HN Logo
Prior Authorization Protocol
GATTEXTM (teduglutide)

NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • For the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of Short Bowel Syndrome
    AND
    • Patient has been dependent on parenteral nutrition (PN) and/or intravenous (IV) fluids continuously for at least 12 months
    AND
    • Failure or clinically significant adverse effects to somatropin (human growth hormone)
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • In both clinical trials by Jeppesen et al., patients were required to be dependent on parenteral support (fluids, electrolytes or nutrients) at least three times per week for a period of at least 12 months prior to the start of the studies.
    • In the study by Jeppesen et al., the primary efficacy endpoint using the graded response score (GRS) criteria was not significantly different from placebo when compared to Gattex 0.10 mg/kg/day (8/32 vs. 1/16, p=0.16). The GRS criteria relied on the timing and reduction from baseline in weekly parenteral volumes. The protocol-defined reduction was set a minimum of 20% and a maximum of 100%. The duration of response was considered the response at weeks 16, 20 and 24.
    • Gattex has a Risk Evaluation and Mitigation Strategy (REMS) program that consists of a Medication Guide and a Dear Healthcare Professional Letter. Patient and physician enrollment in the manufacturer's REMS program is required. The purpose of the Gattex REMS is to inform healthcare providers and patients about the following risks: possible acceleration of neoplastic growth and enhancement of polyp growth, gastrointestinal obstruction, and biliary and pancreatic disorders associated with Gattex.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    somatropin (ZorbtiveR)*

    0.1 mg/kg SC QD

    8 mg per day for 4 weeks

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Gattex

    0.05 mg/kg SC QD

    Reduce dose by 50% in patients with creatinine clearance less than 50 mL/min and end-stage renal disease
    Initial:
    6 months

    Reauthorization for length of benefit will require documentation of response to therapy (i.e. 20% reduction in weekly PN/IV volume from baseline)
  7. Product Availability:
    Vial: 5 mg single-use (1 vial kit or a 30 vial kit)
  8. References:
    1. Gattex [package insert]. Bedminster, NJ: NPS Pharmaceuticals; December 2012.
    2. Jeppesen PB, Pertikiewicz M, Messing B, et al. Teduglutide Reduces Need for Parenteral Support Among Patients With Short Bowel Syndrome With Intestinal Failure. Gastroenter 2012;143:1374-1481.
    3. Jeppesen PB, Gilroy R, Pertkiewicz M, et al. Randomized placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut 2011;60:902-914.
    4. Micromedex Healthcare Series [Internet Database]. Greenwood Village, Colo:Thompson Healthcare. Updated periodically. Accessed June 4, 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.