Spinraza

Brand (proprietary) name

Spinraza

Generic (nonproprietary) name

Nusinersen

Active ingredient(s)

nusinersen

Strength(s)

10 mg/mL; 2.4 mg/mL; 5.6 mg/mL

Dosage form(s)

Injection, Solution

Route(s)

Intrathecal

Manufacturer / labeler

Biogen Inc.

Product class

Brand (derived from FDA marketing category)

Marketing category

NDA

Application number(s)

NDA209531

Earliest marketing start

Dec 23, 2016

Products / packages indexed

3 / 3

FDA pharmacologic class: Antisense Oligonucleotide [EPC]; Antisense [CS]; Increased Protein Synthesis [PE]; Survival Motor Neuron-2-directed RNA Interaction [EPC]

Also searchable as: Spinraza · Nusinersen

Prescribing information on DailyMed (NLM)

• J2326JJ-code: Drugs administered other than oral method; chemotherapy drugsActiveDerived calculation

  Injection, nusinersen, 0.1 mg

  Derived: 3 of 3 NDC package(s) for this drug appear in the CMS NDC–HCPCS crosswalk for J2326. CMS quarters Q1 2021 – Q4 2026

  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 nusinersen NCDs, LCDs, and Billing & Coding articles in the CMS Medicare Coverage Database that mention “nusinersen”. Covered diagnosis codes are listed in the articles.
• Coverage documents for J2326 NCDs, LCDs, and Billing & Coding articles in the CMS Medicare Coverage Database that mention “J2326”. Covered diagnosis codes are listed in the articles.

No current Medicare Billing and Coding article lists J2326.

• 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.