Roctavian

Brand (proprietary) name

ROCTAVIAN

Generic (nonproprietary) name

No authoritative public data was located for this field.

Active ingredient(s)

No authoritative public data was located for this field.

Strength(s)

No authoritative public data was located for this field.

Dosage form(s)

No authoritative public data was located for this field.

Route(s)

No authoritative public data was located for this field.

Manufacturer / labeler

BioMarin Pharmaceutical Inc.

Product class

Biologic (BLA) (derived from FDA marketing category)

Marketing category

BLA

Application number(s)

BLA125720

Earliest marketing start

Jun 29, 2023

Products / packages indexed

1 / 1

Also searchable as: ROCTAVIAN · valoctocogene roxaparvovec-rvox

Prescribing information on DailyMed (NLM)

• J1412JJ-code: Drugs administered other than oral method; chemotherapy drugsActiveDerived calculation

  Injection, valoctocogene roxaparvovec-rvox, per ml, containing nominal 2 x 10^13 vector genomes

  Derived: 1 of 1 NDC package(s) for this drug appear in the CMS NDC–HCPCS crosswalk for J1412. CMS quarters Q1 2024 – Q3 2026Not in the latest CMS crosswalk.

  J-codes are permanent national codes for drugs and biologicals — most often clinician-administered (buy-and-bill) products paid under Medicare Part B — plus certain immunosuppressive, inhalation (via DME), and oral anticancer/antiemetic drugs. Units are reported in multiples of the dosage in the code descriptor.

No authoritative public data was located for this field.

Home infusion per diem (S-codes)

Medicare

Not payable by Medicare — CMS coverage code I (all 2 codes)

Part B pricing indicator

00 — Not separately priced by Part B (all 2 codes)

National payment amount

No authoritative public data was located for this field.

Which Medicare benefit pays for this drug?

• Coverage documents for J1412 NCDs, LCDs, and Billing & Coding articles in the CMS Medicare Coverage Database that mention “J1412”. Covered diagnosis codes are listed in the articles.
• Self-administered drug (SAD) exclusion lists Drugs each MAC excludes from “incident to” Part B coverage because they are usually self-administered.

No current Medicare Billing and Coding article lists J1412.

• FDA NDC Directory data is submitted by labelers; FDA notes that inclusion does not mean the information was verified or that a product is approved, covered, or reimbursable.
• HCPCS links are derived from CMS NDC–HCPCS crosswalks, which support ASP-based Part B payment and are not a complete list of billable NDCs.
• Product class (brand, generic, biosimilar) is derived from the FDA marketing category and Purple Book license type, not from a commercial compendium.
• Payment limits are Medicare Part B national limits; they do not reflect payer contracts, OPPS rates, 340B pricing, or acquisition cost.
• Home infusion per diem S-codes are matched by therapy category from the FDA pharmacologic class and route, not from a CMS crosswalk. Payers choose which per diem codes they accept, and the right code can depend on the dosing schedule, infusion method, or daily volume.