ModifiedCentenePolicy CP.PHAR.439

Valrubicin (Valstar) intravesical therapy

This policy governs medical necessity and prior authorization criteria for intravesical valrubicin (Valstar) for treatment of carcinoma in situ of the urinary bladder and related off-label uses, affecting providers prescribing or administering valrubicin for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyValrubicin (Valstar) intravesical therapy

Policy CodePolicy CP.PHAR.439

Change TypeCriteria clarified and revised (material)

Effective Date09.04.18

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria and request prior authorization when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added option of urologist to fulfill the specialist requirement.

Clarified that policy applies to generic valrubicin and that brand Valstar requests require use of generic unless contraindicated or adverse effects occur.

Clarified initial approval does not exceed a total of 6 doses consistent with authorization duration.

Removed requirement that a urologist fulfill specialist requirement; removed specification of recurrent or persistent disease and added option for use as initial intravesical chemotherapy for NMIBC per NCCN; clarified failure of BCG to member is refractory to BCG treatment and added criterion that member is not a candidate for cystectomy per FDA labeling; references reviewed and updated.

800 mgdose per week

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Coverage Criteria for Valrubicin (Valstar)

Initial Therapy — Bladder Cancer (CIS)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of carcinoma in situ (CIS) of the urinary bladder.
Prescribed by or in consultation with an oncologist or urologist.
Member is age ≥ 18 years.
One of the following:
- Member is refractory to BCG treatment and is not a candidate for cystectomy. (Prior authorization may be required for BCG immunotherapy).
- Prescribed as initial or adjuvant intravesical chemotherapy for non‑muscle invasive bladder cancer (NMIBC) in the event of a documented BCG shortage (see plan Appendix for BCG shortage guidance).
For brand Valstar requests, member must use generic valrubicin unless contraindicated or clinically significant adverse effects are experienced.
Dose limits (one of):
- Dose does not exceed 800 mg per week for a total of 6 doses.
- Dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Continuation Therapy — Bladder Cancer (CIS)

Covered when ALL of the following are met:

ALL of the following

Member is currently receiving valrubicin via the Centene benefit, or documentation supports the member has been receiving valrubicin/Valstar for a covered indication for at least 30 days.
Member is responding positively to therapy.
Member has not yet received a total of 6 doses of valrubicin.
For brand Valstar requests, member must use generic valrubicin unless contraindicated or clinically significant adverse effects are experienced.
If request is for a dose increase, one of the following must be met:

Coverage conditions (summary)

Coverage is aligned with FDA‑approved labeling and NCCN guidance; coverage is limited to the indications and conditions described below.

ALL of the following

Indication: Carcinoma in situ (CIS) of the urinary bladder (non‑muscle invasive bladder cancer).
Use per FDA labeling: valrubicin is indicated for treatment of BCG‑refractory CIS in patients for whom cystectomy would be associated with unacceptable morbidity or mortality; member must not be a candidate for cystectomy for the BCG‑refractory criterion to be met.
NCCN alignment: Policy allows initial or adjuvant intravesical chemotherapy for NMIBC as an alternative during documented BCG shortage per NCCN guidance.
Off‑label use: Non‑FDA‑approved indications not addressed in this policy require sufficient documentation of efficacy and safety per the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for HIX, CP.PMN.53 for Medicaid) or evidence of coverage documents.

Non‑FDA approved indications not addressed in this policy are excluded from coverage unless there is sufficient documentation of efficacy and safety consistent with the plan’s off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Coverage is subject to the member's contract, evidence of coverage, and applicable administrative policies and procedures. This policy may be superseded by legal, regulatory, or plan‑level requirements; where discrepancies exist, law and regulation govern.

Determinations about non‑medical necessity (NMN) conditions, prior authorization requirements, and other administrative eligibility decisions will be handled per the member’s coverage documents and the Health Plan’s standard procedures.

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Valstar (valrubicin) when the clinical criteria in this policy are met. Requests should demonstrate the indication and regimen align with the policy (e.g., CIS of the bladder, BCG‑refractory and not a candidate for cystectomy, or use during a documented BCG shortage per NCCN/AUA guidance).

Prior authorization may also be required for BCG immunotherapy when referenced in criteria.
Approval durations: Initial = 6 weeks (6 doses); Continuation = up to a total of 6 weeks (up to 6 doses).

Note

Clinical-condition Verification for Prior Authorization

Prior authorization requests must verify the clinical condition and alignment with FDA labeling and NCCN recommendations. For bladder CIS, documentation must show: diagnosis of CIS, prescriber is an oncologist or urologist (or consult documented), age ≥ 18, and either BCG‑refractory and not a candidate for cystectomy OR prescribed as intravesical chemotherapy during a BCG shortage per NCCN/AUA guidance.

Coding and Dosing Information

HCPCS CodesHCPCS

J9357

Injection, valrubicin, intravesical, 200 mg

inv-09: Maximum per-dose and course — Valrubicin dosing limits

Standard per-dose800 mg intravesical once weekly

Standard course durationUp to 6 weekly doses (approval duration: 6 weeks)

Maximum single-dose amount recorded800 mg per dose (maximum dose listed)

Authorization noteInitial approval duration: 6 weeks (6 doses); continuation allowed if criteria met and total doses have not exceeded 6

Definitions

inv-19: BCG-refractory CIS — Definition

DefinitionBCG-refractory carcinoma in situ (CIS) — carcinoma in situ of the urinary bladder that is refractory to bacillus Calmette-Guérin (BCG) therapy

FDA indication contextValstar is indicated for intravesical therapy of BCG-refractory CIS in patients for whom immediate cystectomy would have unacceptable morbidity or mortality.

