CurrentAnthemPolicy CC-0048

Spinraza (nusinersen) — Clinical Coverage Criteria

Clinical criteria for medical benefit coverage and prior authorization of Spinraza (nusinersen) for treatment of spinal muscular atrophy (SMA) in children and adults.

Policy Summary

PayerAnthem

PolicySpinraza (nusinersen) — Clinical Coverage Criteria

Policy CodePolicy CC-0048

Change TypeReviewed

Effective Date10/01/2025

Next Review DateAug 15, 2025

Key ActionObtain prior authorization and submit SMA diagnostic testing, baseline motor assessments, and documentation that prescriber is a neurologist specializing in SMA.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsapproval duration

J2326HCPCS code

96450CPT (intrathecal)

1 vial/4 moquantity limit

Coverage Criteria for Spinraza (nusinersen)

Initial Therapy

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Initial approval criteria: 1) Diagnostic confirmation of SMA by either: A) SMA diagnostic test results verifying 0 copies of SMN1; OR B) Molecular genetic testing of 5q SMA showing homozygous gene deletion, homozygous conversion mutation, or compound heterozygote; AND 2) Documentation of SMA-associated signs and symptoms; AND 3) Baseline motor ability assessments appropriate for age (examples: Hammersmith Infant Neurological Examination, CHOP-INTEND, HFMSE, 6MWT, RULM) that support the diagnosis; AND 4) Medication prescribed by or in consultation with a neurologist who specializes in spinal muscular atrophy; AND 5) Patient does not require invasive ventilatory support (tracheotomy with positive pressure) or non-invasive ventilatory support (BiPAP) for more than 16 hours per day due to SMA.

Initial Therapy After Gene Therapy

Initial requests following prior gene therapy (Zolgensma) may be approved when ALL of the following are met:

Post-gene-therapy initiation: 1) Spinraza meets the Initial Therapy criteria above; AND 2) Documentation of clinical decline (for example, loss of motor milestone) since receipt of gene therapy (onasemnogene abeparvovec-xioi).

Continuation Therapy

Continuation requests may be approved when ALL of the following are met:

Continuation therapy: 1) Initial therapy met the policy criteria; AND 2) Documentation of motor ability assessments demonstrating improvement or stabilization compared to baseline assessments (examples: Hammersmith Infant Neurological Examination, CHOP-INTEND, HFMSE, 6MWT, RULM); AND 3) Patient does not require invasive ventilatory support (tracheotomy with positive pressure) or non-invasive ventilatory support (BiPAP) for more than 16 hours per day due to SMA.

Billing and Coding

CPTCPT

96450

Chemotherapy administration, into CNS (eg, intrathecal), requiring and including spinal puncture

HCPCSHCPCSCovered

J2326

Injection, nusinersen, 0.1 mg [Spinraza]

ICD-10ICD-10

G12.0	Infantile spinal muscular atrophy, type I (Werdnig-Hoffman)
G12.1	Other inherited spinal muscular atrophy
G12.20	Motor neuron disease, unspecified
G12.21	Amyotrophic lateral sclerosis
G12.22	Progressive bulbar palsy
G12.23	Primary lateral sclerosis
G12.24	Familial motor neuron disease
G12.25	Progressive spinal muscle atrophy
G12.29	Other motor neuron disease
G12.8	Other spinal muscular atrophies and related syndromes

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1/2

inv-09: Quantity limit (vial)

Quantity limit1 vial (12 mg/5 mL) per 4 months

Loading doses (initiation)May approve four 12 mg (1 vial) loading doses in the first 4 months of therapy

Vial size12 mg per 5 mL vial

Actions Required by Ordering Providers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Spinraza (nusinersen). Initial and continuation approvals are for 6 months. Quantity limits apply as specified below; loading-dose schedules may be approved at initiation.

Prior authorization required for Spinraza (nusinersen).
Initial and continuation approvals: up to 6 months per approval.
Quantity limit: Spinraza (nusinersen) 12 mg/5 mL vial — limit = 1 vial (12 mg) per 4 months.
Initiation/loading: may approve up to 4 loading doses of 12 mg (1 vial) each in the first 4 months of therapy (per override/clinical criteria).

Denial Risk

Concomitant Therapy Restriction

Concomitant use of Spinraza with other SMA disease‑modifying therapies is addressed. Requests for Spinraza used in combination with Evrysdi (risdiplam) will not be approved.

Policy notes other SMA treatments (Zolgensma, Evrysdi).
Concomitant use with Evrysdi (risdiplam) is not approved.

Documentation Required

Submit documentation to support diagnosis, clinical status, and baseline/ongoing motor assessments. Include genetic testing results and evidence of SMA‑associated signs/symptoms, as well as documentation from a SMA‑specialist neurologist when applicable.

SMA diagnostic testing: SMN1 results verifying 0 copies OR molecular 5q SMA testing (homozygous deletion, homozygous conversion mutation, or compound heterozygote).
Documentation of SMA-associated signs and symptoms.
Baseline motor ability assessments appropriate for age (examples: HINE, CHOP‑INTEND, HFMSE, 6MWT, RULM).
For continuation: documentation of improvement or stabilization on motor assessments compared with baseline.
Prescribing clinician: prescribed by or in consultation with a neurologist who specializes in SMA.

Denial Risk

Denial Triggers

Requests may be denied when required clinical criteria or documentation are not met, or when Spinraza is requested in combination with Evrysdi (risdiplam).

Denial triggers include failure to meet diagnostic, clinical, or motor assessment criteria.
Requests for use in combination with Evrysdi (risdiplam) will not be approved.

Background

Spinal muscular atrophy (SMA) is an autosomal recessive genetic disorder caused by deficiency of the SMN1 gene leading to degeneration of motor neurons and progressive muscle weakness across a spectrum of severity. SMN2 copy number partially modifies phenotype but is not fully predictive. Spinraza (nusinersen) is an intrathecal antisense oligonucleotide that modulates SMN2 splicing to increase full‑length SMN protein and has demonstrated clinical benefit in both infantile- and later-onset SMA.

Definitions and Assessments

inv-15: Diagnostic confirmation of SMA

Diagnostic test - SMN1 deletion/mutationDiagnosis confirmed by SMN1 gene testing demonstrating deletion of both SMN1 genes or mutation(s)

Molecular 5q SMA testingMolecular genetic testing for 5q SMA showing homozygous gene deletion, homozygous conversion mutation, or compound heterozygote

Common test methodSMN1 gene deletion test using PCR is commonly used to diagnose SMA

inv-16: Motor ability assessments

Infant motor scaleCHOP-INTEND (Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders)

Neurologic exam - infantsHINE (Hammersmith Infant Neurologic Examination) / HINE-2

Functional motor scalesHFMSE (Hammersmith Functional Motor Scale - Expanded) and MFM-20 (Motor Function Measure-20)

Ambulation and upper limb6MWT (6-Minute Walk Test) and RULM (Revised Upper Limb Module)