Xermelo (telotristat ethyl) — Blue Cross Blue Shield of Alabama
carcinoid syndrome diarrhea
Initial criteria
- ONE of the following:
- - The patient has a diagnosis of carcinoid syndrome diarrhea AND BOTH of the following:
- • The patient has tried and had an inadequate response with a long-acting somatostatin analog (e.g., Sandostatin LAR [octreotide], Somatuline Depot [lanreotide]) for at least 3 months
- • The requested agent will be used in combination with a long-acting somatostatin analog (e.g., Sandostatin LAR [octreotide], Somatuline Depot [lanreotide])
- OR
- - The patient has another FDA approved indication for the requested agent
- AND
- If the patient has an FDA approved indication, ONE of the following:
- • The patient’s age is within FDA labeling for the requested indication for the requested agent for the requested indication
- • The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication
- AND
- - The prescriber is a specialist in the area of the patient’s diagnosis (e.g., oncologist, endocrinologist) 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
Reauthorization criteria
- The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
- AND
- ONE of the following:
- - For a diagnosis of carcinoid syndrome diarrhea BOTH of the following:
- • The patient has had clinical benefit with the requested agent (e.g., reduction in average number of daily bowel movements)
- • The requested agent will be used in combination with a long-acting somatostatin analog (e.g., Sandostatin LAR [octreotide], Somatuline Depot [lanreotide])
- OR
- - For another FDA approved indication, the patient has had clinical benefit with the requested agent
- AND
- - The prescriber is a specialist in the area of the patient’s diagnosis (e.g., oncologist, endocrinologist) 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
Approval duration
initial 6 months; renewal 12 months