`J3401` Vyjuvek 5x10^9pfu/ml, 0.1 ml

Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 pfu/ml vector genomes, per 0.1 ml

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

Medically Unlikely Edits (effective October 1, 2026)

Practitioner: max 25 units per day (clinical), rationale: CMS Policy
Outpatient hospital: max 25 units per day (clinical), rationale: CMS Policy

Medicare pricing for J3401

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

J3401 payment limit: $1,029.469 per 0.1 ML, effective October 1, 2026 through December 31, 2026, based on 2Q26 ASP data. Coinsurance 20%.

NDCs that bill under J3401 (CMS ASP NDC-HCPCS crosswalk, October 2026)

82194-0510-02 Vyjuvek, Krystal Biotech, Inc.: 25 billing units per package (1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1.5 mL in 1 VIAL)

Physician Fee Schedule (CY 2026, RVU26D)

Status E: excluded from the PFS by regulation.

Payer policies and prior authorization for J3401

81 of 81 payer prior-auth lists that name J3401 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 Idaho, Molina Healthcare of Illinois, Molina Healthcare of Michigan, Molina Healthcare of Mississippi, Molina Healthcare of New Mexico, Molina Healthcare of Texas, Neighborhood Health Partnership, Oxford Health Plans, Passport by Molina Healthcare (Kentucky), 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	PA ends 2026-01-31	Dec 13, 2023	Medical Benefit Pharmacy Prior Approval List
Blue Cross Blue Shield of Arizona (AZ Blue)	AZ Blue-administered Medicare Advantage (M2K)	AZ	prior auth required		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	Medicare Advantage	All	prior auth required		Aug 25, 2026	Aetna Medicare Part B drug list (partbname.xml)
Cigna	ACA/IFP	All	prior auth required		Jan 1, 2024	Master Precertification List (For Health Care Providers)
Cigna	Basic Standard	All	prior auth required		Jan 1, 2024	Master Precertification List (For Health Care Providers)
Cigna	Complete/PHS+/Preferred	All	prior auth required		Jan 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	Apr 1, 2024	BCBSTX Outpatient Prior Authorization Exemption Clinical Guidelines (max units, PA exempt date range)
HealthSpring	Medicare Advantage	All	prior auth required		Apr 1, 2026	2026 Q4 Prior Authorization List
CarePlus Health Plans	CarePlus Health Plans	FL	prior auth required		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		Jul 1, 2026	H1036-280 Humana Fully Integrated Florida prior authorization and notification list
Humana	Humana D-SNP (IL)	IL	prior auth required		Jan 1, 2027	Humana Dual Fully Integrated Illinois prior authorization and notification list
Humana	Humana D-SNP (IN)	IN	prior auth required		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		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		Jul 1, 2026	Humana Dual Integrated South Carolina prior authorization and notification list
Humana	Humana D-SNP (VA)	VA	prior auth required		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	FL	prior auth required		Jan 1, 2027	Humana Healthy Horizons in Florida Prior Authorization and Notification List
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		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 Idaho	Medicaid	ID	prior auth required		Jan 1, 2025	Idaho Medicaid Prior Auth (PA) Code Matrix and Idaho code/benefit exceptions, Q1 2025
Molina Healthcare of Illinois	Medicaid	IL	prior auth required		Jan 1, 2024	Molina Healthcare of Illinois Codification Grid Q3 2026
Molina Healthcare of Michigan	Medicaid	MI	prior auth required	This service is carved out to MDHHS	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 New Mexico	Medicaid	NM	prior auth required		Jul 1, 2026	New Mexico Medicaid Prior Auth (PA) Code Matrix, effective July 1, 2026
Molina Healthcare of Texas	Outpatient drug services (medical benefit)	TX	prior auth required	Prior authorization requests for codes used for gene therapy to be faxed to 866-420-3639	Jan 1, 2024	Medicaid Prior Authorization (PA) Code Matrix for Outpatient Drug Services (Texas), 2026-08
