Takhzyro - NC Standard

Restricted Product(s)

• Takhzyro® (lanadelumab-flyo)

FDA Approved Use

• Indicated for routine prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 2 years and older.

Criteria for Approval of Restricted Product(s)

Initial Coverage

1. The patient has a diagnosis of hereditary angioedema (HAE) as confirmed through complement testing (Please submit medical record documentation to demonstrate C4 level, C1-inhibtor level, and C1-INH function where applicable); AND
   1. If HAE-I, please demonstrate low C4 and C1-inhibitor level; AND 
   2. If HAE-II, please demonstrate low C4 with a normal C1-inhibitor level and a decreased C1-INH function; AND 
   3. If HAE-III, please demonstrate normal C4 and C1-inhibitor and family history of angioedema; AND 
2. The patient is 2 years of age or older; AND 
3. The patient will be treated with Takhzyro for routine prophylaxis and NOT for treatment of acute HAE attacks; AND
4. Treatment dosing details have been provided for review (including patient’s current weight and dosing schedule); AND 
5. Prescriber attests that patient has experienced attacks of a severity and/or frequency such that they would clinically benefit from prophylactic therapy with Takhzyro (e.g., 2 or more attacks within the last 2 months) (medical record documentation required); AND 
6. The patient will not be treated with another anti-HAE medication in the prevention of HAE attacks (Haegarda, Orladeyo, Cinryze); AND 
7. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
8. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND 
9. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 210 days

Continuation Criteria

1. The patient has been previously approved with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND
2. For patients that are well controlled and attack free for at least 6 months, a dosing interval of every 4 weeks will be utilized; AND
3. The patient has shown a reduction in HAE attacks since initiation of the requested agent (medical record documentation required); AND 
4. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis.
   
   Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The request is for maintenance dosing using a dosing interval of every 2 weeks; AND
   1. The patient is uncontrolled on their current dosing regimen; AND
   2. The provider has submitted medical record documentation to substantiate the need for 2 injections per 28 days (medical record documentation required); OR
2. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
3. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

March 2025: Criteria update: Update format and moved criteria to review approval for the need for 2 syringes to quantity limit section.February 2023: Criteria change: Addition of expanded indication to include pediatric patients 2 years and older. Added new 150 mg/mL prefilled syringe to criteria.
April 2022: Criteria change: Added evaluation of frequency/severity of previous HAE attacks to warrant prophylactic treatment. Added patient will NOT be using the requested agent in combination with another anti-HAE agent. Added prescriber is a specialist or consulted a specialist. Added dose and quantity are appropriate based on FDA labeling.
February 2022: Criteria update: Added new to market prefilled syringe.
April 2021: Criteria change: Addition of requirement for continuation: the patient has shown a reduction in HAE attacks since initiation of the requested agent.
Oct 2018: updated to address quantity limit on initial approval.