Does Q5134 require prior authorization?

Yes, Q5134 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for Q5134?

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

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`Q5134`, Injection, natalizumab-sztn (tyruko), biosimilar, 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 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).

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).
Adult patients (18+) with relapsing forms of multiple sclerosis may be covered for natalizumab (Tysabri) or biosimilar Tyruko as monotherapy when (1) medical record documents a relapsing MS form including clinically isolated syndrome, RRMS, or active SPMS, and (2) an MRI brain scan is documented prior to initiating therapy.
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.

20 Active Policies

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

MULTI

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

MULTI

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

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

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

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

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

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

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

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

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

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

UHC-POL-natalizumab, Natalizumab (Tyruko & Tysabri)

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

UMR-POL-UMR-natalizumab, Natalizumab (Tyruko & Tysabri)

SUREST-POL-SUREST-natalizumab, Natalizumab (Tyruko & Tysabri)

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

`Q5134`, Injection, natalizumab-sztn (tyruko), biosimilar, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

Q5134, Injection, natalizumab-sztn (tyruko), biosimilar, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Related Codes

Have a follow-up question?

`Q5134`, Injection, natalizumab-sztn (tyruko), biosimilar, 1 mg