CurrentCignaPolicy V091020

Evrysdi (risdiplam) prior authorization - Coverage Criteria

Prior authorization form and requirements for coverage of Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) for Cigna members. Applies to prescribers requesting coverage or continuation of Evrysdi.

Policy Summary

PayerCigna

PolicyEvrysdi (risdiplam) prior authorization - Coverage Criteria

Policy CodePolicy V091020

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionAttach genetic testing results and supportive documentation confirming bi-allelic SMN1 mutation and provide clinical documentation to support initial or continued therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

urgent phone lineurgent contact

requiredgenetic testing

Accredopreferred pharmacy

Coverage Criteria

Initial and Continuation Coverage Criteria

Coverage consideration is based on provision of ALL required documentation and answers confirming diagnosis and treatment plan.

Documentation and diagnosis: Attach supportive documentation including genetic testing confirming bi-allelic SMN1 mutation (homozygous deletion, homozygous mutation, or compound heterozygous mutation) and, if available, SMN2 copy number; provide objective signs consistent with SMA Types 1–3.

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Prescriber and setting: Prescribed by or in consultation with a physician who specializes in SMA/neuromuscular disorders; indicate site of medication procurement and administration as appropriate (Accredo specialty pharmacy, physician office, home infusion, infusion center, hospital).

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Prior and concurrent therapies: Document prior treatment with Zolgensma and/or Spinraza and indicate whether Evrysdi is a new start, a replacement for another SMA therapy, or being used concurrently; attach details of prior therapies and plan for concurrent use if applicable.

Policy Summary

PayerCigna

PolicyEvrysdi (risdiplam) prior authorization - Coverage Criteria

Policy CodePolicy V091020

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionAttach genetic testing results and supportive documentation confirming bi-allelic SMN1 mutation and provide clinical documentation to support initial or continued therapy.

SourceLink

On This Page

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Safety and dosing information: Confirm patient is not pregnant and has been counseled to use effective contraception during treatment and until 1 month after the last dose; document hepatic impairment status and current weight for dosing calculations.

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Continuation-specific question: If request is for continued therapy, provide documentation of a documented beneficial response (for example, by an objective measurement and/or assessment tool). If no objective benefit, provide clinical rationale for continued use.

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The prior authorization form does not list specific clinical exclusions, but it explicitly requires attachment of supportive documentation (e.g., genetic testing, chart notes, lab/test results) for all answers on the form. Failure to provide the required supportive documentation may preclude coverage because the request cannot be confirmed without the requested evidence.

The form requests documentation of genetic testing and specific confirmation of the SMA diagnosis (see questions about SMN1 results). Failure to document genetic confirmation or to attach other requested clinical information may render the request not approvable, as the form requires these materials to support the clinical diagnosis and coverage decision.

Procedure and Billing Codes

Procedure/CPT Codes (provider-supplied)CPT

CPT Code(s):_______________________________________

Placeholder for procedure/CPT codes to be supplied by provider

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Evrysdi (ridsiplam). Requests must include documentation of the diagnosis of spinal muscular atrophy (SMA), results of genetic testing confirming SMN1 bi-allelic mutation status, and SMN2 copy number when applicable.

Medication: Evrysdi (ridsiplam)
Include genetic testing results confirming SMN1 bi-allelic mutation (homozygous deletion, homozygous mutation, or compound heterozygous mutation)
Document SMN2 copy number (two to four copies) when applicable

Documentation Required

Form Completion & Attestation

Complete all required patient and provider identifying fields on the form. All items marked with an asterisk (*) must be filled in. The prescriber must sign and date the attestation statement affirming the accuracy of the information.

Complete all asterisked fields (patient name, Cigna ID, DOB, prescriber identifiers such as DEA/NPI/TIN)
Prescriber signature and date required on the attestation
Submit via CoverMyMeds or SureScripts to expedite processing

Documentation Required

Prior Therapy Documentation

Provide a full prior therapy history. Indicate prior or current use of other SMA-directed therapies (e.g., Zolgensma, Spinraza) and whether Evrysdi will replace or be used concurrently with other treatments.