Molina Healthcare of Texas	STAR	TX	prior auth required		Feb 19, 2025	Molina Healthcare of Texas Prior Authorization Annual Review Report (STAR), reviewed 2025-02-19
Molina Healthcare of Texas	STAR+PLUS	TX	prior auth required		Feb 19, 2025	Molina Healthcare of Texas Prior Authorization Annual Review Report (STAR+PLUS), reviewed 2025-02-19
Molina Healthcare of Texas	STAR, STAR+PLUS, STAR Kids, CHIP (Medicaid PA code matrix)	TX	prior auth required		Jan 1, 2024	Medicaid Behavioral Health and Medical Prior Authorization (PA) Code Matrix (Texas), 2026-Q3
Molina Healthcare of Texas	Exchange	TX	prior auth required		Jan 1, 2024	Marketplace Prior Authorization (PA) Code Matrix (Texas), effective July 1, 2026
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 required		Sep 1, 2026	Prior authorization requirements for Neighborhood Health Partnership Effective September 1, 2026
Oxford Health Plans	Oxford Health Plans	All	prior auth required		Oct 1, 2026	Prior Authorization Requirements for Oxford Effective October 1, 2026
Surest	Surest health plans	All	prior auth required		Oct 1, 2026	Prior Authorization Requirements for Surest Effective October 1, 2026
UnitedHealthcare	Preferred Care Network and Preferred Care Partners of Florida	FL	prior auth required		Oct 1, 2026	Prior authorization requirements for Preferred Care Network and Preferred Care Partners of Florida Effective October 1, 2026
UnitedHealthcare	UnitedHealthcare Commercial	All	prior auth required		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 Medicare Advantage, Peoples Health and Dual Complete (D-SNP)	All	prior auth required	Excluded plans: for therapeutic radiopharmaceuticals: UHC Nursing Home Plan and UHC Care Advantage Plan (I-SNP)	Oct 1, 2026	UnitedHealthcare® Medicare Advantage/ Peoples Health Plans prior authorization requirements Effective October 1, 2026
UnitedHealthcare	UnitedHealthcare Mid-Atlantic Health Plans	All	prior auth under conditions	If prior authorization requirements for the drug aren’t met, UnitedHealthcare will call the health care professional’s office within 3 days.	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 required		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
UnitedHealthcare Community Plan	Louisiana Medicaid (Healthy Louisiana)	LA	prior auth required		Jan 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of Louisiana
UnitedHealthcare Community Plan	Maryland HealthChoice	MD	prior auth required		Sep 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of Maryland Effective September 1, 2026
UnitedHealthcare Community Plan	Massachusetts OneCare	MA	prior auth required		Nov 1, 2025	Prior authorization requirements for Massachusetts OneCare Effective November 1, 2025
UnitedHealthcare Community Plan	Massachusetts Senior Care Options (SCO)	MA	prior auth required		Nov 1, 2025	CPT® is a registered trademark of the American Medical Association. Prior authorization requirements for Massachusetts Senior Care Options Effective November 1, 2025
UnitedHealthcare Community Plan	Massachusetts Senior Care Options (SCO) and OneCare	MA	prior auth required		Oct 1, 2026	Prior authorization requirements for Massachusetts MA SCO OneCare Effective October 1, 2026
UnitedHealthcare Community Plan	Minnesota Metro Medicaid	MN	prior auth required		Oct 1, 2024	Prior authorization requirements for Minnesota Medicaid Effective October 1, 2024
UnitedHealthcare Community Plan	Mississippi CHIP	MS	prior auth required		Apr 1, 2025	Prior authorization requirements for Mississippi Children’s Health Insurance Program Effective Apr. 1, 2025
UnitedHealthcare Community Plan	MississippiCAN	MS	prior auth required		Apr 1, 2025	Prior authorization requirements for UnitedHealthcare Community Plan of Mississippi – Mississippi Coordinated Access Network (MississippiCAN) Effective Apr. 1, 2025
UnitedHealthcare Community Plan	Nebraska Heritage Health	NE	prior auth required		Jul 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of Nebraska Effective July 1, 2026 General Information This list contains prior authorization requirements for participating United
