CurrentmhnPolicy CP.PHAR.327

Nusinersen (Spinraza)

Defines medical necessity, prior authorization criteria, and coverage conditions for nusinersen (Spinraza) for pediatric and adult patients with spinal muscular atrophy across Centene-affiliated health plans (Commercial, HIM, Medicaid).

Policy Summary

Payermhn

PolicyNusinersen (Spinraza)

Policy CodePolicy CP.PHAR.327

Change TypeNo material changes

Effective DateMar 1, 2017

Next Review Date

Key ActionSubmit prior authorization with genetic test results, baseline motor function scores, office notes and documentation to support criteria for medical director review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsApproval duration (initial and renewal)

4Maximum total initial doses allowed (12 mg each)

12Standard intrathecal dose (mg)

J2326HCPCS code (0.1 mg unit)

Medical Necessity Criteria for Nusinersen (Spinraza)

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ALL of the following

Diagnosis of spinal muscular atrophy (SMA)
Genetic confirmation (one of)
- Homozygous deletions of SMN1 gene (e.g., absence of SMN1 gene)
- Homozygous mutation in the SMN1 gene (e.g., biallelic mutations of exon 7)
- Compound heterozygous mutation in SMN1 (e.g., deletion of SMN1 exon 7 on one allele and mutation on the other)
Prescribed by or in consultation with a neurologist
Genetic testing documents no more than 4 copies of SMN2 gene
Policy allows up to 4 copies; 2+ copies discussed in background
Baseline motor function test (one of, age-dependent)
- For age < 2 years: CHOP-INTEND score OR HINE Section 2 motor milestone score
- For age ≥ 2 years: HFMSE, RHS, ULM, RULM, or 6-Minute Walk Test (6MWT)
Step therapy and treatment history requirements
- Failure of a trial of Evrysdi (risdiplam), unless contraindicated or clinically significant adverse effects are experienced
  Failure defined as decline in motor function test score(s) from baseline
- Spinraza is not prescribed concurrently with Evrysdi or onasemnogene abeparvovec-xioi (Zolgensma)
- If currently on Evrysdi, prescriber attestation of Evrysdi discontinuation upon initiation of Spinraza is required
- If prior Zolgensma treatment (must meet both)
  - Evidence of poor response to Zolgensma (e.g., sustained decrease in CHOP-INTEND over 6 months)
  - Provider attestation of clinical deterioration following Zolgensma
Total initial dose does not exceed four doses of 12 mg intrathecal≤ 4 doses of 12 mg

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Not authorized indications

Coverage not authorized for:

ALL of the following

Non-FDA approved indications not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policies

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Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization and medical director review required

All requests reviewed under this policy require prior authorization and medical director review. Providers must submit documentation supporting that the member meets all approval criteria, including office chart notes, genetic test results, and baseline motor function scores (age-appropriate tests).

Submit office chart notes and other clinical information
Provide genetic testing results confirming SMN1 mutation/deletion
Provide baseline motor function scores (see Appendix D for appropriate tests)

Documentation Required

Genetic testing and SMN2 copy documentation

Provider must supply genetic testing confirming one of the following SMN1 findings: homozygous deletion, homozygous mutation, or compound heterozygous mutation; documentation must also confirm no more than 4 copies of the SMN2 gene.

Genetic evidence of SMA due to SMN1 (homozygous deletion, homozygous mutation, or compound heterozygote)
Documentation showing ≤ 4 copies of SMN2

Documentation Required

Baseline and follow-up motor function testing

Providers must submit baseline motor function scores using age-appropriate tests and ongoing follow-up results to demonstrate response per the policy's point thresholds for continued therapy.

Age < 2 years: CHOP-INTEND or HINE Section 2 motor milestone score (baseline and follow-up)
Age ≥ 2 years: HFMSE, RHS, ULM, RULM, or 6MWT (baseline and follow-up)
Continued therapy requires meeting specified improvement/maintenance thresholds (e.g., CHOP-INTEND ≥ +4 from baseline; HFMSE/RHS ≥ +3 for those >2 years; ULM ≥ +2; RULM ≥ +4)

Step Therapy

Evrysdi trial required before Spinraza

A trial failure of Evrysdi (risdiplam) is required prior to approval of Spinraza unless contraindicated or clinically significant adverse effects occur; failure is defined as a decline in motor function test score(s) from baseline. For Illinois HIM requests, the step therapy requirement does not apply per IL HB 5395 effective 1/1/2026.

