CurrentCignaPolicy N/A

Oncology - Vistogard Drug Quantity Management Policy - Per Rx

Defines quantity limits, exceptions, and prior authorization/override rules for Vistogard (uridine triacetate oral granules) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Vistogard Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeClarification / Annual revision

Effective DateN/A

Next Review DateN/A

Key ActionApprove a one-time 4-packet override for patients who vomit within 2 hours of dosing (override duration: 30 days).

SourceLink

POLICY UPDATE CHANGES

Policy statement was updated to clarify that 'One-time' overrides are provided for 30 days.

Annual revision entries show review dates including 03/27/2024, 03/03/2025, and 03/11/2026 with no criteria changes in some revisions.

20maximum quantity per Rx

4one-time override (vomiting)

10packet size (g)

20adult total doses

96early-onset window (hrs)

Coverage Criteria

Quantity Limit Exception — Vomiting within 2 hours

Exceptions to the 20-packet quantity limit are covered as medically necessary when the following are met.

Vomiting override: If a patient requires additional dosing due to vomiting within 2 hours of taking a Vistogard dose, approve a one-time override of 4 additional packets at retail or home delivery.4 packets

One-time override duration: 30 days

Any request for coverage that does not meet the specific exceptions and criteria listed in this policy is considered not medically necessary. The Drug Quantity Limits for Vistogard are set by this policy; exceptions are covered only when the explicit criteria are satisfied.

Vistogard is indicated for emergency uses only — specifically for fluorouracil or capecitabine overdose and for early-onset, severe or life‑threatening toxicity within ≤ 96 hours of fluoropyrimidine administration. It is not recommended for non-emergent treatment of adverse events associated with fluorouracil or capecitabine because such use may diminish the efficacy of those chemotherapeutic agents.

Coding and Time Windows

Policy Summary

PayerCigna

PolicyOncology - Vistogard Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeClarification / Annual revision

Effective DateN/A

Next Review DateN/A

Key ActionApprove a one-time 4-packet override for patients who vomit within 2 hours of dosing (override duration: 30 days).

SourceLink

On This Page

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Covered CPT Codes, Not Covered, Experimental, Cosmetic, Presumptivemixed

No codes listed

inv-05: time window for early-onset severe toxicity (≤ 96 hours)

Time window for early-onset severe toxicity≤ 96 hours from end of fluorouracil or capecitabine administration

Indication contextEarly-onset, severe or life‑threatening toxicity affecting cardiac/CNS or unusually severe adverse reactions (e.g., gastrointestinal toxicity, neutropenia)

Limitation of useNot recommended for non‑emergent treatment of adverse events as it may diminish chemotherapy efficacy

Provider Actions & Billing Rules

Billing Rule

Billing & Coding

When billing, providers must use the most appropriate codes as of the date of submission. Reimbursement will only be provided if the submitted service is accompanied by covered diagnosis and/or procedure code(s) that align with the applicable coverage policy. Claims submitted without covered diagnosis or procedure codes consistent with this policy will be denied as not covered.

Use the most appropriate CPT/HCPCS/ICD-10 codes current on the date of submission.
Claims lacking covered diagnosis/procedure codes per this policy will be denied.

Prior Authorization

Quantity Limit / Drug Quantity Management

Vistogard (uridine triacetate oral granules) is subject to a Drug Quantity Management limit. The retail or home delivery maximum quantity per prescription is 20 packets. If the Drug Quantity Management rule is not met at the point of service, coverage will be determined according to the criteria in this policy. Approvals provided as overrides at the point of service are one-time and limited to 30 days.

Drug Quantity Management limit: max 20 packets per Rx for Vistogard (10 g packets).
One-time overrides are provided for a 30-day duration.
If the quantity limit rule is not met at point of service, adjudication will follow the policy criteria for coverage determination.

Denial Risk

Quantity Limit Exceptions

Exceptions to the above quantity limits may be considered medically necessary only when the specific exception criteria outlined in the policy are met. Any other exception will be considered not medically necessary and will be denied.

Exceptions are covered only when all specified exception criteria are satisfied.
Requests that do not meet exception criteria will be denied as not medically necessary.

Documentation Required

Provider Action for Overrides

Providers should submit requests and supporting documentation when seeking overrides or exception coverage so that coverage determinations can be made when the Drug Quantity Management rule is not met at point of service.

Include clinical documentation supporting the medical necessity of exceeding the 20-packet limit.
Document duration of therapy and rationale for quantity requested.

Denial Risk

Denial Risk — Missing or Non‑covered Codes

Reimbursement for services will be denied when billed for conditions or diagnoses that are not covered under this policy. Coverage determinations depend on the terms of the applicable benefit plan document and applicable laws/regulations; each request is reviewed on its own merits.

Claims billed for non-covered diagnoses/conditions per this policy will be denied.
Coverage determinations also consider benefit plan terms and applicable laws/regulations.

Background

Vistogard (uridine triacetate) is a pyrimidine analog indicated for the emergency treatment of adults and pediatric patients for: (1) fluorouracil or capecitabine overdose (regardless of symptoms) and (2) early‑onset, severe or life‑threatening fluoropyrimidine toxicity (including cardiac or central nervous system toxicity or unusually severe adverse reactions such as gastrointestinal toxicity or neutropenia) occurring within 96 hours after the end of fluorouracil or capecitabine administration.

Vistogard is supplied as oral granules in 10 gram single‑dose packets. The adult dosing is 10 grams (1 packet) orally every 6 hours for 20 doses; pediatric dosing is 6.2 g/m2 (not to exceed 10 g/dose) every 6 hours for 20 doses. If a patient vomits within 2 hours of taking a dose, another complete dose should be initiated as soon as possible and subsequent dosing continued on the regular schedule.

For dispensing, Vistogard is available in cartons of 4 or 20 packets and this policy sets a Retail or Home Delivery maximum of 20 packets per Rx, with specified one‑time override provisions described elsewhere in the policy.

Product Definitions & Dosing

inv-12: Dosing — adult and pediatric dosing summary

Adult dosing10 grams (1 packet) orally every 6 hours for 20 doses

Pediatric dosing6.2 g/m² orally every 6 hours for 20 doses (not to exceed 10 g per dose)

Administration noteDiscard any unused portion of granules; do not save open packet contents for subsequent dosing

inv-13: Product availability — packet size and carton options

Packet size10 gram single‑dose packets

Carton optionsCartons available in either 4 packets or 20 packets per carton

Package descriptionOral granules supplied in single‑dose packets

Quantity Limits

inv-14: Vistogard (uridine triacetate) packets — 20 packets maximum per Rx

Maximum per prescription (retail or home delivery)20 packets per Rx

Applies toRetail or home delivery maximum quantity per Rx

Coverage stanceExceptions to the quantity limit are covered when criteria are met; other exceptions are not medically necessary

inv-15: Vistogard (uridine triacetate) packets — 4 additional packets (one-time override)

One-time override quantity4 additional packets (one-time override)

Trigger for overridePatient vomits within 2 hours of taking a Vistogard dose

Delivery settingsApproved for retail or home delivery when criteria are met

Site of Care

Note

Retail or home delivery maximum: 20 packets per Rx

The retail or home delivery maximum of 20 packets per prescription applies; site of care does not change the per‑Rx maximum.

Package size: 10 gram single‑dose packets (cartons of 4 or 20 packets).
Retail or home delivery maximum quantity per Rx = 20 packets.