CurrentAetnaPolicy N/A

Spinraza (nusinersen) Injectable Precertification Request

Aetna precertification/authorization request form to collect patient, prescriber, dispensing, diagnosis and clinical information required for review of requests to initiate or continue Spinraza (nusinersen) therapy.

Policy Summary

PayerAetna

PolicySpinraza (nusinersen) Injectable Precertification Request

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionProviders must submit genetic confirmation of 5q SMA and baseline motor assessments (HINE-2, HFMSE, or CHOP-INTEND) with scores and dates as part of the precertification request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes identified in this brief.

3Assessment tools referenced

3Post-gene therapy decline thresholds

1Loading dose schedule specified

Policy summary and scope

Document: Spinraza (nusinersen) Injectable Precertification Request form. Payer: Aetna. Policy title/subject: Spinraza (nusinersen) precertification request form. Policy number:

Purpose: This Aetna precertification/authorization form is used to collect the clinical and administrative information needed to evaluate requests to initiate, continue, or re‑initiate Spinraza (nusinersen) therapy. The form gathers patient identification and contact details, insurance information, prescriber credentials and specialty, dispensing/provider and place of administration details (including CPT administration codes), and specific product request information (dose and frequency).

Clinical data required: The form requires documentation of spinal muscular atrophy (SMA) diagnosis and genetic confirmation of 5q SMA when applicable, baseline and follow‑up motor assessments using HINE‑2, HFMSE, or CHOP‑INTEND with dates and scores, information about prior gene replacement therapy and objective decline thresholds if applicable, loading dose schedule and maintenance dose limits, ventilation and concomitant Evrysdi use, and a signed acknowledgement by the requestor.

Information and Clinical Documentation Required for Precertification

All fields must be completed and legible; clinical documentation must be submitted with request. Different sections apply for initiation, continuation, and restarting post-gene therapy.

ALL of the following

Patient identification and contact information completed (A)
Insurance information completed (B)
Prescriber information completed including specialty and credentials (C)
Dispensing provider / administration information completed including place of administration and CPT administration codes if applicable (D)
Product information: request is for Spinraza (nusinersen); dose and frequency specified (E)
Primary and any secondary ICD diagnosis codes provided (F)
Clinical confirmation
- Documented diagnosis of spinal muscular atrophy (SMA) indicated (G)
- If no documented SMA diagnosis, request lacks required diagnosis confirmation
Prescriber and treatment context
- Name of the gene therapy designated center where drug will be administered provided
- Is medication prescribed by or in consultation with a physician who specializes in treatment of SMA? (Yes/No) — documented
- Ventilation status documented: dependent on invasive ventilation/tracheostomy? dependent on non-invasive ventilation beyond naps/nighttime? (Yes/No)
- Concomitant use with Evrysdi (risdiplam) indicated (Yes/No)

Initiation of Therapy (patient NOT currently receiving nusinersen)

Required items to support initiation requests

ALL of the following

Genetic confirmation of 5q SMA via homozygous gene mutation, homozygous gene deletion, or compound heterozygote documented (Yes/No)
Baseline assessment completed using appropriate tool based on age and motor ability with date: HINE-2, HFMSE, or CHOP-INTEND (Yes/No; indicate which and score)
History of prior gene replacement therapy documented (Yes/No)
If prior gene therapy
- Documentation of clinical worsening since gene therapy demonstrated by decline from highest score on HINE-2, HFMSE, or CHOP-INTEND with dates and magnitude as specified
- Specific decline thresholds for post-gene therapy worsening: HINE-2: decline of at least 2 points on kicking and 1 point on any other milestone excluding voluntary grasp; HFMSE: decline of at least 3 points; CHOP-INTEND: decline of at least 4 points
Whether loading doses have been received and whether loading doses are dosed at 12 mg (5 mL) on days 0, 14, 28, and 58 (Yes/No)
Whether maintenance dose will exceed 12 mg (5 mL) every 4 months (Yes/No)

Re-initiation after Gene Therapy

Information required when restarting nusinersen after prior gene therapy

ALL of the following

Patient age at initiation of nusinersen therapy documented
Genetic confirmation of 5q SMA documented (Yes/No)
Baseline assessment completed using HINE-2, HFMSE, or CHOP-INTEND with date and scores (Yes/No)
Documentation of clinical worsening since gene therapy demonstrated by decline from highest score as per specified thresholds (Yes/No)

