CurrentMass General Brigham Health PlanPolicy N/A

Topical Immunomodulators

Step-therapy policy governing pharmacy benefit coverage and prior authorization rules for topical immunomodulators for Mass General Brigham Health Plan Commercial/Exchange members; defines first- and second-line products, approval conditions, and quantity/term limits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTopical Immunomodulators

Policy CodePolicy N/A

Change TypeMaterial updates (added agent, clarified coverage, continuation rules)

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionSubmit a prior authorization when a prescription does not meet initial step-therapy requirements; include documentation of two prior first-line trials or qualifying exception evidence.

SourceLink

POLICY UPDATE CHANGES

Nujo (tacrolimus) solution was added as a second-line agent.

Pimecrolimus will be covered without prior authorization.

Policy updated to indicate tacrolimus approvals if the member is continuing treatment with the agent.

12 monthsapproval duration for authorizations

60Nujo quantity limit

30Pimecrolimus quantity limit

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Coverage Criteria

Products obtained as samples or provided through a manufacturer's patient assistance program are excluded from the continuation/new-to-plan exception. In other words, members who present product supplied as samples or via a manufacturer assistance program do not qualify for the 90‑day new-to-plan continuation allowance and must meet the standard step‑therapy requirements or obtain prior authorization.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prescriptions that do not meet the initial step-therapy requirements will deny at point-of-sale with a message indicating that prior authorization (PA) is required. Submit a PA request for members who fail initial step therapy criteria.

Point-of-sale denial when step therapy unmet
Submit PA for members who do not meet initial requirements

Step Therapy

Initial Step-Therapy Requirements

First-line medications are covered without prior authorization. Second-line medications require documentation of prior trials: the member must have filled at least two first-line medications or a second-line medication within the past 180 days, or meet the documented exception criteria below.

First-line = covered without PA
Second-line requires ≥2 first-line fills or a second-line fill in past 180 days

Documentation Required

Required Documentation for Second-Line Approval

When requesting approval for a second-line agent, include documentation of prior trials and outcomes. Required documentation: medication names, dates of fills, duration of therapy, and clinical rationale (treatment failure, intolerance, or allergy). For members new to the plan within 90 days who are currently stable on therapy, include documentation they were receiving the medication from their prior coverage (exclude samples or manufacturer patient assistance programs).

List of ≥2 first-line agents tried with fill dates and durations
Clinical reason for failure of each trial (side effect, allergy, or treatment failure)
If new to plan ≤90 days, proof of ongoing treatment (prior plan records) — samples/PAP excluded

Denial Risk

Denial at Point of Sale if Step Therapy Unmet

If the member meets the documented exception (e.g., has tried ≥2 first-line agents and had documented side effect, allergy, or treatment failure with all), the second-line agent may be approved. Ensure the PA includes the specific first-line agents tried and the documented adverse outcome for each.

Approval allowed when ONE of the exception criteria is met (see documentation requirements)
Include specific first-line agents and documented adverse outcomes in PA

Definitions

First-line medications — coverage status

Medium/high/very high potency topical corticosteroidsCovered as first-line without prior authorization (see appendix for examples).

Pimecrolimus 1% creamCovered as first-line without prior authorization.

Tacrolimus 0.03% ointmentCovered as first-line without prior authorization.

Tacrolimus 0.1% ointmentCovered as first-line without prior authorization.

Second-line medications — prior authorization

Nujo 0.1% (tacrolimus) solutionClassified as second-line; requires prior authorization unless step-therapy exceptions met (e.g., two prior first-line fills within 180 days or continuation/new-to-plan exception).

Initial Therapy

Continuation Therapy

Step Therapy Requirements

Coverage requirement	Details / acceptable documentation
Two prior first-line medication trials within the past 180 days	Documentation that the member filled at least TWO first-line agents (medium/high/very high potency topical corticosteroids, pimecrolimus 1% cream, or tacrolimus 0.03% or 0.1% ointment) and had documented side effect, allergy, or treatment failure with the trialed agents.
Prior second-line medication fill within the past 180 days	Record of a prior fill for a second-line medication within the past 180 days.
Qualifying continuation or new-to-plan exception	Member is continuing treatment with the second-line agent or is new to the plan within the last 90 days and stable on therapy (note: products obtained as samples or via manufacturer patient assistance programs are excluded).

Quantity and Duration Limits

Nujo solution — quantity limit

Nujo solution quantity limit60 grams per 30 days (1 = 60 g/30 days).

Approval durationApprovals will be granted for 12 months (see limitations).

Counting period for step-therapy trialsPrior medication trials are considered within the past 180 days per step-therapy rules.

Pimecrolimus cream — quantity limit

Pimecrolimus cream quantity limit30 grams per 30 days (1 = 30 g/30 days).

Coverage statusPimecrolimus 1% cream is listed as a first-line agent and covered without prior authorization.

Background

Topical immunomodulators — including pimecrolimus 1% cream and tacrolimus formulations — are nonsteroidal agents used for inflammatory skin conditions such as atopic dermatitis. The policy distinguishes first‑line topical options (generic topical corticosteroids, pimecrolimus 1% cream, tacrolimus 0.03% and 0.1% ointments) from second‑line products (for example, Nujo 0.1% tacrolimus solution), with coverage and authorization governed by the step‑therapy rules described in this document.