Is Mepolizumab (Nucala) medically indicated for a 43-year-old female patient with severe persistent asthma and a history of hospitalizations due to asthma exacerbations, currently treated with inhaled corticosteroids and additional controllers?

Medical Necessity Determination for Mepolizumab (Nucala)

Mepolizumab is medically indicated for this 43-year-old female patient with severe persistent asthma, multiple hospitalizations, and inadequate control despite optimized therapy, though critical documentation gaps must be addressed before approval.

Key Approval Criteria Assessment

Criteria Met

Age and Specialist Requirements

• Patient is 43 years old (meets ≥6 years requirement) and is being managed by a pulmonologist, satisfying prescriber specialty requirements 1, 2

Uncontrolled Asthma with Severe Exacerbations

• Patient has been hospitalized for asthma this year with multiple exacerbations requiring systemic corticosteroids, clearly meeting the criterion of "one or more asthma exacerbation resulting in hospitalization" 1, 3
• This pattern of frequent exacerbations requiring steroids and hospitalization represents severe persistent asthma with significant morbidity risk 3, 2

Continuation of Maintenance Therapy

• Treatment plan appropriately includes continuation of Trelegy Ellipta, Airsupra, and Montelukast alongside Nucala 1

Critical Documentation Gaps Requiring Clarification

Eosinophil Count Status (ESSENTIAL)

• The CPB requires either: (1) baseline blood eosinophil count ≥150 cells/µL, OR (2) systemic corticosteroid dependence 1, 3
• This is the most critical missing piece - mepolizumab specifically targets eosinophilic asthma phenotypes and requires documented eosinophilia for FDA-approved indication 2
• Without eosinophil count documentation, cannot confirm the patient has the eosinophilic phenotype required for on-label use 1

Systemic Corticosteroid Dependence (PARTIALLY MET)

• Patient takes "occasional prednisone with exacerbations" - this does NOT meet the criterion for corticosteroid dependence 3
• Corticosteroid dependence means requiring daily or near-daily oral steroids for asthma control, not PRN use during exacerbations 4
• However, the multiple exacerbations requiring steroids may still qualify if eosinophil count criterion is met 3

High-Dose Inhaled Corticosteroid Verification (UNCLEAR)

• Fluticasone propionate 50 mcg nasal spray is NOT an inhaled corticosteroid for asthma - it is a nasal spray for rhinitis 5
• Trelegy Ellipta contains fluticasone furoate 200 mcg, which IS a high-dose inhaled corticosteroid component 5
• Documentation must clarify that Trelegy Ellipta represents the high-dose ICS requirement 1

Additional Controller Medication (MET)

• Trelegy Ellipta contains vilanterol (LABA) and umeclidinium (LAMA), providing two additional controllers beyond the ICS component 5
• Montelukast (leukotriene modifier) provides a third controller 5
• Albuterol is a rescue medication, not a controller 5

Clinical Rationale for Approval

Severe Disease Burden

• Multiple hospitalizations represent life-threatening asthma with significant mortality risk 3
• Persistent symptoms despite triple therapy (ICS/LABA/LAMA plus leukotriene modifier) indicate treatment-refractory disease 1, 3
• This level of uncontrolled asthma substantially impairs quality of life and carries high morbidity risk 3

Evidence for Mepolizumab Efficacy

• In patients with severe eosinophilic asthma and frequent exacerbations despite high-dose ICS, mepolizumab reduces exacerbation rates by 50-64% 3, 6
• The MENSA and SIRIUS trials demonstrated significant reductions in clinically relevant exacerbations requiring oral corticosteroids 1, 2
• Mepolizumab 100 mg subcutaneously every 4 weeks is the FDA-approved dose for this indication 1, 2

Required Documentation Before Approval

Obtain the following within past 12 months:

1. Blood eosinophil count - must be ≥150 cells/µL at baseline or ≥300 cells/µL within the prior year 1, 3
2. Confirmation of high-dose ICS therapy - document that Trelegy Ellipta 200 mcg fluticasone furoate represents high-dose ICS 1
3. Spirometry or peak flow documentation - to establish baseline lung function and severity 5

Common Pitfalls to Avoid

Do not approve without eosinophil documentation - mepolizumab specifically targets IL-5 mediated eosinophilic inflammation and is ineffective in non-eosinophilic asthma phenotypes 1, 2

Do not confuse nasal corticosteroids with inhaled corticosteroids - fluticasone nasal spray does not count toward the high-dose ICS requirement 5

Do not mistake PRN corticosteroid use during exacerbations for corticosteroid dependence - these are distinct criteria, though frequent exacerbations requiring steroids may still qualify the patient 3, 4

Ensure continuation of all controller medications - mepolizumab is add-on therapy, not replacement therapy, and discontinuing ICS or other controllers will result in treatment failure 1