ModifiedUnitedHealthcarePolicy 2026D0059P

Spinraza (nusinersen) — Medical Benefit Drug Policy (coverage criteria)

Medical benefit drug policy describing coverage criteria, documentation, and coding for Spinraza (nusinersen) for treatment of spinal muscular atrophy (SMA) under UnitedHealthcare Commercial plans.

Policy Summary

PayerUnitedHealthcare

PolicySpinraza (nusinersen) — Medical Benefit Drug Policy

Policy CodePolicy 2026D0059P

Change TypeRevised coverage criteria (admission restriction)

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, genetic confirmation of 5q mutation/deletion, baseline motor assessment, and do not request a planned inpatient admission solely to administer Spinraza.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria; added criterion requiring the provider does not request a planned inpatient admission for the sole purpose of administering Spinraza.

Updated Background, Clinical Evidence, and References sections to reflect the most current information.

Revised coverage criteria; added criterion requiring the provider does not request a planned inpatient admission for the sole purpose of administering Spinraza.

Archived previous policy version 2025D0059O.

J2326HCPCS

≤4 loading dosesInitial auth

≤3 maintenance dosesReauth limit

G12.0/G12.1/G12.9

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Therapy: Diagnosis of spinal muscular atrophy (SMA) by, or in consultation with, a neurologist with expertise in SMA.

Genetic confirmation: Submission of medical records confirming mutation or deletion in chromosome 5q consistent with SMA (e.g., homozygous deletion of exon 7 at locus 5q13 or compound heterozygous SMN1 mutations).

Examples: homozygous deletion of exon 7 at locus 5q13 or compound heterozygous mutations.

Ventilation status: Patient is not dependent on invasive ventilation or on non-invasive ventilation beyond use for naps and nighttime sleep.

Baseline motor assessment: Submission of baseline exam using an age-appropriate motor scale (HINE‑2, HFMSE, RULM, or CHOP INTEND). Baseline assessments are not required for patients <2 months to avoid treatment delay.

Prior gene therapy: Either the patient has not previously received gene replacement therapy (e.g., onasemnogene abeparvovec) OR, if previously treated with gene replacement therapy, submission of medical records documents a clinically meaningful functional decline (e.g., loss of motor milestone) since that therapy.

Examples: Zolgensma (onasemnogene abeparvovec-xioi).

Concomitant therapy exclusion: Patient is not receiving concomitant chronic SMN‑modifying therapy (e.g., risdiplam/Evrysdi).

Administration and dosing: Spinraza to be administered intrathecally by, or under the direction of, healthcare professionals experienced in lumbar puncture; dosing consistent with FDA‑approved labeling; provider does not request a planned inpatient admission solely to administer Spinraza.

Initial authorization limited to no more than 4 loading doses.

Continuation Therapy

Covered when ALL of the following are met:

Diagnosis and prior treatment: Diagnosis of SMA by, or in consultation with, a neurologist with expertise in SMA, and patient has previously received Spinraza therapy.

Ventilation status: Patient is not dependent on invasive ventilation or on non-invasive ventilation beyond use for naps and nighttime sleep.

Concomitant therapy exclusion: Patient is not receiving concomitant chronic SMN‑modifying therapy (e.g., risdiplam/Evrysdi).

Evidence of positive clinical response

HINE-2: Improvement or maintenance of previous improvement: ≥2‑point (or maximal) increase in ability to kick OR ≥1‑point increase in other HINE‑2 milestones (excluding voluntary grasp), OR net positive milestones, OR achieved and maintained new motor milestones.

Not Proven / Not Medically Necessary

Not proven/not medically necessary: Spinraza is not proven or medically necessary for spinal muscular atrophy without chromosome 5q mutations or deletions; and for concomitant treatment of SMA in patients receiving SMN‑modifying therapy (e.g., risdiplam/Evrysdi).

General medical necessity criteria

Covered when supported by clinical evidence consistent with trial populations and documentation of diagnosis and baseline function, and when administration does not require a planned inpatient admission solely for dosing.

General coverage criteria: Patient has genetically confirmed SMA (SMN1 mutation/deletion) with documented SMN2 copy number when available; treatment intent aligns with populations studied in clinical trials (infantile‑onset and later‑onset SMA as applicable); baseline motor function documented with appropriate scales (e.g., HFMSE, HINE‑2, CHOP INTEND); and provider does not request a planned inpatient admission solely for administration of Spinraza.

See clinical trials (ENDEAR, CHERISH) for age and functional inclusion criteria and trial‑based efficacy thresholds.

