CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Inlexzo (gemcitabine intravesical system) — coverage criteria for BCG‑unresponsive NMIBC

Defines indications, contraindications, exclusions, coding, and prior‑authorization expectations for Inlexzo (gemcitabine intravesical system) use in adults with BCG‑unresponsive non‑muscle invasive bladder cancer; intended for providers and utilization management staff processing medication requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInlexzo (gemcitabine intravesical system) — coverage criteria for BCG‑unresponsive NMIBC

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization showing BCG‑unresponsive NMIBC with documentation of adequate prior BCG therapy and that dosing (≤225 mg per dose) and total doses (≤14) meet policy limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

BCG‑unresponsive NMIBCprimary covered indication

225 mgsingle dose maximum

14 dosestreatment duration limit

J9999billing code listed

Commercial, Medicaid

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Coverage Criteria for Inlexzo (gemcitabine intravesical system)

Initial coverage criteria

Covered when ALL of the following are met

Indication: Adult member with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

BCG adequacy: History of adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course plus 2 of 3 maintenance doses, or at least 2 of 6 doses of a second induction course.

Supporting evidence: Use supported by FDA labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Dosing and duration limits: Single dose must be ≤225 mg and total treatment must not exceed 14 doses (8 doses once every 3 weeks for up to 6 months, then 6 doses once every 12 weeks for up to 18 months).Single dose ≤225 mg; max 14 doses

Requests will be excluded when there is documented disease progression while taking Inlexzo (gemcitabine intravesical system). Requests are also excluded for concurrent use with other anticancer therapies, for members who are eligible for or have undergone radical cystectomy, for dosing that exceeds the single dose limit of 225 mg, and for treatment that exceeds the maximum duration limit of 14 total doses (specified as 8 doses once every 3 weeks for up to 6 months followed by 6 doses once every 12 weeks for up to 18 months).

Inlexzo used for an off‑label indication is considered investigational and not supported unless the use is documented by evidence acceptable to CMS. The policy requires support from CMS‑recognized compendia or acceptable peer‑reviewed literature. Evidence will be evaluated for adequate representation of the patient and cancer characteristics, appropriate regimen representation, clinically meaningful outcomes (for example ASCO‑recommended thresholds such as hazard ratio < 0.80 or survival benefit thresholds), and study design appropriateness. Isolated case reports and abstracts without a full peer‑reviewed article generally do not provide sufficient evidence to support coverage.

Regimen	Dosing details	Coverage status
Inlexzo (gemcitabine intravesical system)	Per prescribing information: single dose ≤225 mg; total treatment up to 14 doses given as 8 doses once every 3 weeks for up to 6 months, followed by 6 doses once every 12 weeks for up to 18 months.	Covered with criteria

Billing and Coding

Billing codeHCPCS

J9999

gemcitabine solution

inv-05: Single dose limit — 225 mg

Single dose limit225 mg per single intravesical dose of Inlexzo (gemcitabine intravesical system)

Policy consequenceRequests with dosing that exceeds 225 mg for a single administration will be excluded/denied

Related coding noteBilling code J9999 applies to gemcitabine solution; ensure single‑dose administered does not exceed 225 mg

inv-06: Maximum total doses — 14 total doses

Maximum total doses14 total doses

Schedule detail - induction phase8 doses given once every 3 weeks for up to 6 months (induction/initial phase)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Inlexzo (gemcitabine intravesical system). Evolent (on behalf of Neighborhood Health Plan of Rhode Island) must process all medication requests; medications not authorized may be deemed not approvable and not reimbursable.

Indication: BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors in adults
BCG-unresponsive defined as: ≥5 of 6 doses of induction + ≥2 of 3 maintenance OR ≥2 of 6 doses of a second induction course
Dose and duration limits and exclusion criteria (see Denial/Exclusion callout)

Step Therapy

Continuation / Step Therapy Rules

Continuation (step therapy) requests may be approved without re-evaluation when all of the following are met:

Member has not experienced disease progression on the requested medication

Key Definitions

inv-12: BCG-unresponsive NMIBC (adequate BCG therapy)

DefinitionBCG‑unresponsive NMIBC after adequate BCG therapy is defined as a minimum of 5 of 6 full doses of an induction course plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course.

Indication contextApplies to adult members with BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Documentation requiredPrior authorization requests must document prior adequate BCG therapy per the above minimum dosing criteria.

Line of Therapy

Second-line

Line: For adults with BCG-unresponsive NMIBC after adequate BCG therapy; specifies use after failing BCG rather than as first-line BCG treatment.

Background

Inlexzo is a gemcitabine intravesical delivery system indicated for adults with BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC), particularly carcinoma in situ with or without papillary tumors. Use is intended after prior adequate BCG therapy and within specified dosing limits: a single intravesical dose of up to 225 mg and a maximum of 14 total doses following the approved schedule. Contraindications include hypersensitivity to gemcitabine and bladder perforation; the policy also requires prior authorization documenting BCG‑unresponsive disease and adherence to dosing and duration limits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyInlexzo (gemcitabine intravesical system) — coverage criteria for BCG‑unresponsive NMIBC

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization showing BCG‑unresponsive NMIBC with documentation of adequate prior BCG therapy and that dosing (≤225 mg per dose) and total doses (≤14) meet policy limits.

SourceLink

On This Page

Schedule detail - maintenance phase6 doses given once every 12 weeks for up to 18 months (maintenance phase)

Policy consequenceTreatment courses exceeding 14 total doses will be excluded/denied

Requested medication was used within the last year without a lapse of more than 30 days of active authorization

No additional medication(s) are being added to the continuation request

Documentation Required

Required Supporting Documentation

Supporting documentation must be provided with the prior authorization request. Use one or more of the following to justify medical necessity per CMS standards:

FDA-approved product labeling for Inlexzo (gemcitabine intravesical system)
CMS-approved compendia
National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines
Acceptable peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements (includes assessment of patient population, regimen representation, clinically meaningful outcomes, and study design)

Denial Risk

Triggers for Exclusion / Denial

Requests meeting any of the following conditions should be denied or excluded from coverage.

Disease progression while taking Inlexzo (gemcitabine intravesical system)
Concurrent use with other anticancer therapies
Members who are eligible for or have undergone radical cystectomy
Dosing that exceeds the single dose limit of 225 mg
Treatment that exceeds the maximum duration limit of 14 total doses (8 doses once every 3 weeks up to 6 months, plus 6 doses once every 12 weeks up to 18 months)
Investigational or off-label indications lacking sufficient evidence per CMS compendia or acceptable peer-reviewed literature (insufficient if clinical characteristics, regimen representation, clinically meaningful outcomes, or study design are inadequate; case reports alone are generally insufficient)