CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Valstar (valrubicin) — intravesical therapy coverage criteria

Defines accepted indications, coverage criteria, exclusions, and utilization management for Valstar (valrubicin) intravesical therapy for members; applies to medication requests processed by the payer's UM department and ordering network providers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyValstar (valrubicin) — intravesical therapy coverage criteria

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical changes

Effective DateAug 30, 2024

Next Review DateAug 14, 2024

Key ActionSubmit prior authorization to Utilization Management with documentation of prior intravesical BCG therapy and supporting evidence per FDA label or recognized compendia.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

800 mgsingle dose maximum

2 cyclesmax induction

10 cyclesmax maintenance

30 dayscontinuation window

08/30/24effective

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Coverage Criteria for Valstar (valrubicin)

Initial Therapy - Indication and evidence

Covered when ALL of the following are met

Indication and prior therapy

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

Supportive evidence: Use is supported by FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

Coverage excludes members with an active urinary tract infection (UTI). Requests will be denied if dosing exceeds the policy limits: a single dose greater than 800 mg, total induction doses exceeding 2 cycles (12 doses), or total maintenance doses exceeding 10 cycles (10 doses). Additionally, use of Valstar (valrubicin) for investigational or off‑label indications that lack sufficient supporting evidence (i.e., not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature) is excluded.

Initial Therapy Requirements

Initial therapy requirements

Initial coverage is limited to the labeled/off‑label indication with supportive evidence and prior BCG failure as defined.

Indication: Tis (carcinoma in situ) that is recurrent or persistent and refractory or intolerant to intravesical BCG.

Evidence requirement: Medical necessity supported by FDA labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature per CMS requirements.

Prior BCG therapy: History of intravesical BCG including at least one induction course (5-6 doses) and subsequent maintenance/second induction of ≥2 doses unless documented intolerance; refractory defined as loss of response within 6 months of induction or within 12 months of maintenance.

If the member is intolerant to BCG, document intolerance.

Step	Requirement	Notes
1
Prior intravesical BCG induction (5-6 doses) and maintenance/second induction (≥2 doses)
Required unless patient is intolerant; refractory defined as loss of response within 6 months of induction or within 12 months of maintenance after the specified BCG dosing.

Continuation Therapy and Exception Rules

Continuation Therapy Exception

Covered when ALL of the following are met:

ALL of the following

The 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.
Additional medication(s) are not being added to the continuation request.

Denial Risk

Prior Authorization and Documentation Requirements

Prior Authorization

Prior authorization and approval authority

All medication requests for Valstar are processed by the payer’s Utilization Management (UM) function and require UM review; final approval authority rests with the Utilization Management Committee.

Step Therapy

Step requirement — prior intravesical BCG

Valstar is indicated only for recurrent or persistent non‑muscle invasive bladder carcinoma in situ (Tis) that is refractory or intolerant to intravesical BCG; the policy requires documentation that the disease is BCG‑refractory/intolerant per the defined timing and dosing criteria.

BCG refractory defined as loss of response within 6 months of induction or within 12 months of maintenance after at least first induction (5–6 doses) plus maintenance/second induction (≥2 doses)

Key Definitions

BCG refractory

DefinitionLoss of response to BCG within 6 months of induction or within 12 months of maintenance after at least the first induction course (5–6 doses) followed by maintenance/second induction of ≥2 doses.

Minimum prior BCG dosing requiredAt least one induction course of 5–6 doses plus maintenance/second induction of at least 2 doses.

Clinical contextApplies to recurrent or persistent non‑muscle invasive bladder carcinoma in situ (Tis) that is refractory or intolerant to intravesical BCG.

Quantity and Dosing Limits

Valstar (valrubicin) quantity limits

Single‑dose maximum≤ 800 mg per intravesical dose.

Induction total limitMaximum of 2 cycles (total 12 doses) for induction therapy.

Maintenance total limitMaximum of 10 cycles (10 doses) for maintenance therapy.

Background on Valrubicin (Valstar)

Valrubicin (Valstar) is indicated as intravesical therapy for non‑muscle invasive bladder carcinoma in situ (Tis) when disease is recurrent or persistent and the member is refractory or intolerant to intravesical BCG. The policy requires documentation of prior BCG treatment and defines BCG refractory as loss of response within 6 months of induction or within 12 months of maintenance after at least the first induction course (5–6 doses) followed by maintenance or a second induction of ≥2 doses.

Required Prior Therapies

Step	Requirement	Notes
1
Prior intravesical BCG induction (5-6 doses) and maintenance/second induction (≥2 doses)
Required unless patient is intolerant; refractory defined as loss of response within 6 months of induction or within 12 months of maintenance after the specified BCG dosing.