CurrentUnitedHealthcarePolicy N/A

Evrysdi (risdiplam) prior authorization form — coverage criteria

Form for prescribers requesting initial authorization or reauthorization of Evrysdi (risdiplam) for beneficiaries with 5q‑autosomal recessive spinal muscular atrophy (SMA); documents clinical criteria and prescriber attestation used by UnitedHealthcare.

Policy Summary

PayerUnitedHealthcare

PolicyEvrysdi (risdiplam) prior authorization form — coverage criteria

Policy CodePolicy N/A

Change TypeAdministrative — no material changes noted

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form including diagnosis, SMA phenotype, specialist involvement, concomitant‑use status, adverse effects, and documented evidence of clinically meaningful response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Initial + ReauthRequest types

6 itemsRequired responses

30–365 daysTherapy durations

Motor/respiratory/weightAccepted evidence types

Coverage Criteria for Evrysdi (risdiplam)

inv-01: Initial Authorization

Covered when ALL of the following are met for initial authorization

Initial Authorization - Evrysdi: Beneficiary has a diagnosis of 5q-autosomal recessive spinal muscular atrophy (SMA).

Answered on form question 1.

Beneficiary SMA phenotype documented (1, 2, or 3).

Answered on form question 2.

Prescriber indicates whether Evrysdi will be used concomitantly with nusinersen (Spinraza) or onasemnogene abeparvovec (Zolgensma).

Answered on form question 3.

Medication is prescribed by or in consultation with a neurologist (prescriber attests).

Answered on form question 4.

Policy Summary

PayerUnitedHealthcare

PolicyEvrysdi (risdiplam) prior authorization form — coverage criteria

Policy CodePolicy N/A

Change TypeAdministrative — no material changes noted

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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inv-02: Reauthorization / Continuation Therapy

Covered continuation when ALL of the following are addressed for reauthorization

Reauthorization - Adverse Effects/Toxicity: Documentation of presence or absence of treatment-related adverse effects or unacceptable toxicity.

Answered on form question 5; prescriber signature required.

Reauthorization - Clinical Response: Documentation of clinically meaningful response demonstrated by at least ONE of the following: stability or improvement in net motor function/milestones on validated scales (HINE, HFMSE, CHOP INTEND, BSID-III, 6MWT, ULM, MFM-32, RULM, etc.); stability or improvement in respiratory function tests (e.g., FVC); reduction in respiratory exacerbations requiring hospitalization and/or antibiotics in the preceding year/timeframe; stable or increased patient weight (for patients without a gastrostomy tube); or slowed rate of decline in the aforementioned measures.At least 1 outcome measure must be checked

Answered on form question 6; prescriber signature mandatory.

For reauthorization, the prescriber must document the presence or absence of treatment‑related adverse effects or unacceptable toxicity and must demonstrate a clinically meaningful response by selecting at least one of the listed outcome measures. If the record documents unacceptable treatment‑related toxicity or fails to show clinically meaningful response on the form (for example, no stability/improvement on validated motor scales, no improvement/stability in respiratory tests, no reduction in respiratory exacerbations, no appropriate weight stability/increase, or no slowed rate of decline), continuation of Evrysdi may be considered not medically necessary and the request may be denied.

Initial Therapy Criteria

inv-15: Initial Authorization

Initial authorization prerequisites

Initial Therapy: Confirm diagnosis of 5q-autosomal recessive spinal muscular atrophy (SMA).

Form question 1.

Document SMA phenotype (1, 2, or 3).

Form question 2.

Disclose concomitant use with nusinersen (Spinraza) or onasemnogene abeparvovec (Zolgensma).

Form question 3.

Confirm medication is prescribed by or in consultation with a neurologist.

Form question 4.

Continuation / Reauthorization Criteria

inv-16: Reauthorization

Reauthorization requires documentation of adverse effects and clinical benefit

Reauthorization: Document absence or presence of unacceptable treatment-related toxicity and demonstrate clinically meaningful response by at least one specified measure (motor scales, respiratory tests such as FVC, reduction in respiratory exacerbations requiring hospitalization/antibiotics, stable/increased weight for patients without gastrostomy, or slowed rate of decline).At least 1 specified measure required to demonstrate response

Prescriber signature required on reauthorization form; see questions 5–6.

Provider Actions and Documentation Requirements

Prior Authorization

Evrysdi Prior Authorization Required

Prior authorization for Evrysdi requires completion of the prior authorization form with all requested fields for initial or reauthorization requests. Incomplete forms or missing required answers may delay review or result in denial.

Initial and reauthorization requests must use the Evrysdi PA form and include the clinical answers and documentation described below.
Ensure prescriber signature and date are present on all submissions.

Documentation Required

Required Form Fields and Signature

The PA form must include completed beneficiary demographics, prescriber NPI and contact information, drug name/strength/quantity per 30 days, selected length of therapy, and the prescriber signature with date. The prescriber signature is mandatory and submissions without it may be returned or denied.

