CurrentCignaPolicy N/A

Prior authorization and documentation requirements for nusinersen (Spinraza) for spinal muscular atrophy

Prior authorization form and clinical documentation requirements for Cigna coverage of Spinraza (nusinersen) for patients with spinal muscular atrophy; applies to providers submitting requests for medication initiation or continuation.

Policy Summary

PayerCigna

PolicyPrior authorization and documentation requirements for nusinersen (Spinraza) for spinal muscular atrophy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete prior authorization form and attach genetic test results and baseline or follow-up motor assessments to support initiation or continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for drug coverage requests

urgent phone linephone number for urgent requests

Spinraza listedmedication covered by form

Coverage Criteria for Nusinersen (Spinraza)

Initiation and continuation documentation-based criteria

Covered when ALL of the following documentation and conditions are provided and confirmed on the form

Policy Summary

PayerCigna

PolicyPrior authorization and documentation requirements for nusinersen (Spinraza) for spinal muscular atrophy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionComplete prior authorization form and attach genetic test results and baseline or follow-up motor assessments to support initiation or continuation.

SourceLink

On This Page

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Genetic confirmation: Documentation of genetic test confirming diagnosis of spinal muscular atrophy (SMA) with bi-allelic pathogenic variants in SMN1 (may include homozygous deletion, compound heterozygous mutation, or other pathogenic SMN1 mutations)

required for both new and continuing patients

Accepted baseline motor assessment: Baseline motor ability assessment performed with one of: Bayley Scales of Infant and Toddler Development; CHOP-INTEND; HFMSE; HINE-2; MFM-32; RULM; or WHO motor milestone scale

for patients NOT currently receiving nusinersen (initiation); documentation must be attached

SMN2 copy number documentation: Document SMN2 copy number (two, three, or four copies). For patients with four SMN2 copies, provide additional documentation of objective signs consistent with SMA Types 1, 2, or 3

form contains separate paths based on SMN2 copy number; documentation must be attached

Continuation evidence: For patients currently receiving nusinersen, provide documentation of positive clinical response or stabilization from pretreatment baseline within the past 4 months using accepted assessment tools or clinical/physician monitoring measures (examples: Bayley, CHOP-INTEND, HFMSE, HINE-2, MFM-32, RULM, WHO milestones, pulmonary function, reduced need for respiratory support)within the past 4 months

required for ongoing therapy authorization; medical documentation must be attached or request could be denied

Physician specialty: Prescribed by a physician who has consulted with or specializes in management of patients with SMA and/or neuromuscular disorders (prescriber attestation on form)

physician attestation required on form

Provider Actions, Documentation & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for Spinraza. Complete the prior authorization form and attach required clinical documentation (see documentation callout).

Prior authorization is required before therapy is initiated.
Ensure urgency is indicated (Standard or Urgent) on the form.

Prior Authorization

Prior Gene Therapy Inquiry

Form asks whether the patient has previously received onasemnogene abeparvovec-xioi (Zolgensma) and requires the prescriber to confirm if the patient has not previously received Zolgensma. If the patient has received Zolgensma, note this on the form and attach relevant chart documentation.

Question: “Has the patient received Zolgensma (onasemnogene abeparvovec-xioi) in the past?” — Yes / No.
Prescriber confirmation required: “It is confirmed by the prescribing physician that the patient has not previously received Zolgensma.” or “It is not confirmed.”
Attach chart notes supporting prior gene therapy status.

Documentation Required

Required Supporting Documentation

Attach all required supporting documentation with the request. Missing documentation may result in denial.

Genetic test results confirming bi-allelic pathogenic variants in SMN1 (e.g., homozygous deletion, compound heterozygous mutation).
SMN2 copy number documentation (two, three, or four copies as applicable).
Baseline motor ability assessment (if not currently receiving Spinraza) using one of: Bayley Scales, CHOP-INTEND, HFMSE, HINE-2, MFM-32, RULM, or WHO motor milestone scale.
For patients currently receiving Spinraza: documentation of positive clinical response or stabilization within the past 4 months using validated assessments (CHOP-INTEND, HFMSE, HINE-2, etc.) and recent physician monitoring/assessment notes (pulmonary function, bulbar function, respiratory support needs, infection frequency, etc.).
Chart notes and any other relevant medical records referenced on the form.

Billing Rule

Pharmacy and Administration Details

Specify where the medication will be obtained and provide administration billing details.

Indicate pharmacy source: Accredo Specialty Pharmacy (orders can be placed via Fax 877.327.8413) or Other (specify).
Provide any CPT codes that will be billed for drug administration on the form.
Include directions for use, quantity, and duration of therapy on the request.

Denial Risk

Missing Documentation Risks Denial

Requests may be denied if required documentation is not attached. Provide all chart notes, genetic test results, baseline and follow-up motor assessments, and physician attestations to avoid denial or delays.

Failure to attach genetic testing, SMN2 copy number, baseline/response motor assessments, or chart notes may result in denial.
Ensure documentation of specialist involvement/consultation in SMA or neuromuscular disorders when applicable.
If marking request as urgent, follow up by phone to expedite review.

Definitions and Assessment Tools

Bi-allelic pathogenic variants in SMN1

DefinitionGenetic confirmation of SMA requires documentation of bi-allelic pathogenic variants in the SMN1 gene

Acceptable mutation typesMay include homozygous deletion, compound heterozygous mutation, or other rare pathogenic SMN1 mutations as reported on genetic testing

Required actionAttach genetic test results to the prior authorization request

Accepted motor assessment tools

Accepted instruments (infants/toddlers)Bayley Scales of Infant and Toddler Development

Accepted instruments (infant neuromuscular)CHOP-INTEND (Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders)

Accepted instruments (ambulatory/older children)Hammersmith Functional Motor Scale Expanded (HFMSE) and Hammersmith Infant Neurological Exam Part 2 (HINE-2)

Additional accepted measuresMotor Function Measure-32 (MFM-32), Revised Upper Limb Module (RULM), or World Health Organization motor milestone scale

OpenPayer

Prior authorization and documentation requirements for nusinersen (Spinraza) for spinal muscular atrophy

Coverage Criteria for Nusinersen (Spinraza)

Medication and Coding

Provider Actions, Documentation & Prior Authorization

Background

Definitions and Assessment Tools