`Q5134` Inj, tyruko, 1 mg

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

Medicare coverage: Carrier judgment
Status: active (October 2026 file)

Medically Unlikely Edits (effective October 1, 2026)

Practitioner: max 300 units per day (clinical), rationale: Prescribing Information
Outpatient hospital: max 300 units per day (clinical), rationale: Prescribing Information
DME supplier: max 300 units per day (clinical), rationale: Prescribing Information

Medicare pricing for Q5134

Medicare Part B drug payment limit (ASP, October 2026)

Q5134 payment limit: $24.397 per 1 MG, effective October 1, 2026 through December 31, 2026, based on 2Q26 ASP data. Coinsurance 20%.

NDCs that bill under Q5134 (CMS ASP NDC-HCPCS crosswalk, October 2026)

61314-0543-94 Tyruko, Sandoz Inc.: 300 billing units per package (1 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE)

Physician Fee Schedule (CY 2026, RVU26D)

Status E: excluded from the PFS by regulation.

Payer policies and prior authorization for Q5134

46 of 46 payer prior-auth lists that name Q5134 require prior authorization or set conditions: Aetna, Arkansas Blue Cross and Blue Shield, Blue Cross Blue Shield of Arizona (AZ Blue), Blue Cross and Blue Shield of Texas, Blue Shield of California Promise Health Plan, CarePlus Health Plans, Cigna, HealthSpring, Humana, Molina Complete Care (Virginia), Molina Healthcare of California, Molina Healthcare of Illinois, Molina Healthcare of Michigan, Molina Healthcare of Mississippi, Molina Healthcare of Utah, Neighborhood Health Partnership, Oxford Health Plans, Passport by Molina Healthcare (Kentucky), Surest, UnitedHealthcare, and others.

