Pharmacy Prior Authorization Criteria

Xermelo (telotristat ethyl)

For diagnosis of Carcinoid syndrome diarrhea
Indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

AND

Diarrhea is inadequately controlled by a stable dose of somatostatin analog (SSA) therapy (e.g., octreotide [Sandostatin, Sandostatin LAR], lanreotide [Somatuline Depot]) for at least 3 months [A,B,1-6]

AND

AND

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

AND

2024-11-01, 2023-10-10, 2022-11-02, 2021-10-25, 2020-10-09

Xermelo Prescribing Information. Lexicon Pharmaceuticals, Inc. The Woodlands, TX. September 2022.
Pandit S, Annamaraju P, Bhusal K. Carcinoid syndrome. StatPearls [Internet]. Treasure Island (FL): Stat Pearls Publishing; 2024 Jan. Available at: https://www.ncbi.nlm.nih.gov/books/NBK448096. Accessed October 13, 2024.
Eriksson B, Klöppel G, Krenning E, et al. Consensus guidelines for the management of patients with digestive neuroendocrine tumors – well-differentiated jejunal-ileal tumor/carcinoma. Neuroendocrinology 2008;87:8-19.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Neuroendocrine and Adrenal Tumors v2.2024. Available by subscription at: https://www.nccn.org/professionals/physician_gls/PDF/neuroendocrine.pdf. Accessed October 9, 2024.
Kulke MH, Anthony LB, Bushnell DL, et al. NANETS Treatment Guidelines: Well differentiated neuroendocrine tumors of the stomach and pancreas. Pancreas. 2010 Aug; 39(6): 735–752. doi: 10.1097/MPA.0b013e3181ebb168.
Kulke MH, Horsch D, Caplin ME, et al. Telotristat ethyl, a tryptophan hydroxylase inhibitor for the treatment of carcinoid syndrome. J Clin Oncol. 2017 Jan;35(1):14-23. Epub 2016 Oct 28.
Horsch D, Anthony L, Gross DJ, et al. Long-term treatment with telotristat ethyl in patients with carcinoid syndrome symptoms: Results from the TELEPATH study. Neuroendocrinology. 2022 Mar;112(3):298-309.

In the pivotal trial population, patients were experiencing 4 to 12 bowel movements (BM) daily despite the use of SSA therapy (e.g., octreotide, lanreotide) at a stable dose for at least 3 months [1].
Diarrhea is often chronic with carcinoid syndrome, in about 80% of cases, and can occur up to 30 times a day. SSA therapy provides symptomatic relief in 50 to 70% of patients. [2].
In an open label extension of the TELESTAR trial, bowel movement (BM) reductions were consistent with the results from the double-blind trial period [6].
Long-term safety and efficacy were demonstrated in the open label extension study. Throughout the up to 6 years of follow up, patients experienced symptomatic relief but no new safety concerns [7].