Does J2323 require prior authorization?

Yes, J2323 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J2323?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J2323`, Injection, natalizumab, 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

For MS initial authorization: documentation of relapsing form of multiple sclerosis (clinically isolated syndrome, relapsing-remitting, or active secondary progressive) and age ≥18.
For MS initial authorization: documentation of prior trial and inadequate efficacy or intolerance to at least one disease-modifying agent for MS OR documentation supporting the diagnosis of highly-active/aggressive MS (clinical deterioration, disabling relapses with suboptimal steroid response, MRI findings, or cognitive impairment).
For MS reauthorization: documentation of at least one objective measure demonstrating beneficial clinical response (examples: MRI reports showing stabilization/reduced activity or new lesion data; EDSS scores over time; documentation of NEDA-3/NEDA-4; FSIQ-RMS scores; relapse history showing reduction/absence of relapses; six-minute walk test or 12-Item MSWS results; MSFC scores; brain volume change assessments) OR clinical notes documenting stabilization, slowed progression, or improvement in specified symptoms (motor, fatigue, vision, bowel/bladder, spasticity, walking/gait, pain/numbness/tingling).
For Crohn's disease initial authorization: documentation of moderately to severely active Crohn's disease with evidence of inflammation and age ≥18, and documentation of prior trials of at least two biologics (names and dates), with notation that biosimilars of the same molecule count as a single trial.
For Crohn's disease reauthorization: documentation that patient has been on natalizumab for ≥6 months (or if <6 months or restarting, treat as initial); documentation of beneficial clinical response by at least one objective measure such as fecal markers, serum markers, imaging studies, endoscopic assessment, or reduced corticosteroid dose OR documentation of improvement in symptoms (decreased pain, fatigue, stool frequency, blood in stool).
Documentation that prescriber is a neurologist or MS specialist for MS, or a gastroenterologist for Crohn's disease, or that the appropriate consultation occurred.

Key Coverage Criteria

Relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease) in adults — natalizumab indicated as monotherapy for treatment.
Moderately to severely active Crohn's disease with evidence of inflammation in adults — natalizumab indicated for inducing and maintaining clinical response and remission in patients who have had an inadequate response to, or are unable to tolerate, conventional Crohn's disease therapies and inhibitors of TNF-α.
This policy addresses only the determination of medical necessity for the hospital outpatient setting for infusion and injectable therapy; the medical necessity of the pharmacologic or biologic medication itself may be reviewed separately.
Requests for select medications intended for administration in a hospital outpatient setting will be directed to a preferred alternative site of care (non-hospital affiliated outpatient facility or home).
Covered indication for Natalizumab includes FDA-approved indications and compendial uses, provided the member has no exclusions to the prescribed therapy and all approval criteria are met.
Natalizumab (Tysabri) or Tyruko may be covered as monotherapy for relapsing MS in patients with inadequate response, intolerance, or contraindication to glatiramer (e.g., Copaxone) after documented compliance, with prior trials of Avonex, Betaseron, or Rebif.

20 Active Policies

ARKBLUE-NATALIZUMAB-E-G-TYSABRI-AND-BIOSIMILARS-D690424A56, Natalizumab (e.g., Tysabri) and Biosimilars

FLORIDA_BLUE-FLBLUE-NATALIZUMAB-TYSABRI-0A850689E3, Natalizumab (Tysabri)

HEALTHPARTNERS-CC-ENTRY-187829, Natalizumab (Tysabri, Tyruko) - Minnesota Health Care Programs

MULTI

HEALTHPARTNERS-CC-AENTRY-046241, Natalizumab (Tysabri, Tyruko)

MULTI

BCBSND-NATALIZUMAB-TYSABRI-2-8BC90352C3, Natalizumab Tysabri 2

BCBSND-NATALIZUMAB-TYSABRI-ME-A39BDC8FC5, Natalizumab Tysabri ME

BCBSNJ-DRUGS-050-C2C9BE12BE, Natalizumab (Tysabri)

MODA-TYSABRI-02A0F76224, Natalizumab: (Tysabri; Tyruko)

HEALTHNET_OR-HNOR-NATALIZUMAB-TYSABRI-NATALIZUMAB-SZTN-TYRUKO-CP-PHAR-259-7140B670A0, Natalizumab (Tysabri) Natalizumab-sztn (Tyruko); CP.PHAR.259

IBX-MEDICARE-ADVANTAGE-MA08-029D-E0D79F9C28, Natalizumab (Tysabri) and Related Biosimilars

IBX-COMMERCIAL-08-00-64I-EA1FBB092C, Natalizumab (Tysabri) and Related Biosimilars

AMERIHEALTH-COMMERCIAL-08-00-64I-EF210313D8, Natalizumab (Tysabri) and Related Biosimilars

AMERIHEALTH-MEDICARE-ADVANTAGE-MA08-029D-8FB9357A2F, Natalizumab (Tysabri) and Related Biosimilars

BCBSTN-6d64c3d73a, Natalizumab (Tysabri), Natalizumab-sztn (Tyruko)

EVICORE-MEDICAL_DRUG-4EBBD2EA719F, Natalizumab Products (Tysabri, Tyruko)

OSCAR-NATALIZUMAB-AND-NATALIZUMAB-BIOSIMILARS-TYSAB-5CDA1FF2D5, Natalizumab and Natalizumab Biosimilars (Tysabri, Tyruko) (PG195, Ver. 6)

UHC-COMM-MD-NATALIZUMAB-TYRUKO-TYSABRI-COMMUNITY-PLA-5253ECC75B, Natalizumab (Tyruko & Tysabri) – Community Plan Medical Benefit Drug Policy

BCBSIL-RX501.059, Natalizumab and Associated Biosimilar(s)

UHC-EXCH-MD-NATALIZUMAB-TYRUKO-TYSABRI-INDIVIDUAL-EX-3141AE96E1, Natalizumab (Tyruko & Tysabri) – Individual Exchange Medical Benefit Drug Policy

BCBSIL-ADM1001.034, Specialty Medication Administration Site of Care

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J2323, Injection, natalizumab, 1 mg