Payer	Plan	State	Prior auth	Conditions	Since	Source
Arkansas Blue Cross and Blue Shield	Drugs under the medical benefit (not ASE/PSE or FEP, which use EBRx and Prime)	AR	prior auth required		Dec 1, 2025	Medical Benefit Pharmacy Prior Approval List
Blue Cross Blue Shield of Arizona (AZ Blue)	AZ Blue-administered Medicare Advantage (M2K)	AZ	prior auth required	Step therapy	Sep 1, 2026	AZ Blue Medicare Advantage Prior Authorization Requirements Code List (Effective 09/01/2026)
Blue Cross Blue Shield of Arizona (AZ Blue)	Federal Employee Program (FEP)	AZ	prior auth required		Sep 1, 2026	Federal Employee Program (FEP) Prior Authorization Requirements Code List (Updated 09/01/2026)
Blue Cross Blue Shield of Arizona (AZ Blue)	Standard PA code list (most commercial plans)	AZ	prior auth required	site of care: site-of-service review	Sep 1, 2026	AZ Blue Standard Prior Authorization Requirements Code List (09/01/2026)
Blue Cross Blue Shield of Arizona (AZ Blue)	State of Arizona employee group (SYD, S3Z)	AZ	prior auth required	site of care: site-of-service review	Sep 1, 2026	State of Arizona Group Prior Authorization Requirements Code List (09/01/2026)
Blue Cross Blue Shield of Arizona (AZ Blue)	Teamsters group (TYW)	AZ	prior auth required		Sep 1, 2026	Teamsters Group Prior Authorization Requirements Code List (Updated 09/01/2026)
Blue Shield of California Promise Health Plan	Promise Health Plan Medi-Cal	CA	prior auth required		Sep 1, 2026	Medi-Cal Prior Authorization List
Aetna	Commercial	All	prior auth required	site of care: drug and site of care	Oct 1, 2026	Participating provider precertification list for Aetna®
Aetna	Medicare Advantage	All	prior auth required		Oct 1, 2026	Participating provider precertification list for Aetna®
Aetna	Medicare Advantage	All	prior auth required	Step therapy applies	Aug 25, 2026	Aetna Medicare Part B drug list (partbname.xml)
Cigna	ACA/IFP	All	prior auth required		Apr 1, 2024	Master Precertification List (For Health Care Providers)
Cigna	Basic Standard	All	prior auth required		Apr 1, 2024	Master Precertification List (For Health Care Providers)
Cigna	Complete/PHS+/Preferred	All	prior auth required		Apr 1, 2024	Master Precertification List (For Health Care Providers)
Blue Cross and Blue Shield of Texas	Texas PA exemption (gold card), outpatient, fully insured	TX	prior auth required	Gold-card exemption available	Jan 1, 2025	BCBSTX Outpatient Prior Authorization Exemption Clinical Guidelines (max units, PA exempt date range)
HealthSpring	Medicare Advantage	All	prior auth required		Jan 1, 2025	2026 Q4 Prior Authorization List
CarePlus Health Plans	CarePlus Health Plans	FL	prior auth required	Step therapy	Jan 1, 2027	Medicare Advantage and Dual Eligible Special Needs Plans Prior Authorization and Notification List We have updated our CarePlus Health Plans Prior Authorization and Notification List for CarePlus Medi
Humana	Humana D-SNP (FL)	FL	prior auth required	Step therapy	Jul 1, 2026	H1036-280 Humana Fully Integrated Florida prior authorization and notification list
Humana	Humana D-SNP (IL)	IL	prior auth required	Step therapy	Jan 1, 2027	Humana Dual Fully Integrated Illinois prior authorization and notification list
Humana	Humana D-SNP (IN)	IN	prior auth required	Step therapy	Jan 1, 2027	Humana PathWays Dual Care (HMO-POS D-SNP) prior authorization and notification list Important notes:
Humana	Humana D-SNP (MI)	MI	prior auth required	Step therapy	Oct 14, 2026	Humana Dual Integrated (health maintenance organization Dual Eligible Special Needs Plan (HMO D- SNP) Michigan prior authorization and notification list (PAL)
Humana	Humana D-SNP (SC)	SC	prior auth required	Step therapy	Jul 1, 2026	Humana Dual Integrated South Carolina prior authorization and notification list
Humana	Humana D-SNP (VA)	VA	prior auth required	Step therapy	Jul 1, 2026	Prior authorization and notification list Humana Dual Fully Integrated H2875-001 (Virginia) Humana Dual Fully Integrated H2875-003 (Virginia)