Has the patient previously received Zolgensma? (Yes/No)
Has the patient received Spinraza? (Yes/No/Unknown)
If prior or current Spinraza use, indicate if Evrysdi will replace Spinraza, be added concurrently, or if both are being used

Denial Risk

Supportive Documentation Required — Provide All Relevant Records

Attach supportive documentation to the request. Failure to provide required documents (genetic testing results, chart notes, lab/test results) may result in denial or delayed review.

Attach genetic testing results and copies of reports confirming SMN1/SMN2 status
Attach clinic notes, objective measures of benefit for continued therapy, and relevant lab/test results
Incomplete or missing documentation may result in denial of the request

Background

Evrysdi (risdiplam) is an oral medication for spinal muscular atrophy (SMA). The authorization form requests genetic testing information, including whether testing was performed and, if so, documentation confirming SMA with bi-allelic mutations in the SMN1 gene (reported as a homozygous deletion, homozygous mutation, or compound heterozygous mutation). These genetic results and other supportive documentation must be attached to the request to establish diagnosis and support coverage.

Definitions

Genetic confirmation of SMA

Required genetic confirmationDocumentation confirming SMA with bi-allelic SMN1 mutations: at least one of (1) homozygous deletion, (2) homozygous mutation, or (3) compound heterozygous mutation; include copy of genetic test results.

SMN2 copy numberIf available, document SMN2 gene copy number (two to four copies) as requested on the form.

Objective clinical signsDocument objective signs consistent with spinal muscular atrophy Types 1, 2, or 3 (form asks whether such documentation exists).

Prior SMA-directed therapiesReport prior treatments: has the patient received Zolgensma or Spinraza and indicate whether Evrysdi will replace, be added to, or is the only therapy.

Safety and counselingConfirm patient is not pregnant and has been counseled to use effective contraception during treatment and until 1 month after last Evrysdi dose.

Initial Therapy

Initial therapy requires genetic confirmation and clinical documentation.

Diagnosis confirmation: Did the patient undergo genetic testing? Attach copy of results showing diagnosis of SMA with bi-allelic SMN1 mutations (homozygous deletion, homozygous mutation, or compound heterozygous mutation). If available, document SMN2 copy number (two to four copies).

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Clinical signs: Provide documentation of objective signs consistent with spinal muscular atrophy Types 1, 2, or 3 (clinical exam, chart notes, or assessment tools).

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Prescriber specialty: Prescribed by or in consultation with a physician who specializes in the management of patients with spinal muscular atrophy and/or neuromuscular disorders.

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Safety checks: Confirm patient is NOT currently pregnant and document counseling to use effective contraception during treatment and until 1 month after the last Evrysdi dose; document hepatic impairment status and record current weight and dosing.

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Continuation Therapy

For continued therapy the form requests documentation of benefit and whether objective measurement supports continuation.

Continuation benefit: If continued therapy is requested, provide documentation of a documented beneficial response (for example, by an objective measurement and/or assessment tool). If no objective benefit is documented, provide clinical support for continued use of Evrysdi.

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Step Therapy / Prior Treatments

Prior therapy	Received?	How Evrysdi will be used relative to prior therapy
Zolgensma	[ ] Yes [ ] No	(No specific options in form) Provide details in Additional Pertinent Information if prior Zolgensma received; form requests documentation of prior treatment
Spinraza	[ ] Yes [ ] No	Select one: - The patient is NOT taking Spinraza, nor will they in the future (Evrysdi only). - The patient is currently on another Spinraza, but this drug will be stopped and Evrysdi will be started. - The patient is currently on Spinraza, and Evrysdi will be added (may continue both). - The patient is currently on BOTH Evrysdi AND Spinraza. - other/unknown

Site of Care and Specialty Pharmacy

Note

Specify site of care and pharmacy vendor

Indicate the site where medication will be obtained; options include Accredo Specialty Pharmacy (Cigna's nationally preferred specialty pharmacy), physician office stock, home health/home infusion vendor, ambulatory infusion center, or hospital inpatient/outpatient.

Accredo Specialty Pharmacy (preferred)
Physician's office stock
Home Health / Home Infusion vendor
Ambulatory Infusion Center
Hospital – Inpatient or Outpatient