UnitedHealthcare Community Plan	New Jersey FamilyCare	NJ	prior auth required		Oct 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of New Jersey Effective October 1, 2026 General Information This list contains prior authorization requirements for participating U
UnitedHealthcare Community Plan	New Mexico Turquoise Care	NM	prior auth required		Oct 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of New Mexico Effective October 1, 2026
UnitedHealthcare Community Plan	Ohio Medicaid	OH	prior auth required		Nov 1, 2025	Prior authorization requirements for Ohio Medicaid Effective November 1, 2025 General Information This list contains prior authorization requirements for participating UnitedHealthcare Community Plan
UnitedHealthcare Community Plan	Pennsylvania CHIP	PA	prior auth required		Jul 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of Pennsylvania CHIP Effective July 1, 2026
UnitedHealthcare Community Plan	Pennsylvania Medicaid	PA	prior auth required		Jul 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of Pennsylvania Effective July 1, 2026
UnitedHealthcare Community Plan	Rhode Island Medicaid	RI	prior auth required		May 1, 2026	Prior authorization requirements for Rhode Island Medicaid Effective May 1, 2026 This list contains prior authorization requirements for participating UnitedHealthcare Community Plan of Rhode Island h
UnitedHealthcare Community Plan	TennCare	TN	prior auth required		Oct 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of Tennessee Effective October 1, 2026
UnitedHealthcare Community Plan	Texas CHIP	TX	prior auth required		Apr 1, 2024	Prior authorization requirements for Texas CHIP Effective September 1, 2026 This list contains prior authorization requirements for participating UnitedHealthcare Community Plan Texas CHIP health care
UnitedHealthcare Community Plan	Texas STAR	TX	prior auth under conditions	Dx group: June 1, 2024 April 1, 2024	Jul 1, 2025	Prior authorization requirements for Texas STAR Effective September 1, 2026 This list contains prior authorization review requirements for participating UnitedHealthcare Community Plan of Texas STAR h
UnitedHealthcare Community Plan	Texas STAR Kids	TX	prior auth required		Apr 1, 2024	Prior authorization requirements for STAR Kids Effective September 1, 2026 This list contains prior authorization review requirements for participating UnitedHealthcare Community Plan of Texas STAR Ki
UnitedHealthcare Community Plan	Texas STAR+PLUS	TX	prior auth required		Apr 1, 2024	Prior authorization requirements for STAR+Plus Effective September 1, 2026 This list contains prior authorization requirements for participating UnitedHealthcare Community Plan STAR+PLUS health care p
UnitedHealthcare Community Plan	UnitedHealthcare Community Plan of Florida	FL	prior auth required		Oct 1, 2026	Prior authorization requirements for UnitedHeathcare Community Plan of Florida Effective October 1, 2026
UnitedHealthcare Community Plan	UnitedHealthcare Community Plan of Hawaii (QUEST Integration)	HI	prior auth required		Oct 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of Hawaii Effective October 1, 2026
UnitedHealthcare Community Plan	UnitedHealthcare Community Plan of Kentucky	KY	prior auth required		Jul 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of Kentucky Effective July 1, 2026
UnitedHealthcare Community Plan	UnitedHealthcare Community Plan of New York	NY	prior auth required		Oct 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of New York Effective October 1, 2026
UnitedHealthcare Community Plan	UnitedHealthcare Connected (Texas MMP)	TX	prior auth required		Jan 1, 2024	Prior authorization requirements for UnitedHealthcare Connected (Medicare-Medicaid Plan) Texas Effective November 1, 2025 This list contains prior authorization review requirements for participating U
UnitedHealthcare Community Plan	Virginia Cardinal Care LTSS	VA	prior auth required		Oct 1, 2026	Prior authorization requirements for Virginia Cardinal Care LTSS Effective October 1, 2026
UnitedHealthcare Community Plan	Virginia Cardinal Care Medicaid	VA	prior auth required		Oct 1, 2026	Prior authorization requirements for Virginia Cardinal Care Effective October 1, 2026