Revised Coverage Criteria (admission requirement)

Coverage criteria revised (summary in Policy History).

Admission restriction: Provider must not request a planned inpatient admission for the sole purpose of administering Spinraza.

Added in 01/01/2026 revision.

Spinraza is not proven or medically necessary for treatment of spinal muscular atrophy in patients who do not have chromosome 5q mutations or deletions. The policy explicitly excludes coverage when the SMA diagnosis lacks genetic confirmation of 5q SMN1 mutation/deletion.

The policy does not recommend use of two disease‑modifying SMA therapies together outside of controlled clinical trials. The 2024 European consensus update states that, in the absence of convincing evidence of superiority for combination approaches (for example, gene therapy plus nusinersen or risdiplam), combinatorial therapies cannot be recommended at the moment and simultaneous use should be limited to clinical trial settings.

Coverage criteria were revised effective 01/01/2026 to restrict requests that include a planned inpatient admission solely for the purpose of administering Spinraza. As of the revision, providers must not request a planned inpatient admission when the only reason for admission is intrathecal administration of nusinersen.

The policy considers concomitant treatment of SMA with chronic SMN modifying therapies (for example, risdiplam/Evrysdi) together with Spinraza to be not medically necessary. Requests for simultaneous chronic SMN‑modifying therapy and nusinersen may be denied per policy.

A disqualifying condition for coverage was added in the 01/01/2026 revision: a planned inpatient admission requested solely to administer Spinraza will render the request ineligible under the revised coverage criteria. Providers should ensure authorization requests do not include planned inpatient admission for the sole purpose of dosing.

Relevant Billing and Diagnosis Codes

Applicable HCPCSHCPCS

J2326

Injection, nusinersen, 0.1 mg.

Applicable ICD-10 CodesICD-10

G12.0	Infantile spinal muscular atrophy, type I [Werdnig-Hoffmann].
G12.1	Other inherited spinal muscular atrophy.
G12.9	Spinal muscular atrophy, unspecified

Prior Authorization, Documentation, and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization required for initial and continuation Spinraza (nusinersen) therapy. Initial requests must be submitted by, or in consultation with, a neurologist experienced in SMA and include documentation of SMA diagnosis with confirmed 5q deletion/mutation (e.g., homozygous SMN1 exon 7 deletion or compound heterozygous mutation), the proposed drug regimen and dosing (in accordance with FDA labeling), prior SMA treatments and responses, and baseline motor function assessment appropriate for age (e.g., HINE-2, HFMSE, RULM, or CHOP INTEND). Initial authorization will be limited to no more than 4 loading doses. Continuation requests must document prior receipt of Spinraza, current SMA diagnosis, lack of invasive ventilation dependence (or noninvasive ventilation only for naps/nighttime), and objective clinical improvement from pretreatment baseline (using HINE-2, HFMSE, RULM, or CHOP INTEND).

Initial authorization: ≤4 loading doses
Reauthorization: ≤3 maintenance doses over 12 months
Dosing must follow FDA‑approved labeling (max 12 mg)
Provider: neurologist with SMA expertise (or in consultation)

Clinical Background and Context

Spinal muscular atrophy (SMA) is a rare, autosomal recessive neuromuscular disease caused primarily by biallelic pathogenic variants of the SMN1 gene leading to degeneration of lower motor neurons and progressive, symmetric weakness. SMA phenotypes range from prenatal (type 0) through infantile (type I) to later‑onset forms (types II–IV); clinical severity generally correlates with SMN2 copy number. Nusinersen (Spinraza) is an SMN2‑directed antisense oligonucleotide approved to increase inclusion of exon 7 in SMN2 transcripts, thereby raising functional SMN protein levels; randomized and open‑label trials demonstrated improved motor milestones and survival in infantile‑onset SMA and functional gains in later‑onset populations.

Key Terms and Definitions

SMN modifying therapy — definition and examples

DefinitionSMN modifying therapy: therapies that modify survival motor neuron (SMN) protein levels or function; policy examples include Evrysdi (risdiplam).

Policy implicationConcomitant chronic use of SMN modifying therapy with Spinraza is excluded — patients must not be receiving concomitant chronic SMN modifying therapy (e.g., risdiplam) to meet coverage criteria.

ExamplesEvrysdi (risdiplam) is listed as an example of an SMN modifying therapy referenced in the policy.

