nusinersen
Marketed as SPINRAZA.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| NDA209531 | SPINRAZA | 2016-12-23 | BIOGEN IDEC |
Manufacturers
BIOGEN IDEC
Common denial patterns
- SMN1 deletion documentation required
- Functional motor score thresholds (HFMSE, CHOP-INTEND)
- Age restrictions disputing late-onset adult initiation
- Site-of-care reduction for intrathecal administration
Specific notes
Brand: Spinraza. Antisense oligonucleotide for spinal muscular atrophy (all types, all ages). Intrathecal administration loading (days 0, 14, 28, 63) then maintenance every 4 months.
Biogen SMA SUPPORT: https://www.spinraza.com/en_us/home/support-and-resources.html
Frequently asked questions
Why does insurance commonly deny nusinersen?
SMN1 deletion documentation required; Functional motor score thresholds (HFMSE, CHOP-INTEND); Age restrictions disputing late-onset adult initiation; Site-of-care reduction for intrathecal administration.
When was nusinersen FDA approved?
Earliest FDA approval on record: 2016-12-23.
What brand names are sold as nusinersen?
SPINRAZA.
Is there a patient assistance program for nusinersen?
Yes — Biogen SMA SUPPORT at https://www.spinraza.com/en_us/home/support-and-resources.html.
What's specific to nusinersen?
Brand: Spinraza. Antisense oligonucleotide for spinal muscular atrophy (all types, all ages). Intrathecal administration loading (days 0, 14, 28, 63) then maintenance every 4 months.
Sources
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