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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

Mepolizumab (Nucala) requires prior authorization from HealthPartners Pharmacy Administration. The setting of drug administration will be reviewed as part of the prior authorization.

Note:

For all inquiries, transfer to the Medical Injectable Line (ext 26135).

Coverage

Nucala is generally covered subject to the indications below when all of the following criteria are met, and per member plan documents.

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; and,
  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; and,
  6. Patient is not currently using another biologic therapy for the treatment of asthma such as Cinqair, Dupixent, Fasenra or Xolair; and,
  7. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Initial authorizations:

Will be provided for 12 months.

Reauthorizations:

  1. Patient has been seen by provider within the past 12 months; and,
  2. Patient has been adherent to therapy; and,
  3. Patient has not experienced unacceptable toxicity from the drug such as parasitic (helminth) infection or herpes zoster infection; and,
  4. Patient has a clinically meaningful response to the medication as defined:
    1. Decreased frequency of exacerbations defined as:
      1. Improvement of asthma control, demonstrated by decreased use of oral or systemic corticosteroids; or,
      2. Less frequent hospitalizations; or,
      3. Reduced frequency of emergency department visits; or,
    2. Improvement in lung function measured in FEV1; and,
  5. Nucala is prescribed within the FDA-approved dosing regimen.

Reauthorizations will be provided for 12 months

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.
  5. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Initial Authorizations:

Will be provided for 6 months.

Reauthorizations:

  1. Patient has been seen by provider within the past 12 months; and,
  2. Patient has been adherent to therapy; and,
  3. Patient has a clinically meaningful response to the medication as defined:
    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
  4. Nucala is prescribed within the FDA-approved dosing regimen.

Reauthorizations will be provided for 12 months

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.

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

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

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

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Policy activity

  • 02/16/2016 - Date of origin
  • 04/01/2019 - Effective date
Review date
  • 02/2019
Revision date
  • 02/04/2019

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