Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Initial Evaluation
Tezepelumab-ekko (Tezspire) may be considered medically necessary when an individual meets ALL of the following criteria:
- ONE of the following:
- Information has been provided that indicates the individual has been treated with tezepelumab-ekko (Tezspire) (starting on samples is not approvable) within the past 90 days; or
- The prescriber states the individual has been treated with tezepelumab-ekko (Tezspire) (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed
- The individual has a diagnosis of severe asthma AND ALL of the following:
- The individual has a history of uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following:
- Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months; or
- Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months; or
- Controlled asthma that worsens when the doses of inhaled and/or systemic corticosteroids are tapered; or
- The individual has baseline (prior to therapy with tezepelumab-ekko (Tezspire)) Forced Expiratory Volume (FEV1) that is less than 80% of predicted; and
- ONE of the following:
- The individual is NOT currently being treated with tezepelumab-ekko (Tezspire) AND is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months; or
- The individual is currently being treated with tezepelumab-ekko (Tezspire) AND ONE of the following:
- Is currently treated with an inhaled corticosteroid for at least 3 months that is adequately dosed to control symptoms; or
- Is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months; or
- The individual has an intolerance or hypersensitivity to inhaled corticosteroid therapy; or
- The individual has an FDA labeled contraindication to ALL inhaled corticosteroids; and
- ONE of the following:
- The individual is currently being treated for at least 3 months with ONE of the following:
- A long-acting beta-2 agonist (LABA); or
- A leukotriene receptor antagonist (LTRA); or
- Long-acting muscarinic antagonist (LAMA); or
- Theophylline; or
- The individual has an intolerance or hypersensitivity to therapy with LABA, LTRA, LAMA, or theophylline; or
- The individual has an FDA labeled contraindication to ALL LABA, LTRA, LAMA, AND theophylline therapies; and
- ONE of the following:
- If the individual has a diagnosis of allergic type asthma, then ONE of the following:
- The individual has tried and had an inadequate response to omalizumab (Xolair) used for a minimum of 4 months for the treatment of allergic asthma; or
- The individual has an intolerance or hypersensitivity to omalizumab (Xolair); or
- The individual has an FDA labeled contraindication to omalizumab (Xolair); or
- If the individual has a diagnosis of oral corticosteroid dependent type asthma, then ONE of the following:
- The individual has tried and had an inadequate response to dupilumab (Dupixent) used for a minimum of 4 months for the treatment of asthma; or
- The individual has an intolerance or hypersensitivity to dupilumab (Dupixent); or
- The individual has an FDA labeled contraindication to dupilumab (Dupixent); or
- If the individual has a diagnosis of eosinophilic type asthma, then ONE of the following:
- The individual has tried and had an inadequate response to dupilumab (Dupixent) or an IL-5 inhibitor (e.g., benralizumab (Fasenra), mepolizumab (Nucala)) used for a minimum of 4 months for the treatment of asthma; or
- The individual has an intolerance or hypersensitivity to dupilumab (Dupixent) or an IL-5 inhibitor; or
- The individual has an FDA labeled contraindication to dupilumab (Dupixent) AND IL-5 inhibitors; or
- The prescriber has provided information indicating the individual has severe asthma that is not allergic type, eosinophilic type, or oral corticosteroid dependent type; and
- The individual will continue asthma control therapy (e.g., ICS, LABA, LTRA, LAMA, theophylline) in combination with tezepelumab-ekko (Tezspire); or
- The individual has another FDA approved indication for tezepelumab-ekko (Tezspire) and route of administration; or
- The individual has another indication that is supported in compendia for tezepelumab-ekko (Tezspire) and route of administration; and
- ONE of the following:
- The individual is twelve (12) years of age or older; or
- The prescriber has provided information in support of using tezepelumab-ekko (Tezspire) for the individual’s age for the requested indication; and
- The prescriber is a specialist in the area of the individual’s diagnosis (e.g., allergist, immunologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
- The individual will NOT be using tezepelumab-ekko (Tezspire) in combination with another biologic agent for the requested indication [e.g., omalizumab (Xolair), IL-5 inhibitor (reslizumab (Cinqair), benralizumab (Fasenra), mepolizumab (Nucala)), dupilumab (Dupixent)]; and
- The individual does NOT have any FDA labeled contraindications to tezepelumab-ekko (Tezspire).
Compendia Allowed: DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use
Tezepelumab-ekko (Tezspire) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.
Procedure Codes
