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    v1.0.28
    OpenPayerPolicy UpdatesNeurology/Neurosurgerymoda_health_plan_inc Qalsody Coverage Prior Auth |…
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    Currentmoda_health_plan_incPolicy IC-0704

    Qalsody (tofersen) (Intrathecal) — Coverage Criteria

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    Defines prior authorization, dosing, coding, and medical necessity criteria for intrathecal Qalsody (tofersen) for members with SOD1‑mutation amyotrophic lateral sclerosis (ALS) and who meet specified clinical measures. Applies to Moda Health Plan Inc coverage determinations.

    Policy Summary
    Payermoda_health_plan_inc
    PolicyQalsody (tofersen) (Intrathecal) — Coverage Criteria
    Policy CodePolicy IC-0704
    Change TypeNo material change
    Effective Date
    Last ReviewJul 1, 2026
    Next Review DateJul 1, 2026
    Key ActionObtain prior authorization and provide documentation of age ≥18, SOD1 mutation, baseline %SVC ≥65%, baseline ALSFRS‑R item scores (each ≥2), and baseline plasma NfL.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsinitial PA validity
    12 monthsrenewal interval
    100 mgdose per admin
    J1304HCPCS

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    G12.21ICD-10

    Coverage and Medical Necessity Criteria

    Initial Approval Criteria

    Covered when ALL of the following are met:

    Initial authorization criteria: Member is at least 18 years of age
    Initial authorization criteria: Baseline plasma neurofilament light chain (NfL) measurement documented
    Initial authorization criteria: Diagnosis of clinically definite or probable amyotrophic lateral sclerosis (ALS) based on El Escorial revised criteria, Gold Coast criteria, or Awaji criteria
    Initial authorization criteria: Presence of a pathogenic mutation in the superoxide dismutase 1 (SOD1) gene
    Initial authorization criteria: Slow vital capacity (%SVC) ≥ 65%>= 65%
    Initial authorization criteria: Baseline documentation of retained functionality for most activities of daily living: ALSFRS‑R item scores of 2 or better on each individual item

    Renewal Criteria

    Renewal may be authorized when ALL of the following are met:

    Renewal authorization criteria: Member continues to meet the indication‑specific criteria from Initial Approval
    Renewal authorization criteria: Absence of unacceptable toxicity from the drug (examples include: serious myelitis, radiculitis, papilledema with elevated intracranial pressure, aseptic meningitis)
    Renewal authorization criteria: Improvement in plasma neurofilament light chain (NfL) levels compared with baseline
    Renewal authorization criteria: Clinical response defined as disease stability or mild progression indicating a slowing of decline on the ALSFRS‑R (no rapid disease progression while on therapy)

    Unacceptable toxicity observed during therapy may preclude renewal of prior authorization. Examples of unacceptable toxicity expressly cited in the policy include serious myelitis, radiculitis, papilledema with elevated intracranial pressure, and aseptic meningitis. Documented occurrence of these or similar severe adverse events should prompt reassessment and may result in denial of continued coverage.

    Requests for Qalsody (tofersen) will be considered not medically necessary when the member does not meet the policy’s diagnostic, genetic, respiratory, or functional criteria. Specifically, therapy is not supported if the member lacks a documented SOD1 gene mutation, does not have a diagnosis of clinically definite or probable ALS by El Escorial revised, Gold Coast, or Awaji criteria, or has a baseline % Slow Vital Capacity (SVC) < 65%. In addition, the policy requires baseline documentation of retained functionality on the ALSFRS‑R (each item scored 2 or better); absence of this baseline preservation or evidence of rapid disease progression are also exclusions for coverage. Providers should include the required baseline measurements to avoid denial.

    Billing, Diagnosis, and Product Codes

    Covered HCPCS CodesHCPCSCovered
    J1304Injection, tofersen, 1 mg; 1 billable unit = 1 mg
    NDCNDC
    64406-0109-xx100 mg/15 mL solution in a single-dose glass vial (preservative free)
    Covered ICD-10 CodesICD-10Covered
    G12.21Amyotrophic lateral sclerosis
    inv-08: % Slow Vital Capacity (SVC) — threshold requirement
    Threshold% Slow Vital Capacity (SVC) ≥ 65%
    Context in criteriaRequired for initial authorization and renewal determinations (member must have %SVC ≥65%)
    Measurement%SVC (percent predicted) — respiratory function assessment used to evaluate eligibility

    Authorization, Documentation, and Utilization Management

    Prior Authorization

    Prior authorization validity

    Initial prior authorization is valid for 6 months (180 days); renewals may be authorized every 12 months (365 days).

