tolvaptan — Blue Cross Blue Shield of Alabama

other FDA labeled indication for the requested agent and route of administration

Initial criteria

ONE of the following:
• The patient has a diagnosis of autosomal dominant polycystic kidney disease (ADPKD) AND BOTH of the following:
– The patient does not have stage 5 chronic kidney disease (CKD)
– The patient is not on dialysis
OR
• The patient has another FDA labeled indication for the requested agent and route of administration
OR
• The patient has another indication that is supported in compendia for the requested agent and route of administration
AND
If the patient has an FDA labeled indication, then ONE of the following:
– The patient’s age is within FDA labeling for the requested indication for the requested agent
OR
– There is support for using the requested agent for the patient’s age for the requested indication
AND
• The patient will NOT be using the requested agent in combination with another tolvaptan agent for the requested indication
AND
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., nephrologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
AND
• The patient does NOT have any FDA labeled contraindications to the requested agent
Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
AND
• The patient has had clinical benefit with the requested agent
AND
• The patient will NOT be using the requested agent in combination with another tolvaptan agent for the requested indication
AND
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., nephrologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
AND
• The patient does NOT have any FDA labeled contraindications to the requested agent

12 months