Tezspire (tezepelumab-ekko) — Blue Cross Blue Shield of Alabama
severe asthma
Initial criteria
- ONE of the following:
- The requested agent is eligible for continuation of therapy AND ONE of the following:
- - Patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
- - Prescriber states patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed
- OR BOTH of the following:
- - Patient has a diagnosis of severe asthma AND
- - Patient has a history of uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following:
- • Frequent severe exacerbations requiring ≥2 courses of systemic corticosteroids (steroid burst) within past 12 months OR
- • Serious exacerbations requiring hospitalization, mechanical ventilation, or ER/urgent care visit within past 12 months OR
- • Controlled asthma that worsens when inhaled/systemic corticosteroids are tapered OR
- • Baseline FEV1 <80% predicted
- OR Patient has another FDA labeled indication for requested agent and route of administration
- AND if patient has an FDA labeled indication, then ONE of the following:
- • Patient’s age is within FDA labeling for indication OR
- • There is support for use at patient’s age for indication OR
- • Indication supported in compendia (AHFS, DrugDex 1 or 2a, or NCCN 1 or 2a) for agent and route
- AND if diagnosis is severe asthma, ALL of the following:
- ONE of the following:
- - Patient is NOT currently treated with requested agent AND is currently treated with maximally tolerated inhaled corticosteroid (ICS) for ≥3 months AND adherent for 90 of past 120 days OR
- - Patient is currently treated with requested agent AND ONE of:
- • Currently treated with adequately dosed ICS for ≥3 months AND adherent for 90 of past 120 days OR
- • Currently treated with maximally tolerated ICS for ≥3 months AND adherent for 90 of past 120 days OR
- • Has intolerance/hypersensitivity or FDA labeled contraindication to ALL ICS
- AND ONE of the following:
- - Currently treated for ≥3 months AND adherent for 90 of past 120 days with ONE of:
- • LABA OR LAMA OR LTRA OR Theophylline
- OR Patient has intolerance/hypersensitivity or FDA labeled contraindication to ALL LABA and LAMA
- AND Patient will continue asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline) in combination with requested agent
- AND Prescriber is a specialist (allergist, immunologist, pulmonologist) or has consulted with one
- AND ONE of the following regarding concomitant therapy:
- - Patient will NOT use another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
- - If used in combination, BOTH of:
- • Prescribing info for requested agent does NOT limit combination AND
- • There is support for combination use (clinical trials, Phase III studies, or guidelines submitted)
- AND Patient has no FDA labeled contraindications to requested agent
Reauthorization criteria
- Patient previously approved for requested agent through plan’s PA process
- AND ONE of the following:
- - Patient has diagnosis of severe asthma AND BOTH of:
- • Demonstrated improvement or stabilization with therapy as shown by ONE of:
- - Increased percent predicted FEV1 OR
- - Decreased dose of ICS needed OR
- - Decreased need for systemic corticosteroids due to exacerbations OR
- - Decreased hospitalizations, need for ventilation, or urgent/ER visits due to exacerbations
- AND Patient currently treated within past 90 days and compliant with asthma control therapy (ICS, ICS/LABA, LTRA, LAMA, theophylline)
- OR Patient has diagnosis other than severe asthma AND has had clinical benefit with requested agent
- AND Prescriber is a specialist (allergist, immunologist, pulmonologist) or has consulted with one
- AND ONE of the following:
- - Patient will NOT be using requested agent with another immunomodulator (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
- - If used in combination, BOTH of:
- • Prescribing info for requested agent does not limit combination AND
- • There is support for combination therapy (clinical trials, Phase III studies, or guidelines submitted)
- AND Patient does not have FDA labeled contraindications to requested agent
Approval duration
initial 6 months; renewal 12 months