Modifiedhusky_healthPolicy N/A

Spinraza (nusinersen) prior authorization and coverage

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Defines clinical and administrative requirements for prior authorization, initial approval, and reauthorization of intrathecal Spinraza (nusinersen) for treatment of spinal muscular atrophy (SMA) for HUSKY Health (Connecticut Medicaid) providers.

Policy Summary

Payerhusky_health

PolicySpinraza (nusinersen) prior authorization and coverage

Policy CodePolicy N/A

Change TypeCriteria additions and authorization duration update

Effective DateMar 1, 2026

Last ReviewMay 13, 2026

Next Review DateN/A

Key ActionSubmit a completed HUSKY Health Spinraza prior authorization form with required genetic testing, baseline motor exam, baseline labs (platelets, coagulation, urine protein), and provider signature.

SourceLink

POLICY UPDATE CHANGES

Added Itvisma as an example of gene therapy for SMA.

Added requirement of repeat testing for first reauthorization to be performed by a physician or physical therapist experienced in treating SMA.

Added criteria regarding platelet count, coagulation laboratory testing, and quantitative spot urine protein testing.

Duration of authorization changed to 12 months.

Split up procedure section into initial authorization and reauthorization.

Updated select verbiage for clarity and updated references.

12 moInitial approval duration

12 moReauthorization duration

Types 1-3SMA types covered

Types 0 & 4Not covered

Prior authRequirement

J2326Billing code

Coverage Criteria for Spinraza (nusinersen)

Initial Therapy

Covered when ALL of the following are met for initial requests:

Initial coverage criteria: A. Spinraza has been ordered by or in consultation with a physician specializing in the management of SMA or other neuromuscular disorders;

Condition A required

Initial coverage criteria: B. Diagnosis of SMA type 1, type 2, or type 3 made by or in consultation with a physician with expertise in diagnosing SMA;

Condition B required

Initial coverage criteria: C. Submission of genetic testing confirming documentation of homozygous deletion, homozygous mutation, or compound heterozygous mutations of the SMN1 gene on chromosome 5q;

Condition C required

Initial coverage criteria: D. The individual is not dependent on permanent ventilatory support (defined as invasive ventilation/tracheostomy or non-invasive ventilatory support for at least 16 hours per day for >21 days in the absence of an acute reversible event);

Condition D required

Initial coverage criteria: E. Submission of medical records confirming a baseline motor exam completed by a physician or physical therapist experienced in treating SMA utilizing at least one of: HINE-2, CHOP INTEND, HFMSE, or RULM (other standardized tests may be considered);

Condition E required

Initial coverage criteria: F. Baseline platelet count, coagulation laboratory testing, and quantitative spot urine protein testing have been obtained;

Condition F required

Initial coverage criteria: G. One of the following applies: 1) The individual has not previously received gene replacement therapy (e.g., Zolgensma or Itvisma); OR 2) The individual previously received gene replacement therapy and has experienced a decline in clinical status;

Condition G required

Initial coverage criteria: H. The individual is not on concurrent SMN modifying therapy (e.g., risdiplam);

Condition H required

Initial coverage criteria: I. The treating provider will follow all FDA-approved labeling for dosing, administration, and additional monitoring for Spinraza;

Condition I required

Initial coverage criteria: J. A description of the benefits, risks and treatment expectations has been provided to the individual, parent or guardian;

Condition J required

Reauthorization (First and Subsequent)

Reauthorization criteria — first reauthorization and all subsequent reauthorizations:

First reauthorization clinical response options: For the first reauthorization, one of the following must apply: 1) Demonstrated clear response on repeat motor testing as confirmed by a physician or physical therapist experienced in treating SMA — defined as: HINE-2: improved in one or more milestones with more milestones improved than worsened; CHOP INTEND: at least a 4-point increase from pretreatment baseline; HFMSE: at least a 3-point increase from pretreatment baseline; RULM: at least a 2-point increase from pretreatment baseline; OR 2) The individual has achieved and maintained any new motor skills from pretreatment baseline that would otherwise be unexpected; OR 3) The individual has maintained all prior motor skills without decline in functional status; OR 4) The individual has demonstrated decline in functional status but the treating physician provides a letter explaining why Spinraza should be continued with supporting medical literature;

One of these required for first reauthorization

All reauthorizations general criteria: For all reauthorizations the following ALL must be met: A) Either the individual has not received gene replacement therapy since Spinraza was originally approved OR Spinraza was prescribed due to clinical worsening after gene replacement therapy and there is documentation of stabilization or improvement with Spinraza; B) The individual is not on concurrent SMN modifying therapy (e.g., risdiplam); C) The individual is not dependent on permanent ventilatory support (as defined); D) Documentation shows that the benefits of treatment continue to outweigh the risks; E) The treating provider continues to obtain platelet counts, coagulation laboratory testing, and quantitative spot urine protein testing prior to each dose; F) The treating provider will continue to follow all FDA-approved labeling for dosing, administration, and monitoring for Spinraza;

All conditions A-F required for ongoing authorization

Spinraza (nusinersen) is considered investigational and not medically necessary for the treatment of SMA Type 0 and Type 4. This position reflects that nusinersen has not been clinically evaluated for these SMA types and therefore coverage is not supported for these indications.

