CurrentAnthemPolicy CC-0293

Inlexzo (gemcitabine intravesical system) coverage and coding

Defines medical necessity, prior authorization expectations, coverage criteria, approval durations, and coding guidance for Inlexzo used to treat BCG‑unresponsive non‑muscle invasive bladder cancer (CIS with or without papillary tumors). Applies to Anthem medical benefit reviews and prior authorization determinations.

Policy Summary

PayerAnthem

PolicyInlexzo (gemcitabine intravesical system) coverage and coding

Policy CodePolicy CC-0293

Change TypeNew prior authorization and coding additions

Effective DateNov 14, 2025

Next Review DateN/A

Key ActionObtain prior authorization for Inlexzo; initial approvals limited to 6 months and continuation requires documented complete response for 12‑month approval.

SourceLink

POLICY UPDATE CHANGES

New prior authorization (PA) policy for Inlexzo (gemcitabine intravesical system) was created.

HCPCS not‑otherwise‑classified codes C9399 and J9999 were added to represent Inlexzo.

ICD-10 diagnosis codes C67.0-C67.9 and D09.0 were added for malignant neoplasm and carcinoma in situ of bladder.

Approval durations specified: initial approval 6 months; continuation approval 12 months with complete response requirement.

225 mggemcitabine per system

3 weeksdwell time

6 moinitial approval

Policy Summary

PayerAnthem

PolicyInlexzo (gemcitabine intravesical system) coverage and coding

Policy CodePolicy CC-0293

Change TypeNew prior authorization and coding additions

Effective DateNov 14, 2025

Next Review DateN/A

Key ActionObtain prior authorization for Inlexzo; initial approvals limited to 6 months and continuation requires documented complete response for 12‑month approval.

SourceLink

On This Page

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Coverage and Medical Necessity Criteria

Initial Therapy

Initial requests for Inlexzo may be approved when ANY of the following are met:

Initial approval any path: Either (A) individual is under 19 years of age OR (B) individual is using Inlexzo as an intravesical instillation AND has a diagnosis of BCG‑unresponsive, non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

Continuation Therapy

Continuation requests for Inlexzo may be approved when ANY of the following are met:

Continuation approval any path: Either (A) individual is under 19 years of age OR (B) individual is using Inlexzo as an intravesical instillation AND has a diagnosis of BCG‑unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors, AND has a complete response to initial therapy defined as negative cystoscopy and negative urine cytology.

Continuation approval duration is 12 months when criteria met.

Requests for Inlexzo (gemcitabine intravesical system) are not approved for individuals with muscle invasive (T2–T4), locally advanced, metastatic, or extra‑vesical urothelial carcinoma (including urethra, ureter, or renal pelvis).

Use is also not approved for patients with a perforated bladder, and for any situation where the policy’s stated approval criteria are not met or for indications outside the specified BCG‑unresponsive non‑muscle invasive bladder cancer population.

Inlexzo is considered not medically necessary for treatment of muscle‑invasive disease (T2‑T4), locally advanced, metastatic, or extra‑vesical urothelial carcinoma and for patients with a perforated bladder.

Requests will be denied when the documented clinical criteria for BCG‑unresponsive NMIBC with CIS (with or without papillary tumors) and the other coverage requirements are not met, or when the drug is sought for indications beyond those specified in this policy.

Billing and Diagnosis Codes

HCPCS NOC CodesHCPCS

C9399	Unclassified drugs or biologicals [when specified as Inlexzo (gemcitabine intravesical)]
J9999	Not otherwise classified, antineoplastic drugs [when specified as Inlexzo (gemcitabine intravesical)]

ICD-10 Diagnosis CodesICD-10

C67.0-C67.9	Malignant neoplasm of bladder
D09.0	Carcinoma in situ of bladder

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Inlexzo (gemcitabine intravesical system). Submit initial prior authorization requests with documentation of indication, planned route of administration (intravesical), patient age, and supporting clinical records. Initial approval duration: 6 months; continuation approval duration: 12 months.

Initial approval duration: 6 months
Continuation approval duration: 12 months
Required documentation: indication, route (intravesical), clinical records

Step Therapy

Therapy sequencing — place in treatment

Inlexzo is one of several FDA‑approved options for BCG‑unresponsive NMIBC with CIS (e.g., pembrolizumab, nadofaragene firadenovec, nogapendekin alfa inbakicept‑pmln). Consider Inlexzo’s role as a locally acting intravesical chemotherapeutic option when sequencing therapy: it may be appropriate after BCG failure for patients with CIS ± papillary tumors, recognizing differences in mechanism and administration compared with systemic immunotherapy or gene therapy.

Background and Drug Description

Inlexzo is an intravesical gemcitabine‑containing system intended for bladder instillation in patients with BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in situ (with or without papillary tumors). The therapy is delivered via intravesical instillation and policy continuation criteria require documentation of a complete response to initial therapy defined by negative cystoscopy and negative urine cytology.

Key Definitions

Complete Response (CR)

DefinitionThe disappearance of all signs of cancer as a result of treatment; also called complete remission; does not indicate the cancer has been cured.

SynonymComplete remission

Clinical implicationUsed as an endpoint for continuation approval documentation (e.g., negative cystoscopy and urine cytology required in this policy).

ECOG Performance Status

DefinitionA performance-status scale used to assess disease impact on daily living and guide treatment and prognosis (also called WHO or Zubrod score).

Scale range0 = Fully active; 1 = Restricted in strenuous activity but ambulatory; 2 = Ambulatory and capable of self-care but unable to work; 3 = Limited self-care, confined to bed/chair >50% of waking hours; 4 = Completely disabled; 5 = Dead.

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