CurrentCignaPolicy N/A

Prior authorization requirements for Inlexzo (gemcitabine intravesical system)

Prior authorization documentation and requirements for coverage of Inlexzo (gemcitabine intravesical system) for patients (e.g., with NMIBC) under Cigna plans; intended for prescribers and provider offices submitting requests.

Policy Summary

PayerCigna

PolicyPrior authorization requirements for Inlexzo (gemcitabine intravesical system)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form including required patient, prescriber, medication, dosing, facility, and clinical information for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

855-840-1678fax to submit form

800-882-4462urgent request phone

Accredospecialty pharmacy

Coverage Criteria and Clinical Inputs

Prior authorization information and clinical inputs

Coverage decisions are determined after review of submitted information; the form solicits key clinical criteria.

Form submission requirements: Completed form with required patient, prescriber, medication, dosing, facility, and clinical information must be submitted via fax or online for review.

See documentation module for required fields (patient identifiers, physician name/specialty/DEA/NPI/TIN, medication requested, ICD-10 diagnosis, dose/frequency/duration, facility/dispensing details).

Clinical scenarios queried: Patient has non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors; prior BCG therapy status and response must be provided.

Form asks yes/no to NMIBC with CIS, prior BCG, and response to BCG.

Administration setting consideration: Administration site must be documented; per some Cigna plans, infusion/administration must occur in the least intensive medically appropriate setting and home infusion candidacy or site of care redirection is queried.

Policy Summary

PayerCigna

PolicyPrior authorization requirements for Inlexzo (gemcitabine intravesical system)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form including required patient, prescriber, medication, dosing, facility, and clinical information for review.

SourceLink

On This Page

Prior Authorization Requirements and Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Inlexzo (225 mg intravesical system). Complete and submit the Cigna prior authorization form — requests missing required clinical or administrative information may be delayed or denied.

Medication: Inlexzo 225mg Intravesical System
Submit via Cigna PA form (paper or CoverMyMeds/SureScripts)
Standard response time: 5 business days; call to expedite urgent requests

Prior Authorization

BCG Trial Consideration — Document Prior BCG and Response

The PA form asks whether the patient has a diagnosis of non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and whether the patient has tried Bacillus Calmette‑Guérin (BCG) and the response to BCG. Prior BCG therapy and response status are required elements for medical appropriateness determinations.

Confirm diagnosis: NMIBC with CIS (with/without papillary tumors) — Yes/No
Document prior BCG exposure — Yes/No
If prior BCG: document whether patient responded — Yes/No

Documentation Required

Required Documentation on PA Form

Ensure the completed PA form includes all required administrative and clinical fields to avoid processing delays.

Physician name and specialty
DEA, NPI or TIN
Office contact, phone, fax and addresses
Patient identifiers: name, Cigna ID, DOB, address, phone
Medication details: drug name, dose, frequency, duration, ICD‑10
Facility/dispensing site and tax ID if applicable
Prescriber signature and date

Billing Rule

Setting Requirement — Least Intensive Medically Appropriate Setting

Per some Cigna plans, the medication MUST be administered in the least intensive, medically appropriate setting. If infusion/administration occurs in a more intensive setting without medical justification, coverage may be affected. Indicate whether the patient is a candidate for home infusion or alternate site and whether the physician has an in‑office infusion capability.

Select administration setting on form (home, physician office, hospital outpatient, other)
Document candidacy for redirection to alternate setting and medical rationale if not appropriate
Document if patient is candidate for home infusion and if physician has in‑office infusion site

Definitions and Product Details

Inlexzo product details

Product nameInlexzo (gemcitabine intravesical system)

Formulation / strength225 mg intravesical system

Route of administrationIntravesical (bladder instillation)

Place on formListed under 'Medication Requested' as 'Inlexzo 225mg Intravesical System'

Submission notePrescribers may submit the form online via CoverMyMeds or SureScripts in the EHR; standard response time is 5 business days

NMIBC with CIS (form query)

DefinitionNon‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors — as queried on the prior authorization form (Yes/No).

Form questionForm asks: 'Does the patient have a diagnosis of non‑muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors?'

Related clinical inputForm also queries prior BCG therapy and response to BCG, which informs appropriateness for intravesical gemcitabine.

Action for providerIndicate Yes or No on the form and supply supporting clinical documentation regarding diagnosis and prior BCG response when applicable.

Inlexzo 225mg	Inlexzo (gemcitabine intravesical system) — medication requested (no CPT/HCPCS provided on form)
NCPDP 4436920	Accredo pharmacy NCPDP number

OpenPayer

Prior authorization requirements for Inlexzo (gemcitabine intravesical system)

Coverage Criteria and Clinical Inputs

Medication and Pharmacy Identifiers

Prior Authorization Requirements and Provider Actions

Background

Definitions and Product Details