WHA

Nemluvio (nemolizumab-ilto) - PA, NF

Indications for Prior Authorization

Nemluvio (nemolizumab-ilto)
  • For diagnosis of Prurigo Nodularis (PN)
    Indicated for the treatment of adults with prurigo nodularis.

  • For diagnosis of Atopic Dermatitis (AD)
    Indicated for the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies.

Criteria

Nemluvio

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Prurigo Nodularis (PN)

  • Diagnosis of prurigo nodularis (PN)
    • AND
  • Patient has at least 20 nodular lesions
    • AND
  • Prescribed by or in consultation with one of the following:
    • Allergist/Immunologist
    • Dermatologist
    AND
  • Trial and failure, contraindication, or intolerance to one medium or higher potency topical corticosteroid [2, 3]
    • AND
  • Trial and failure, contraindication, or intolerance to Dupixent (dupilumab)
Nemluvio

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Prurigo Nodularis (PN)

  • Patient demonstrates a positive clinical response to therapy as evidenced by at least ONE of the following:
    • Reduction in the number of nodular lesions from baseline
    • Improvement in symptoms (e.g., pruritus, inflammation) from baseline
Nemluvio

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Prurigo Nodularis (PN)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of prurigo nodularis (PN)
    • AND
  • Patient has at least 20 nodular lesions
    • AND
  • Prescribed by or in consultation with one of the following:
    • Allergist/Immunologist
    • Dermatologist
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to one medium or higher potency topical corticosteroid [2, 3]
    • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to Dupixent (dupilumab)
Nemluvio

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Atopic Dermatitis (AD)

  • Diagnosis of moderate to severe atopic dermatitis (AD)
    • AND
  • One of the following:
    • Involvement of at least 10% body surface area (BSA)
    • SCORing Atopic Dermatitis (SCORAD) index value of at least 25 [A]
    AND
  • Patient is 12 years of age or older
    • AND
  • Will be used in combination with topical corticosteroids and/or calcineurin inhibitors (e.g., tacrolimus ointment)
    • AND
  • Prescribed by or in consultation with one of the following:
    • Allergist/Immunologist
    • Dermatologist
    AND
  • Trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to ONE of the following [4]:
    • Medium or higher potency topical corticosteroid
    • Generic topical calcineurin inhibitor (e.g., tacrolimus ointment)
    • Eucrisa (crisaborole) ointment
    • Opzelura (ruxolitinib) cream
    • Zoryve (roflumilast) 0.15% cream
    AND
  • Trial and failure, contraindication, or intolerance to TWO of the following:
    • Dupixent (dupilumab)
    • Adbry (tralokizumab-ldrm)
    • Ebglyss (lebrikizumab-lbkz)
    • Cibinqo (abrocitinib)
    • Rinvoq (upadacitinib)
Nemluvio

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Atopic Dermatitis (AD)

  • Patient demonstrates positive clinical response to therapy as evidenced by at least ONE of the following [1, 4, 5]:
    • Reduction in body surface area involvement from baseline
    • Reduction in SCORing Atopic Dermatitis (SCORAD) index value from baseline [A]
Nemluvio

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Atopic Dermatitis (AD)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of moderate to severe atopic dermatitis (AD)
    • AND
  • One of the following:
    • Involvement of at least 10% body surface area (BSA)
    • SCORing Atopic Dermatitis (SCORAD) index value of at least 25 [A]
    AND
  • Patient is 12 years of age or older
    • AND
  • Will be used in combination with topical corticosteroids and/or calcineurin inhibitors (e.g., tacrolimus ointment)
    • AND
  • Prescribed by or in consultation with one of the following:
    • Allergist/Immunologist
    • Dermatologist
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to ONE of the following [4]:
    • Medium or higher potency topical corticosteroid
    • Generic topical calcineurin inhibitor (e.g., tacrolimus ointment)
    • Eucrisa (crisaborole) ointment
    • Opzelura (ruxolitinib) cream
    • Zoryve (roflumilast) 0.15% cream
    AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to TWO of the following:
    • Dupixent (dupilumab)
    • Adbry (tralokizumab-ldrm)
    • Ebglyss (lebrikizumab-lbkz)
    • Cibinqo (abrocitinib)
    • Rinvoq (upadacitinib)

  • Guideline ID
    GL-164127

  • Formulary
    premium

  • Effective date
    Apr 1, 2025

  • P&T approval date
    Oct 16, 2024

P & T Revisions

2025-02-09, 2024-10-16, 2024-10-03

  1. Nemluvio Prescribing Information. Galderma Laboratories, L.P. Dallas, TX. August 2024.
  2. Williams KA, Huang AH, Belzberg M, et al. Prurigo nodularis: pathogenesis and management. J Am Acad Dermatol. 2020;83(6):1567-75.
  3. Leis M, Fleming P, Lynde CW. Prurigo nodularis: review and emerging treatments. Skin Therapy Lett. 2021;26(3):5-8.
  4. Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023;89(1):e1-e20.
  5. European Task Force on Atopic Dermatitis. Severity scoring of atopic dermatitis: the SCORAD index. Consensus report of the European Task Force on atopic dermatitis. Dermatology. 1993; 186:23-31.
  6. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet 2017; 389(10086)(suppl):2287-2303.
  7. Oranje AP. Practical issues on interpretation of scoring atopic dermatitis: SCORAD index, objective SCORAD, patient-oriented SCORAD and three-item severity score. Curr Probl Dermatol. 2011; 41:149-55.
  1. The Scoring Atopic Dermatitis (SCORAD) index is a clinical tool for assessing the severity of atopic dermatitis lesions based on affected body area and intensity of plaque characteristics. [5, 6] The extent and severity of AD over the body area (A) and the severity of 6 specific symptoms (erythema, edema/papulation, excoriations, lichenification, oozing/crusts, and dryness) (B) are assessed and scored by the Investigator. Subjective assessment of itch and sleeplessness is scored by the patient (C). The SCORAD score is a combined score (A/5 + 7B/2 + C) with a maximum of 103. Higher scores indicate greater severity/worsened state. A score of 25 to 50 indicates moderate disease severity and greater than 50 indicates severe disease. [7]
  • 2025-02-09: Addition of criteria for atopic dermatitis
  • 2024-10-16: New program
  • 2024-10-03: New program