Clinical staging noteCIS corresponds to Tis in the TNM staging system (early cancer not spread to neighboring tissue).

inv-20: BCG-refractory — Policy clarification

Policy definition of BCG-refractoryBCG-refractory is defined as failure of BCG treatment; the policy requires the member be refractory to BCG and not a candidate for cystectomy per FDA labeling.

Policy requirement

Background

Valrubicin (Valstar) is an anthracycline topoisomerase inhibitor formulated for intravesical administration. It is indicated for treatment of BCG‑refractory carcinoma in situ of the urinary bladder in patients for whom immediate cystectomy would result in unacceptable morbidity or mortality; intravesical chemotherapy including valrubicin is also recognized as an alternative when BCG is unavailable or not tolerated. Use of valrubicin should align with FDA labeling and relevant guideline recommendations.

Revision History

11.25P&T approvalLatest

Policy revisions approved by the Pharmacy & Therapeutics committee clarifying that a urologist is no longer required to fulfill the specialist requirement, removing specification of recurrent or persistent disease, adding option for initial intravesical chemotherapy for NMIBC per NCCN, clarifying BCG-refractory definition and that member is not a candidate for cystectomy per FDA labeling, and updating references.

09.04.18effective date

Policy effective date recorded in document metadata.

Policy Summary

PayerCentene

PolicyValrubicin (Valstar) intravesical therapy

Policy CodePolicy CP.PHAR.439

Change TypeCriteria clarified and revised (material)

Effective Date09.04.18

Next Review Date

SourceLink

On This Page

New dose does not exceed 800 mg per week up to a total of 6 doses.

New dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Dose and duration limits: Approvals are generally for up to 6 weeks (up to a total of 6 intravesical doses) and doses exceeding 800 mg per week require supporting guideline or literature evidence if used off‑label.

Brand vs generic: Brand Valstar will be approved only if generic valrubicin is contraindicated or causes clinically significant adverse effects.

Approval durations: Initial approvals — 6 weeks (6 doses). Continuation approvals — up to a total of 6 weeks (up to 6 doses) total.

Clinical and administrative exceptions: Coverage is subject to member’s contract, state and federal requirements, and applicable Health Plan administrative policies and procedures; the Health Plan may require prior authorization and documentation to support the criteria above.

BCG‑refractory must be supported by clinical notes documenting prior BCG and lack of response and documentation that the member is not a surgical candidate for cystectomy.

If used during a BCG shortage, cite applicable NCCN/AUA recommendations or facility shortage documentation (see Appendix D).

Denial Risk

Potential Denial Triggers

Coverage may be denied if documentation does not support that the member meets the policy requirements (for example: not BCG‑refractory, is a candidate for cystectomy, diagnosis is not CIS, or the requested indication is a non‑FDA approved use without sufficient supporting evidence). Off‑label uses not addressed by this policy require adequate supporting peer‑reviewed evidence per the plan's off‑label policies.

Non‑FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy/safety is provided per CP.CPA.09, HIM.PA.154, or CP.PMN.53 as applicable.
Requests lacking evidence that member is not a cystectomy candidate or lacking prior BCG treatment records may be denied.

Documentation Required

Documentation and Administrative Requirements

Providers must submit supporting documentation with the prior authorization request (e.g., office chart notes, pathology reports, prior BCG treatment records, surgical consultation notes regarding cystectomy candidacy, and relevant lab/imaging results). Providers must also comply with Health Plan administrative policies and contractual terms; coverage decisions remain subject to plan provisions and applicable law.

Include documentation of prior therapies and dates, response assessments, and rationale for using valrubicin (including guideline citations for off‑label regimens when applicable).
For brand Valstar requests, demonstrate generic valrubicin was tried or is contraindicated/caused significant adverse effects.

Step Therapy

Therapeutic Sequencing and BCG Shortage Guidance

Therapeutic sequencing: intravesical BCG is the standard first‑line intravesical therapy for high‑risk NMIBC/CIS; valrubicin is intended for patients who are BCG‑refractory and not candidates for cystectomy per FDA labeling and NCCN guidance. During documented BCG shortages, valrubicin and other intravesical chemotherapies may be considered as initial or adjuvant alternatives per NCCN/AUA recommendations; providers should reference shortage guidance and guideline recommendations in the request.

NCCN/AUA recommend prioritizing BCG for high‑risk patients and dose‑splitting if feasible; when BCG is unavailable, alternatives include intravesical chemotherapies (e.g., valrubicin, gemcitabine, mitomycin, docetaxel) or radical cystectomy if the patient is a surgical candidate.
Prescribed regimen must be FDA‑approved or recommended by NCCN; dose limits: generally ≤ 800 mg/week for up to 6 doses unless supported by guidelines or peer‑reviewed literature (submit supporting evidence for off‑label dosing).

Member must be refractory to BCG treatment and not a candidate for cystectomy to meet initial approval under the BCG-refractory criterion.

Implication for prior authorizationPrior authorization should verify that BCG therapy failed (member is refractory) and that cystectomy is not a suitable option, consistent with the revised policy language.