CurrentColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial PlansPolicy 2025 P 2217-7

Evrysdi® (risdiplam) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Defines initial authorization and reauthorization medical necessity criteria, prescriber requirement, required documentation, and limits for Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) for UnitedHealthcare Commercial Plans under Colorado Rocky Mountain Health Plans program. Effective date listed as 2025-06-01 in header; authorization duration specified for reauthorization.

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial Plans

PolicyEvrysdi® (risdiplam) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 2217-7

Change TypeRevised criteria (including prior gene therapy pathway)

Effective DateJun 1, 2025

Next Review Date

Key ActionFor initial authorization submit medical records confirming SMA diagnosis, SMN1 mutation/deletion documentation, baseline motor exam results, ventilation status, prior gene therapy history, and note prescriber is a neurologist or in consultation with one.

SourceLink

POLICY UPDATE CHANGES

Revised criteria for patients that have documented decline from pretreatment baseline status following administration of gene replacement therapy.

Revised prescriber requirement and updated Upper Limb Module to Revised Upper Limb Module test.

Updated criteria to align with new labeled indication in patients of all ages.

12Authorization duration (reauth)

5Accepted baseline motor assessments

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Required positive response exams

Allowed with declinePrior gene therapy pathway

Coverage Summary

Coverage stance: covered_with_criteria for Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA).

Scope summary: Defines initial authorization and reauthorization medical necessity criteria, prescriber requirement, required documentation, and limits for Evrysdi (risdiplam) for treatment of SMA for UnitedHealthcare Commercial Plans under Colorado Rocky Mountain Health Plans program.

Effective date: 2025-06-01. Authorization duration for reauthorization: 12 months.

Policy metadata

Policy number2025 P 2217-7

PayerColorado Rocky Mountain Health Plans / UnitedHealthcare Commercial Plans

Effective date2025-06-01

Last review2025-04

StatusCURRENT

Authorization duration12 months (reauthorization)

Initial Therapy Criteria

Initial Authorization

Evrysdi will be approved based on all of the following criteria:

ALL of the following

Diagnosis of spinal muscular atrophy (SMA)
ALL of the following
- ONE of
  - Homozygous gene deletion or mutation of SMN1 gene (e.g., homozygous deletion of exon 7 at locus 5q13)
  - Compound heterozygous mutation of SMN1 gene (e.g., deletion of SMN1 exon 7 [allele 1] and mutation of SMN1 [allele 2])
Ventilation status

Continuation / Reauthorization Criteria

Reauthorization

Evrysdi will be approved for reauthorization based on all of the following criteria:

ALL of the following

ALL of the following
- ANY of the following
  - CHOP INTEND: Improvement or maintenance of previous improvement of at least a 4 point increase in score from pretreatment baseline OR patient has achieved and maintained any new motor milestone from pretreatment baseline when they would otherwise be unexpected to do so>= 4 point increase
  - HINE-2: One of: improvement or maintenance of previous improvement of at least 2 point (or maximal score) increase in ability to kick; OR improvement or maintenance of previous improvement of at least 1 point increase in any other HINE-2 milestone (excluding voluntary grasp); OR net positive change in HINE motor milestones (more improved/maintained than worsened); OR achievement and maintenance of any new motor milestone

Provider Actions

Prior Authorization

Submit medical records for initial authorization

Submit medical records confirming SMA diagnosis, documentation of SMN1 mutation or deletion (e.g., homozygous deletion of exon 7 or compound heterozygous mutation), baseline motor exam results (at least one of CHOP INTEND, HINE-2, HFMSE, RULM, MFM-32), ventilation status (not dependent on invasive ventilation or non-invasive ventilation beyond naps/nighttime), prior gene therapy history, and a note that the prescriber is a neurologist or in consultation with one.

Confirm SMA diagnosis
Provide SMN1 mutation/deletion documentation (e.g., exon 7 deletion or compound heterozygous mutation)
Include baseline motor exam results: CHOP INTEND, HINE-2, HFMSE, RULM, or MFM-32 (at least one)
Document ventilation status (no invasive ventilation; no chronic non‑invasive ventilation beyond naps/nighttime)
Document prior gene replacement therapy history
Note prescriber is a neurologist or in consultation with a neurologist experienced in SMA

Prior Authorization

Submit medical records for reauthorization

Applicable Codes

Diagnosis codes referencedICD-10

No codes listed

Clinical Evidence & Rationale

Evrysdi (risdiplam) is an SMN2 splicing modifier indicated for treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

This policy sets medical necessity criteria for initiation and continuation of Evrysdi, and specifies required clinical assessments and documentation to establish baseline and measure response.

Key evidence and administrative references include P&T approval history: 9/2020, 9/2021, 7/2022, 8/2023, 7/2024, 12/2024, 4/2025, and the manufacturer package insert: Evrysdi [package insert], Genentech; September 2024.

Definitions

Clinically meaningful functional decline: Documented loss of motor milestone or decline in function since receiving gene replacement therapy.

Concomitant chronic SMN modifying therapy: Ongoing treatment with other SMN modifying agents such as nusinersen (Spinraza).

