CurrentAetnaPolicy N/A

Evrysdi (risdiplam) Medication Precertification Request - Coverage Criteria

Precertification request form and required clinical documentation for initiating or continuing Evrysdi (risdiplam) therapy for patients with spinal muscular atrophy (SMA); used by providers and Aetna for coverage determination.

Policy Summary

PayerAetna

PolicyEvrysdi (risdiplam) Medication Precertification Request - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification form with required clinical documentation to Aetna Precertification for start or continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3pages in form

multipleassessment tools

1-866-752-7021Precert phone

Coverage Criteria for Evrysdi (risdiplam)

Initiation and Continuation Criteria

Requests are assessed based on documentation that ALL of the following are met for initiation or continuation as applicable.

Diagnosis and prescriber: Diagnosis of spinal muscular atrophy (SMA) documented and confirmed by genetic testing (5q SMA homozygous gene mutation, homozygous gene deletion, or compound heterozygote); medication prescribed by or in consultation with a physician who specializes in treatment of SMA.

Form requests confirmation of diagnosis, genetic confirmation, and whether prescribed by an SMA specialist.

SMA type and ventilation: Provider must indicate SMA type (Type 1, 2, 3, SMN Type 4, or Unknown) and whether the patient is dependent on invasive ventilation/tracheostomy or dependent on non-invasive ventilation beyond naps/nighttime.

Fields on form request SMA type and ventilation dependence.

Prior therapies and concomitant treatment: Documentation of prior therapies required: whether the patient previously received gene replacement therapy (e.g., Zolgensma) and whether the requested drug will be used concomitantly with Spinraza. If re-starting after gene therapy, indicate that this was the reason for prescription and provide dates/scores as applicable.

Policy Summary

PayerAetna

PolicyEvrysdi (risdiplam) Medication Precertification Request - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed precertification form with required clinical documentation to Aetna Precertification for start or continuation requests.

SourceLink

On This Page

Continuation criteria: For continuation, documentation of stabilization or improvement in clinical status per the most recent assessments (HINE-2, HFMSE, CHOP-INTEND, MFM32, BSID-III) performed within 1 month prior to the request; specific minimal point improvements or achievement/maintenance of milestones as enumerated on the form are required for each scale.

Form specifies scale-specific thresholds (e.g., HINE-2: >=2 points for kicking or >=1 point for other milestones; HFMSE: >=3 points; CHOP-INTEND: >=4 points; MFM32: clinically significant functional improvement; BSID-III: sit without support >=5 seconds after 12 months).

Provider Actions and Submission Requirements

Prior Authorization

Precertification Required

Precertification is required for Evrysdi (risdiplam). All start or continuation requests must be submitted to Aetna Precertification using the Evrysdi (risdiplam) Medication Precertification Request form. All fields on the form must be completed and legible for precertification review.

Submit requests to Aetna Precertification: Phone 1-866-752-7021, FAX 1-888-267-3277
For Medicare Advantage Part B: Phone 1-866-503-0857, FAX 1-844-268-7263
Form includes indication to mark Start of treatment (with start date) or Continuation of therapy (with date of last treatment)

Note

Treatment History Considerations

Treatment history and concomitant therapy details must be provided on the form. The form asks whether the patient was previously treated with gene replacement therapy (e.g., Zolgensma) and whether the requested drug will be used concomitantly with Spinraza. Providers must indicate if the patient is re-starting therapy after gene therapy and document any clinical worsening after gene replacement therapy when relevant.

Was the patient previously established and re-starting therapy after gene replacement therapy (e.g., Zolgensma)? Yes/No
Was the requested drug prescribed due to clinical worsening after receiving gene replacement therapy? Yes/No
Will the requested drug be used concomitantly with Spinraza? Yes/No

Documentation Required

Required Documentation

Providers must complete all required fields on the Evrysdi precertification form and supply the requested clinical documentation. Required sections include patient, insurance, prescriber and dispensing provider information, product information (dose, frequency, ICD codes), and detailed clinical documentation for initiation or continuation of therapy. For clinical sections, baseline and follow-up assessment dates and scores (HINE-2, HFMSE, CHOP-INTEND, MFM32, BSID-III, or other specified scales) must be provided where applicable.

Complete all form fields including patient demographics, insurance, prescriber, dispensing provider, product (dose, frequency, ICD codes)
For ALL requests: confirm documented diagnosis of SMA and SMA type, ventilation dependency status, and whether medication prescribed by or in consultation with an SMA specialist
For Initiation: provide genetic confirmation of 5q SMA mutation or deletion and baseline motor assessment scores with dates
For Continuation: provide recent assessment (within 1 month) demonstrating stabilization, improvement, or specific changes on HINE-2, HFMSE, or other listed measures; indicate dates and scores
Indicate requested dose based on patient's age and weight (0.2 mg/kg, 0.25 mg/kg, or 5 mg) and confirm daily dose does not exceed recommended dose

Denial Risk

Incomplete Documentation Risk

Failure to provide complete and legible required clinical information and form fields may prompt the plan to request additional information or clarification and may delay review or result in denial.

All required clinical information must be completed in its entirety for precertification review
The plan may request additional information or clarification if needed to evaluate requests

Key Definitions

Diagnosis confirmation (5q SMA) - definition

DefinitionDiagnosis of SMA must be confirmed by genetic testing demonstrating 5q SMA: homozygous SMN1 gene mutation, homozygous gene deletion, or compound heterozygote.

Required form fieldFor initiation of therapy the form requires the provider to confirm genetic diagnostic test result (checkbox) and provide relevant baseline assessment date and scores.

Related documentationGenetic confirmation is listed alongside required baseline motor assessments (HINE-2, HFMSE, CHOP-INTEND, MFM32, BSID-III) to establish eligibility.

Ventilatory dependence - definition

DefinitionVentilatory dependence is defined as dependence on invasive ventilation or tracheostomy, or dependence on non‑invasive ventilation support beyond naps and nighttime sleep.

Required form fieldThe form asks providers to indicate whether the patient is dependent on invasive ventilation/tracheostomy (Yes/No) and whether the patient uses non‑invasive ventilation beyond naps/nighttime (Yes/No).

Relevance to coverageVentilation status is a required element on the precertification form and is used with SMA type and other clinical data to assess initiation or continuation eligibility.

Background

This precertification form is for patients with spinal muscular atrophy (SMA) being considered for Evrysdi (risdiplam). It collects verification of diagnosis and asks providers to confirm the SMA type, ventilatory dependence (invasive tracheostomy or invasive ventilation, and non‑invasive ventilation beyond naps/nighttime), and whether the medication is prescribed by or in consultation with an SMA specialist. For initiation the form requires genetic confirmation of 5q SMA (homozygous mutation, homozygous deletion, or compound heterozygote) and baseline motor assessment using one of the listed standardized scales to establish baseline motor ability; for patients with prior gene therapy the form requests documentation of clinical decline using specified point‑change thresholds on those same scales.

Primary ICD Code	Requested primary diagnosis ICD code (provider to supply)
Secondary ICD Code	Requested secondary diagnosis ICD code (provider to supply)
Other ICD Code	Other ICD codes (provider to supply)

OpenPayer

Evrysdi (risdiplam) Medication Precertification Request - Coverage Criteria

Coverage Criteria for Evrysdi (risdiplam)

Coding (Diagnosis and Procedure Codes)

Provider Actions and Submission Requirements

Key Definitions

Background