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

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

One case of 84 tablets per 28 days

MHCP Provider Call Center 651-431-2700 or 800-366-5411