    Note

    PA applied as a utilization management NQTL

    Prior authorization is applied as a utilization management NQTL; factors considered in applying PA include the drug indication and the cost of the drug.

    • PA functions as a utilization management method (NQTL).
    • Design considerations included indication and drug cost.

    Clinical Background

    Qalsody (tofersen) is an intrathecal antisense oligonucleotide indicated for treatment of amyotrophic lateral sclerosis associated with mutations in the SOD1 gene. This policy limits use to adults (age ≥18) with genetically confirmed SOD1‑mutation ALS who meet respiratory and functional thresholds, including baseline % SVC ≥ 65% and preserved function on the ALS Functional Rating Scale‑Revised (ALSFRS‑R) (each item scored 2 or better). Baseline plasma neurofilament light chain (NfL) is also required and used to monitor response over time.

    Key Measure Definitions

    inv-14: ALS Functional Rating Scale - Revised (ALSFRS‑R) — scale description and scoring (12 items, 0–4 each, total 48)
    Scale description12-item questionnaire assessing bulbar, fine motor, gross motor, and respiratory function
    Scoring per itemEach item scored 0–4 on a five-point ordinal scale (0 = loss/significant impairment; 4 = normal function)
    Total score rangeTotal possible score 0–48 (sum of 12 items)
    Baseline requirementPolicy requires a score of 2 or better on each individual ALSFRS‑R item at baseline (minimum total 24 if each item ≥2)
    Policy Summary
    Payermoda_health_plan_inc
    PolicyQalsody (tofersen) (Intrathecal) — Coverage Criteria
    Policy CodePolicy IC-0704
    Change TypeNo material change
    Effective Date
    Last ReviewJul 1, 2026
    Next Review DateJul 1, 2026
    Key ActionObtain prior authorization and provide documentation of age ≥18, SOD1 mutation, baseline %SVC ≥65%, baseline ALSFRS‑R item scores (each ≥2), and baseline plasma NfL.
    SourceLink
    On This Page
    Coverage and Medical Necessity CriteriaBilling, Diagnosis, and Product CodesAuthorization, Documentation, and Utilization ManagementClinical BackgroundKey Measure Definitions
    Renewal authorization criteria:
    Member does not have a cumulative ALSFRS‑R score ≤ 3
    Documentation Required

    Required documentation to support PA

    Provider must supply documentation that the member is ≥18 years, baseline plasma neurofilament light chain (NfL) is measured, diagnostic evidence of clinically definite or probable ALS per El Escorial/Gold Coast/Awaji criteria is present, SOD1 mutation is documented, %SVC is ≥65%, and baseline ALSFRS‑R item scores are each ≥2. Billing should use HCPCS J1304 and the applicable NDC when relevant.

    • Age ≥18 documented.
    • Baseline plasma NfL level recorded.
    • Diagnostic criteria for ALS (El Escorial revised, Gold Coast, or Awaji) documented.
    • Presence of SOD1 gene mutation documented.
    • %SVC ≥65% documented.
    • Baseline ALSFRS‑R item scores (each item ≥2) documented.
    • Use HCPCS code J1304 and applicable NDC (64406-0109-xx) for billing.
    Denial Risk

    Denial triggers for PA

    Requests will be denied if the member fails to meet age, diagnostic, genetic, respiratory, or baseline ALSFRS‑R criteria, or if unacceptable toxicity is present at renewal.

    • Member is <18 years of age.
    • No documentation of clinically definite or probable ALS per required criteria.
    • No documented SOD1 mutation.
    • %SVC <65%.
    • Baseline ALSFRS‑R items scored <2.
    • Unacceptable toxicity on therapy (examples: serious myelitis, radiculitis, papilledema with elevated intracranial pressure, aseptic meningitis).