Humana	Humana Healthy Horizons	KY	prior auth required		Oct 7, 2026	Humana Healthy Horizons in Kentucky Prior Authorization and Notification List
Humana	Humana Healthy Horizons	LA	prior auth required		Oct 14, 2026	Humana Healthy Horizons in Louisiana Prior Authorization and Notification List
Humana	Humana Healthy Horizons	OH	prior auth required		Oct 14, 2026	Humana Healthy Horizons in Ohio prior authorization and notification List
Humana	Humana Healthy Horizons	OK	prior auth required		Oct 14, 2026	Humana Healthy Horizons in Oklahoma Prior Authorization and Notification List
Humana	Humana Healthy Horizons	SC	prior auth required		Oct 14, 2026	Humana Healthy Horizons in South Carolina prior authorization and notification list
Humana	Humana Healthy Horizons	VA	prior auth required		Oct 14, 2026	Humana Healthy Horizons in Virginia professionally administered medication prior authorization and notification list
Humana	Humana MA and D-SNP	All	prior auth required	Step therapy	Jan 1, 2027	Medicare Advantage and Dual Eligible Special Needs Plans prior authorization and notification list Important notes:
Molina Complete Care (Virginia)	Medicaid	VA	prior auth required		Apr 1, 2025	Virginia Medicaid PA Code Matrix and Virginia code/benefit exceptions, effective Q2 2025
Molina Healthcare of California	Medicaid	CA	prior auth required		Apr 1, 2026	Medicaid Prior Auth (PA) Code Matrix (California), effective Q2 2026
Molina Healthcare of Illinois	Medicaid	IL	prior auth required		Apr 1, 2024	Molina Healthcare of Illinois Codification Grid Q3 2026
Molina Healthcare of Michigan	Medicaid	MI	prior auth required		Jul 1, 2026	Molina Healthcare of Michigan PA Matrix 2026-Q3
Molina Healthcare of Michigan	Medicare Advantage	MI	prior auth required		Jul 1, 2026	Molina Healthcare of Michigan PA Matrix 2026-Q3
Molina Healthcare of Mississippi	Medicaid	MS	prior auth required		Jan 1, 2025	Mississippi Medicaid Prior Auth (PA) Code Matrix and exceptions, effective Q1 2025
Molina Healthcare of Utah	Medicaid	UT	prior auth required		Jan 1, 2025	Utah Medicaid Prior Auth (PA) Code Matrix and Utah code/benefit exceptions, Q1 2025
Passport by Molina Healthcare (Kentucky)	Medicaid	KY	prior auth required		Jul 1, 2026	Kentucky Medicaid Prior Auth (PA) Code Matrix and Kentucky PA Code Exceptions, effective Q3 2026
Neighborhood Health Partnership	Neighborhood Health Partnership	FL	prior auth under conditions	place of service 19, 22	Sep 1, 2026	Prior authorization requirements for Neighborhood Health Partnership Effective September 1, 2026
Oxford Health Plans	Oxford Health Plans	All	prior auth under conditions	place of service 19, 22	Oct 1, 2026	Prior Authorization Requirements for Oxford Effective October 1, 2026
Surest	Surest health plans	All	prior auth under conditions	place of service 19, 22	Oct 1, 2026	Prior Authorization Requirements for Surest Effective October 1, 2026
UnitedHealthcare	UnitedHealthcare Commercial	All	prior auth under conditions	place of service 19, 22	Oct 1, 2026	Prior authorization requirements for UnitedHealthcare commercial plans Effective October 1, 2026
UnitedHealthcare	UnitedHealthcare Complete (Individual & Family plans)	All	prior auth required		Sep 1, 2026	Prior authorization requirements for UnitedHealthcare Complete Effective September 1, 2026
UnitedHealthcare	UnitedHealthcare Individual Exchange plans	All	prior auth required		Oct 1, 2026	Prior authorization requirements for UnitedHealthcare Individual Exchange plans Effective October 1, 2026
UnitedHealthcare	UnitedHealthcare Mid-Atlantic Health Plans	All	prior auth under conditions	place of service 19, 22	Oct 1, 2026	Prior authorization requirements for UnitedHealthcare Mid-Atlantic Health Plans Effective October 1, 2026
UnitedHealthcare	UnitedHealthcare of the River Valley	All	prior auth under conditions	place of service 19, 22	Oct 1, 2026	Prior authorization requirements for UnitedHealthcare of the River Valley Effective October 1, 2026
UnitedHealthcare Community Plan	KanCare	KS	prior auth required		Oct 1, 2026	Prior authorization requirements for Kansas Medicaid Effective October 1, 2026

