HAEGARDA (C1 Esterase Inhibitor SQ [human])

HAEGARDA (C1 Esterase Inhibitor SQ [human]) 

SELF ADMINISTRATION - Subcutaneous

Indications for Prior Authorization:

Indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older.

Coverage Criteria:

1. For diagnosis of Hereditary Angioedema (HAE)

• Dose does not exceed weight-based dosing, AND
• Patient is at least 6 years of age and older, AND
• Prescribed by or in consultation by an immunologist or allergist, AND
• Diagnosis confirmed by C1 inhibitor (C1-INH) deficiency or dysfunction (Type 1 or II HAE) as documented by ONE of the following:
  • C1-INH antigenic level below the lower limit of normal, OR
  • C1-INH functional level below the lower limit of normal, AND
• For prophylaxis against HAE attacks, AND
• Not used in combination with other approved treatments for prophylaxis against HAE attacks

Reauthorization Criteria:

For diagnosis of Hereditary Angioedema (HAE)

• Dose does not exceed weight-based dosing, AND
• Patient shows a positive clinical response to therapy

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Dosing:

• Intended for self (or caregiver)-administration after reconstitution at a dose of 60 IU per kg by subcutaneous injection twice weekly (every 3 to 4 days)
• Patient or caregiver should be trained on how to administer
• Each vial is for single-use only

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Administration – for subcutaneous only
  • Patient or caregiver should be trained on how to self-administer

Policy Updates:

• 10/19/2021 – Policy update: expanded indication to allow use in patients 6 years of age and older

References:

• Haegarda Prescribing Information. CSL Behring, LLC. Kankakee, IL. September 2020.