Gattex (teduglutide) — Prior Authorization Criteria for Short Bowel Syndrome
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Prior authorization form and clinical criteria used by HMSA/CVS Caremark to determine coverage for Gattex (teduglutide) for patients with short bowel syndrome (SBS), including adult and pediatric initial and continuation criteria and site-of-care information. Affects prescribers and pharmacy specialty program staff administering or dispensing Gattex.
No material clinical or coverage changes in this revision.
Coverage Criteria for Gattex (teduglutide)
Continuation Therapy - SBS
Covered when the member continues to meet dependence/response criteria while on Gattex:
Initial Therapy - SBS Adult
Adult initial coverage is assessed using sequential questions; key criteria include:
Initial Therapy - SBS Pediatric
Pediatric initial coverage requires meeting age-appropriate clinical thresholds:
The form explicitly queries pediatric history of malignancy. A documented history of active cancer or clinically significant lymphoproliferative disease (excluding in situ nonaggressive lesions and cancers that have been surgically resected) is asked on the pediatric initial-therapy section and may exclude the patient from Gattex therapy unless otherwise addressed in clinician documentation.
Requests will not meet criteria if the submission lacks the clinical documentation required by the form. For adults, the form requires evidence that the member has required parenteral support at least 3 times per week for at least 12 continuous months prior to Gattex initiation; absence of this documentation or evidence of non‑dependence is a basis for denial. For pediatrics, the form requires age‑appropriate thresholds (for example, BMI <5th percentile for age or <10 kg/m2 and parenteral support stability); failure to meet those pediatric nutritional or parenteral‑support thresholds or to provide supporting chart notes will render the request not medically necessary.
Initial therapy criteria
Initial therapy assessment for adults and pediatrics uses sequential screening questions to document SBS etiology, comorbidities, prior therapies, hospitalizations, and parenteral support history.
Initial Therapy Assessment
Initial therapy criteria
Detailed initial assessment branches by age, SBS etiology, comorbidities, prior therapies, and parenteral support history:
Continuation Therapy Requirements
Continuation criteria
Continuation approvals depend on documented clinical response or continued dependence:
Continuation Therapy - SBS
Covered when the member continues to meet dependence/response criteria while on Gattex (see continuation criteria):
Coding and Thresholds
| ICD-10 code | Blank field on form requesting the ICD-10 diagnosis code for the indication |
Provider Actions, Submission & Documentation
Submission and contact for prior authorization
Submit the completed CVS Caremark Specialty Programs prior authorization fax form to CVS Caremark at 1-866-237-5512. For prior authorization questions contact CVS Caremark at 1-808-254-4414; for Specialty Customer Care inquiries (eligibility, copay, delivery) contact CaremarkConnect at 1-800-237-2767.
Document prior therapy use and timing on the form
On the PA form, document prior use and timing of therapies that may affect appropriateness for Gattex, including native GLP-2, GLP-1, human growth hormone, biologic agents, and immunosuppressant therapy; indicate recent introductions or changes where asked (e.g., biologics within 6 months, immunosuppressants within 3 months).
- Question 18 asks about native GLP-2 or human growth hormone use within the last 6 months (adult).
- Questions 14–15 and 16–17 ask about immunosuppressant and biologic therapy and whether introduced/changed within specified recent time windows.
- Question 32 asks about native GLP-2, GLP-1, or human growth hormone use within the past 3 months (pediatric).
Attach chart notes and supportive documentation
Attach supporting clinical documentation when requested: chart notes showing baseline and on-therapy parenteral support volumes in liters per week, evidence of parenteral support history (e.g., requirement ≥3 times/week for adults), and documentation of Crohn's disease remission when applicable.
- Continuation questions (#6 and #7) request chart notes of parenteral support volume in liters per week at baseline.
- Adult initial question #21 asks for supportive documentation demonstrating requirement of parenteral support (≥3 times/week for ≥12 months).
- Adult question #10 requests supportive documentation if Crohn's clinical remission ≥12 weeks is indicated.
Incomplete or inaccurate documentation may result in denial
Failure to provide an accurate diagnosis and the requested supporting documentation may prevent an appropriate coverage determination and lead to denial; approvals may also be subject to dosing limits per FDA labeling, compendia, or guidelines.
- The form emphasizes providing the most accurate diagnosis for the prescribed medication.
- Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.
Dispensing and Administration Site
Indicate dispensing and administration site (no site restriction on form)
The form asks where the drug will be dispensed and administered (examples include home, office, infusion center, hospital outpatient, and pharmacy) but does not impose a site-of-care restriction on the form.
- Dispensing options listed include pharmacy and various facility types; administration options include home, office, outpatient hospital, and pharmacy.
Prior Therapy and Step Requirements
| Question | Form response options / notes |
|---|---|
| Is the member receiving treatment with a biologic agent for IBD? | Yes — Continue to #17; No — Continue to #18 |
| Has the biologic agent been introduced or changed within the last 6 months? | Yes — Continue to #18; No — Continue to #18 |
| Has the member used a native GLP-2 or human growth hormone within the last 6 months? | Yes — Continue to #19; No — Continue to #19 |
| Has the member used native GLP-2, GLP-1, or human growth hormone within the past 3 months? (pediatric) | Yes — Continue to #33; No — Continue to #33 |
| Is the member on immunosuppressant therapy for IBD? | Yes — Continue to #15; No — Continue to #16 |
| Has the immunosuppressant therapy been introduced or changed within the last 3 months? | Yes — Continue to #16; No — Continue to #16 |
Definitions and Clinical Terms
Background
Gattex (teduglutide) is a glucagon‑like peptide‑2 (GLP‑2) analog indicated for treatment of adult and pediatric patients with short bowel syndrome (SBS) who are dependent on parenteral support. The clinical assessment on the prior authorization form focuses on documented dependence on parenteral nutrition and/or IV fluids and measures of response such as a ≥20% reduction in parenteral support from baseline or successful weaning off parenteral support while on therapy; pediatric and adult initial‑therapy questions collect age‑appropriate nutritional thresholds, parenteral support history, prior biologic or growth‑factor exposure, and recent hospital admissions to inform eligibility.
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