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Vyjuvek™ (beremagene geperpavec-svdt)

Policy Number: PH-0709

Topical

Last Review Date: 02/01/2024

Date of Origin: 07/05/2023

Dates Reviewed: 07/2023, 02/2024

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

  1. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

  • Vyjuvek single-dose vial containing 5×109 PFU/mL: 1 vial every 7 days

B. Max Units (per dose and over time) [HCPCS Unit]:

  • 25 billable units every 7 days
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 6 months of age; AND

Universal Criteria 1

  • Patient has not received a skin graft within the prior 3 months; AND

Dystrophic Epidermolysis Bullosa (DEB) † Ф 1,2

  • Patient has a diagnosis of dystrophic epidermolysis bullosa as established by detection of mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene on molecular genetic testing; AND
  • Patient has cutaneous wound(s) which are clean with adequate granulation tissue, excellent vascularization, and do not appear infected

FDA Approved Indication(s); Compendia Recommended Indication(s); Ф Orphan Drug

  1. Renewal Criteria 1

Coverage can be renewed based on the following criteria:

  • Patient continues to meet the indication-specific relevant criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: any severe medication reactions warranting therapy discontinuation, etc.; AND
  • Disease response with treatment as defined by improvement (healing) of treated wound sites, reduction in skin infections, etc.; AND
  • Patient requires continued treatment due to new or existing open wounds
  1. Dosage/Administration 1

Indication

Dose

Wound treatment of Dystrophic

Epidermolysis Bullosa (DEB)

Vyjuvek gel is applied topically to wound(s), by a healthcare professional, once a week. Apply Vyjuvek gel to the selected wound(s) in droplets spaced evenly within the wound, approximately 1cm-by-1cm apart.

Age Range

Maximum Weekly Dose (plaque forming units; PFU)

Maximum Weekly Volume (milliliter; mL) *

6 months to <3 years old

1.6 ×109

0.8

≥3 years old

3.2 ×109

1.6

*Maximum weekly volume after mixing VYJUVEK biological suspension with excipient gel.

 

Wound Area (cm2) *

Dose (PFU)

Volume (mL)

<20

4×108

0.2

20 to <40

8×108

0.4

40 to 60

1.2×109

0.6

*For wound area over 60 cm2, recommend calculating the total dose based on this table until the maximum weekly dose is reached.

  • It may not be possible to apply Vyjuvek gel to all the wounds at each treatment visit.
  • Apply Vyjuvek gel to wounds until they are closed before selecting new wound(s) to treat. Prioritize weekly treatment to previously treated wounds if they re-open.
  • If a dose is missed, apply Vyjuvek gel as soon as possible and resume weekly dosing thereafter.
  • Only a healthcare professional (HCP) should apply Vyjuvek gel either at a healthcare professional setting (e.g., clinic) or the home setting.
  • Individuals who are pregnant should not prepare or apply Vyjuvek gel and should avoid direct contact with the treated wounds or dressings from treated wounds.
  1. Billing Code/Availability Information

HCPCS Code:

  • J3401 – Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 109 pfu/ml vector genomes, per 0.1 ml; 1 billable unit = 0.1 mL

NDC:

  • Vyjuvek 1.0 mL extractable volume in a single-use, single-dose vial containing 5×109 PFU/mL: 82194-0510-xx (outer carton) and 82194-0501-xx (inner drug vial)
  1. References
  1. Vyjuvek™ [package insert]. Pittsburgh, PA; Krystal Biotech, Inc.; May 2023. Accessed January 2024.
  2. Guide SV, Gonzalez ME, Bagci S, et al. Trial of Beremagene Geperpavec (B-VEC) for Dystrophic Epidermolysis Bullosa. N Engl J Med 2022; 387:2211-2219. DOI: 10.1056/NEJMoa2206663.
  3. Pfender EG, Lucky AW. Dystrophic Epidermolysis Bullosa. GeneReviews. https://www.ncbi.nlm.nih.gov/books/NBK1304/ (Accessed on May 25, 2020).

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

Q81.2

Epidermolysis Bullosa Dystrophic

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC