (including continuation without documented benefit) are not consistent with the labeled indication.

Coding and Prescriber Requirements

Topical corticosteroid trial (step therapy threshold)

RequirementFilled prescription for at least a 14-day supply of at least one medium or higher potency topical corticosteroid within the past 180 days

ScopeApplies to prior step-therapy logic under the prescription benefit; system will reject and require PA if not met

ExamplesSee compendial examples of medium-potency topical corticosteroids in source (e.g., betamethasone, betamethasone valerate, clocortolone)

Age thresholds for Protopic formulations

Age threshold>= 16 years for Protopic (tacrolimus) 0.1% formulation

0.03% formulationNo age restriction for 0.03% per document; 0.03% used in children 2–15 years and in compendial pediatric use under 2 years

Source noteAge requirement referenced in compendial uses and coverage criteria

Provider Actions and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization required for coverage — Prior authorization required; drug will be covered only when specified criteria for indication, age, prior therapy, and clinical response are met. If the patient has not met the step-therapy requirement for prior corticosteroid use (see below), the system will reject the claim and require submission of a prior authorization for review.

Step Therapy

Step Therapy Requirement for Topical Corticosteroid

Step therapy requirement for topical corticosteroid — The system will reject and require prior authorization if the patient has not filled at least a 14-day supply of a medium or higher potency topical corticosteroid within the past 180 days under the prescription benefit. Examples of medium or higher potency topical corticosteroids are provided in the policy (see Table 1).

Must have filled ≥ 14-day supply of a medium or higher potency topical corticosteroid within the past 180 days
If requirement not met, PA trigger: system rejection and PA submission required

Documentation Required

Clinical Response Documentation

Clinical response documentation — For continuation of therapy requests, documentation must demonstrate that the patient has achieved or maintained a positive clinical response. Acceptable evidence includes clinician assessment of improvement or maintenance (e.g., clear or almost clear outcome, meaningful repigmentation, patient satisfaction) and improvement/resolution of signs and symptoms (erythema, edema, xerosis, erosions, excoriations, oozing/crusting, lichenification, pruritus).

Continuation requests require documentation of positive clinical response (improvement or maintenance)
Examples: clear/almost clear, meaningful repigmentation, reduction in erythema, edema, pruritus, etc.

Denial Risk

PA Trigger on Prior Corticosteroid Use

PA trigger on prior corticosteroid use — The prior authorization requirement is triggered when the patient has not filled a prescription for at least a 14-day supply of at least one medium or higher potency topical corticosteroid within the past 180 days. When triggered, the system will reject the claim and require PA submission; submitted requests will then be evaluated against the PA criteria in this policy.

Trigger: no record of ≥14-day supply of medium or higher potency topical corticosteroid in past 180 days
Action: system rejection with instruction to submit prior authorization for evaluation

Definitions and Background

Protopic (tacrolimus) ointment is FDA-indicated as a second-line, short-term, non-continuous chronic treatment for moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed or cannot use other topical prescription treatments. The label specifies both 0.03% and 0.1% formulations for adults and only 0.03% for children aged 2–15 years.

For atopic dermatitis, the policy requires that initial requests be consistent with the short-term, non-continuous treatment intent described in the FDA indication. Continuation requests must include documentation of a positive clinical response (improvement in signs/symptoms or patient-reported clear/almost clear outcome) to meet coverage criteria.

FDA-approved indication

Indication (FDA)Second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments or when those treatments are not advisable

FormulationsBoth 0.03% and 0.1% for adults; only 0.03% for children aged 2–15 years

Age limitationProtopic ointment is not indicated for children younger than 2 years of age (FDA statement)

Compendial uses

Compendial indicationsPsoriasis on the face, genitals, or skin folds; vitiligo on the head or neck; atopic dermatitis in patients under 2 years (Protopic 0.03%)

ContextCompendial uses provide alternative coverage pathways and list examples of topical corticosteroids for step therapy

Formulation noteCompendia specify Protopic 0.03% for some pediatric (under 2) uses despite FDA non‑indication for <2 years