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Prior Authorization Protocol

VISTOGARDTM (uridine triacetate)

NATL

Interim Guidelines; Final Review and Approval by the P&T Committee Pending

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:
    • Vistogard is a pyrimidine analog indicated for the emergency treatment of adult and pediatric patients:
      • following a fluorouracil or capecitabine overdose regardless of the presence of symptoms,

    or

      • who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of fluorouracil or capecitabine overdose

    OR

    • Diagnosis of severe or life-threatening toxicity or severe adverse reactions within 96 hours following the end of fluorouracil or capecitabine administration
  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:
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  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
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    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Vistogard

    Adults: 10 gms PO every 6 hours for 20 doses
    Pediatric: 6.2 gms/m2 of body surface area PO every 6 hours for 20 doses

    Length of Benefit

  7. Product Availability:

    Oral granules: 10 gm packets

  8. References:

    1. Vistogard [Prescribing Information]. Gaithersburg, MD: Wellstat Therapeutics Corp.; December 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.
Draft Prepared: 03-MAR-16 SA
Approved By Health Net National P&T:
Revised: 06-APR-16 NN