Revision History

April 2025revisedLatest

Revised criteria for patients that have documented decline from pretreatment baseline status following administration of gene replacement therapy.

December 2024revised

Revised prescriber requirement and updated Upper Limb Module to Revised Upper Limb Module test.

July 2022revised

Policy Summary

PayerColorado Rocky Mountain Health Plans | UnitedHealthcare Commercial Plans

PolicyEvrysdi® (risdiplam) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 2217-7

Change TypeRevised criteria (including prior gene therapy pathway)

Effective DateJun 1, 2025

Next Review Date

SourceLink

On This Page

Invasive ventilation
Use of non-invasive ventilation beyond use for naps and nighttime sleep

Patient is not receiving concomitant chronic survival motor neuron (SMN) modifying therapy (e.g., Spinraza [nusinersen])

ALL of the following

ANY of the following
- Patient has not previously received gene replacement therapy for the treatment of SMA (e.g., Zolgensma [onasemnogene abeparvovec-xioi])
- OR - Prior gene therapy with documented decline: Patient has previously received gene replacement therapy for SMA AND submission of medical records documenting a clinically meaningful functional decline (e.g., loss of motor milestone) since receiving gene replacement therapy

ALL of the following

One or more of the following baseline motor exams: CHOP INTEND; HINE-2; HFMSE; Revised Upper Limb Module (RULM) Test; Motor Function Measure 32 (MFM-32)

Prescribed by or in consultation with a neurologist with expertise in the treatment of SMA

kick >= 2 points; other milestones >= 1 point

excludes voluntary grasp

HFMSE: Improvement or maintenance of previous improvement of at least a 3 point increase in score from pretreatment baseline OR patient has achieved and maintained any new motor milestone from pretreatment baseline when they would otherwise be unexpected to do so>= 3 point increase

RULM: Improvement or maintenance of previous improvement of at least a 2 point increase in score from pretreatment baseline OR patient has achieved and maintained any new motor milestone from pretreatment baseline when they would otherwise be unexpected to do so>= 2 point increase

MFM-32: Improvement or maintenance of previous improvement of at least a 3 point increase in score from pretreatment baseline OR patient has achieved and maintained any new motor milestone from pretreatment baseline when they would otherwise be unexpected to do so>= 3 point increase

Ventilation status: Patient is not dependent on either of the following: invasive ventilation; use of non-invasive ventilation beyond use for naps and nighttime sleep

Patient is not receiving concomitant chronic SMN modifying therapy (e.g., Spinraza [nusinersen])

Prescribed by or in consultation with a neurologist with expertise in the treatment of SMA

Numeric thresholds

CHOP INTEND>= 4 point increase from pretreatment baseline

HINE-2 kick>= 2 point (or maximal score) increase in ability to kick from pretreatment baseline

HINE-2 other milestones>= 1 point increase in any other HINE-2 milestone from pretreatment baseline (excluding voluntary grasp)

HFMSE>= 3 point increase from pretreatment baseline

RULM>= 2 point increase from pretreatment baseline

MFM-32>= 3 point increase from pretreatment baseline

Submit recent medical records showing a positive clinical response to Evrysdi compared to pretreatment baseline on at least one accepted motor exam (examples and thresholds: CHOP INTEND ≥4‑point improvement or new unexpected motor milestone; HINE‑2: ≥2‑point increase in kicking or ≥1‑point in other milestones or net positive milestones; HFMSE ≥3‑point improvement or new milestone; RULM ≥2‑point improvement or new milestone; MFM‑32 ≥3‑point improvement or new milestone). Also document ventilation status (permitted uses exclude invasive or chronic non‑sleep/non‑nap non‑invasive ventilation) and that the prescriber is a neurologist or in consultation with one.

Provide most recent motor exam results comparing to pretreatment baseline
CHOP INTEND: ≥4‑point increase or new unexpected motor milestone
HINE‑2: ≥2‑point increase in kicking or ≥1‑point in other milestones or net positive milestone count
HFMSE: ≥3‑point increase or new unexpected motor milestone
RULM: ≥2‑point increase or new unexpected motor milestone
MFM‑32: ≥3‑point increase or new unexpected motor milestone
Document ventilation status and prescriber specialty

Documentation Required

Document clinically meaningful decline after gene therapy

If the patient previously received gene replacement therapy, submit medical records documenting a clinically meaningful functional decline (for example, loss of a motor milestone) since receiving gene therapy to qualify under the prior gene therapy pathway.

Documentation must show clinically meaningful functional decline since gene replacement therapy (e.g., loss of motor milestone)

Documentation Required

Prescriber specialty requirement

Evrysdi must be prescribed by, or in consultation with, a neurologist with expertise in the treatment of spinal muscular atrophy.

Denial Risk

Concomitant SMN therapy exclusion

Claims may be denied if the patient is receiving concomitant chronic SMN modifying therapy (for example, nusinersen/Spinraza); Evrysdi is not approved for use with ongoing chronic SMN modifying therapy.

Do not continue concurrent chronic SMN modifying therapy (e.g., nusinersen) when requesting Evrysdi

Billing Rule

Authorization duration

Reauthorization (authorization for continued therapy) will be issued for 12 months.

Updated criteria to align with new labeled indication in patients of all ages.