Pharmacy Policy Bulletin
Interleukin (IL)-5 Antagonists – Medicare
Number: J-0470 Category: Prior Authorization
Line(s) of Business:

Commercial
Healthcare Reform
Medicare

Benefit(s):

Not Applicable
Region(s):

All
Delaware
New York
Pennsylvania
West Virginia

Additional Restriction(s):

None


Drugs Products
  • Nucala (mepolizumab)
  • Fasenra (benralizumab)
FDA-Approved Indications:
  • Nucala (mepolizumab)
    • Add-on maintenance treatment of patients with severe asthma aged 6 years and older, and with an eosinophilic phenotype.
    • Treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
    • Treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for ≥ 6 months without an identifiable non-hematologic secondary cause.
    • Add-on maintenance treatment of adult patients 18 years and older with chronic rhinosinusitis with nasal polyps (CRSwNP).
  • Fasenra (benralizumab)
    • Add-on maintenance treatment of patients with severe asthma aged 12 years and older and with an eosinophilic phenotype


Background:
  • Nucala and Fasenra work by binding to and inhibiting interleukin-5 (IL-5), the major cytokine responsible for growth and differentiation, recruitment, activation, and survival of eosinophils. IL-5 inhibition reduces the production and survival of eosinophils, but the exact mechanism of action for the treatment of asthma has not been definitively established.
  • EGPA is a rare form of vasculitis; it causes inflammation in small and medium sized blood vessels, which can result in damage to organs throughout the body. In most people, blood vessels in the lungs are affected, causing breathing and lung issues.
  • HES is a rare group of inflammatory disorders that affects approximately 20,000 people world-wide. Patients with HES have persistent and marked overproduction of eosinophils. When eosinophils infiltrate certain tissues, they can cause inflammation and organ damage. If left untreated, the symptoms of HES become progressively worse; the disease can be life-threatening.
  •  About 20% of patients with chronic rhinosinusitis (CRS) have nasal polyps, diagnosed with evidence of bilateral chronic sinonasal inflammation. Symptoms of CRSwNP include nasal drainage, nasal congestion, facial pressure or pain, and a decrease in sense of smell lasting for more than 12 weeks. Patient’s enrolled in the clinical trial evaluating Nucala, had at least 1 surgery for the removal of nasal polyps within the previous 10 years.
  • Nucala single-dose prefilled syringe and autoinjector are only to be used in patients with severe asthma 12 years of age and older. Nucala lyophilized powder in a single-dose vial is indicated for patients aged 6 to 11 years with severe asthma and is given 40 mg subcutaneously once every 4 weeks. The 100mg/mL single-dose prefilled syringe and autoinjector are unable to appropriately administer a 40 mg dose.
  • The Nasal Congestion Score is a patient reported tool used to measure changes in nasal congestion and obstruction. It ranges from 0 – 3, and is the monthly average of the daily morning AM patient-assessed daily symptom severity (0 = no symptoms to 3 = severe symptoms).
  • The Nasal Polyp Score (NPS), the sum of right and left nostril scores, is a physician-reported assessment used to characterize the patient’s polyps from 0 = no polyps to 4 = severe disease with large polyps causing complete obstruction of the inferior nasal cavity. Each nostril is scored on a scale of 0 to 4, with the total score being the sum of left and right nostril scores (range: 0-8).

Estimated Comparative Daily Inhaled Corticosteroid Dosages for Patients 6 to 11 years old

Drug

Low Dose*

Moderate Dose*

High Dose*

Beclomethasone dipropionate (CFC)

100-200

>200-400

>400

Beclomethasone dipropionate (HFA)

50-100

>100-200

>200

Budesonide (DPI)

100-200

>200-400

>400

Ciclesonide (HFA)

80

>80-160

>160

Fluticasone propionate (DPI)

100-200

>200-400

>400

Fluticasone propionate (HFA)

100-200

>200-500

>500

Mometasone furoate

110

≥220-<440

≥440

Triamcinolone acetonide

400-800

>800-1200

>1200

Abbreviations: CFC: chlorofluorocarbon propellant; DPI: dry powder inhaler; HFA: hydrofluoroalkane