Nusinersen (Spinraza) — drug definition and indication

Drug class and mechanismNusinersen (Spinraza) is an SMN2-directed antisense oligonucleotide that increases exon 7 inclusion in SMN2 transcripts to produce full-length SMN protein.

Indication

Policy Summary

PayerUnitedHealthcare

PolicySpinraza (nusinersen) — Medical Benefit Drug Policy

Policy CodePolicy 2026D0059P

Change TypeRevised coverage criteria (admission restriction)

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

HFMSE: Improvement or maintenance of previous improvement: ≥3‑point increase from pretreatment baseline OR achieved and maintained new motor milestone.HFMSE ≥3 points

RULM: Improvement or maintenance of previous improvement: ≥2‑point increase from pretreatment baseline OR achieved and maintained new motor milestone.RULM ≥2 points

CHOP INTEND: Improvement or maintenance of previous improvement: ≥4‑point increase from pretreatment baseline OR achieved and maintained new motor milestone.CHOP INTEND ≥4 points

Reauthorization limited to no more than 3 maintenance doses (12 months).

Denial Risk

Planned Inpatient Admission Restriction

Provider must not request a planned inpatient admission solely for the purpose of administering Spinraza. Requests that include a planned inpatient admission for the sole purpose of drug administration may be disallowed under the revised coverage criteria.

Operational note: prior authorization requests should not list a planned inpatient admission just to administer Spinraza
Administration setting: intrathecal administration should be performed by, or under the direction of, clinicians experienced in lumbar puncture

Note

Member‑Specific Benefit Plan Governs

When applying this policy, the member specific benefit plan document controls. The policy is an interpretive guide for UnitedHealthcare standard benefit plans; check the member’s specific plan and any applicable federal or state mandates before approving coverage. In case of conflict, the member specific benefit plan governs.

Verify member-specific benefits and applicable mandates prior to authorization
This policy may be informational only and does not guarantee coverage

Documentation Required

Gene Therapy and Prior Treatment Consideration

Confirm prior gene therapy and prior SMN‑modifying therapies before authorization. Document all prior SMA treatments (including gene replacement therapy such as onasemnogene abeparvovec), dates of service, and treatment responses. Requests for Spinraza following gene therapy should include clear documentation of prior therapies and clinical rationale.

Document any prior onasemnogene abeparvovec (Zolgensma) administration with dates and response
Include prior treatment history and rationale for additional SMN‑targeting therapy

Prior Authorization

Use with Other Disease‑Modifying Therapies

Concomitant use of two disease‑modifying SMA therapies (e.g., nusinersen plus risdiplam or gene therapy) is not recommended outside of controlled clinical trials; requests for concomitant chronic SMN‑modifying therapy (e.g., Evrysdi/risdiplam) are considered not proven or not medically necessary. Temporary bridging (short‑term use) may be appropriate in select situations but requires clear justification.

Concomitant chronic SMN therapy (e.g., risdiplam) — generally not covered
Bridging use: may be considered with justification when a therapy is not immediately available
Evidence: consensus recommends against routine combinatorial use outside trials

Indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

Regulatory statusFDA approved December 23, 2016; approval supported by randomized sham-procedure controlled trials in infantile-onset SMA and extrapolated evidence for later-onset SMA.

Maintenance dosing interval

IntervalMaintenance dosing interval: once every 6 months (maintenance dose given 6 months after last loading dose).

RationaleInterval selected based on estimated spinal tissue and CSF drug half-life (4–6 months) to maintain predicted pharmacologically active spinal cord tissue levels.

Dosing contextCHERISH study used 12 mg loading doses on days 1, 29, 85, then maintenance dosing on day 274 (6 months after last loading dose).

Minimal clinically important differences (MCID)

ConceptMinimal clinically important differences (MCID): the smallest change in a functional motor score perceived as meaningful, referenced in SMA literature (Stolte et al., 2020).

Context of useMCID has been described for functional motor scores in adults with SMA and is used in interpreting clinical significance of score changes.

ReferenceStolte B et al., 'Minimal clinically important differences in functional motor scores in adults with spinal muscular atrophy', Eur J Neurol. 2020;27(12):2586–2594.

European consensus on gene therapy for SMA — 2024 statement

DocumentEuropean consensus on gene therapy for SMA: 2024 update (Kirschner J et al., 2024) referenced in policy references.

ScopeProvides updated consensus recommendations on gene therapy practices for SMA; referenced alongside discussion of combination disease-modifying therapies.

Policy relevancePolicy cites the 2024 European consensus when discussing use of combination disease-modifying treatments and gene therapy considerations.