Pharmacy Prior Authorization Criteria

Gattex (teduglutide)

Indications for Prior Authorization

Gattex (teduglutide)

• For diagnosis of Short Bowel Syndrome (SBS)
  Indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Criteria

Gattex

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of short bowel syndrome
AND
• Patient is 1 year of age and older
AND
• Documentation that the patient is dependent on parenteral nutrition/intravenous (PN/IV) support for at least 12 consecutive months [A]
AND
• Prescribed by or in consultation with a gastroenterologist [C]

Gattex

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Documentation that the patient has had a reduction in weekly parenteral nutrition/intravenous (PN/IV) support from baseline while on Gattex therapy [B]
AND
• Prescribed by or in consultation with a gastroenterologist [C]

P & T Revisions

2024-01-01, 2022-12-30, 2022-06-08, 2021-12-05, 2021-09-27, 2021-05-19, 2021-01-05, 2019-12-06

References

1. Gattex Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. October 2022.
2. Van Gossum A, Cabre E, Hébuterne X, et al. ESPEN Guidelines on Parenteral Nutrition: gastroenterology. Clin Nutr. 2009;28(4):415-27.
3. Nightingale J, Woodward JM on behalf of the Small Bowel and Nutrition Committee of the British Society of Gastroenterology. Guidelines for management of patients with a short bowel. Gut. 2006;55(Suppl 4):iv1-12.
4. National Institute of Diabetes and Digestive and Kidney Diseases. Short Bowel Syndrome. https://www.niddk.nih.gov/health-information/digestive-diseases/short-bowel-syndrome. Accessed December 7, 2020.
5. Buchman AL, Scolapio J, Fryer J. AGA technical review on short bowel syndrome and intestinal transplantation. Gastroenterology. 2003;124(4):1111-34.
6. Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012;143(6):1473-1481.
7. Seidner DL, Schwartz LK, Winkler MF, Jeejeebhoy K, Boullata JI, Tappenden KA. Increased intestinal absorption in the era of teduglutide and its impact on management strategies in patients with short bowel syndrome-associated intestinal failure. J Parenter Enteral Nutr. 2013;37(2):201-11.
8. Naberhuis JK, Tappenden KA. Teduglutide for safe reduction of parenteral nutrient and/or fluid requirements in adults: a systematic review. J Parenter Enteral Nutr. 2016;40(8):1096-1105.
9. DiBaise, J. UptoDate. Management of the short bowel syndrome in adults. November 2022. Available at: https://www.uptodate.com/contents/management-of-the-short-bowel-syndrome-in-adults?search=GATTEX&source=search_result&selectedTitle=2~8&usage_type=default&display_rank=1. Accessed December 30, 2022.
10. Stamm, D., Duggan, C. UptoDate. Management of short bowel syndrome in children. November 2022. Available at: https://www.uptodate.com/contents/management-of-short-bowel-syndrome-in-children?search=GATTEX&source=search_result&selectedTitle=3~8&usage_type=default&display_rank=2. Accessed December 30, 2022.
11. Iyer, K., DiBaise, J., et al. AGA Clinical Practice Update on Management of Short Bowel Syndrome: Expert Review. June 2022. Available at: https://www.cghjournal.org/article/S1542-3565(22)00561-4/fulltext#pageBody. Accessed December 30, 2022.

---

End Notes

1. Twelve consecutive months on parenteral nutrition is an inclusion criterion in clinical trials. [1]
2. In clinical trial data, treatment with Gattex has been shown to reduce the volume and number of days that patients with short bowel syndrome require parenteral nutrition/intravenous (PN/IV) support, with some patients remaining on Gattex therapy even if PN/IV support was no longer required. [1, 6-8]
3. Patients with short bowel syndrome (SBS) have undergone one or more surgical bowel resections due to underlying disease, congenital defects, or other trauma. These resections lead to inadequate digestion and absorption, requiring patients to become dependent on parenteral nutrition and/or intravenous (PN/IV) support. The management of PN/IV is complex and must be individualized to each patient as the degree of malabsorption can vary among patients with SBS. Long-term use of PN/IV can often lead to other complications, such as bacterial infections, blood clots, gallbladder disease, and liver and kidney problems. For SBS patients on chronic PN/IV, the goal of treatment is to reduce the need for PN/IV in order to improve the patients’ quality of life and reduce the risk of any life-threatening complications. Careful monitoring of patients treated with Gattex is recommended in order to assess continued safety and manage any adverse effects or complications. [1-7]

---

Revision History

• 2024-01-01: 2024 Annual Review
• 2022-12-30: 2023 Annual Review
• 2022-06-08: Guideline Update
• 2021-12-05: 2022 Annual Review
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2021-01-05: 2021 Annual Review, no changes to criteria.
• 2019-12-06: 2020 Annual Review, no changes to criteria.

---