Xermelo
Drug - Xermelo (telotristat ethyl) [Lexicon]
October 2017
Therapeutic Area - Gastrointestinal
Initial approval criteria
- Patient is at least 18 years old AND
- Patient has a carcinoid/neuroendocrine tumor and has been diagnosed with carcinoid syndrome AND
- Patient has diarrhea defined as having at least 4 bowel movements per day
- Patient has been receiving concomitant therapy with the FDA-approved maximum (or highest tolerated) dose of a somatostatin analog therapy (e.g. octreotide I/R or LAR, lanreotide depot) for at least 3 months AND
- Patient must have a prior documented trial and failure to antidiarrheals (e.g., loperamide)
- Initial approval is for 6 months
Renewal approval criteria
- Absence of unacceptable toxicity (e.g. severe constipation, abdominal pain, etc.) AND
- Disease response as indicated by a reduction in the average number of bowel movements from pre-treatment baseline AND
- Patient continues to receive the maximum (or highest tolerated) dose of a somatostatin analog in conjunction with Xermelo
- Renewal approval is for 6 months
Quantity limits
One case of 84 tablets per 28 days
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411