Pharmacy Prior Authorization Criteria

Hereditary Angioedema Agents (HAE) Quantity Limit Override

Indications for Prior Authorization

Berinert (C1 esterase inhibitor [Human])

For diagnosis of Acute treatment of Hereditary Angioedema (HAE)
Indicated for the treatment of acute abdominal, facial, or laryngeal attacks of HAE in adult and adolescent patients. The safety and efficacy of Berinert for prophylactic therapy have not been established.

Firazyr (icatibant)

For diagnosis of Acute treatment of Hereditary Angioedema (HAE)
Indicated for the treatment of acute attacks of HAE in adults 18 years of age and older.

Sajazir (icatibant)

For diagnosis of Acute treatment of Hereditary Angioedema (HAE)
Indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Kalbitor (ecallantide)

For diagnosis of Acute treatment of Hereditary Angioedema (HAE)
Indicated for treatment of acute attacks of HAE in patients 12 years of age and older.

Ruconest (C1 esterase inhibitor [Recombinant])

For diagnosis of Acute treatment of Hereditary Angioedema (HAE)
Indicated for the treatment of acute attacks in adult and adolescent patients with HAE. Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks.

Criteria

Brand Firazyr, Generic icatibant, Sajazir, Ruconest, Kalbitor, Berinert

Approve requests to MDD ceiling limits. Refer to background table for ceiling limits. *If all criteria above are met EXCEPT for the ceiling limit criterion, issue a partially favorable decision (i.e. approve to ceiling limit and deny quantities above ceiling limit for medical necessity). Denied quantities are reviewed on appeal.

Quantity Limit Override

Length of Approval: 3 Month(s)

Prescriber attests patient has 3 or more acute HAE attacks per month (document number of attacks per month if available)

AND

Prescriber attests patient has been evaluated for the use of prophylactic therapy