Signifor LAR Prior Authorization Criteria – Medicare Part D

Prior Authorization Criteria for Approval

Initial Evaluation

Signifor LAR will be approved when BOTH of the following are met:

1. ONE of the following:

   1. The patient has a diagnosis of acromegaly AND ONE of the following:

      1. The patient had an inadequate response to surgery as indicated by growth hormone and serum IGF-1 levels that are above the reference ranges for the patient’s gender and age
         OR
      2. The patient is NOT a candidate for surgery:
         OR

   2. The patient has a diagnosis of Cushing’s disease (CD) AND ONE of the following:

      1. The patient had an inadequate response to pituitary surgical resection
         OR
      2. The patient is NOT a candidate for pituitary surgical resection
         OR

   3. The patient has an indication that is supported in CMS approved compendia for the requested medication
      AND

2. The patient does NOT have severe hepatic impairment (i.e., Child Pugh C)

Length of Approval:

6 months for Acromegaly

7 months for Cushing’s disease

12 months for all other diagnoses

Renewal Evaluation

Signifor LAR will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria
   AND

2. ONE of the following:

   1. The patient has a diagnosis of acromegaly AND ONE of the following:

      1. The patient has growth hormone and serum IGF-1 levels that are within normal limits for the patient’s gender and age reference range
         OR
      2. The patient has had clinical improvement (e.g., reduction in tumor size, decreased headaches, improved cardiovascular or respiratory symptoms)
         OR

   2. The patient has a diagnosis of Cushing’s disease (CD) AND BOTH of the following:

      1. The patient has a urinary free cortisol level less than or equal to the upper limit of normal
         AND

      2. The patient has had improvement in at least ONE of the following clinical signs and symptoms:

         1. Fasting plasma glucose
            OR
         2. Hemoglobin A1c
            OR
         3. Hypertension
            OR
         4. Weight
            OR

   3. BOTH of the following:

      1. The patient has an indication that is supported in CMS approved compendia for the requested medication
         AND
      2. The patient has had clinical benefit with the requested medication
         AND

3. The patient does NOT have severe hepatic impairment (i.e., Child Pugh C)

Length of Approval: 12 months