Cinryze — Blue Cross Blue Shield of New Mexico

Initial criteria

• ONE of the following: (A) The requested agent is eligible for continuation of therapy AND the following: The prescriber states the 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 (B) ALL of the following:
• 1. The patient has a diagnosis of hereditary angioedema (HAE) due to C1INH deficiency evidenced by ONE of the following:
• A. Type 1 HAE: Decreased quantities of C4 level, C1-INH protein level, and C1-INH function level OR
• B. Type 2 HAE: Decreased quantities of C4 level and C1-INH function level (C1-INH protein level may be normal or elevated) OR
• C. The patient’s diagnosis has been confirmed by mutation in the C1-INH gene altering protein synthesis and/or function;
• 2. The requested agent is being prescribed for HAE prophylaxis;
• 3. The patient has a history of at least three moderate to severe acute HAE attacks per month;
• 4. If the patient has an FDA labeled indication, then ONE of the following: (A) The patient’s age is within FDA labeling for the requested indication OR (B) There is support for using the requested agent for the patient’s age for the requested indication;
• 5. If TAKHZYRO is requested, age- and duration-specific criteria:
• * Adult or ≥12 years: initiating, <6 months, or ≥6 months treated AND attack-free dose adjustment (300 mg q4w or supported q2w) OR not attack-free;
• * Age 6–<12 years: initiating, <6 months, or ≥6 months treated AND attack-free dose adjustment (150 mg q4w or supported q2w) OR not attack-free;
• * Age 2–<6 years: eligible as specified;
• 6. Medications known to cause angioedema (ACE inhibitors, estrogens, ARBs) have been evaluated and discontinued when appropriate;
• 7. Prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist) or has consulted with such specialist;
• 8. The patient will NOT be using the requested agent in combination with another agent indicated for prophylaxis of HAE attacks (Andembry, CINRYZE, Dawnzera, HAEGARDA, Orladeyo, TAKHZYRO);
• 9. The patient does NOT have any FDA labeled contraindications to the requested agent.
• Special plan-specific approvals: BCBS MT Fully Insured or HIM members under age 18 with peer-reviewed support OR BCBS NM Fully Insured/HIM rare-disease indications OR Ohio Fully Insured/HIM rare-disease compendia support as detailed in policy.

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process;
• 2. Prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist) or has consulted with such specialist;
• 3. The patient has had clinical benefit with the requested agent as indicated by ONE of the following:
• A. Decrease in frequency of acute HAE attacks from baseline; OR
• B. Decrease in use of on-demand therapy;
• 4. The patient will NOT be using the requested agent in combination with another HAE prophylactic agent (Andembry, Dawnzera, CINRYZE, HAEGARDA, Orladeyo, TAKHZYRO);
• 5. If TAKHZYRO is requested, age- and duration-specific continuation criteria identical to initial request;
• 6. The patient does NOT have any FDA labeled contraindications.

Approval duration

BCBSIL/BCBSMT:12mo; Others:3mo(Cinryze),4mo(Haegarda),6mo(Andembry/Orladeyo),9mo(Takhzyro); Renewal:12mo