Gattex Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Initial Evaluation

Gattex will be approved when ALL of the following are met:

1. The patient has a diagnosis of short bowel syndrome (SBS)
   AND
2. The patient is dependent on parenteral nutrition OR intravenous (PN/IV) fluids
   AND
3. ONE of the following:
   1. The patient is aged 1 year to 17 years AND BOTH of the following:
      1. A fecal occult blood test has been performed within 6 months prior to initiating treatment with the requested medication
         AND
      2. ONE of the following:
         1. There was no unexplained blood in the stool
            OR
         2. There was unexplained blood in the stool AND a colonoscopy or a sigmoidoscopy was performed
            OR
   2. The patient is 18 years of age or over AND BOTH of the following:
      1. The patient has had a colonoscopy within 6 months prior to initiating treatment with the requested medication
         AND
      2. If polyps were present at this colonoscopy, the polyps were removed
         AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
5. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval: 6 months

Renewal Evaluation

Gattex 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. The patient has a diagnosis of short bowel syndrome (SBS)
   AND
3. The patient has had a reduction from baseline in parenteral nutrition OR intravenous (PN/IV) fluids
   AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
5. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval: 12 months