Continuation Requests (patient currently receiving nusinersen)

Required evidence of clinical benefit or stabilization for continuation

ALL of the following

Patient age at initiation of nusinersen therapy documented
Evidence of positive clinical response since pretreatment baseline using HINE-2, HFMSE, or CHOP-INTEND with date (Yes/No)
Acceptable demonstration of response — HINE-2
- Improvement or maintenance of at least a 2-point (or maximal score) increase in ability to kick
- Improvement or maintenance of at least a 1-point (or maximal score) increase in any other HINE-2 milestone excluding voluntary grasp
- None of the above
Acceptable demonstration of response — HFMSE
- Improvement or maintenance of at least a 3-point increase in score
- Achievement and maintenance of any new motor milestone from pretreatment baseline that would otherwise be unexpected
- None of the above
Acceptable demonstration of response — CHOP-INTEND
- Improvement or maintenance of at least a 4-point increase in score
- Achievement and maintenance of any new motor milestone from pretreatment baseline that would otherwise be unexpected
- None of the above
If prescribed due to clinical worsening after gene therapy, documentation must indicate that and demonstrate stabilization or improvement

Thresholds

HINE-2 decline (post-gene therapy)>= 2 points on kicking and >=1 point on any other milestone excluding voluntary grasp

HFMSE decline (post-gene therapy)>= 3 points

CHOP-INTEND decline (post-gene therapy)>= 4 points

HINE-2 improvement (continuation)>= 2 points on kicking or >=1 point on any other milestone excluding voluntary grasp

HFMSE improvement (continuation)>= 3 points

CHOP-INTEND improvement (continuation)>= 4 points

Loading dose schedule12 mg (5 mL) on days 0, 14, 28 and 58

Maintenance dose limit

Required provider actions and documentation

Documentation Required

Submit genetic confirmation and baseline assessments

Providers must submit genetic confirmation of 5q SMA and baseline motor assessments with scores and dates as part of the precertification request.

HINE-2: score and date
HFMSE: score and date
CHOP-INTEND: score and date

Prior Authorization

Precertification required

Precertification request must be completed with all required sections and submitted to Aetna Precertification Notification via phone or fax for review prior to therapy start or continuation.

Documentation Required

Document prior gene therapy and clinical worsening

If patient received prior gene replacement therapy, providers must document the prior therapy and objective decline from highest achieved scores per the specified thresholds to support initiation or re-initiation.

HINE-2: decline of at least 2 points on kicking and 1 point on any other milestone (excluding voluntary grasp)
HFMSE: decline of at least 3 points
CHOP-INTEND: decline of at least 4 points

Documentation Required

Demonstrate benefit for continuation

For continuation requests, providers must document stabilization or improvement on an appropriate motor scale. The most recent assessment must be completed less than 1 month prior to the continuation request.

Billing Rule

Provide administration site and CPT codes

Providers must indicate the place of administration and include applicable CPT administration code(s) on the form.

Place of Administration (e.g., Physician's Office, Outpatient Infusion Center, Home Infusion)
Administration code(s) (CPT) — list applicable CPT code(s) on the form

Documentation Required

Acknowledgement signature

The request form must be signed and dated by the requestor. Providing materially false information or concealing material information may constitute a fraudulent insurance act subject to criminal and civil penalties.

Definitions of assessment tools

Term	Definition
HINE-2
Hammersmith Infant Neurological Exam Part 2 — motor assessment tool referenced for baseline and follow-up.
HFMSE
Hammersmith Functional Motor Scale Expanded — motor assessment tool referenced for baseline and follow-up.
CHOP-INTEND
Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders — motor assessment tool referenced for baseline and follow-up.

Policy Summary

PayerAetna

PolicySpinraza (nusinersen) Injectable Precertification Request

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionProviders must submit genetic confirmation of 5q SMA and baseline motor assessments (HINE-2, HFMSE, or CHOP-INTEND) with scores and dates as part of the precertification request.

SourceLink

On This Page

OpenPayer

Spinraza (nusinersen) Injectable Precertification Request

Policy summary and scope

Information and Clinical Documentation Required for Precertification

Initiation of Therapy (patient NOT currently receiving nusinersen)

Re-initiation after Gene Therapy

Continuation Requests (patient currently receiving nusinersen)

Coding fields (to be provided on form)

Required provider actions and documentation

Definitions of assessment tools