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Coverage criteria policies

Mepolizumab (Nucala®) – Minnesota Health Care Programs

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Mepolizumab (Nucala) requires prior authorization from HealthPartners Pharmacy Administration.

Authorization Criteria

Initial authorization criteria:

Severe asthma:

  1. Patient must be 12 years of age or older; and,
  2. Has a diagnosis of severe eosinophilic asthma with a documented blood eosinophiol count of either ≥150 cells/microliter at baseline OR ≥ 300 cells/microliter in the past 12 months as documented in chart notes; and,
  3. Patient’s symptoms are not well controlled despite a 3 month adherent trial of high-dose inhaled corticosteroids in combination with a long-acting bronchodilator or leukotriene modifier; and,
  4. Patient has had 2 or more exacerbations requiring treatment with systemic corticosteroids in the past 12 months; and,
  5. Patient must not have concurrent use of Xolair, Fasenra or Cinqair; and,
  6. At time of request, baseline FEV1 and frequency of asthma exacerbation per month are provided.

Initial authorization will be for 6 months in duration.

Eosinophilic Granulomatosis with Polyangiitis (EGPA) treatment,

  1. Patient is followed by an asthma specialist, allergist, pulmonologist, or rheumatologist; and,
  2. Patient is 18 years of age or older and Nucala is prescribed within the FDA approved dosing regimen; and,
  3. Patient has a documented diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) with history or presence of asthma with eosinophilia (>10% eosinophils on the differential white blood cell count) and at least two of the following additional features of EGPA:
    1. A biopsy showing histopathological evidence of eosinophilic vasculitis, or
      1. Perivascular eosinophilic infiltration, or eosinophil–rich granulomatous
      2. Inflammation
    2. Neuropathy, mono or poly (motor deficit or nerve conduction abnormality)
    3. Pulmonary infiltrates, non–fixed
    4. Sino–nasal abnormality
    5. Cardiomyopathy (established by echocardiography or MRI)
    6. Glomerulonephritis (hematuria, red cell casts, proteinuria)
    7. Alveolar hemorrhage (by bronchoalveolar lavage)
    8. Palpable purpura
    9. Positive test for ANCA (MPO or PR3); and,
  4. Patient has tried and failed at least one of the following immunosuppressants: azathioprine, cyclophosphamide, or methotrexate. Treatment failure defined as one of the following:
    1. EGPA flare requiring OCS dose increase or hospitalization, or
    2. EGPA symptom recurrence while tapering OCS dose, or
    3. Patient has contraindications or clinical inappropriateness to all immunosuppressant options.

Initial authorization will be for 6 months in duration.

Renewal authorization criteria:

Severe asthma:

  1. Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following:
    1. Parasitic (helminth) infection
    2. Herpes zoster infection
  2. Treatment has resulted in clinical improvement as documented by at least ONE of the following:
    1. Decreased frequency of exacerbations (defined as improvement of asthma as demonstrated by decreased use of oral/systemic corticosteroids and/or less frequent hospitalizations and/or reduced frequency of ER visits)
    2. Improvement in lung function, measured in FEV1

Renewal approval will be for 12 months in duration.

Eosinophilic Granulomatosis with Polyangiitis (EGPA),

Reauthorization for EGPA will be authorized in patients with adequate clinical response, defined as either:

  1. Prednisolone or prednisone dose less than or equal to 4 mg/day; or,
  2. Remission: Prednisolone dose ≤7.5 mg/day (or equivalent OCS) and BVAS = 0.

Renewal approval will be for 12 months in duration.

Quantity limit

Severe Asthma: One injection (100 mg) per 28 days.

Eosinophilic Granulomatosis with Polyangiitis: 300 mg per 28 days.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

The services associated with these codes require prior authorization:

HCPCS Codes

Codes

Description

J2182

Injection, mepolizumab, 1 mg

NDC Codes

Codes

Description

00173088101

Nucala 100 MG SOLR

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. https://mn.gov/dhs/partners-and-providers/policies-procedures/minnesota-health-care-programs/provider/types/rx/pa-criteria/nucala.jsp

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Policy activity

  • 05/07/2018 - Date of origin
  • 10/01/2018 - Effective date

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