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Prior Authorization for Monoclonal Antibody Therapy to Change Effective December 1, 2021

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Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to eligible clients. Administrative procedures such as prior authorization, pre-certification, referrals, and claims/encounter data filing may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the client's specific MCO for details.

Effective for dates of service on or after December 1, 2021, prior authorization criteria will change for monoclonal antibody therapy for Texas Medicaid.

Authorization Requirements for Omalizumab

Prior authorization for omalizumab (Xolair) will be considered for the following:

  • Moderate to severe asthma
    • For clients who are 6 years of age or older
    • For clients who have a diagnosis of moderate to severe asthma (diagnosis codes J4540 and J4550)
  • Chronic idiopathic urticaria (CIU)
    • For clients who are 12 years of age or older
    • For clients who have a diagnosis of CIU with symptoms despite H1 antihistamine treatment (diagnosis code L501)
    • With documentation supporting medical necessity for the treatment of CIU with omalizumab submitted with the authorization request that includes the following:
      • Documented failure of or contraindication to antihistamine and leukotriene inhibitor therapies
      • Evidence of an evaluation that excludes other medical diagnoses associated with chronic urticaria
  • Add-on maintenance treatment of nasal polyps
    • For clients who are 18 years of age or older
    • For clients who have a diagnosis of nasal polyps (diagnosis codes J330, J331, J338, and J339) with inadequate response to nasal corticosteroids
    • With documentation supporting medical necessity for maintenance treatment of nasal polyps with omalizumab submitted with the authorization request that includes the following:
      • Diagnosis of bilateral nasal polyposis confirmed by physical examination or nasal endoscopy
      • Documented failure of or contraindication to prior corticosteroids as monotherapy
    • Documented inadequate response to prior corticosteroid treatments

Authorization Requirements for Benralizumab

Prior authorization for benralizumab (Fasenra) will be considered for clients who are 12 years of age or older with severe asthma with eosinophilic phenotype (diagnosis codes J4450, J4451, and J4452).

Authorization Requirements for Mepolizumab

Prior authorization for mepolizumab (Nucala) will be considered for the following:

  • Severe asthma with eosinophilic phenotype
    • For clients who are 6 years of age or older
    • For clients who have a diagnosis of severe asthma with eosinophilic phenotype (diagnosis codes J4450, J4451, and J4452)
  • Eosinophilic granulomatosis with polyangiitis (EGPA)
    • For clients who are 18 years of age or older
    • With confirmed diagnosis of eosinophilic granulomatosis with polyangiitis (diagnosis code M301)
    • With documentation supporting medical necessity for treatment of EGPA with meoplizumab submitted with the authorization request that includes the following:
      • Diagnosis of EGPA
      • Medical history of asthma
      • Presence of at least 2 of the following EGPA characteristics:
        • Histopathological findings of eosinophilic vascularitis, perivascularitis eosinophilic infiltration, or eosinophil-rich granulomatous inflammation
        • Neuropathy
        • Pulmonary infiltrates, non-fixed; sino-nasal abnormality
        • Cardiomyopathy
        • Glomerulonephritis
        • Alveolar hemorrhage
        • Palpable purpura
        • Anti-neutrophils cytoplasmic antibody
    • Refractory disease or a history of EGPA relapse
  • Hypereosinophilic symptoms (HES)
    • For clients who are 12 years of age or older
    • Diagnosis of HES for 6 months or longer without identifiable non-hematologic secondary cause (diagnosis codes D72110, D72111, D72118, and D72119)
    • With documentation supporting medical necessity for treatment of HES in clients who are 12 years of age or older with mepolizumab submitted with the authorization request that meets all the following criteria:
      • Diagnosis of HES for 6 months or longer without any non-hematologic secondary cause
      • History of 2 or more HES flares (defined as worsening clinical symptoms or blood eosinophil counts requiring an increase in prior therapy) within the past 12 months prior to the initiation on mepolizumab therapy
      • The prescribing physician’s attestation that the client has been on a stable dose of HES therapy that includes but is not limited to corticosteroids, immunosuppressive, and cytotoxic therapy
  • Chronic rhinosinusitis with nasal polyps (CRSwNP)
    • Prior authorization for mepolizumab (Nucala) will be considered for clients as an add-on maintenance treatment of chronic rhinosinusitis with nasal polyps when all the following criteria are met:
      • For clients who are 18 years of age or older
      • Confirmed diagnosis of chronic rhinosinusitis with nasal polyps (diagnosis codes J330, J331, J338, and J339)
      • Evidence of inadequate response to nasal corticosteroid

Authorization Requirements for Reslizumab

Prior authorization for reslizumab (Cinqair) will be considered for clients who are 18 years of age or older with severe asthma (diagnosis codes J4450, J4451, and J4452.

Asthma: Moderate to Severe (Omalizumab) and Severe (Benralizumab, Mepolizumab, and Reslizumab)

Documentation supporting medical necessity for the treatment of asthma with omalizumab, benralizumab, mepolizumab, or reslizumab must be submitted with the authorization request and include the following:

  • Symptoms are inadequately controlled with the use of either combination therapy:
    • 12 months of high-dose inhaled corticosteroid (ICS) given in combination with a minimum of 3 months of controller medication (either a long-acting beta2-agonist [LABA], leukotriene receptor antagonist [LTRA], or theophylline) unless the client is intolerant of or has a medical contraindication to these agents
    • 6 months of ICS with daily oral glucocorticoids given in combination with a minimum of 3 months of controller medication (a LABA, LTRA, or theophylline) unless the client is intolerant of or has a medical contraindication to these agents

For more information, call the TMHP Contact Center at 800-925-9126.