Neighborhood Health Plan RI mepolizumab Prior Auth

Coverage Criteria and Authorization Rules

inv-01: Asthma — Initial Therapy

Authorization of 6 months may be granted for treatment of severe asthma when ALL of the following are met:

Asthma initial criteria: Member is 6 years of age or older.

Asthma initial criteria: Member meets either baseline blood eosinophil count of at least 150 cells per microliter OR is dependent on systemic corticosteroids.>=150 cells per microliter

Asthma initial criteria: Member has uncontrolled asthma as demonstrated by at least one of: two or more exacerbations requiring oral or injectable corticosteroid treatment in the past year; one or more exacerbation(s) resulting in hospitalization or emergency medical care visit(s); OR poor symptom control (frequent symptoms or reliever use, activity limited by asthma, or night waking due to asthma).

Asthma initial criteria: Member has inadequate asthma control despite optimized doses of both: high-dose inhaled corticosteroid AND an additional controller (long-acting beta2-agonist, long-acting muscarinic antagonist, leukotriene modifier, or sustained-release theophylline).

Asthma initial criteria: Member will continue to use maintenance asthma treatments (inhaled corticosteroid and additional controller) in combination with the requested medication.

inv-02: EGPA — Initial Therapy

Authorization of 12 months may be granted for treatment of eosinophilic granulomatosis with polyangiitis when ALL of the following are met:

EGPA initial criteria: Member is 18 years of age or older.

EGPA initial criteria: Member is currently taking oral corticosteroids unless contraindicated or not tolerated.

EGPA initial criteria: Member has at least two of the following disease characteristics: biopsy showing eosinophilic vasculitis/perivascular eosinophilic infiltration/eosinophil-rich granulomatous inflammation; neuropathy (mono or poly); non-fixed pulmonary infiltrates; sino-nasal abnormality; cardiomyopathy; glomerulonephritis; alveolar hemorrhage; palpable purpura; ANCA positive.

EGPA initial criteria: Member has had at least one relapse within 2 years prior to starting treatment with the requested medication or has refractory disease.

inv-03: Initial Therapy - Severe Asthma

Authorization of 6 months may be granted for members 6 years of age or older who have previously received a biologic drug indicated for asthma in the past year or who meet the following.

Asthma initial criteria: Member is 6 years of age or older.

6-month auth; prior biologic within past year allows 6-month auth

Asthma initial criteria: Member meets either baseline blood eosinophil ≥150 cells/µL OR is dependent on systemic corticosteroids.>=150 cells/µL

Asthma initial criteria: Uncontrolled asthma as shown by at least one of: ≥2 exacerbations requiring oral/injectable corticosteroids in the past year; ≥1 exacerbation resulting in hospitalization or ED visit(s); OR poor symptom control (frequent symptoms or reliever use, activity limitation, night waking).

inv-04: Initial Therapy - EGPA

Authorization of 12 months may be granted for members 18 years or older who have previously received a biologic indicated for EGPA in the past year or who meet the following.

EGPA initial criteria: Member is 18 years of age or older.

12-month auth

EGPA initial criteria: Member has a history or the presence of an eosinophil count of more than 1000 cells per microliter or a blood eosinophil level greater than 10%.>1000 cells/µL or >10%

EGPA initial criteria: Member is currently taking oral corticosteroids unless contraindicated or not tolerated.

EGPA initial criteria: Member has at least two EGPA disease characteristics from the listed set (e.g., biopsy evidence, neuropathy, non-fixed pulmonary infiltrates, sino-nasal abnormality, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, ANCA positive).

inv-05: Initial Therapy - HES

Authorization of 12 months may be granted for treatment of HES when all of the following criteria are met.

HES initial criteria: Member is 12 years of age or older.

12-month auth

HES initial criteria: Member has a history or presence of a blood eosinophil count of at least 1000 cells per microliter.>=1000 cells/µL

HES initial criteria: Member will not use the requested medication as monotherapy.

HES initial criteria: Member has been on a stable dose of HES therapy (eg, oral corticosteroid, immunosuppressive, and/or cytotoxic therapy).

inv-05: Initial Therapy - CRSwNP

Authorization of 6 months may be granted for members 18 years of age or older who have previously received a biologic indicated for CRSwNP in the past year or who meet the following.

CRSwNP initial criteria: Member is 18 years of age or older.

6-month auth

CRSwNP initial criteria: Member has bilateral nasal polyposis and chronic symptoms of sinusitis despite intranasal corticosteroid treatment for at least 4 weeks unless contraindicated or not tolerated.

CRSwNP initial criteria: CRSwNP despite prior sinonasal surgery OR prior systemic corticosteroids within the last two years that were ineffective unless contraindicated or not tolerated.

CRSwNP initial criteria: Objective evidence of polyps by one of: bilateral nasal endoscopy/anterior rhinoscopy/CT showing polyps reaching below the lower border of the middle turbinate in each nostril; Meltzer Clinical Score ≥2 in both nostrils; OR total endoscopic nasal polyp score (NPS) ≥5 with ≥2 per nostril.

inv-06: Initial Therapy - COPD

Authorization of 12 months may be granted for members 18 years of age or older who have previously received a biologic indicated for COPD in the past year or who meet the following.

COPD initial criteria: Member is 18 years of age or older.

12-month auth

COPD initial criteria: Diagnosis confirmed by spirometry showing FEV1/FVC < 0.7 post-bronchodilation.

