Nucala. Nucala (mepolizumab) Description

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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Nucala Page: 1 of 5 Last Review Date: December 2, 2016 Nucala Description Nucala (mepolizumab) Background Nucala is used with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Nucala is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines. Nucala reduces severe asthma attacks by reducing the levels of blood eosinophils- a type of white blood cell that contributes to the development of asthma (1). Regulatory Status FDA-approved indication: Nucala is an interleukin-5 ant monoclonal antibody (IgG1 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype (1). Limitations of use: (1) Nucala is not indicated for treatment of other eosinophilic conditions Nucala is not indicated for the relief of acute bronchospasm or status asthmaticus Subjects enrolled in Nucala trial were required to have at least 1 of the following criteria: blood eosinophil count greater than or equal to 300 cells/mcl in past 12 months, eosinophil count greater than or equal 150 cells/ mcl in the past 90 days or sputum eosinophil count greater than or equal to 3% (1).

2 Subject: Nucala Page: 2 of 5 In clinical trials herpes zoster have occurred in some patients receiving Nucala and varicella vaccination should be considered if medically appropriate prior to starting therapy (1). Clinical studies with Nucala in pediatric patients less than 12 years of age have not been conducted (1). Related policies Xolair Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. Nucala may be considered medically necessary in patients 12 years of age and older as addon maintenance treatment of patients with severe asthma with an eosinophilic phenotype, patient must use in combination with a corticosteroid inhaler and long acting beta2-; in patients who have had inadequate control of asthmatic symptoms after a minimum of 3 months of high dose corticosteroid inhaler in combination with a long acting beta2-; not for the treatment of other eosinophilic conditions; not used for the relief of acute bronchospasm or status asthmaticus; no dual therapy with another monoclonal antibody for the treatment of asthma; prescriber will assess the medical appropriateness for a varicella vaccination prior to therapy; patient must have one of the following: eosinophil count greater than or equal 150 cells/ mcl in the past 90 days, or eosinophil count greater than or equal 300 cells/mcl in the past 12 months. Nucala is considered investigational in patients under the age of 12 and for all other indications. Prior-Approval Requirements Age 12 years of age or older Diagnosis Patient must have the following: Severe Asthma with an eosinophilic phenotype

3 Subject: Nucala Page: 3 of 5 AND ALL of the following: 1. Used in combination with a corticosteroid inhaler and long acting beta2-2. Inadequate control of asthmatic symptoms after a minimum of 3 months of high dose corticosteroid inhaler in combination with a long acting beta2-3. NOT for the treatment of other eosinophilic conditions 4. NOT used for the relief of acute bronchospasm or status asthmaticus 5. NO dual therapy with another monoclonal antibody for the treatment of asthma 6. Prescriber will assess the medical appropriateness for a varicella vaccination prior to therapy AND ONE of the following: 1. Eosinophil count greater than or equal 150 cells/ mcl in the past 90 days 2. Eosinophil count greater than or equal 300 cells/mcl in the past 12 months Prior Approval Renewal Requirements Age 12 years of age or older Diagnosis Patient must have the following: Policy Guidelines Severe asthma with an eosinophilic phenotype AND ALL of the following: 1. Used in combination with a corticosteroid inhaler and long acting beta 2-2. Decreased exacerbations and improvement in symptoms 3. Decreased utilization of rescue medications 4. NOT for the treatment of other eosinophilic conditions 5. NOT used for the relief of acute bronchospasm or status asthmaticus 6. NO dual therapy with another monoclonal antibody for the treatment of asthma

4 Subject: Nucala Page: 4 of 5 Pre - PA Allowance None Prior - Approval Limits Duration 6 months Prior Approval Renewal Limits Duration 12 months Rationale Summary Nucala has been shown to decrease the incidence of asthma exacerbations in adult and adolescent patients 12 years of age and older severe asthma whose symptoms are inadequately controlled with inhaled corticosteroids. Nucala is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines (1). Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Nucala while maintaining optimal therapeutic outcomes. References 1. Nucala [package insert]. Philadelphia, PA: GlaxoSmithKline LLC.; November Policy History Date December 2015 March 2016 June 2016 Action Addition to PA Annual editorial review Addition of the requirement of the patient must have one of the following: eosinophil count greater than or equal 150 cells/ mcl in the past 90 days, or eosinophil count greater than or equal 300 cells/mcl in the past 12 months also, varicella vaccination has been given prior to Nucala therapy per SME Policy number change from Annual review

5 Subject: Nucala Page: 5 of 5 September 2016 December 2016 Clarified dual therapy statement and addition of age to renewal Change of the varicella vaccination requirement to Prescriber will assess the medical appropriateness for a varicella vaccination prior to therapy Annual review Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on December 2, 2016 and is effective on January 1, Deborah M. Smith, MD, MPH