VISTOGARD, Uridine Triacetate (Emergency Treatment) Form

Uridine acetate (Vistogard®) is a pyrimidine analog. FDA Approved Indication(s) Vistogard is 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.
Limitation(s) of use: • Vistogard is not recommended for the non-emergent treatment of adverse reactions associated with fluorouracil or capecitabine because it may diminish the efficacy of these drugs. • The safety and efficacy of Vistogard initiated more than 96 hours following the end of fluorouracil or capecitabine administration have not been established.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Vistogard is medically necessary when the following criteria are met: I. Initial Approval Criteria
A. Fluorouracil or Capecitabine Overdose or Toxicity (must meet all):

1. Prescribed for the management of overdose or toxicity due to fluorouracil or capecitabine administration;
2. Request is within 96 hours of the last administered dose of fluorouracil or capecitabine;

3. Dose does not exceed both of the following (i and ii):
   i. 40 g per day;
   ii. 4 packets per day.
   Approval duration: 1 month (up to 20 doses) *Total therapy should not exceed 20 doses
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   CLINICAL POLICY
   Uridine Triacetate B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or
5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
   II. Continued Therapy A. Fluorouracil or Capecitabine Overdose or Toxicity (must meet all):
6. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
7. Member has not received ≥ 20 doses;
   
   3. If request is for a dose increase, new dose does not exceed both of the following (i and ii):
      i. 40 g per day; ii. 4 packets per day.
      Approval duration: 1 month (up to 20 doses) *Total therapy should not exceed 20 doses B. Other diagnoses/indications (must meet 1 or 2):
8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or

9. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
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   CLINICAL POLICY
   Uridine Triacetate III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy – HIM.PA.154 for health insurance marketplace or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives Not applicable Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration
   Indication Fluorouracil or capecitabine overdose or toxicity Dosing Regimen Adults: 10 g (1 packet) PO Q6H for 20 doses Pediatrics: 6.2 g/m2 of body surface area (not to exceed 10 g per dose) PO Q6H for 20 doses Maximum Dose 10 g/dose (for up to 20 doses) VI. Product Availability
   Oral granules: 10 g per single-dose packet VII.