Beneficiary: last name, first name, beneficiary ID, DOB, gender.
Prescriber: name, NPI, requester contact name, phone and ext.
Drug: name, strength, quantity per 30 days, and selected length of therapy (30–365 days options).
Prescriber signature and date (mandatory).

Documentation Required

Clinical Answers Required (Initial Requests)

For initial authorization the form asks specific clinical questions that must be answered and documented. Failure to document diagnosis or answer required clinical questions may lead to denial.

Confirm whether the beneficiary has a diagnosis of 5q-autosomal recessive spinal muscular atrophy (SMA) (Yes/No).
Document whether the beneficiary has SMA phenotype 1, 2, or 3 (Yes/No).
Indicate if Evrysdi will be used concomitantly with nusinersen (Spinraza) or onasemnogene abeparvovec-xioi (Zolgensma) (Yes/No).
Confirm the medication is prescribed by or in consultation with a neurologist (Yes/No).

Denial Risk

Diagnosis Documentation Required

A documented diagnosis of 5q-autosomal recessive SMA is required. If the diagnosis question is left unanswered or answered 'No', the request may be denied.

Provide documentation supporting the diagnosis of 5q-autosomal recessive SMA (genetic testing or clinical documentation).

Denial Risk

Specialist Involvement Required

Requests must indicate that the medication is prescribed by or in consultation with a neurologist. If the prescriber does not indicate neurologist involvement, the request may be denied.

Include consult notes or documentation of neurologist involvement when applicable.

Prior Authorization

Reauthorization Response Criteria

For reauthorization, the form requires documentation of absence of unacceptable toxicity and evidence of clinically meaningful response. Lack of documented benefit or presence of unacceptable treatment-related toxicity may trigger denial of continued coverage.

Report any treatment-related adverse effects or unacceptable toxicity (Yes/No).
Provide evidence of clinically meaningful response with at least one of the listed measures (motor function scales, respiratory function tests, reduced hospitalizations for respiratory infections, stable/increased weight when appropriate, or slowed rate of decline).
If 'Other' is selected, include supporting explanation and documentation.

Step Therapy / Concomitant Treatment

Step	Requirement / Question	Notes
1	Does the beneficiary have a diagnosis of 5q-autosomal recessive spinal muscular atrophy (SMA)?	Form requires Yes/No response for initial authorization (question 1).
2	Does the beneficiary have SMA phenotype 1, 2, or 3?	Form requires Yes/No response to document phenotype (question 2).
3	Will the beneficiary use Evrysdi concomitantly with nusinersen (Spinraza) or onasemnogene abeparvovec (Zolgensma)?	Form asks concomitant-use status but does not mandate a prior therapy or step sequence (question 3).
4	Is this medication being prescribed by or in consultation with a neurologist?	Form requires documentation of neurologist involvement for initial authorization (question 4).

Definitions and Clinically Meaningful Response

SMA — 5q‑autosomal recessive spinal muscular atrophy (SMA)

Diagnosed condition5q-autosomal recessive spinal muscular atrophy (SMA) — prescriber must indicate Yes/No on initial authorization.

Phenotype documentationPrescriber must document SMA phenotype 1, 2, or 3 (Yes/No checkbox on form).

Concomitant therapy disclosurePrescriber must indicate whether Evrysdi will be used concomitantly with nusinersen (Spinraza) or onasemnogene abeparvovec (Zolgensma).

Specialist involvementPrescriber must confirm medication is prescribed by or in consultation with a neurologist.

Clinically meaningful response — acceptable outcome measures

Validated motor scales and milestonesEvidence may include stability or improvement on HINE, HFMSE, CHOP INTEND, BSID-III, 6MWT, ULM, MFM-32, RULM, etc.

Respiratory functionStability or improvement in respiratory function tests (e.g., forced vital capacity [FVC]).

Respiratory exacerbationsReduction in exacerbations requiring hospitalization and/or antibiotic therapy in the preceding year/timeframe.

Weight and nutritionStable or increased patient weight for patients without a gastrostomy tube.

Slowed declineDocumentation of slowed rate of decline in the aforementioned measures (motor/respiratory/weight).

Background

Spinal muscular atrophy (SMA) is a genetic neuromuscular disorder caused by loss of SMN1 function; the prior‑authorization form is specific to beneficiaries with 5q‑autosomal recessive SMA. Risdiplam (Evrysdi) is an oral, SMN‑enhancing disease‑modifying therapy used across SMA phenotypes. The form captures essential clinical details for both initiation and continuation of therapy — initial requests require confirmation of diagnosis, SMA phenotype, concomitant‑use status with nusinersen or onasemnogene abeparvovec, and neurologist involvement, while reauthorization requires documentation of adverse effects/toxicity and evidence of clinically meaningful response using validated motor and respiratory measures or other listed outcomes.

OpenPayer