Payer coverage policies that name J3401

J3401 appears in 16 coverage policies from Aetna, Blue Cross & Blue Shield of Mississippi, BlueCross BlueShield of South Carolina, 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	Beremagene Geperpavec-svdt (Vyjuvek) (1033)	covered if criteria are met	Jun 12, 2026	payer document
Aetna	Injectable Medications (0020)	listed, no stance (range J2550-J3520)	Mar 5, 2026	payer document
Aetna	Prademagene Zamikeracel (Zevaskyn) (1084)	listed, no stance	May 27, 2026	payer document
Blue Cross & Blue Shield of Mississippi	Treatment Of Epidermolysis Bullosa (S.5.01.605)	listed, no stance		payer document
Blue Cross & Blue Shield of Mississippi	Treatment Of Epidermolysis Bullosa (L.5.01.605)	listed, no stance		payer document
BlueCross BlueShield of South Carolina	Vyjuvek (beremagene geperpavec) (CAM 909)	listed, no stance	Jan 1, 2026	payer document
Centene	Beremagene Geperpavec-svdt (Vyjuvek) (CP.PHAR.592)	covered if criteria are met	Aug 1, 2026	payer document
Cigna	Dermatology – Gene Therapy – Vyjuvek (IP0572)	covered if criteria are met	Jun 18, 2026	payer document
Health Care Service Corporation (BCBS IL, TX, OK, NM, MT)	Gene Therapies for Treatment of Wounds in Dystrophic Epidermolysis Bullosa (RX501.164)	listed, no stance	Jun 15, 2026	payer document
Premera Blue Cross	Pharmacologic Treatment of Epidermolysis Bullosa (5.01.635) Page \| 5 of 13 \| ∞	listed, no stance	Jul 14, 2026	payer document
UnitedHealthcare	Denied Drug Codes – Pharmacy Benefit Drugs (for Arizona Only) (CS2026D0990AB)	listed, no stance	Jul 1, 2026	payer document
UnitedHealthcare	Provider Administered Drugs – Site of Care (2026D0121W)	listed, no stance	Sep 1, 2026	payer document
UnitedHealthcare	Vyjuvek® (Beramagene Geperpavec-Svdt) (2026D0127G)	listed, no stance	Jan 1, 2026	payer document
UnitedHealthcare	Vyjuvek® (Beramagene Geperpavec-Svdt) (CS2026D00127J)	listed, no stance	Apr 1, 2026	payer document
UnitedHealthcare	Vyjuvek® (Beramagene Geperpavec-Svdt) (for Ohio Only) (CSOH2026D00127.F)	listed, no stance	Feb 1, 2026	payer document
Wellmark Blue Cross Blue Shield	Vyjuvek (beremagene geperpavec-svdt) (05.05.11)	listed, no stance	Jun 1, 2026	payer document

Recent prior-auth changes

Sep 1, 2026: conditions changed, UnitedHealthcare Community Plan
Aug 1, 2026: PA added, Molina Healthcare of Texas
Mar 1, 2026: PA removed, uhc:pa:summary-of-changes
Mar 1, 2026: PA added, UnitedHealthcare
Mar 1, 2026: PA removed, UnitedHealthcare Community Plan
Jan 1, 2026: PA added, Molina Healthcare of Michigan
Jan 1, 2026: PA removed, Blue Cross and Blue Shield of New Mexico
Nov 1, 2025: conditions changed, UnitedHealthcare Community Plan
Nov 1, 2025: PA added, UnitedHealthcare
Nov 1, 2025: PA added, UnitedHealthcare

Medicaid fee-for-service

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

AZ: $964.05 (asc), effective Oct 1, 2026
IN: $928.20 (professional, Advanced Practice Nurse (85%), non-facility), effective Apr 1, 2026
KS: $0.00 (asc, facility), effective Jan 1, 2024
KY: $1014.79 (asc), effective Jan 1, 2026
MS: $829.70 (comprehensive, facility), effective Oct 1, 2025
NE: $1032.43 (injectables), effective Jul 1, 2026
OH: $1032.44 (provider_administered_drugs), effective Jul 1, 2026
OK: $1032.44 (physician, non-facility), effective Jul 1, 2026
TX: $1014.79 (nurse_practitioner_clinical_nurse_specialist, Nurse Practitioner/Clinical Nurse Specialist, non-facility), effective Sep 1, 2026
VA: $1032.43 (medical), effective Jul 1, 2026
VT: $779.33 (outpatient_hospital_opps), effective Feb 1, 2026
WY: $434.84 (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.

J3401 Vyjuvek 5x10^9pfu/ml, 0.1 ml