The policy's publication history documents multiple updates since the original October 2017 approval. Earlier updates added SMA types 2 and 3 and introduced language that treatment with Spinraza was considered investigational for SMA Type 0 and Type 4. Subsequent revisions removed presymptomatic criteria, clarified reauthorization and clinical guideline language, and updated references and coding. The most recent updates (2025–2026) added examples of gene therapy (e.g., Itvisma), revised reauthorization testing requirements, added laboratory safety testing requirements, changed the authorization duration, and split the procedure section into separate initial authorization and reauthorization requirements.

Because nusinersen has not been clinically evaluated for SMA Types 0 and 4, treatment for these types is not covered under this policy. Requests for Spinraza for SMA Type 0 or Type 4 do not meet medical necessity criteria and should be denied as investigational.

Note

Authorization ≠ Guarantee of Payment

Authorization is not a guarantee of payment; payment is based on the individual having active coverage, benefits and policies in effect at the time of service.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J2326

Injection, nusinersen, 0.1 mg

inv-08: Authorization duration

Authorization duration12 months

Reauthorization intervalApproved in twelve (12) month intervals following demonstration that criteria are met

Effective policy changeDuration of authorization changed to 12 months (per publication history)

Provider Actions, Documentation, and Authorization Rules

Prior Authorization

Prior Authorization Required; Initial Approval 12 Months

Prior authorization is required for Spinraza (nusinersen). When initial criteria are met, initial approval will be granted for twelve (12) months.

Prior Authorization

Reauthorization Duration — 12 Months

Reauthorization approvals are granted in twelve (12) month intervals after reevaluation demonstrates that the reauthorization criteria are met.

Prior Authorization

Prior Authorization Based on Medical Necessity

Prior authorization is required for Spinraza (nusinersen) under the HUSKY Health Program and authorizations are issued based on medical necessity at the time the authorization is reviewed.

Step Therapy

No Concurrent SMN‑Modifying Therapy or Permanent Ventilatory Dependence

Individuals must not be on concurrent SMN‑modifying therapy (e.g., Evrysdi® [risdiplam]) and must not be dependent on permanent ventilatory support to meet authorization criteria.

Note

Consider Prior Gene Therapy (Zolgensma/Itvisma) in Eligibility

Prior gene therapy status affects eligibility: individuals who have not received gene replacement therapy (e.g., Zolgensma® or Itvisma®) or who previously received gene therapy and experienced clinical decline are addressed in the criteria and must be documented.

Documentation Required

Required Documentation: Completed PA Form and Clinical Evidence

Submit a fully completed State of Connecticut HUSKY Health Spinraza prior authorization request form including the physician's order and signature, plus genetic testing confirming SMN1 mutation, baseline motor assessment results, baseline laboratory testing (platelets, coagulation, quantitative spot urine protein), and signed provider attestations.

Documentation Required

Initial vs Reauthorization Documentation; First Reauth Repeat Testing Requirement

The procedure/documentation requirements are separated for initial authorization vs reauthorization; the first reauthorization requires repeat motor testing performed by a physician or physical therapist experienced in treating SMA.

Billing Rule

Billing Code — J2326 for Nusinersen 0.1 mg

Use HCPCS code J2326 (Injection, nusinersen, 0.1 mg) for billing and documentation of nusinersen administration.

Denial Risk

Denial Risk: Missing Documentation or Not Meeting Medical Necessity

Authorizations are issued based on medical necessity at the time of review; insufficient or missing required documentation or failure to meet medical necessity criteria may result in denial.

Note

Authorization Based on Medical Necessity and Coverage Activity

Authorization is based on medical necessity at the time it is issued and is not a guarantee of payment; payment requires the member to have active coverage and benefits in effect at time of service.

Background on Spinal Muscular Atrophy and Therapy

Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disorder caused by insufficient survival motor neuron (SMN) protein, leading to progressive muscle weakness. SMA is classified by age of onset and clinical severity into types 0 through 4. Therapeutic approaches such as Spinraza (nusinersen) target SMN2-directed mechanisms to increase SMN protein and modify disease course; coverage decisions in this policy are aligned to clinical evidence, SMA type, and medical necessity determinations.

