ModifiedmhnPolicy CP.PHAR.439

Valrubicin (Valstar) intravesical therapy for bladder carcinoma in situ

Defines medical necessity and prior authorization criteria for valrubicin (Valstar) intravesical treatment of carcinoma in situ (CIS) of the urinary bladder and related off-label uses per NCCN guidance; applies to providers requesting coverage from the payer.

Policy Summary

Payermhn

PolicyValrubicin (Valstar) intravesical therapy for bladder carcinoma in situ

Policy CodePolicy CP.PHAR.439

Change TypeMaterial updates: generic-substitution requirement, specialist expansion to include urologists, allowed initial NMIBC use during BCG shortage, and clarified BCG-refractory/cystectomy criteria

Effective DateSep 4, 2018

Next Review Date

Key ActionSubmit prior authorization demonstrating criteria are met for J9357 (valrubicin intravesical 200 mg) with supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

Policy clarified that member must use generic valrubicin for brand Valstar requests unless contraindicated or adverse effects occur.

Specialist requirement expanded to include urologists in addition to oncologists; BCG-refractory definition and cystectomy candidacy were clarified per FDA labeling.

Removed specification of recurrent or persistent disease and added option for use as initial intravesical chemotherapy for NMIBC per NCCN (e.g., during BCG shortage).

References reviewed and updated.

6maximum total doses routinely authorized

800 mgmaximum dose per weekly instillation

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200 mg vialproduct availability

Coverage Criteria

inv-01: Initial Approval — Bladder Cancer (CIS) — Covered when ALL of the following are met

Covered when ALL of the following are met

ALL of the following

Diagnosis of CIS of the urinary bladder
Prescriber: Prescribed by or in consultation with an oncologist or urologist
Age ≥ 18 years
BCG or NMIBC condition
- BCG-refractory: Member is refractory to BCG treatment and is not a candidate for cystectomy
- BCG shortage NMIBC use: Prescribed as initial or adjuvant intravesical chemotherapy for non-muscle invasive bladder cancer (NMIBC) in the event of a BCG shortage
Generic substitution: For brand Valstar requests, member must use generic valrubicin unless contraindicated or clinically significant adverse effects are experienced
Dose limits
- Standard dosing: Dose does not exceed 800 mg per week for a total of 6 doses
- Off-label supported dosing: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use; prescriber must submit supporting evidence

Approval duration: 6 weeks (6 doses)

inv-02: Continuation/Renewal Criteria — Bladder Cancer — Covered when ALL of the following are met

Covered when ALL of the following are met

ALL of the following

Current therapy: Currently receiving medication via Centene benefit, or documentation supports that member has received Valstar or valrubicin for a covered indication for at least 30 days
Response: Member is responding positively to therapy
Dose total: Member has not yet received a total of 6 doses
Generic substitution: For brand Valstar requests, member must use generic valrubicin unless contraindicated or clinically significant adverse effects are experienced

inv-03: Coverage criteria (summary) — Covered when criteria per NCCN and FDA labeling are met; material updates noted below.

Covered when criteria per NCCN and FDA labeling are met; material updates noted below.

ALL of the following

Specialist requirement: Treatment must be prescribed by or managed in consultation with an appropriate specialist (oncologist or urologist).
added option of urologist
Indication timing
- Initial NMIBC per NCCN: Valrubicin may be used as initial intravesical chemotherapy for NMIBC per NCCN guidance (for example, during a BCG shortage).
- BCG-refractory per FDA: Valrubicin may be used for members refractory to BCG who are not candidates for cystectomy, consistent with FDA labeling.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the plan's off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid) or the member's evidence of coverage documents support the use.

Valrubicin is contraindicated for intravesical use in members with a perforated bladder or compromised bladder mucosa, those with a known hypersensitivity to anthracyclines or polyoxyl castor oil, members with concurrent urinary tract infections, and members with small bladder capacity who are unable to tolerate a 75 mL instillation. No boxed warnings are reported in the source document.

This clinical policy is subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and to applicable state and federal requirements. Where state Medicaid provisions conflict with this policy, state Medicaid provisions take precedence. The Health Plan may change, amend, or withdraw this clinical policy as needed.

Uses that are non‑FDA approved and are not supported by evidence consistent with the Health Plan's off‑label use policies are considered not authorized (not medically necessary) under this policy unless the required supporting documentation is submitted and meets the plan standards.

Coverage determinations and administration of benefits under this policy must align with the Health Plan's coverage documents and applicable legal and regulatory requirements. If there is a discrepancy between this clinical policy and applicable law or regulation, the law or regulation governs. Providers are responsible for following plan authorization procedures and submitting required documentation.

Coding and Dose Limits

HCPCS CodesHCPCS

J9357

Injection, valrubicin, intravesical, 200 mg

Covered/affected codesmixed

affected codes

Not specified in this document portion; refer to full policy for specific CPT/HCPCS/NDC codes

inv-11: Maximum dose per instillation — 800 mg

Maximum dose per instillation800 mg per instillation (intravesical)

Dosing frequencyOnce weekly

Recommended regimen for Bladder CIS800 mg intravesically once every week for 6 weeks

inv-12: Maximum total doses authorized — 6 doses (once weekly)

Maximum total doses authorizedUp to 6 doses total (approval duration: 6 weeks)

FrequencyOnce weekly instillations

Continuation limit

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for valrubicin (HCPCS J9357). Providers must demonstrate that the member meets all clinical criteria in this policy and submit supporting documentation. Approvals are time-limited to the coverage window specified in the policy (initial approvals: 6 weeks / 6 doses; continuation approvals: up to a total of 6 weeks / 6 doses).

