tezepelumab-ekko — Blue Cross Blue Shield of New Mexico
FDA labeled indication for requested agent
Initial criteria
- Requester must meet ONE of the following: (A) eligible for continuation of therapy AND prescriber states patient has been treated with requested agent (not sample) within past 90 days and at risk if changed; OR (B) BOTH of the following: (1) ONE of the following: (A) BOTH: patient has diagnosis of severe asthma AND history of uncontrolled asthma while on asthma control therapy demonstrated by ONE of: frequent severe exacerbations (≥2 systemic corticosteroid bursts in past 12 months) OR serious exacerbations requiring hospitalization, mechanical ventilation, or ER/urgent care visits in past 12 months OR controlled asthma worsens when corticosteroids tapered OR baseline FEV1 <80% predicted; OR (B) patient has another FDA labeled indication; OR (C) patient has another indication supported in compendia. AND (2) Patient’s age is within FDA labeling OR supported for off-label use.
- If patient has severe asthma THEN ALL of the following: (A) ONE of the following: (1) Not currently on requested agent AND currently treated with maximally tolerated inhaled corticosteroid ≥3 months AND adherent 90 days of past 120; OR (2) Currently on requested agent AND either currently treated with adequately dosed inhaled corticosteroid ≥3 months AND adherent 90/120 days OR currently treated with maximally tolerated inhaled corticosteroid ≥3 months AND adherent 90/120 days; OR (3) Has intolerance or hypersensitivity to inhaled corticosteroid; OR (4) Has FDA labeled contraindication to ALL inhaled corticosteroids; AND (B) ONE of the following: (1) Treated ≥3 months AND adherent 90/120 days with ONE of: LABA, LAMA, LTRA, or theophylline; OR (2) Has intolerance or hypersensitivity to therapy with LABA, LAMA, LTRA, or theophylline; OR (3) Has FDA labeled contraindication to ALL LABA and LAMA; AND (C) Will continue asthma control therapy (ICS, ICS/LABA, LTRA, LAMA, theophylline) with requested agent.
- Prescriber must be specialist in patient’s diagnosis area (e.g., allergist, immunologist, pulmonologist) OR has consulted with such a specialist.
- ONE of the following regarding concomitant immunomodulators: (A) Will NOT be used with another immunomodulatory agent (e.g., TNF inhibitor, JAK inhibitor, IL-4 inhibitor) OR (B) If used in combination, prescribing information does not limit combo AND supporting clinical trial/guideline data provided.
- Patient must NOT have FDA labeled contraindications to requested agent.
- Alternative Ohio policy path: Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND BOTH of: (A) No FDA labeled contraindication; AND (B) ONE of: another FDA labeled indication OR another compendia-supported indication OR TWO major peer-reviewed journal articles support use.
Reauthorization criteria
- Patient previously approved for requested agent through plan’s PA process.
- ONE of the following: (A) If severe asthma: BOTH of (1) demonstrated improvement or stabilization vs baseline by ONE of: increased FEV1, decreased corticosteroid dose, decreased systemic corticosteroid use for exacerbations, or decreased hospitalizations/ER/urgent care visits; AND (2) currently treated within past 90 days and compliant with asthma control therapy (ICS, ICS/LABA, LTRA, LAMA, theophylline); OR (B) If other diagnosis, has had clinical benefit with requested agent.
- Prescriber is or has consulted with relevant specialist (e.g., allergist, immunologist, pulmonologist).
- ONE of the following for immunomodulators: (A) Will NOT be used concurrently with another immunomodulatory agent OR (B) If used, labeling allows and supporting data provided.
- Patient does NOT have FDA labeled contraindications.
Approval duration
Initial 6mo (BCBSNM and others), Renewal 12mo