CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Valstar (valrubicin) — Coverage Criteria

Defines accepted indications, authorization requirements, exclusions, and medication management for Valstar (valrubicin) for members of Neighborhood Health Plan of Rhode Island; applies to utilization management and prescribing providers requesting coverage.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyValstar (valrubicin) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 30, 2024

Next Review DateAug 14, 2024

Key ActionSubmit prior authorization demonstrating prior intravesical BCG exposure and supporting evidence (FDA label, CMS compendia, or NCCN/ASCO) for BCG‑refractory CIS.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

800 mgsingle dose maximum

2 cycles / 12 dosesinduction limit

10 cycles / 10 dosesmaintenance limit

BCG‑refractory/CISprimary indication

2024-08-30effective

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Coverage Criteria for Valstar (valrubicin)

Initial and Continuation Coverage Criteria

Covered when ALL of the following are met

BCG exposure and disease status: Member has recurrent or persistent non‑muscle invasive carcinoma of the bladder (Tis/CIS) that is refractory or intolerant to intravesical BCG

Refractory defined as loss of response within 6 months of induction or within 12 months of maintenance after the first induction course (5–6 doses) followed by maintenance/second induction of at least 2 doses.

Continuation request exemption: For continuation of a medication that would otherwise be not‑approvable, member must meet ALL of the following: no disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of active authorization; and no additional medications are being added to the continuation request.

Applies only when all three conditions in policy section A are satisfied.

Coverage will be denied or excluded when any of the listed exclusion criteria apply. Common denial reasons include an active urinary tract infection (UTI), which must be resolved prior to intravesical administration; requests where the ordered dose exceeds the single-dose maximum of 800 mg for Valstar (valrubicin); or therapy that would exceed the policy’s cumulative limits — specifically more than 2 induction cycles (12 total induction doses) or more than 10 maintenance cycles (10 total maintenance doses). Requests for investigational or off‑label uses lacking adequate supporting evidence (i.e., not supported by CMS‑recognized compendia, NCCN/ASCO guidance, or acceptable peer‑reviewed literature) are also excluded.

Initial Authorization Criteria

Initial authorization

Initial authorization expectation

BCG failure prior to valrubicin: Member must have BCG‑refractory or intolerant Tis/CIS defined as loss of response within 6 months of induction or within 12 months of maintenance after properly administered BCG (minimum: induction 5–6 doses plus maintenance/second induction of at least 2 doses)

Policy requires documentation of prior intravesical BCG exposure per the specified minimum courses before valrubicin is considered.

Continuation / Reauthorization Criteria

Continuation requests

Criteria for continuation requests when medication would otherwise be not‑approvable

Continuation exemption: Member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and additional medication(s) are not being added to the continuation request.

All three conditions must be met for the continuation exemption to apply.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization and Required Documentation

Prior authorization is required for valrubicin (Valstar) when used for BCG‑refractory carcinoma in situ (CIS) of the bladder. Requests must document prior intravesical BCG exposure and clinical evidence of BCG‑refractory or BCG‑intolerant disease. Authorization decisions are supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or peer‑reviewed literature meeting CMS standards.

Affected indication: Non‑muscle invasive bladder cancer — Tis/CIS refractory or intolerant to intravesical BCG
Documentation must show prior BCG exposure: at minimum first course induction (5–6 doses) plus maintenance/second induction (≥2 doses) where applicable
Acceptable supporting evidence: FDA product label, CMS‑recognized compendia, NCCN or ASCO guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements
Operational note: Requests lacking required prior BCG documentation or adequate supportive evidence may be denied

Documentation Required

Quantity and Dosing Limits

Valstar (valrubicin) single dose maximum

Single-dose maximum800 mg per intravesical administration

ApplicabilityApplies to Valstar (valrubicin) intravesical dosing

Denial triggerRequests exceeding this single-dose limit will be excluded/denied per policy

Valstar (valrubicin) maximum total induction doses

Maximum total induction exposure2 cycles (equivalent to 12 doses)

Definition contextInduction course counted toward this limit for initial treatment prior to maintenance

Denial trigger

Definitions and Terms

Refractory (to BCG)

Refractory definitionLoss of response to intravesical BCG within 6 months of induction or within 12 months of maintenance after at least the first induction course (5–6 doses) followed by maintenance/second induction of at least 2 doses.

Required prior BCG exposureAt minimum, a properly administered BCG induction (5–6 doses) plus maintenance/second induction (≥2 doses) are expected before labeling disease as refractory.

Clinical contextUsed to determine eligibility for valrubicin (Valstar) in recurrent or persistent non‑muscle invasive carcinoma of the bladder (Tis/CIS).

Background

Valrubicin (Valstar) is an intravesical antineoplastic agent used for non‑muscle invasive bladder cancer, particularly carcinoma in situ (Tis) that is refractory or intolerant to bacillus Calmette‑Guérin (BCG). The policy’s exclusions and quantity limits reflect safety and evidence considerations specific to intravesical use — for example, the single‑dose limit of 800 mg and cumulative induction and maintenance dose caps to limit excessive exposure.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyValstar (valrubicin) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateAug 30, 2024

Next Review DateAug 14, 2024

Key ActionSubmit prior authorization demonstrating prior intravesical BCG exposure and supporting evidence (FDA label, CMS compendia, or NCCN/ASCO) for BCG‑refractory CIS.

SourceLink

On This Page

Prior BCG Required Before Valrubicin

Valrubicin is expected to be used only after documented intravesical BCG therapy has failed or been not tolerated. "Refractory" is loss of response within 6 months of induction or within 12 months of maintenance, following at minimum an initial induction course (5–6 doses) and subsequent maintenance/second induction (≥2 doses).

Minimum prior BCG: first induction course (5–6 doses) plus maintenance or second induction of at least 2 doses, unless intolerance is documented
Refractory timing: loss of response within 6 months of induction or within 12 months of maintenance

Documentation Required

Required Supporting Evidence

Provide supporting evidence with the authorization request. Acceptable sources include the FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that satisfies CMS evidence standards (see CMS Medicare Benefit Policy Manual Chapter 15).

FDA product label for Valstar (valrubicin)
CMS‑recognized compendia
NCCN or ASCO clinical practice guidelines
Peer‑reviewed full‑text literature meeting CMS standards (not meeting abstracts or isolated case reports)

Denial Risk

Exclusion‑Based Denial Triggers

Requests will be denied when explicit exclusion criteria are met. Confirm dosing limits, treatment counts, and absence of active infection before authorization.

Active urinary tract infection (UTI) — absolute exclusion
Single dose exceeds 800 mg — denial trigger
Total induction doses exceed 2 cycles (or 12 doses) — denial trigger
Total maintenance doses exceed 10 cycles (or 10 doses) — denial trigger
Investigational or off‑label uses lacking sufficient evidence (not supported by CMS compendia, accepted guidelines, or adequate peer‑reviewed literature) — denial

Total induction doses exceeding 2 cycles (12 doses) will be excluded/denied

Valstar (valrubicin) maximum total maintenance doses

Maximum total maintenance exposure10 cycles (10 doses)

ScopeCumulative maintenance dosing count for Valstar (valrubicin)

Denial triggerTotal maintenance doses exceeding 10 cycles (10 doses) will be excluded/denied