Definitions and Program Scope

inv-20: Permanent ventilatory support — Definition and criteria

DefinitionPermanent ventilatory support: invasive ventilation/tracheostomy or non-invasive ventilatory support for at least 16 hours per day for > 21 days in the absence of an acute reversible event.

Exclusion from eligibilityIndividuals dependent on permanent ventilatory support do not meet authorization criteria for Spinraza under initial and reauthorization requirements.

Assessment noteDependence on permanent ventilatory support must be determined in the absence of an acute reversible event.

inv-21: HUSKY Health Program — Definition of programs included

Included programsHUSKY A, HUSKY B, HUSKY C, HUSKY D, and HUSKY Limited Benefit programs (collectively the HUSKY Health Program)

Population examplesIncludes Medicaid for children and parents, CHIP for higher-income uninsured children, Medicaid for older adults and those with disabilities, and Medicaid for low-income adults without dependent children.

Program purposeProvides Medicaid/CHIP coverage in Connecticut across the listed program components.

inv-22: Medically Necessary or Medical Necessity — Definition used in policy

Medically Necessary definitionServices required to prevent, identify, diagnose, treat, rehabilitate or ameliorate an individual's medical condition and consistent with generally-accepted standards of medical practice; clinically appropriate in type, frequency, timing, site, extent and duration; not primarily for convenience; not more costly than alternatives of equivalent effectiveness; and based on assessment of the individual (per Connecticut General Statutes §17b-259b).

Application to prior authorizationPrior Authorization is a process for approving covered services prior to delivery based on CHNCT determination of medical necessity.

Policy implicationAuthorization decisions and payment depend on medical necessity at the time the authorization is issued and active coverage/benefits at time of service.

Revision History and Material Changes

2017-10-23Original publication / approval

Original publication approved by DSS on October 23, 2017 (Clinical Quality Subcommittee approval December 18, 2017).

2018-07-25Code update & committee approval

HCPCS code J2326 (Injection, nusinersen, 0.1 mg) added effective January 1, 2018; policy approved at the July 25, 2018 Medical Policy Review Committee and later approved by CHNCT Clinical Quality Subcommittee and DSS in September 2018.

2019-06-21Clinical guideline update

June 2019 updates added SMA types 2 and 3, noted Spinraza investigational for SMA types 0 and 4, created presymptomatic guidelines, updated motor tests and reauthorization guidance; approved June 21, 2019 by DSS.

2020-05-13Added prior gene therapy criteria

May 2020 change added criteria related to previous gene therapy to inform eligibility reviews.

2021-06-28Removed SMN2 copy requirement & gene therapy clarifications

June 2021 update removed requirement for at least 2 SMN2 copies and revised criteria to address prior treatment with Zolgensma and concurrent gene-based therapy; approved by DSS on June 28, 2021.

2022-07-05Requests-to-continue guidance update

June 2022 update revised clinical guideline for continuing therapy in symptomatic patients (Types 1–3) and added guidance for individuals previously treated with Zolgensma; approved by DSS July 5, 2022.

2023-06-28Reorganization and removal of presymptomatic criteria

June 2023 update removed presymptomatic criteria, reorganized remaining criteria, and added statements regarding prior Zolgensma treatment and ventilatory support placement into criteria; approved by DSS in June 2023.

2024-06-26Reviewed and approved with no changes

Policy reviewed in May 2024 and approved by CHNCT Clinical Quality Subcommittee and DSS on June 26, 2024 with no changes.

2025-05Content update (introduction/description)

May 2025 update revised the introduction and updated the Spinraza description to reflect current FDA information.

2026-03-01Effective date of current document versionLatest

Policy effective date set to March 1, 2026 reflecting material updates including authorization duration, laboratory safety testing requirements, and reauthorization testing requirements.

Material changes in this revision include: addition of Itvisma as an example of prior gene therapy for SMA; introduction of specific laboratory safety testing requirements (platelet count, coagulation testing, and quantitative spot urine protein) prior to authorization; a requirement that repeat testing for the first reauthorization be performed by a physician or physical therapist experienced in treating SMA; the duration of authorization changed to 12 months; and an operational split of the procedure section into separate initial authorization and reauthorization requirements.

Policy Summary

Payerhusky_health

PolicySpinraza (nusinersen) prior authorization and coverage

Policy CodePolicy N/A

Change TypeCriteria additions and authorization duration update

Effective DateMar 1, 2026

Last ReviewMay 13, 2026

Next Review DateN/A

SourceLink

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