Mepolizumab (Nucala)  

OFFICE ADMININSTRATION

Indications for Prior Authorization: 

  • Severe Eosinophilic Asthma

All of the following must be met as a condition(s) for coverage:

  • Must be prescribed AND followed by a pulmonologist or immunologist, AND
  • Patient must be at least 12 years of age, AND
  • Eosinophil blood count of 150 cells µL within last 6 weeks or ≥ 300 cells/µL within the last 12 months, AND 
  • Patient had inadequate response to a high-dose inhaled corticosteroid in combination with long-acting beta agonist [LABA] and has been compliant with therapy for at least 3 months, AND
  • Patient meets one of the following within the past year:
    • One or more acute asthma-related ED visit(s)
    • One or more acute inpatient visits where asthma was the principle diagnosis
    • Use of chronic systemic steroids due to severe asthma OR two or more acute asthma exacerbations requiring oral systemic steroids AND
  • Will not be used in combination with Xolair (omalizumab), AND
  • Patient is not a current smoker

Patients for whom therapy with mepolizumab is not indicated include:

  • Combination use with Omalizumab (Xolair)
  • Monotherapy use
  • Patients with Chronic Obstructive Pulmonary Disease (COPD)

Dosing:

Adult

  • Up to 100 mg subcutaneously once every 4 weeks

Pediatric 12 years and older

  • 100 mg subcutaneously once every 4 weeks
Younger than 12 years
  • Safety and efficacy have not been established

Approval:

  • Initially for 24 weeks (6 months)
  • Re-Authorization consideration for 1 year (after initial 24 weeks) of therapy if the following criteria are met
    • Prescribed by a pulmonologist or immunologist, AND
    • Patient is continually compliant with all asthma medications, AND
    • Response to treatment with mepolizumab (Nucala), as evidenced by at least one of the following [must be documented in the medical record]:
      • Reduction in asthma symptoms (e.g., decreased number of sick days, improvement in physical activity, reduction in "as needed" use of short acting beta agonists), OR
      • Reduction in dose and frequency of inhaled steroids compared to baseline, OR
      • Reduction in acute asthma exacerbations requiring oral systemic steroids
  • Subsequent re-Authorization consideration - yearly if all of the following criteria are met
    • Prescribed by a pulmonologist or immunologist, AND
    • Patient is continually compliant with all asthma medications, AND
    • Continued response to treatment with mepolizumab (Nucala), as documented by at least one of the following [must be documented in the medical record]:
      • Stable or reduced asthma symptoms (e.g., no increase in number of sick days, decrease in physical activity, increase in "as needed" use of short acting beta agonists), OR
      • Stable or reduced (but not discontinued) dose and frequency of inhaled steroids compared to baseline, OR
      • Stable or reduced asthma exacerbations requiring oral systemic steroids

                          

Last review date: July 31, 2016