Tezspire - NC Standard

Restricted Product(s)

• Tezspire® (tezepelumab-ekko) injection

FDA Approved Use

• For the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Criteria for Approval of Restricted Product(s)

Initial Criteria for Approval

1. The patient is 12 years of age or older; AND
2. The patient has a diagnosis of severe asthma; AND
3. ALL of the following:
   1. The patient has a history of inadequately controlled asthma despite adherence to asthma control therapy as demonstrated by ONE of the following:
      1. Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months; OR
      2. Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months; OR 
      3. Controlled asthma that worsens when the doses of inhaled and/or systemic corticosteroids are tapered; OR 
      4. The patient has baseline (prior to therapy with the requested agent) Forced Expiratory Volume (FEV1) that is less than 80% of predicted; AND
   2. ONE of the following:
      1. The patient is NOT currently being treated with the requested agent AND is currently treated with and adherent to a maximally tolerated inhaled corticosteroid for at least 3 months; OR
      2. The patient is currently being treated with the requested agent AND ONE of the following:
         1. Is currently treated with and adherent to an inhaled corticosteroid for at least 3 months that is adequately dosed to control symptoms; OR
         2. Is currently treated with and adherent to a maximally tolerated inhaled corticosteroid for at least 3 months; OR
      3. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL inhaled corticosteroid therapy; AND
   3. ONE of the following:
      1. The patient is currently being treated and adherent for at least 3 months with ONE of the following:
         1. A long-acting beta-2 agonist (LABA); OR 
         2. A leukotriene receptor antagonist (LTRA); OR 
         3. A long-acting muscarinic antagonist (LAMA); OR
         4. Theophylline; OR 
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL LABA, LTRA, LAMA, and theophylline therapies; AND
   4. The patient will continue asthma control therapy [e.g., inhaled corticosteroids (ICS), LABA, LTRA, LAMA, theophylline] in combination with the requested agent; AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, pulmonologist) or has consulted with a specialist in the area of the patient’s diagnosis; AND 
5. The patient will NOT be using the requested agent in combination with another biologic immunomodulator agent used for the same indication [e.g., benralizumab (Fasenra), dupilumab (Dupixent), mepolizumab (Nucala), reslizumab (Cinqair), omalizumab (Xolair)]; AND 
6. The patient does NOT have any FDA labeled contraindications to the requested agent; AND 
7. The provider is aware that if approved, any previous authorizations through Blue Cross NC for biologic agents used for the same indication as the requested agent will be terminated; AND 
8. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

Continuation Criteria for Approval

1. The patient has been previously approved for Tezspire (tezepelumab-ekko) with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND
2. The patient has a diagnosis of severe asthma AND BOTH of the following:
   1. The patient has had improvements or stabilization with the requested agent from baseline (prior to therapy with the requested agent) as indicated by ONE of the following:
      1. The patient has had an increase in percent predicted Forced Expiratory Volume (FEV1); OR
      2. The patient has had a decrease in the dose of inhaled corticosteroids required to control the patient’s asthma; OR 
      3. The patient has had a decrease in need for treatment with systemic corticosteroids due to exacerbations of asthma; OR 
      4. The patient has had a decrease in number of hospitalizations, need for mechanical ventilation, or visits to urgent care or emergency room due to exacerbations of asthma; AND
   2. The patient is currently treated and is compliant with asthma control therapy [e.g., inhaled corticosteroids, long-acting beta-2 agonist (LABA), leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), theophylline]; AND 
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, pulmonologist) or has consulted with a specialist in the area of the patient’s diagnosis; AND
4. The patient will NOT be using the requested agent in combination with another biologic immunomodulator agent used for the same indication [e.g., benralizumab (Fasenra), dupilumab (Dupixent), mepolizumab (Nucala), reslizumab (Cinqair), omalizumab (Xolair)]; AND
5. The patient does NOT have any FDA labeled contraindications to the requested agent; AND 
6. The provider is aware that if approved, any previous authorizations through Blue Cross NC for biologic agents used for the same indication as the requested agent will be terminated; AND 
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
2. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
3. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

January 2024: Policy change: Removed step requirements through Xolair, Dupixent, Fasenra, Nucala for associated indications. Added Xolair to concomitant use statement in initial and continuation coverage criteria. Updated initial duration of approval to one year.
February 2023: Original utilization management criteria issued.