*Doses are in mcg

 

Estimated Comparative Daily Inhaled Corticosteroid Dosages for Patients ≥ 12 years old

Drug

Low Dose*

Moderate Dose*

High Dose*

Beclomethasone dipropionate (CFC)

200-500

>500-1000

>1000

Beclomethasone dipropionate (HFA)

100-200

>200-400

>400

Budesonide (DPI)

200-400

>400-800

>800

Ciclesonide (HFA)

80-160

>160-320

>320

Fluticasone propionate (DPI)

100-250

>250-500

>500

Fluticasone propionate (HFA)

100-250

>250-500

>500

Mometasone furoate

110-220

>220-440

>440

Triamcinolone acetonide

400-1000

>1000-2000

>2000

Abbreviations: CFC: chlorofluorocarbon propellant; DPI: dry powder inhaler; HFA: hydrofluoroalkane

*Doses are in mcg

 

  • Prescribing considerations:
    • Nucala is not intended for relief of acute bronchospasm or status asthmaticus.
    • Fasenra is not indicated for treatment of other eosinophilic conditions nor for relief of acute bronchospasm or status asthmaticus.
    • Patients should not utilize dual therapy with another monoclonal antibody for the treatment of asthma.
    • Systemic or inhaled corticosteroids should not be discontinued abruptly upon initiation of therapy with Nucala or Fasenra, but decreased gradually, if appropriate.
    • Opportunistic infections including herpes zoster may occur during treatment. Patients should consider vaccination prior to treatment, if clinically appropriate.
    • Patients with pre-existing helminth infections should be treated prior to initiating therapy with these agents.
    • 1 microliter (ul or mcL) = 1 cubic millimeter (mm3)
    • 1 Liter = 106 microliter
    • Converting from liter to microliter: Absolute eosinophils (decimal) X 109/Liter = Absolute eosinophils (decimal) X 1,000/microliter


Approval Criteria

Approval Criteria

I.     Nucala

When a benefit, coverage for Nucala may be approved when one (1) of the following criteria are met (A. through D.):

A.    The member has a diagnosis of severe asthma and all of the following criteria are met (1. through 4.):

1.     The member is 6 years of age or older.

2.     The member has a diagnosis of asthma evidenced by one (1) of the following (a., b., or c.):

a.     Prebronchodilator forced expiratory volume in 1 second (FEV1) below 80% in adults.

b.     Prebronchodilator FEV1 below 90% in adolescents.

c.     FEV1 reversibility of at least 12% and 200 milliliters (ml) after albuterol (salbutamol) administration.

3.     The member meets one (1) of the following criteria (a. or b.):

a.     The member has history of 2 or more exacerbations in the previous 12 months.

b.     The member has inadequate symptom control with an inhaled corticosteroid in combination with at least 3 months of a controller medication (e.g., long-acting beta-2 agonist [LABA], leukotriene receptor antagonist [LTRA], or theophylline), unless intolerant of, or has contraindications to all of these agents.

4.     The member meets one (1) of the following blood eosinophil counts (a. or b.):

a.     Baseline (pre-treatment) levels greater than or equal to 150 cells/microliter within the past 6 weeks.

b.     Greater than or equal to 300 cells/microliter within the past 12 months.

B.    The member has a diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) and all of the following criteria are met (1. and 2.):

1.     The member has a history of relapsing or refractory disease.

2.     The member will be receiving standard of care while on therapy with glucocorticoid treatment (e.g. prednisone or prednisolone), with or without immunosuppressive therapy (e.g. cyclosporine, leflunomide, azathioprine etc.).

C.   The member has a diagnosis of hypereosinophilic syndrome (HES) and all of the following criteria are met (1. through 4.):

1.     The member is 12 years of age or older.

2.     The member has HES without an identifiable non-hematologic secondary cause for ≥ 6 months.

3.     The member has experienced at least 2 HES flares (HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy) within the past 12 months.

