EBGLYSS (lebrikizumab-lbkz) prior authorization for atopic dermatitis
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Defines prior authorization requirements for EBGLYSS (lebrikizumab-lbkz) for members (age ≥12 and ≥40 kg) with moderate-to-severe atopic dermatitis requiring Medicaid coverage decisions.
No material clinical or coverage changes in this revision.
Coverage Criteria for EBGLYSS (lebrikizumab-lbkz)
Initial Authorization
EBGLYSS may be approved based on ALL of the following criteria:
Initial authorization criteria
Treatment scenarios (one required)
- A) Moderate atopic dermatitis: BOTH: (a) One preferred medium to very-high potency topical corticosteroid trial > 2 weeks (evidence: 1 prescription claim in the last 90 days) AND (b) Either one topical calcineurin inhibitor (Elidel/pimecrolimus or Protopic/tacrolimus) OR Eucrisa (crisaborole) used for > 4 weeks (evidence: 1 prescription claim in the last 90 days).
- B) Severe atopic dermatitis: BOTH: (a) One preferred medium to very-high potency topical corticosteroid trial >= 2 weeks (evidence: 1 prescription claim in the last 90 days) AND (b) One topical calcineurin inhibitor (Elidel/pimecrolimus or Protopic/tacrolimus) used >= 4 weeks (evidence: 1 prescription claim in the last 90 days).
- C) Topical therapies inadvisable: Prescriber provides detailed clinical justification with supporting documentation explaining why topical therapies are inadvisable (e.g., failure, intolerance, or contraindication to scenarios A or B).
Use of medication samples is NOT accepted as medical justification; supporting medical records or prescription claims required upon request.
- D) Current Ebglyss therapy: Patient is currently receiving Ebglyss therapy (use of samples excluded).
Reauthorization Criteria
Reauthorization will be issued for 12 months when the following are met:
Use of EBGLYSS in combination with another biologic medication or a JAK inhibitor for the treatment of atopic dermatitis is not permitted. Examples explicitly listed in the policy include Enbrel (etanercept), Remicade/Inflectra (infliximab), Xolair (omalizumab), Rituxan (rituximab), Adbry (tralokinumab-ldrm), Dupixent (dupilumab), and topical JAK inhibitor Opzelura (ruxolitinib).
Clinical Thresholds and Coding-relevant Criteria
Provider Requirements, Documentation, and Prior Authorization Steps
PA required — initial (6 mo) and reauthorization (12 mo) criteria
Prior authorization is required for EBGLYSS. Initial authorizations will be issued for 6 months; reauthorizations will be issued for 12 months. Approval requires meeting diagnosis, BSA, age/weight, prescriber specialty, absence of concurrent biologic or JAK inhibitor use, meeting one of the topical therapy/treatment scenarios or providing clinical justification, and dosing within the specified initial and maintenance limits.
- Initial authorization duration: 6 months.
- Reauthorization duration: 12 months.
- Approval conditions include: diagnosis of moderate-to-severe chronic atopic dermatitis; affected BSA ≥ 10%; age ≥ 12 years and weight ≥ 40 kg per label; prescribed by or in consultation with an allergist, dermatologist, or immunologist; patient not receiving Ebglyss in combination with another biologic or a JAK inhibitor; meets one of treatment scenarios A–D; prescribed dose within specified initial and maintenance dosing limits.
Topical therapy trials required before biologic (step-therapy)
Prior topical therapy trials are required unless a prescriber provides detailed clinical justification. For moderate disease, BOTH a ≥2-week trial of a preferred medium to very‑high potency topical corticosteroid (1 claim in last 90 days) AND either a topical calcineurin inhibitor or crisaborole used for >4 weeks (1 claim in last 90 days) are required. For severe disease, BOTH a ≥2-week trial of a preferred medium to very‑high potency topical corticosteroid (1 claim in last 90 days) AND a topical calcineurin inhibitor used for ≥4 weeks (1 claim in last 90 days) are required.
- Moderate AD (scenario A): preferred medium to very‑high potency topical corticosteroid ≥2 weeks (1 claim in last 90 days) AND either topical calcineurin inhibitor OR Eucrisa (crisaborole) >4 weeks (1 claim in last 90 days).
- Severe AD (scenario B): preferred medium to very‑high potency topical corticosteroid ≥2 weeks (1 claim in last 90 days) AND topical calcineurin inhibitor ≥4 weeks (1 claim in last 90 days).
- Exceptions: prescriber may provide detailed clinical justification why topical therapies are inadvisable (e.g., failure, intolerance, contraindication).
Provide medical records or prescription claims to document required trials or justification
Submission of medical records or prescription claims documenting required prior topical therapy trials or clinical justification is required upon request. Documentation must demonstrate the trial duration and timing (claims in the last 90 days where specified).
- Provide medical records or prescription claims showing the required topical corticosteroid and topical calcineurin inhibitor/crisaborole trials with dates and durations.
- If relying on clinical justification (e.g., intolerance, contraindication), include supporting documentation in the medical record.
Documentation and trial evidence: denial risks and samples not accepted
Failure to submit the required medical records or prescription claims may result in denial of authorization. Medication samples will NOT be accepted as medical justification for prior topical therapy trials.
- Lack of documented trials or absence of clinical justification may trigger denial.
- Samples cannot be used to meet step‑therapy or prior treatment requirements.
Background
EBGLYSS (lebrikizumab-lbkz) is an interleukin-13 (IL-13) antagonist indicated for use in patients with moderate-to-severe atopic dermatitis who meet labeled age and weight criteria. The policy applies to members age ≥ 12 years and weight ≥ 40 kg and incorporates the FDA-approved dosing regimen and clinical prerequisites when evaluating prior authorization requests.
Definitions
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