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Takhzyro — Blue Cross Blue Shield of Texas

hereditary angioedema (HAE) due to C1-INH deficiency [Type 1 or Type 2] for prophylaxis

Initial criteria

  • 1. ONE of the following: (A) continuation of therapy and 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) ALL of the following:
  • • Diagnosis of hereditary angioedema due to C1-INH deficiency confirmed by: (1) decreased C4, C1-INH protein, and C1-INH function levels for Type 1 OR (2) decreased C4 and C1-INH function (protein level normal/elevated) for Type 2 OR mutation in C1-INH gene
  • • Requested agent prescribed for HAE prophylaxis
  • • Patient has a history of at least three moderate to severe acute HAE attacks per month (airway swelling, severe abdominal pain, painful facial swelling)
  • 2. Patient age within FDA labeling OR there is support for use at the patient's age
  • 3. If TAKHZYRO is requested, follow age-specific dosing and duration criteria for age ≥12 years, age 6 to <12 years, or age 2 to <6 years per policy text
  • 4. Medications known to cause angioedema (ACE inhibitors, estrogens, ARBs) evaluated and discontinued when appropriate
  • 5. Prescriber is an allergist/immunologist or has consulted with one
  • 6. Patient will NOT use the requested agent in combination with another HAE prophylaxis agent (Andembry, Cinryze, Dawnzera, Haegarda, Orladeyo, Takhzyro)
  • 7. Patient has no FDA labeled contraindications to the requested agent
  • Additional plan-specific provisions: for certain BCBS MT, NM, OH members may approve unlisted rare/unsupported indications meeting peer-reviewed literature or compendia support criteria

Reauthorization criteria

  • 1. Patient previously approved for requested agent through plan PA process
  • 2. Prescriber is a specialist in allergy/immunology or has consulted with one
  • 3. Patient has experienced clinical benefit as evidenced by decreased frequency of acute HAE attacks or decreased use of on-demand therapy
  • 4. Patient will NOT use with another HAE prophylaxis agent (Andembry, Dawnzera, Cinryze, Haegarda, Orladeyo, Takhzyro)
  • 5. If TAKHZYRO is requested, continue to meet age-specific therapeutic criteria as in initial evaluation
  • 6. No new FDA labeled contraindications present

Approval duration

BCBSIL/BCBSMT: 12 months; others: Cinryze 3 months, Haegarda 4 months, Andembry/Orladeyo 6 months, Takhzyro 9 months; renewals: 12 months