Nucala

Drug - Nucala® (mepolizumab) [GlaxoSmithKline LLC]

January 2017

Therapeutic area - Asthma

Initial approval criteria

• Patient must be 12 years of age or older AND
• Has a diagnosis of severe eosinophilic asthma with a documented blood eosinophiol count of either:
  • ≥150 cells/microliter at baseline or ≥ 300 cells/microliter in the past 12 months as documented in chart notes AND
• Patient’s symptoms are not well controlled despite a 3 month adherent trial of high-dose inhaled corticosteroids in combination with a long-acting bronchodilator or leukotriene modifier AND
• Patient has had 2 or more exacerbations requiring treatment with systemic corticosteroids in the past 12 months AND
• At time of request, provide baseline FEV1 and frequency of asthma exacerbation per month
• Initial approval will be for 6 months in duration

Renewal approval criteria

• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following:
  • Parasitic (helminth) infection
  • Herpes zoster infection
• Treatment has resulted in clinical improvement as documented by at least ONE of the following:
  • Decreased frequency of exacerbations (defined as improvement of asthma as demonstrated by decreased use of oral/systemic corticosteroids and/or less frequent hospitalizations and/or reduced frequency of ER visits)
  • Improvement in lung function, measured in FEV1
• Renewal approval will be for 12 months in duration

Quantity limits

One injection (100 mg) per 28 days

Denial criteria

Concurrent use with Xolair or Cinqair

Billing of Nucala

Nucala is not covered through the MHCP fee-for-service pharmacy benefit and must be submitted as a medical claim. Nucala should be administered by a healthcare professional in a healthcare setting. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended by the manufacturer.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411