Currentculinary health fundPolicy N/A

Oncology (Intravesical) - Valrubicin Products UM Medical De-Identified

Defines recommended prior authorization and medical necessity criteria, dosing limits, prescribing clinician requirements, and coverage duration for intravesical valrubicin (Valstar) for BCG-refractory or BCG-intolerant carcinoma in situ of the urinary bladder and use during BCG shortage.

Policy Summary

Payerculinary health fund

PolicyOncology (Intravesical) - Valrubicin Products UM Medical De-Identified

Policy CodePolicy N/A

Change TypeName and indication wording updated

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; document age ≥18, BCG-refractory/intolerance or BCG shortage justification, and that an oncologist prescribed or was consulted.

SourceLink

POLICY UPDATE CHANGES

Policy name changed to 'Oncology (Intravesical) - Valrubicin Products UM Medical Policy' on 04/04/2025.

Indication wording updated to 'Non-Muscle Invasive Bladder Cancer' (date not specified in history).

1Covered Indications

800 mgMax dose per administration

2 monthsInitial approval duration

Coverage Summary

Coverage stance: covered_with_criteria for intravesical valrubicin. Subject: Valrubicin (intravesical) for non-muscle invasive bladder cancer. Scope: Defines recommended prior authorization and medical necessity criteria, dosing limits, prescribing clinician requirements, and coverage duration for intravesical valrubicin (Valstar) for BCG-refractory or BCG-intolerant carcinoma in situ of the urinary bladder and use during BCG shortage. Indicated population (brief): Intravesical valrubicin for BCG-refractory or BCG-intolerant carcinoma in situ / non-muscle invasive bladder cancer and for use during a BCG shortage.

Initial Therapy Criteria

FDA-Approved Indication (Recommended Authorization Criteria)

Approve for 2 months if the patient meets ALL of the following (A, B, and C):

ALL of the following

ONE of
- Patient has Bacillus Calmette-Guerin (BCG)-refractory carcinoma
- Patient is intolerant of Bacillus Calmette-Guerin (BCG)
- According to the prescriber, valrubicin will be used due to a Bacillus Calmette-Guerin (BCG) shortage
Patient is ≥ 18 years of age≥ 18 years
Mapped from policy age threshold
The medication is prescribed by or in consultation with an oncologist

ref": "b1_0

title": "FDA-Approved Indication (Recommended Authorization Criteria)"

ref":

Dosing Requirements

Dosing Requirement

Dose limits for approval and continuation

ALL of the following

Each individual dose must not exceed 800 mg administered intravesically<= 800 mg intravesical
Doses must be administered no more frequently than once weeklyNo more frequently than once weekly

Supporting dosing evidence: The recommended dosing per prescribing information is 800 mg administered intravesically once weekly for 6 weeks, and the policy dosing limits state each individual dose must not exceed 800 mg intravesical and doses must be given no more frequently than once weekly.

Authorization Duration and Continuation Criteria

Approval Duration and Extensions

Authorization and extension rules

ALL of the following

Initial approval: 2 months if criteria met2 months
Extensions: Extended approvals are allowed if the patient continues to meet the Criteria and Dosing
Dose exception review: Requests for doses outside of the established dosing will be considered case-by-case by a clinician (Medical Director or Pharmacist)
Month definition: When approval is authorized in months, 1 month = 30 days1 month = 30 days

Approval and dosing limits

Initial approval duration2 months

Max dose per administration800 mg

Clinical Evidence and Background

Valrubicin is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. Per NCCN guidelines, intravesical valrubicin is recommended during a BCG shortage as initial or adjuvant therapy for certain intermediate- or high-risk non-muscle invasive bladder cancers.

Evidence

Dosing recommendation sourceValstar prescribing information; recommended 800 mg once weekly for 6 weeks

GuidelineNCCN Bladder Cancer Clinical Practice Guidelines v2.2025

BCG-refractory: Carcinoma that does not respond to Bacillus Calmette-Guerin therapy (term used as policy criterion; clinical definition per treating physician).

Revision History

04/04/2025revised

Policy name changed to 'Oncology (Intravesical) - Valrubicin Products UM Medical Policy' (previously 'Oncology (Other) - Valrubicin Products UM Medical Policy').

revisedLatest

Indication wording updated to 'Non-Muscle Invasive Bladder Cancer' (previously 'Bladder Cancer').

Policy Summary

Payerculinary health fund

PolicyOncology (Intravesical) - Valrubicin Products UM Medical De-Identified

Policy CodePolicy N/A

Change TypeName and indication wording updated

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; document age ≥18, BCG-refractory/intolerance or BCG shortage justification, and that an oncologist prescribed or was consulted.

SourceLink

On This Page

OpenPayer

Oncology (Intravesical) - Valrubicin Products UM Medical De-Identified

Coverage Summary

Initial Therapy Criteria

Dosing Requirements

Authorization Duration and Continuation Criteria

Provider Actions

Applicable Codes

Clinical Evidence and Background

Revision History