4.     The member has been stable on HES therapy for at least 4 weeks (chronic or episodic oral corticosteroids, immunosuppressive, or cytotoxic therapy).

 

D.    The member has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) and all of the following criteria are met (1. and 2.):

1.  The member is 18 years of age or older.

2.  The member has experienced therapeutic failure, contraindication, or intolerance to an intranasal corticosteroid

 

II.     Fasenra

When a benefit, coverage for Fasenra may be approved when all of the following criteria are met (A. through F.):

A.  The member is 12 years of age or older.

B.  The member has a diagnosis of severe asthma.

C.  The member meets one (1) of the following criteria (1., 2., or 3.):

1.  Prebronchodilator FEV1 below 80% in adults

2.  Prebronchodilator FEV1 below 90% in adolescents

3.  FEV1 reversibility of at least 12% and 200 milliliters (ml) after albuterol (salbutamol) administration

D.    The member has reduced lung function despite regular treatment with one (1) of the following (1., 2., or 3.):

1.  High dose inhaled corticosteroid (ICS) and an additional asthma controller medication.

2.  Medium dose ICS plus a long-acting beta agonist (LABA) with or without oral corticosteroids (OCS) and an additional asthma controller medication.

3.  High dose ICS plus a LABA with or without OCS and an additional asthma controller medication.

E.  The member has a history at least one (1) asthma exacerbation requiring oral or systemic corticosteroid treatment in the past 12 months.

F.  The member meets one (1) of the following blood eosinophil counts (in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known suspected parasitic infection) (1. or 2.):

1.  Baseline (pre-treatment) levels greater than or equal to 150 cells/microliter within the past 6 weeks

2.  Greater than or equal to 300 cells/microliter within the past 12 months

 

III.   Quantity Level Limits

When prior authorization is approved, Fasenra may be authorized in quantities as follows:

A.  Induction therapy: One (30 mg) prefilled syringe or auto-injector every 4 weeks for 3 doses.

B.  Maintenance therapy: One (30 mg) prefilled syringe or auto-injector every 8 weeks.

 

IV.  For Medicare Part D beneficiaries, drug(s) addressed in this policy may be approved when used for a medically accepted indication as defined by the Centers for Medicare & Medicaid Services (CMS)

 

 


Limitations of Coverage

None


Authorization Duration
  • Medicare Part D Plans: If approved, a 12 month authorization will be granted.


Automatic Approval Criteria

None


Version: J-0470-013
Effective Date Begin: 01/01/2022
Effective End Begin: 01/01/2022
Original Date: 03/02/2016
Review Date: 10/06/2021


References:

  1. Nucala [package insert]. Research Triangle Park, North Carolina: GlaxoSmithKline; July 2021.
  2. Fasenra [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019.
  3. American College of Rheumatology. ACR 2018 Vasculitis Guideline Project Plan. Available at: https://www.rheumatology.org/Practice-Quality/Clinical-Support/Clinical-Practice-Guidelines/Vasculitis. Accessed June 21, 2019.
  4. Global Initiative for Asthma. 2019 Diagnosis and Management of Difficult to Treat & Severe Asthma Guidelines. Available at: https://ginasthma.org/wp-content/uploads/2019/04/GINA-Severe-asthma-Pocket-Guide-v2.0-wms-1.pdf. Accessed June 21, 2019.
  5. Global Initiative for Asthma (GINA). Pocket Guide for Asthma Management and Prevention: Updated 2019. Accessed November 5, 2019.
  6. Eosinophilic Granulomatosis with Polyangiitis (EGPA). Available at: https://www.lung.org/lung-health-diseases/lung-disease-lookup/egpa?gclid. Accessed October 5, 2020.
  7. GSK’s Nucala Hits the Mark in Phase III HES Trial, Setting Up Potential Approval. Available at: https://www.biospace.com/article/gsk-plans-for-another-nucala-approval-following-positive-phase-iii-hes-study/. Accessed October 2, 2020.

 

 

 




Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.