COPD initial criteria: Member demonstrates classic signs or symptoms of COPD (eg, dyspnea, wheezing, chest tightness, fatigue, activity limitation, cough with or without sputum).

COPD initial criteria: Member has an absolute blood eosinophil count of at least 150 cells per microliter prior to initiating therapy with the requested medication.>=150 cells/µL

inv-08: Continuation Therapy

Authorization of 12 months may be granted for continuation when demonstrated clinical benefit or stability is shown.

Asthma continuation: Member is 6 years of age or older; asthma control has improved on the requested medication as demonstrated by at least one of: reduction in frequency/severity of symptoms and exacerbations OR reduction in the daily maintenance oral corticosteroid dose; member will continue to use maintenance asthma treatments in combination with the requested medication.

12-month continuation

EGPA continuation: Member is 18 years of age or older; member has beneficial response to treatment as demonstrated by a reduction in relapse frequency OR reduction/discontinuance of daily oral corticosteroid dose OR no active vasculitis.

12-month continuation

HES continuation: Member is 12 years of age or older; member has experienced a reduction in HES flares since starting treatment with the requested medication.

12-month continuation

Coverage will not be provided for treatment of Hypereosinophilic Syndrome (HES) when the HES is secondary to a non-hematologic cause. Examples of non-hematologic causes include drug hypersensitivity, parasitic helminth infection, human immunodeficiency virus (HIV) infection, and non-hematologic malignancy. Additionally, HES that is FIP1L1-PDGFRA kinase–positive is excluded from coverage.

For all indications, concomitant use of the requested medication with any other biologic drug or targeted synthetic drug for the same indication is not allowed. Requests that propose simultaneous therapy with another biologic or targeted synthetic agent for the same condition may be denied.

Prior Authorization and Documentation Requirements

Documentation Required

Initial asthma/HES/COPD documentation

Initial requests - Chart notes or medical record showing pretreatment blood eosinophil count, dependence on systemic corticosteroids if applicable. - Chart notes, medical record documentation, or claims history supporting previous medications tried including drug, dose, frequency, and duration.

Pretreatment absolute blood eosinophil count (where applicable)
Documentation of dependence on systemic corticosteroids (if applicable)
Previous medication history: drug name, dose, frequency, duration, and response

Step Therapy

Asthma step requirements

Authorization of 6 months may be granted for treatment of severe asthma when all of the following criteria are met: - Member is 6 years of age or older. - Member meets either of the following criteria: - Member has a baseline blood eosinophil count of at least 150 cells per microliter. - Member is dependent on systemic corticosteroids. - Member has uncontrolled asthma as demonstrated by experiencing at least one of the following within the past year: - Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment. - One or more asthma exacerbation(s) resulting in hospitalization or emergency medical care visit(s). - Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma). - Member has inadequate asthma control despite current treatment with both of the following medications at optimized doses: - High-dose inhaled corticosteroid. - Additional controller (i.e., long-acting beta2-agonist, long-acting muscarinic antagonist, leukotriene modifier, or sustained-release theophylline). - Member will continue to use maintenance asthma treatments (i.e., inhaled corticosteroid and additional controller) in combination with the requested medication.

Eosinophil Thresholds and Key Values

Asthma eosinophil threshold

Asthma eosinophil threshold>= 150 cells per microliter

Age requirement (asthma)Member is 6 years of age or older

Alternative qualifying criterionOr dependent on systemic corticosteroids (if eosinophil <150)

EGPA eosinophil history

EGPA historical eosinophil level>1000 cells per microliter

EGPA percent eosinophils>10% blood eosinophils

Age requirement (EGPA)

Drug Background and Definitions

Mepolizumab (Nucala) is an anti–IL-5 monoclonal antibody indicated as add-on maintenance therapy for eosinophil-associated conditions, including severe eosinophilic asthma and other eosinophilic phenotypes. It is intended for maintenance use and is not for relief of acute bronchospasm or status asthmaticus. Providers should note that when prescribing mepolizumab, patients must not be treated concomitantly with another biologic or targeted synthetic agent for the same indication.

Limitations of Use

Not for acute bronchospasm/status asthmaticusMepolizumab is not indicated for relief of acute bronchospasm or status asthmaticus

Other non‑FDA indicationsIndications not listed as FDA‑approved are considered experimental/investigational and not medically necessary

FDA‑approved populations (context)Indications include severe asthma (≥6 yrs), EGPA (adults), HES (≥12 yrs), CRSwNP (adults), COPD (adults) per FDA labeling

Clinical Definitions and Measurement Thresholds

Limitations of Use (quick reference)

EGPA eosinophil criteriaEosinophil count >1000 cells/µL or >10%

HES eosinophil criteriaBlood eosinophil count ≥1000 cells/µL

Asthma/COPD eosinophil criteriaEosinophil threshold ≥150 cells/µL

History/presence of elevated eosinophils (quick reference)

EGPA elevated eosinophilsEosinophil count >1000 cells/µL or >10%

HES elevated eosinophilsBlood eosinophil count ≥1000 cells/µL

Asthma/COPD elevated eosinophils

OpenPayer

Mepolizumab (Nucala) — Coverage Criteria

Coverage Criteria and Authorization Rules

Prior Authorization and Documentation Requirements

Eosinophil Thresholds and Key Values

Drug Background and Definitions

Clinical Definitions and Measurement Thresholds