CurrentMass General Brigham Health PlanPolicy N/A

Topical Immunomodulators (pimecrolimus, tacrolimus, Nujo) — Pharmacy Prior Authorization & Step Therapy

Defines pharmacy prior-authorization, step-therapy, and quantity limit rules for topical immunomodulator products (pimecrolimus, tacrolimus, Nujo) for Mass General Brigham Health Plan members under the pharmacy benefit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTopical Immunomodulators — Prior Authorization, Step Therapy, Quantity Limits

Policy CodePolicy N/A

Change TypeStep-therapy revisiondrug list update

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionSubmit a prior authorization when a prescription does not meet initial step-therapy requirements (first-line agents are covered without PA).

SourceLink

POLICY UPDATE CHANGES

Updated policy to indicate that tacrolimus and pimecrolimus will be covered without prior authorization.

Added Nujo (tacrolimus 0.1% solution) as a second-line agent.

12 monthsapproval duration (authorizations)

60 gNujo qty limit

30 gPimecrolimus/tacrolimus qty limit

90 daysnew-to-plan window

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Coverage Criteria

Second-line agent authorization / First-line coverage

Covered when ALL of the following are met for second-line agents (authorization required unless member meets exceptions):

Second-line authorization general

Acceptable reasons for second-line approval
- Prior trials with documented failure: Member has previously tried at least two (2) first-line medications (medium, high, or very high potency topical corticosteroids; pimecrolimus 1% cream; tacrolimus 0.03% or 0.1% ointment) AND has documented side effect, allergy, or treatment failure with all trialed agents
  Documentation should show prior trials and documented intolerance or failure
- Continuation of therapy: Member is continuing treatment with a second-line medication
  Continuation of an existing second-line therapy is an allowed reason for approval
- New-to-plan stable therapy: Member is new to the plan within the last 90 days and is currently receiving the second-line medication and is clinically stable on therapy90 days
  Policy excludes authorizing products obtained as samples or via manufacturer patient assistance programs

First-line coverage: First-line agents (medium, high, or very high potency topical corticosteroids; pimecrolimus 1% cream; tacrolimus 0.03% and 0.1% ointment) are covered without prior authorization

Explicitly listed as first-line agents in the Initial Step-Therapy Requirements and Coverage Guidelines

Authorization exceptions do not apply when the product was obtained as samples or via manufacturer patient assistance programs. This means that members who present therapy obtained through samples or a manufacturer patient assistance program are not eligible for the new-to-plan continuation exception and must meet the standard authorization requirements for the product.

This policy does not list any explicit statements declaring treatments or specific indications as not medically necessary. No procedures or diagnoses are identified within the document as categorically excluded on medical necessity grounds.

Provider Actions & Workflow

Prior Authorization

Prior Authorization Required

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

Point-of-sale denial message will indicate PA is required.

Step Therapy

Step Therapy Requirements

Initial step-therapy: First-line medications are covered without prior authorization. Second-line medications will adjudicate only if the member has filled at least two first-line medications or a second-line medication within the past 180 days.

First-line agents (covered without PA): medium-, high-, or very-high potency topical corticosteroids (generic corticosteroids — see appendix), pimecrolimus 1% cream, tacrolimus 0.03% and 0.1% ointment.
Second-line examples: Nujo 0.1% (tacrolimus) solution — requires meeting step-therapy or PA.
Members new to the plan (within 90 days) who are currently receiving and stable on therapy may be authorized without meeting step-therapy (excludes samples or manufacturer patient assistance programs).

Documentation Required

Required Clinical Documentation

If requesting authorization for a second-line medication, documentation must show prior trials of first-line agents and an accompanying reason for failure, intolerance, or allergy. Approval may be granted when the member meets ONE of the following:

Member has tried at least two (2) first-line agents (medium/high/very-high potency topical corticosteroids, pimecrolimus 1% cream, tacrolimus 0.03% or 0.1% ointment) and had documented side effect, allergy, or treatment failure with all trialed agents.
Member is continuing treatment with a second-line medication and is new to the plan within the last 90 days and currently stable on therapy.

Background

Topical immunomodulators such as pimecrolimus and tacrolimus are nonsteroidal topical therapies used to treat inflammatory skin conditions including atopic dermatitis and may be considered alternatives to topical corticosteroids. The policy lists pimecrolimus 1% cream and tacrolimus 0.03% and 0.1% ointment among first-line agents covered without prior authorization, and references Nujo (tacrolimus 0.1% solution) as a second-line option.

Definitions

inv-09: New to the plan — Member who joined the plan within the previous 90 days and may be authorized to continue current treatment if stable.

DefinitionMember who joined the plan within the previous 90 days and may be authorized to continue current treatment if stable.

ExclusionThis exception does not apply when the product was obtained as samples or via manufacturer patient assistance programs.

ApplicationAuthorization for members new to the plan is limited to continuation of treatment when the member is currently receiving therapy and is stable.

Initial Therapy (First-line)

Initial therapy (first-line)

First-line agents covered without prior authorization

First-line agents: Medium, high, or very high potency topical corticosteroids; pimecrolimus 1% cream; tacrolimus 0.03% and 0.1% ointment are first-line and do not require prior authorization

Listed under Initial Step-Therapy Requirements and Coverage Guidelines

Continuation of Therapy

Continuing treatment when new to plan

Continuation of therapy guidance

Continuation therapy: Authorization may be granted for members new to the plan who joined within the last 90 days and who are currently receiving treatment and are clinically stable on that therapy90 days

Excludes products obtained as samples or via manufacturer patient assistance programs

Step Therapy Details

Requirement	Details
Member fills requirement	Member must have filled at least two first-line medications or a second-line medication within the past 180 days to obtain second-line coverage without prior authorization.
Alternate approval criteria	If the member does not meet the initial step-therapy requirement above, approval for a second-line medication may be granted if the member meets one of the listed exceptions: a) previously tried at least two first-line medications and had documented side effect, allergy, or treatment failure with all trialed agents; OR b) member is continuing treatment with a second-line medication; OR c) member is new to the plan within the last 90 days and is currently receiving treatment and stable.
First-line agents (context)	First-line agents covered without prior authorization include medium, high, or very high potency topical corticosteroids; pimecrolimus 1% cream; tacrolimus 0.03% and 0.1% ointment — these are the medications referenced when assessing prior fills for step-therapy.

Quantity Limits

inv-13: Nujo solution (tacrolimus 0.1%) — 60 grams.

DrugNujo solution (tacrolimus 0.1%).

Quantity limit60 grams per 30 days.

Approval durationApprovals will be granted for 12 months.

inv-14: Pimecrolimus 1% cream — 30 grams.

DrugPimecrolimus 1% cream (Elidel).

Quantity limit30 grams per 30 days.

Coverage statusListed as a first-line agent covered without prior authorization.

inv-15: Tacrolimus 0.03% and 0.1% ointment — 30 grams.

DrugTacrolimus 0.03% and 0.1% ointment (Protopic).

Quantity limit30 grams per 30 days (for each strength).