CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Valstar (valrubicin) intravesical therapy

Defines accepted indications, clinical criteria, exclusions, contraindications, dosing limits, coding, applicable lines of business, and evidence sources for use of Valstar (valrubicin) for non-muscle invasive bladder cancer (carcinoma in situ) including continuation request rules and requirements for supporting evidence.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyValstar (valrubicin) intravesical therapy

Policy CodePolicy N/A

Change TypeTemplate conversion; administrative wording updates

Effective Date

Next Review Date

Key ActionProcess medication requests through Evolent and ensure use is supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1070 Valstar (valrubicin).

Updated 'continuation request' verbiage and NCH to Evolent terminology.

1Indications covered (NMIBC CIS refractory to BCG)

3Contraindication categories listed

3Dose/administration limits specified

Coverage Summary

Covered with criteria: intravesical Valstar (valrubicin) is covered with criteria for treatment of recurrent or persistent non-muscle invasive carcinoma of the bladder (Tis/Carcinoma In Situ) that is refractory or intolerant to intravesical BCG, when documentation meets the policy's BCG failure definition and evidence requirements. Effective/last review date: last review 2025-08-01 (per policy history and dates). Applicable indication: intravesical Valstar for CIS. Coding: J9357.

Dosing and Authorization Thresholds

Single dose limit800 mg

Total induction doses≤ 2 cycles (or ≤ 12 doses)

Total maintenance doses≤ 10 cycles (or ≤ 10 doses)

BCG induction minimum doses5-6 doses

BCG maintenance minimum dosesat least 2 doses

Continuation authorization lapse allowanceNo lapse > 30 days within the last year

Initial Therapy Criteria

Initial Therapy - Indication for Valstar (valrubicin)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of recurrent or persistent non-muscle invasive carcinoma of the bladder (Tis or Carcinoma In Situ)
Disease is refractory or intolerant to local (intravesical) therapy with Bacillus Calmette-Guérin (BCG)
Refractory is defined as loss of response to treatment within 6 months of induction or within 12 months of maintenance after at least the first course of induction (5-6 doses) followed by maintenance/second induction of at least 2 doses of BCG
Use is supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Continuation Therapy Criteria

Continuation Therapy

Continuation requests exempt from this policy when ALL of the following are met:

ALL of the following

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
No additional medication(s) are being added to the continuation request

Documentation Required

Continuation request documentation

Continuation requests are exempt from re-evaluation when all required documentation is provided showing: no disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days in active authorization; and no additional medications are being added to the continuation request.

Documentation that member has not experienced disease progression on the requested medication
Evidence that the requested medication was used within the last year with no lapse > 30 days in active authorization
Confirmation that no additional medication(s) are being added to the continuation request

Contraindications & Warnings

Contraindications / Warnings

Not eligible when ANY of the following are present:

ANY of the following

Known hypersensitivity to anthracyclines, polyoxyl castor oil, or any component of the formulation
Perforated bladder
Active urinary tract infection
Small bladder capacity (unable to tolerate a 75 mL instillation)

Valstar (valrubicin) is an intravesical chemotherapeutic agent indicated for refractory carcinoma in situ of the bladder; Evolent processes medication requests and requires use to be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature. Operational note: continuation requests may be exempt from re-evaluation when the member has no disease progression, the medication was used within the prior year without >30-day lapse in authorization, and no additional medications are being added.

Exclusion Criteria (Not Covered)

Not covered when ANY of the following apply:

ANY of the following

Member has an active urinary tract infection (UTI)
Dosing exceeds single dose limit of Valstar (valrubicin) 800 mg
Total induction doses of Valstar (valrubicin) exceed 2 cycles (or 12 doses)
Total maintenance doses of Valstar (valrubicin) exceed 10 cycles (or 10 doses)
Investigational / Off-label exclusions
- Investigational use or off-label indication not sufficient in evidence or not generally accepted by the medical community
- Insufficient evidence defined by one or more of these: clinical characteristics not represented in published evidence; therapy regimen not represented; study outcomes not clinically meaningful (ASCO metrics e.g., HR <0.80 or OS/PFS benefit >=3 months); inappropriate experimental design; reliance on case reports or abstracts without full peer-reviewed articles

Denial Risk

Denial if exclusion criteria met

Claims or authorizations may be denied if any exclusion criteria are met, including active infection, dosing limits exceeded, or investigational/off‑label use lacking sufficient evidence.

Active urinary tract infection (denial trigger per exclusion criteria)
Dosing limits exceeded: single dose limit of Valstar 800 mg; total induction doses > 2 cycles (or > 12 doses); total maintenance doses > 10 cycles (or > 10 doses) (affects code(s): J9357)
Investigational or off‑label use not supported by CMS‑recognized compendia or acceptable peer‑reviewed evidence (affects code(s): J9357)

Provider Actions & Documentation

Prior Authorization

Authorization requirement and evidence support

Medication requests must be processed by Evolent and use must be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature per the CMS Medicare Benefit Policy Manual Chapter 15.

Affected code: J9357

Documentation Required

Document BCG failure/refractoriness

Provide documentation that the disease is refractory or intolerant to intravesical BCG with timing consistent with the refractory definition and include BCG dosing details.

Timing consistent with refractory definition: loss of response within 6 months of induction or within 12 months of maintenance
BCG dosing details: at least 5–6 induction doses and at least 2 maintenance/second induction doses
Reference definition: refractory (loss of response within 6 months induction or 12 months maintenance after required BCG dosing)

Denial Risk

Denial if exclusion criteria met

Claims may be denied when exclusion criteria apply, including active infection, dosing limit breaches, or insufficient supporting compendia/evidence for off‑label use.

Active urinary tract infection (denial risk) (affects code(s): J9357)
Dosing limit breaches: single dose > 800 mg; total induction > 2 cycles (or > 12 doses); total maintenance > 10 cycles (or > 10 doses) (affects code(s): J9357)
Off‑label or investigational use lacking sufficient CMS‑recognized compendia or acceptable peer‑reviewed evidence (denial risk) (affects code(s): J9357)

Clinical Evidence

Key evidence and guidance supporting use include Sharma P et al. 2015, Dinney CP et al. 2013, Steinberg RL et al. 2016, and the Valstar prescribing information (2016); policy also references NCCN and ASCO guidance and CMS-recognized compendia. When the policy criteria are met, coverage is supported by these peer-reviewed references and compendia per the CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Evidence sources

Prescribing informationValstar PI 2016

Key publicationsSharma 2015; Dinney 2013; Steinberg 2016

Guidelines/CompendiaNCCN, ASCO, Clinical Pharmacology, Micromedex (2025)

Background

Valstar (valrubicin) is indicated as an intravesical therapy for patients with recurrent or persistent non‑muscle invasive carcinoma of the bladder (Tis/CIS) that is refractory or intolerant to intravesical BCG; refractory is defined as loss of response within 6 months of induction or within 12 months of maintenance after required BCG dosing (induction 5–6 doses and maintenance/second induction of at least 2 doses). Evolent processes medication requests and requires that use be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature; continuation requests may be exempt from re-evaluation when the member has not progressed, prior use occurred within the last year without a >30-day authorization lapse, and no additional medications are added.

Definitions

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

Revision History

August 2025revisedLatest

Converted to new Evolent guideline template; replaced prior UM ONC_1070 Valstar (valrubicin); updated indication section and references.

August 2024revised

Administrative wording update: updated 'continuation request' verbiage and changed NCH verbiage to Evolent.