HCPCS: J9357

Documentation Required

Documentation and Submission Requirements

Providers must follow the Health Plan’s prior authorization procedures and supply clinical documentation such as office chart notes, pathology or lab results, treatment history (including BCG use or shortage justification), and rationale for dose or brand exceptions. Requests missing adequate documentation or for non‑FDA indications may be denied.

Submit office notes, labs, pathology, and prior treatment records
If requesting brand Valstar, document contraindication or adverse reaction to generic valrubicin

Background

Valrubicin is an anthracycline topoisomerase inhibitor formulated for intravesical administration and indicated for treatment of carcinoma in situ (CIS) of the urinary bladder in patients for whom cystectomy is not an option. NCCN and AUA identify bacillus Calmette‑Guérin (BCG) as the standard of care for CIS; valrubicin may be used as an intravesical chemotherapeutic alternative when BCG is unavailable, unsuitable, or when members are refractory to BCG and not candidates for cystectomy. Standard intravesical dosing described in the policy supports a maximum of 800 mg per week for up to a total of 6 doses.

Definitions

inv-22: Carcinoma in situ (CIS) — definition

DefinitionCarcinoma in situ (CIS, Tis) refers to early cancer confined to the urothelium that has not invaded neighboring tissue.

Staging noteReferred to as Tis in the TNM staging system.

Typical managementStandard therapy includes lesion resection followed by intravesical BCG per NCCN/AUA guidance.

inv-23: NMIBC — non‑muscle invasive bladder cancer definition

DefinitionNMIBC (non‑muscle invasive bladder cancer) includes carcinoma in situ and other superficial tumors confined to the bladder mucosa or submucosa (non‑muscle invasive).

ComponentsIncludes CIS (Tis) and other superficial tumors; does not involve detrusor muscle invasion.

Revision History and Policy Changes

2025-07-22annual_reviewLatest

Added option for a urologist to fulfill the specialist prescriber requirement; removed requirement specifying recurrent or persistent disease and allowed valrubicin as initial intravesical chemotherapy for NMIBC per NCCN; clarified that BCG failure is considered BCG-refractory and added criterion that the member is not a candidate for cystectomy per FDA labeling.

2024-08-07annual_review

Clarified that the policy applies to generic valrubicin and added a requirement that for brand Valstar requests the member must use generic valrubicin unless contraindicated or clinically significant adverse effects occur.

Policy Summary

Payermhn

PolicyValrubicin (Valstar) intravesical therapy for bladder carcinoma in situ

Policy CodePolicy CP.PHAR.439

Effective DateSep 4, 2018

Next Review Date

Key ActionSubmit prior authorization demonstrating criteria are met for J9357 (valrubicin intravesical 200 mg) with supporting clinical documentation.

SourceLink

On This Page

Dose increase

Not exceed max: New dose does not exceed 800 mg per week up to a total of 6 doses
Supported by literature: New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use; prescriber must submit supporting evidence

Approval duration: Up to a total of 6 weeks (up to a total of 6 doses)

Material updates: added urologist option to specialist requirement; allowed initial NMIBC use per NCCN; clarified BCG-refractory definition and cystectomy candidacy per FDA.

Continuation/renewal allowed provided member has not yet received a total of 6 doses

Note

Coverage Decisions and Policy Scope

Coverage decisions are subject to the terms, conditions, exclusions, and limitations of the member’s contract, applicable state and federal laws, and Health Plan-level administrative policies and procedures. This clinical policy is a guide and does not replace professional medical judgment; providers remain responsible for treatment decisions.

Coverage subject to member’s benefit contract and legal/regulatory requirements
Policy effective date determined by Health Plan; the posting date may differ

Note

Clinical Policy Guide and Provider Responsibilities

This clinical policy serves as a guide to support coverage determinations. Providers must exercise independent professional judgment when treating members and ensure compliance with Health Plan authorization processes and applicable laws. The Health Plan may change, amend, or withdraw this policy at any time.

Policy does not dictate medical care; providers are responsible for treatment
Health Plan may update policy; follow current authorization procedures

Treatment contextWhen BCG is unavailable (e.g., shortage), NCCN/AUA recommend intravesical chemotherapy agents (including valrubicin) as alternatives; radical cystectomy remains an option for surgical candidates.

inv-24: failure of BCG treatment — BCG refractory definition

Definition (BCG refractory)Failure of BCG treatment is defined as the member being refractory to BCG therapy and not a candidate for cystectomy per FDA labeling.

Policy applicationBCG‑refractory patients who are not cystectomy candidates may be eligible for valrubicin intravesical therapy under the policy.

DocumentationPrior authorization and supporting clinical documentation must demonstrate BCG‑refractory status and cystectomy ineligibility as part of approval criteria.

Clarified initial approval limits so requests do not exceed a total of 6 doses in accordance with authorization duration and updated HIM off-label reference to HIM.PA.154.