CurrentMass General Brigham Health PlanPolicy N/A

Intravesical Bladder Cancer Agents — Inlexzo (gemcitabine intravesical system)

Medical benefit prior authorization policy for Inlexzo to treat adult patients with BCG‑unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS); applies to Mass General Brigham Health Plan members under the MassHealth UPPL plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyIntravesical Bladder Cancer Agents — Inlexzo (gemcitabine intravesical system)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 17, 2026

Next Review DateN/A

Key ActionSubmit prior authorization under the medical benefit; new members within 90 days currently receiving treatment may be authorized or otherwise must meet all listed clinical criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

BCG‑unresponsive NMIBC with CISindication covered

Prior authorization requiredprogram type

6 moinitial approval duration

Max 14 dosesdose limit/total

Medical

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Coverage Criteria for Inlexzo (gemcitabine intravesical system)

Initial Authorization

Authorization may be granted under either of the following pathways:

Authorization pathways

Pathway A: Member is new to the plan within the past 90 days AND is currently receiving treatment with the requested medication (product not obtained as samples or via manufacturer patient assistance).
Pathway B (all required): 1) Diagnosis of Bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle-invasive bladder cancer (NMIBC); 2) Disease is high-risk with carcinoma in situ (CIS); 3) Prescriber is an oncologist or urologist; 4) Appropriate dosing.

Continuation of Therapy / Limits

Continuation and limits

Continuation criteria: Resubmission by prescriber will indicate a positive clinical response and may be recertified up to a maximum of 14 total doses.

Initial approvals: 6 months. Reauthorizations: 12 months, subject to the 14-dose total maximum.

Authorization for members who are new to the plan within the past 90 days is limited to those who are currently receiving treatment with the requested medication. Products that were obtained as samples or through a manufacturer's patient assistance program are explicitly excluded from this allowance and therefore do not qualify a member for the new‑member exception.

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior authorization required (medical benefit)

Prior authorization is required under the medical benefit. Members who are new to the plan within the past 90 days and are currently receiving the requested medication may be authorized, provided the product was not obtained as samples or via a manufacturer's patient assistance program; otherwise authorization requires meeting the clinical criteria listed in the policy.

Program type: Prior Authorization (medical benefit).
New-member exception: member new to plan within past 90 days AND currently receiving treatment (excludes samples or manufacturer patient assistance).
If not eligible under new-member exception, must meet all clinical criteria (BCG‑unresponsive NMIBC with CIS, prescriber specialty, appropriate dosing).

Step Therapy

Step therapy not required

No step therapy requirement is specified in this policy.

Background — Indication and Product Information

Inlexzo (gemcitabine intravesical system) is covered under the medical benefit for the indication of BCG‑unresponsive nonmuscle invasive bladder cancer (NMIBC). The policy allows authorization either for members who are new to the plan within the past 90 days and currently receiving treatment (subject to the exclusions above) or when members meet the detailed clinical criteria for BCG‑unresponsive NMIBC.

Definitions

BCG‑unresponsive NMIBC with CIS — definition and key diagnostic elements

DefinitionNonmuscle invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette‑Guérin (BCG) therapy and includes carcinoma in situ (CIS), with or without papillary tumors.

Clinical scopeApplies to adult patients as specified in the Inlexzo indication (BCG‑unresponsive NMIBC with CIS).

Diagnostic element — CISPresence of carcinoma in situ (CIS) is required for this policy‑defined indication (CIS may occur with or without papillary tumors).

Treatment history elementBCG‑unresponsive status: disease must be categorized as unresponsive to prior BCG therapy per the product indication and referenced guidelines.

Relevant referencesPolicy references the Inlexzo prescribing information and major NMIBC guidelines (see policy references).