Failure defined as decline in motor function test score(s) from baseline
Step therapy requirement bypassed for Illinois HIM requests per IL HB 5395 (effective 1/1/2026)

Documentation Required

Attestation for prior therapy discontinuation

If switching from Evrysdi, the prescriber must attest that Evrysdi has been discontinued upon initiation of Spinraza. If the member has prior Zolgensma treatment, the provider must submit evidence of poor response and an attestation of clinical deterioration.

Prescriber attestation of Evrysdi discontinuation when initiating Spinraza
If prior Zolgensma: evidence of poor response (e.g., sustained CHOP-INTEND decrease over 6 months) and provider attestation of clinical deterioration

Denial Risk

Concurrent therapy exclusion

Requests may be denied if Spinraza is prescribed concurrently with Evrysdi (risdiplam) or onasemnogene abeparvovec-xioi (Zolgensma).

Concurrent prescription with Evrysdi or Zolgensma is not allowed under this policy and may result in denial

Numeric and Clinical Thresholds

Thresholds

Maximum initial doses≤ 4 doses of 12 mg intrathecal

Maintenance dosing limit12 mg intrathecal every 4 months

Ventilation exclusionRequires NO tracheostomy or ventilation ≥16 hours/day continuously for >21 days

CHOP-INTEND improvement for <2 yrs continued therapy≥ 4 points from baseline (or maintenance of previous ≥4 improvement)

HFMSE/RHS improvement for >2 yrs continued therapy≥ 3 points from baseline

ULM improvement threshold≥ 2 points from baseline

RULM improvement threshold≥ 4 points from baseline

12 monthsApproval duration (initial and renewal)

4 dosesMaximum total initial doses allowed (12 mg each)

12 mgStandard intrathecal dose

J2326HCPCS code for nusinersen (0.1 mg unit)

Clinical Background

Nusinersen (Spinraza) is an SMN2-directed antisense oligonucleotide approved by the FDA for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. The pivotal efficacy data were established primarily in infantile-onset SMA (type I), where benefits were demonstrated in trials enrolling genetically confirmed infants with typically two copies of the SMN2 gene.

The mechanism of action and clinical evidence support that SMN2 copy number correlates with disease severity and that adequate SMN2 is required for nusinersen to increase production of full-length SMN protein and produce clinical benefit. Genetic testing documenting SMN1 mutations/deletions and the number of SMN2 copies (no more than 4 copies per policy) is therefore required to confirm diagnosis and to support likelihood of response to therapy.

Defined Terms

Definitions

CHOP-INTENDChildren's Hospital of Philadelphia Infant Test of Neuromuscular Disorder; infant motor function scale (0-64)

HINEHammersmith Infant Neurological Examination, Section 2 motor milestone score

HFMSEHammersmith Functional Motor Scale Expanded

RHSRevised Hammersmith Scale

RULMRevised Upper Limb Module

ULMUpper Limb Module

6MWT6-Minute Walk Test

EvrysdiRisdiplam, oral therapy for SMA (therapeutic alternative/step therapy agent)

ZolgensmaOnasemnogene abeparvovec-xioi, gene therapy for SMA

Policy Summary

Payermhn

PolicyNusinersen (Spinraza)

Policy CodePolicy CP.PHAR.327

Change TypeNo material changes

Effective DateMar 1, 2017

Next Review Date

Key ActionSubmit prior authorization with genetic test results, baseline motor function scores, office notes and documentation to support criteria for medical director review.

SourceLink

On This Page

OpenPayer

Nusinersen (Spinraza)

Medical Necessity Criteria for Nusinersen (Spinraza)

Billing Codes

Prior Authorization, Documentation, and Provider Requirements

Numeric and Clinical Thresholds

Clinical Background

Defined Terms

Nusinersen (Spinraza)

Medical Necessity Criteria for Nusinersen (Spinraza)

Billing Codes

Prior Authorization, Documentation, and Provider Requirements

Numeric and Clinical Thresholds

Clinical Background

Defined Terms

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