CurrentCentenePolicy CP PHAR.439

Valrubicin (Valstar)

Defines medical necessity criteria, initial and continued approval criteria, dosing limits, contraindications, and coding implications for valrubicin (Valstar) intravesical therapy for carcinoma in situ (CIS) of the urinary bladder and certain off-label use during BCG shortage. Applies to Commercial, Medicaid, HIM lines of business affiliated with Centene.

Policy Summary

PayerCentene

PolicyValrubicin (Valstar)

Policy CodePolicy CP PHAR.439

Change TypeMultiple updates (dose limits, BCG shortage guidance, generic requirement)

Effective DateSep 4, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

Revised criteria to include adjuvant intravesical chemotherapy for NMIBC in the event of a BCG shortage per NCCN 2A or above off-label indication (10.20.20).

Clarified that requests should not exceed a total of 6 doses in accordance with authorization duration (08.09.21).

Clarified that policy applies to generic valrubicin and added criterion that member must use generic for brand Valstar requests (08.07.24).

Added Commercial line of business to policy (06.30.23).

4Q 2022 annual review noted no significant changes; references reviewed and updated (08.16.22).

1FDA approved indication covered (CIS of bladder)

800 mgPer-dose maximum

Coverage Summary & Scope

Scope: Defines medical necessity criteria, initial and continued approval criteria, dosing limits, contraindications, and coding implications for valrubicin (Valstar) intravesical therapy for carcinoma in situ (CIS) of the urinary bladder and certain off-label use during BCG shortage. Coverage stance: covered_with_criteria. Effective date: 09.04.18. Last review: 11.24. Policy summary: Valrubicin/Valstar intravesical therapy is covered with specific criteria for CIS of the bladder per the FDA indication and may be authorized for certain off-label NMIBC uses (adjuvant intravesical chemotherapy) during a documented BCG shortage in accordance with NCCN/AUA guidance. Dosing limits: 800 mg per week with a maximum of 6 doses (approval duration 6 weeks).

Initial Therapy Criteria

Initial Approval Criteria

Valstar and valrubicin are medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of recurrent or persistent carcinoma in situ (CIS) of the urinary bladder
Bladder cancer (must meet all) - (documented in chart notes/labs/other clinical information)
Prescribed by or in consultation with an oncologist
Member meets one of the following
- Age ≥ 18 years
- Failure of intravesical BCG treatment, unless contraindicated or clinically significant adverse effects are experienced
- Adjuvant intravesical chemotherapy for non-muscle invasive bladder cancer (NMIBC) in the event of a BCG shortage (per Appendix D and NCCN guidance)
For brand Valstar requests, member must use generic valrubicin unless contraindicated or clinically significant adverse effects are experienced
Requested dose does not exceed 800 mg per week for a total of 6 doses800 mg per week; total up to 6 doses
Dose justification for off-label use
- Dose is FDA-approved regimen or recommended by NCCN
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Continuation Therapy Criteria

Continued Therapy

Continue therapy when ALL of the following are met:

ALL of the following

Member is currently receiving valrubicin via Centene benefit, or documentation supports member has been receiving valrubicin for a covered indication for at least 30 days
Member is responding positively to therapy
Member has not yet received a total of 6 dosestotal up to 6 doses
For brand Valstar requests, member must use generic valrubicin unless contraindicated or clinically significant adverse effects are experienced

Other Diagnoses / Off‑label Use Pathways

Other Diagnoses/Indications

Requests for other diagnoses/indications must meet one of the following:

ANY of the following

For drugs on the formulary/PDL, follow the no coverage criteria policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.33 for marketplace, CP.PMN.255 for Medicaid)
For drugs NOT on the formulary/PDL, follow the non-formulary policy for the relevant line of business (CP.CPA.190 commercial, HIM.PA.103 marketplace, CP.PMN.16 Medicaid)
If requested use is not listed under Diagnoses/Indications for which coverage is NOT authorized and initial criteria do not apply, refer to off-label use policy for the relevant line of business (CP.CPA.09 commercial, HIM.PA.154 marketplace, CP.PMN.53 Medicaid)

Provider Actions & Prior Authorization

Documentation Required

Documentation submission required

Provider must submit documentation (office chart notes, lab results or other clinical information) supporting that the member has met all approval criteria.

Prior Authorization

Prior authorization may be required for BCG

Prior authorization may be required for BCG immunotherapy. In the event of BCG supply constraints, see Appendix D and NCCN guidance for recommended BCG-shortage pathways and intravesical chemotherapy alternatives.

Applicable Codes

Relevant HCPCSHCPCS

J9357

Injection, valrubicin, intravesical, 200 mg

Background & Clinical Context

Valrubicin (Valstar) is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. The policy incorporates the FDA-approved indication and aligns with NCCN and AUA guidance; during documented BCG shortages, the policy allows for consideration of intravesical alternatives (including valrubicin) as per NCCN/AUA recommendations and the policy's Appendix D.

Definitions

CIS: Carcinoma in situ of the urinary bladder.

BCG: Bacillus Calmette-Guerin.

NMIBC: Non-muscle-invasive bladder cancer.

Revision History

10.20.20added

Revised criteria to include adjuvant intravesical chemotherapy for NMIBC in the event of a BCG shortage per NCCN 2A or above off-label indication; added HCPCS codes; Appendix D updated with BCG shortage information; references reviewed and updated.

08.09.21clarified

Clarified in initial approval that requests should not exceed a total of 6 doses in accordance with authorization duration; references reviewed and updated.

08.16.22revised

4Q 2022 annual review: template changes applied; no clinical policy statement changes; references reviewed and updated.