Prior Authorization : Services Requiring Prior Authorization

Long-Term Hereditary Angioedema Prophylactic Drugs

Clinical PA is required for long-term HAE prophylactic drugs. Orladeyo and Takhzyro are long-term HAE prophylactic drugs that require PA.

ForwardHealth does not cover treatment with more than one long-term HAE prophylactic drug at a time.

PA requests for long-term HAE prophylactic drugs must be completed, signed, and dated by the prescriber. PA requests for long-term HAE prophylactic drugs must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

The prescriber is required to send the completed PA/DGA form to the pharmacy where the prescription will be filled. The pharmacy provider is required to complete a PA/RF and submit it along with the PA/DGA form received from the prescriber. Prescribers should not submit the PA forms to ForwardHealth.

PA requests for long-term HAE prophylactic drugs may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical Criteria for Long-Term Hereditary Angioedema Prophylactic Drugs

The following clinical criteria must be met and documented for approval of a PA request for long-term HAE prophylactic drugs:

• The member has type I or type II HAE.
• HAE is documented based on evidence of a low C4 level, plus one of the following:
  • A low C1-INH antigenic level (C1-INH antigenic level below the lower limit of normal as defined by the laboratory performing the test)
  • A normal C1-INH antigenic level and a low C1-INH functional level (C1-INH functional level below the lower limit of normal as defined by the laboratory performing the test)
• The member is 12 years of age or older.
• The prescription is written by or in consultation with an allergist, immunologist, hematologist, or a physician who specializes in HAE or related disorders.
• Medications known to cause angioedema (for example, angiotensin-converting enzyme inhibitors, estrogens, angiotensin II receptor blockers) have been evaluated and discontinued when appropriate.
• The member has no signs of current acute angioedema but has a history of clinical symptoms and signs consistent with HAE.
• The member requires HAE prophylaxis as evidenced due to one or more of the following:
  • A history of at least one severe HAE attack per month (defined as an attack that significantly interrupts daily activities despite short-term treatment)
  • Disabling symptoms for at least five days per month
  • A history of laryngeal angioedema
• One of the following is true:
  • The member has experienced an unsatisfactory therapeutic response or a clinically significant adverse drug reaction that prevents the use of Haegarda.
  • The member has a clinically significant drug interaction with Haegarda and another medication the member is taking, or the member has a medical condition(s) that prevents the use of Haegarda.

Supporting clinical information and a copy of the member's current medical records must be included in all PA requests. The supporting clinical information and the medical records must document the following:

• The frequency, severity, and duration of the HAE attacks.
• The member's medical condition being treated.
• Details regarding previous medication use.
• The member's current treatment plan.

If the clinical criteria for long-term HAE prophylactic drugs are met, initial PA requests may be approved for up to 183 days. Renewal PA requests for long-term HAE prophylactic drugs may be approved for up to 365 days.

Renewal PA Requests for Long-Term Hereditary Prophylactic Drugs

Renewal PA requests must meet the clinical criteria for initial PA requests for long-term HAE prophylactic drugs and have documentation to support that the member has experienced a reduction in the frequency, severity, or duration of HAE attacks versus the member's baseline since starting treatment. A copy of the member's current medical records must be included with the PA request for a long-term HAE prophylactic drug.