MEPOLIZUMAB INJ,SOLN
Clinical Criteria Summary
Document 787
Indication & Patient Population
- Add-on maintenance therapy in adults with inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.
- Patients must have an eosinophilic phenotype defined as EOS > 300 microL.
Prior Therapy & Treatment Requirements
- Must be continuing to experience exacerbations despite adherence to maximal inhaled therapies (LAMA+LABA+ICS) with documented proper inhaler use technique.
- A trial of azithromycin and/or roflumilast should be considered prior to mepolizumab in certain patients with exacerbations of COPD.
Dosing & Administration
- 100 mg subcutaneously (SQ) every 4 weeks.
- Available as 100 mg single dose vial, 100 mg single dose prefilled syringe, or prefilled autoinjector.
Contraindications & Precautions
- Contraindicated in patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.
- Not indicated for treating acute symptoms or exacerbations of asthma or COPD.
- Pre-existing parasitic infection (Helminth) must be treated prior to initiating therapy.
- Monitor for risk of hypersensitivity reactions and opportunistic infections (e.g., herpes zoster).
Document 791
Exclusion Criteria
- Untreated acute bronchospasm or acute exacerbation of chronic obstructive pulmonary disease (COPD)
- Untreated parasitic (helminth) infection (infection must be treated prior to initiating mepolizumab)
- Concurrent use with therapeutic biologics unless potential benefit-risk favors use
- Inclusion Criteria (All criteria must be met)
- Provider is a VA or VA Community Care pulmonologist or designated expert
- Moderate to severe COPD (post-bronchodilator FEV1 30-70% predicted and FEV1/FVC <0.7, confirmed by pulmonary function testing)
- Blood eosinophils ≥300 cells/µL obtained prior to treatment (e.g., within the 3 months prior)
- Signs or symptoms of chronic bronchitis (chronic productive cough) for at least 3 months during the past year
- Receiving concurrent triple inhaled therapy with a long-acting beta-agonist (LABA), long-acting anticholinergic (LAMA), and inhaled corticosteroid (ICS) (unless ICS is contraindicated) for at least 3 months
- At least 2 moderate COPD exacerbations (requiring systemic steroids and/or antibiotics) or at least 1 severe COPD exacerbation (requiring hospitalization) in the previous 12 months
- Inadequate symptom control (e.g., mMRC dyspnea scale score > 2) or impaired health status (e.g., CAT score > 15)
- Unable to tolerate or had an inadequate response to a 6-month trial of roflumilast and a 6-month trial of azithromycin, unless not clinically appropriate for either agent
- Adherent to COPD medications as evidenced by prescription refill history review
- Demonstrated correct inhaler technique (documented in chart)
Additional Inclusion Criteria & Clinical Guidance
- Patient is non-smoking or enrolled in a smoking cessation program/on cessation medications; current smokers may be considered if unable or refusing to quit
- Modifiable environmental triggers for Type 2 inflammation should be addressed, if not already done
- For females who can become pregnant: Counseling provided on potential risks vs benefits of treatment and use of effective contraception during therapy
Other Justification
- Hypereosinophilic syndrome (HES) to reduce eosinophilia and minimize exposure to glucocorticoids, prescribed by a specialty provider experienced in managing HES
- Non-severe active eosinophilic granulomatosis with polyangiitis (EGPA) to induce remission, prevent relapse, and minimize exposure to glucocorticoids, prescribed by a specialty provider experienced in managing EGPA with an inadequate response to benralizumab