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HealthPartners

Coverage criteria policies

Mepolizumab (Nucala®)

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

Nucala® requires prior authorization for use from Pharmacy Administration.

Coverage

Mepolizumab (Nucala) is reserved for patients meeting the following criteria:

Severe Asthma, when meeting all criteria:

  1. Patient is followed by an asthma specialist, allergist, or pulmonologist; and
  2. Prescribed within the FDA-approved dosing regimen; and
  3. Patient is 12 years and older with a pre-treatment serum eosinophil count of 150 cells/mcL or greater at screening (within previous 6 weeks); and
  4. Patient has poor asthma control (see criteria #5) despite the following standard therapies:
    1. Regular use of inhaled steroids (such as Flovent);and
    2. Regular use of a long-acting beta-agonist (such as Serevent); and
    3. Regular or periodic use of oral steroids.
  5. Inadequate asthma control despite standard therapies is defined as one of the following:
    1. At least 2 exacerbations requiring oral systemic corticosteroids in the last 12 months, or
    2. At least 1 exacerbation treated in hospital or requiring mechanical ventilation in the last 12 months

All severe asthma authorizations will be for one year. Renewals will be provided annually with documentation that the medication is effective.

Eosinophilic Granulomatosis with Polyangiitis (EGPA), when meeting all four criteria:

  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 EGPA authorizations will be for 6 months.

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.

Definitions

Nucala is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 12 years and older with an eosinophilic phenotype, and the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Limitations of Use:

  • Not for treatment of other eosinophilic conditions.
  • Not for relief of acute bronchospasm or status asthmaticus.

BVAS (Birmingham Vasculitis Activity Score): BVAS is a vasculitis disease activity measure designed to document new or worsening clinically active vasculitis that would be likely to require treatment. It consists of a set of items divided into nine organ based systems.

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.

HCPCS Codes

Codes

Description

J2182

Injection, mepolizumab, 1 mg

NDC Codes

Code

Description

00173088101

100 mg single use vial

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. Nucala Prescribing Information. Glaxo SmithKline LLC, Philadelphia, PA, December 2017.

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Policy activity

  • 02/16/2016 - Date of origin
  • 04/01/2018 - Effective date
Review date
  • 02/2018
Revision date
  • 02/05/2018

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