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DrugXermelo (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


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

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