tezepelumab-ekko — Blue Cross Blue Shield of Texas
severe asthma
Initial criteria
- 1. ONE of the following: (A) The requested agent is eligible for continuation of therapy AND the prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR (B) BOTH of the following apply:
- 1. ONE of the following: (A) BOTH of the following: (1) The patient has a diagnosis of severe asthma AND (2) The patient has a history of uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following: (A) ≥2 systemic corticosteroid bursts in past 12 months OR (B) hospitalization, mechanical ventilation, or emergency/urgent care visit for asthma in past 12 months OR (C) controlled asthma worsens when corticosteroids are tapered OR (D) baseline FEV1 <80% predicted OR (B) patient has another FDA labeled indication for the agent and route AND
- 2. If the patient has an FDA labeled indication, ONE of: (A) patient’s age is within FDA labeling OR (B) evidence supports using agent for patient’s age OR (C) patient has another indication supported in compendia
- 2. If the patient has severe asthma, then ALL of the following:
- A. ONE of the following: (1) Patient not currently treated with requested agent AND currently treated with maximally tolerated inhaled corticosteroid for ≥3 months AND adherent for 90 of past 120 days [chart notes required] OR (2) Patient currently treated with requested agent AND ONE of the following: (A) on inhaled corticosteroid for ≥3 months, adherent for 90 of past 120 days OR (B) on maximally tolerated inhaled corticosteroid for ≥3 months, adherent for 90 of past 120 days OR (3) intolerance or hypersensitivity to inhaled corticosteroid OR (4) FDA labeled contraindication to ALL inhaled corticosteroids
- B. ONE of the following: (1) Treated ≥3 months and adherent for 90 of past 120 days with ONE of: LABA, LAMA, LTRA, or theophylline [chart notes required] OR (2) intolerance/hypersensitivity to LABA, LAMA, LTRA, theophylline OR (3) FDA labeled contraindication to ALL LABA and LAMA
- C. The patient will continue asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline) in combination with the requested agent
- 3. The prescriber is a specialist (e.g., allergist, immunologist, pulmonologist) or has consulted a specialist in the area of diagnosis
- 4. ONE of the following: (A) Patient will NOT use the agent with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) Patient will use in combination AND BOTH of: (1) Prescribing info does not limit combination use AND (2) Support for combination use (clinical trial, phase III study, or guideline provided)
- 5. Patient does NOT have FDA labeled contraindications to the requested agent
- For Ohio members under Fully Insured or HIM Shop plans, approval may also be granted if ALL of the following: (A) No FDA labeled contraindications AND (B) ONE of: another FDA labeled indication for the agent and route OR indication supported in compendia OR two peer-reviewed journal articles support proposed use as generally safe and effective
Reauthorization criteria
- 1. Patient previously approved for the requested agent through the plan’s Prior Authorization process
- 2. ONE of the following: (A) Patient has severe asthma AND BOTH of: (1) Improvement or stabilization from baseline as shown by ONE of: (A) increased FEV1 percent predicted OR (B) decreased inhaled corticosteroid dose OR (C) decreased systemic corticosteroid use for exacerbations OR (D) decreased hospitalizations, mechanical ventilation, or urgent care/ER visits AND (2) Patient treated within past 90 days and compliant with control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline) [chart notes required] OR (B) Patient has other diagnosis and demonstrated clinical benefit with requested agent
- 3. Prescriber is a specialist (e.g., allergist, immunologist, pulmonologist) or has consulted with a specialist
- 4. ONE of the following: (A) Patient will NOT use in combination with immunomodulatory agent OR (B) Patient will use in combination AND BOTH of: (1) Prescribing info does not limit combination use AND (2) Support provided for combination therapy
- 5. Patient does NOT have any FDA labeled contraindications to the requested agent
Approval duration
6-12 months