Payer coverage policies that name Q5134

Q5134 appears in 26 coverage policies from Aetna, Blue Cross & Blue Shield of Mississippi, Centene, Cigna, Health Care Service Corporation (BCBS IL, TX, OK, NM, MT), Premera Blue Cross, UnitedHealthcare, Wellmark Blue Cross Blue Shield.

Payer	Policy	Role in policy	Reviewed	Document
Aetna	Guillain-Barre Syndrome Treatments (0732) Sugammadex; Bifidobacterium infantis	not covered	Dec 19, 2025	payer document
Aetna	Multiple Sclerosis (0264)	covered if criteria are met	Sep 10, 2026	payer document
Aetna	Natalizumab (0751)	covered if criteria are met	Dec 2, 2025	payer document
Aetna	Plasmapheresis/Plasma Exchange/Therapeutic Apheresis (0285)	listed, no stance	Apr 16, 2026	payer document
Aetna	Polymerase Chain Reaction Testing: Selected Indications (0650)	listed, no stance	Sep 10, 2026	payer document
Aetna	Rituximab (0314)	listed, no stance	Sep 15, 2026	payer document
Blue Cross & Blue Shield of Mississippi	Biosimilar Medications (S.5.01.593)	listed, no stance		payer document
Blue Cross & Blue Shield of Mississippi	Biosimilar Medications (L.5.01.593)	listed, no stance		payer document
Blue Cross & Blue Shield of Mississippi	Crohns Disease And Ulcerative Colitis (S.5.01.415)	listed, no stance		payer document
Blue Cross & Blue Shield of Mississippi	Crohns Disease And Ulcerative Colitis (L.5.01.415)	listed, no stance		payer document
Blue Cross & Blue Shield of Mississippi	Multiple Sclerosis (S.5.01.452)	listed, no stance		payer document
Blue Cross & Blue Shield of Mississippi	Multiple Sclerosis (L.5.01.452)	listed, no stance		payer document
Centene	Biologic and Non-biologic DMARDs (CP.CPA.194)	covered if criteria are met	May 1, 2026	payer document
Centene	Biologic and Non-biologic DMARDs	covered if criteria are met	Aug 1, 2026	payer document
Centene	Natalizumab (Tysabri), Natalizumab-sztn (Tyruko) (CP.PHAR.259)	covered if criteria are met	May 1, 2026	payer document
Cigna	Multiple Sclerosis and Crohn’s Disease (Injectable – Other) – Natalizumab Products Prior Authorization Policy (IP0690)	covered if criteria are met	Sep 15, 2026	payer document
Health Care Service Corporation (BCBS IL, TX, OK, NM, MT)	Natalizumab and Associated Biosimilar(s) (RX501.059)	listed, no stance	May 1, 2026	payer document
Health Care Service Corporation (BCBS IL, TX, OK, NM, MT)	Specialty Medication Administration Site of Care HCPCS Codes J0129, J0174, J0175, J0180, J0218, J0219, J0221, J0222, J0223, J0224,	listed, no stance	Jan 1, 2026	payer document
Premera Blue Cross	(effective November 6, 2026) Site of Service: Drugs and Biologic Agents Page \| 10 of 19 \| ∞	listed, no stance	Jul 14, 2026	payer document
Premera Blue Cross	Medical Pharmacologic Treatment of Multiple Sclerosis (5.01.644) Page \| 9 of 13 \| ∞	listed, no stance	Jun 9, 2026	payer document
Premera Blue Cross	Pharmacotherapy of Inflammatory Bowel Disorder (5.01.563) Page \| 38 of 74 \| ∞	listed, no stance	Sep 8, 2026	payer document
Premera Blue Cross	Site of Service: Drugs and Biologic Agents Page \| 10 of 18 \| ∞	listed, no stance	Jul 14, 2026	payer document
UnitedHealthcare	Natalizumab (Tyruko® & Tysabri®) (CS2026D0026X)	listed, no stance	Aug 1, 2026	payer document
UnitedHealthcare	Natalizumab (Tyruko® & Tysabri®) (2026D0026T)	listed, no stance	Jul 1, 2026	payer document
Wellmark Blue Cross Blue Shield	Multiple Sclerosis (05.01.75)	listed, no stance	Jun 1, 2026	payer document
Wellmark Blue Cross Blue Shield	Natalizumab (05.04.91)	listed, no stance	Jun 1, 2026	payer document

Recent prior-auth changes

Oct 14, 2026: PA removed, Humana
Oct 1, 2026: PA added, UnitedHealthcare Community Plan
Jul 1, 2026: conditions changed, CarePlus Health Plans
Jul 1, 2026: conditions changed, Humana
Jun 1, 2026: conditions changed, UnitedHealthcare
May 1, 2026: PA added, Blue Shield of California Promise Health Plan
May 1, 2026: conditions changed, UnitedHealthcare
Jan 1, 2026: PA added, UnitedHealthcare
Jan 1, 2026: PA added, UnitedHealthcare
Jan 1, 2026: PA added, UnitedHealthcare

Medicaid fee-for-service

Prior authorization required or conditional in IN, MS, NE, VA.

IL: $7296.30 (practitioner), effective Apr 1, 2026
KS: $18.30 (default, Mid Level Practitioner), effective Oct 1, 2026
KY: $24.39 (asc), effective Jan 1, 2026
NE: $24.49 (injectables), effective Jul 1, 2026
OH: $24.32 (provider_administered_drugs), effective Jul 1, 2026
OK: $24.49 (physician, non-facility), effective Jul 1, 2026
TX: $24.15 (nurse_practitioner_clinical_nurse_specialist, Nurse Practitioner/Clinical Nurse Specialist, non-facility), effective Apr 1, 2026
VA: $24.49 (medical), effective Jul 1, 2026
VT: $0.00 (outpatient_hospital_opps), effective Feb 1, 2026
WY: $10.53 (outpatient_hospital_apc, Ambulatory Surgical Centers), effective Apr 1, 2026

From payers' published prior-auth lists, coverage policies and state Medicaid fee schedules, updated Oct 16, 2026. The role is what the policy's own code table or text says about the code. Not a guarantee of coverage or payment; verify with the payer. CPT® is a registered trademark of the American Medical Association.

Q5134 Inj, tyruko, 1 mg