J2326, Injection, nusinersen, 0.1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Laboratory values describing the type of mutation or deletion of genes in chromosome 5q (documentation of SMN1 mutation/deletion or compound heterozygous mutation).
- Documentation that the member is not dependent on invasive ventilation or noninvasive ventilation beyond use for naps and nighttime sleep.
- Documentation that the drug is being prescribed by, or in consultation with, a neurologist with expertise in diagnosis/treatment of SMA.
- Prior treatments for SMA, including dates of service and treatment response (including prior gene therapy details if applicable).
Key Coverage Criteria
- Treatment of spinal muscular atrophy (SMA) in patients who meet ALL of the following criteria: diagnosis of SMA by, or in consultation with, a neurologist with expertise in the diagnosis of SMA; AND submission of medical records confirming mutation or deletion of genes in chromosome 5q resulting in one of the following: homozygous gene deletion or mutation (e.g., homozygous deletion of exon 7 at locus 5q13); OR compound heterozygous mutation (e.g., deletion of SMN1 exon 7 (allele 1) and mutation [...]
- Initial therapy: same as above (diagnosis by/with neurologist experienced in SMA; documented 5q SMN1 mutation/deletion), patient is NOT dependent on invasive ventilation OR on non-invasive ventilation beyond use for naps and nighttime sleep, submission of baseline motor exam (HINE-2, HFMSE, RULM, or CHOP INTEND) except baseline assessments for patients < 2 months of age are not necessary, Spinraza prescribed by/with a neurologist experienced in SMA, patient either has not previously received gen [...]
- Continuation therapy: diagnosis by, or in consultation with, a neurologist with expertise in the diagnosis of SMA; patient has previously received Spinraza therapy; patient is NOT dependent on invasive ventilation OR on non-invasive ventilation beyond use for naps and nighttime sleep; patient is NOT receiving concomitant chronic SMN modifying therapy (e.g., risdiplam/Evrysdi); submission of medical records with most recent results documenting a positive clinical response from pretreatment baseli [...]
- Spinraza is to be administered intrathecally by, or under the direction of, healthcare professionals experienced in performing lumbar punctures, and dosing must be in accordance with FDA-approved labeling.
- Medically necessary for initial treatment when: (1) SMA with bi-allelic SMN1 mutations (deletion of both SMN1 or pathogenic variants in both copies, or pathogenic variant in one copy with deletion of the second copy); (2) symptomatic with 2-4 SMN2 copies or asymptomatic with 2-3 SMN2 copies; and (3) not on permanent ventilator dependence.
- Medically necessary nusinersen for initial treatment when (1) SMA confirmed by bi-allelic SMN1 mutations (deletion of both SMN1 or pathogenic variants in both copies or compound heterozygous with one deletion), (2) SMN2 copy number criteria met (symptomatic: 2-4 copies; asymptomatic: 2-3 copies), and (3) not permanently ventilator dependent.
7 Active Policies
UHC-POL-spinraza-nusinersen, Spinraza (Nusinersen)
BCBSIL-RX501.086, Nusinersen
BCBSMT-RX501.086, Nusinersen
BCBSNM-RX501.086, Nusinersen
BCBSOK-RX501.086, Nusinersen
Related Codes
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