Qalsody (tofersen) (Intrathecal) — Coverage Criteria
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Defines prior authorization, dosing, eligibility, renewal, billing codes, and documentation requirements for intrathecal Qalsody (tofersen) in members with SOD1-mutant ALS under Viva Health.
No material clinical or coverage changes in this revision.
Coverage Criteria for Qalsody (tofersen)
Initial Therapy
Covered when ALL of the following are met:
See ALSFRS-R definition and scoring in source (chunk 5).
Continuation/Renewal Therapy
Renewal may be authorized when ALL of the following are met:
Unacceptable toxicity examples are illustrative, not exhaustive.
Therapy is considered inappropriate when the member experiences unacceptable toxicity attributable to intrathecal tofersen. The policy lists illustrative examples of such toxicity including serious myelitis or radiculitis, papilledema or elevated intracranial pressure, and aseptic meningitis. These examples are intended to be illustrative, not exhaustive, and the presence of such adverse events can preclude renewal of authorization.
Members without a documented pathogenic SOD1 mutation, or who do not meet the required ALS diagnostic or baseline functional and respiratory thresholds, are not eligible for coverage. Specifically, the policy requires a diagnosis of clinically definite or probable ALS using El Escorial revised, Gold Coast, or Awaji criteria; a baseline %SVC ≥ 65%; and baseline documentation of retained function with a score of 2 or better on each individual ALSFRS‑R item.
Billing and Coding
| J1304 | Injection, tofersen, 1 mg; 1 billable unit = 1 mg |
| 64406-0109-xx | 100 mg/15 mL solution in a single-dose glass vial (preservative free) |
| G12.21 | Amyotrophic lateral sclerosis |
Provider Actions, Prior Authorization, and Documentation
Prior authorization required; duration and billing code
Prior authorization is required for Qalsody (tofersen). The initial prior authorization validity will be provided for 6 months (180 days); renewals may be authorized every 12 months (365 days) thereafter. Use HCPCS code J1304 (Injection, tofersen, 1 mg; 1 billable unit = 1 mg) for billing.
- Initial PA: 6 months (180 days).
- Renewal interval: every 12 months (365 days).
- Billing code: J1304 (1 mg/unit).
NQTL justification: cost-driven PA
Prior authorization is applied in part due to the cost of the drug, as noted in the NQTL (Non‑Quantitative Treatment Limitations) checklist where 'Cost of drug' was identified as a factor prompting consideration for PA.
- NQTL checklist identifies 'Cost of drug' as a reason to consider prior authorization.
Required documentation to support prior authorization
Providers must submit specific clinical and billing documentation with PA requests to establish eligibility and allow review.
- Member age: documentation that member is at least 18 years of age.
- Baseline plasma neurofilament light chain (NfL) measurement.
- Diagnosis documentation: clinically definite or probable ALS based on El Escorial revised, Gold Coast, or Awaji criteria.
- Genetic confirmation of a pathogenic SOD1 gene mutation.
- Baseline respiratory function: slow vital capacity (%SVC) ≥ 65%.
- Baseline functional status: ALSFRS‑R item scores documented with each individual item ≥ 2.
- Dosing plan consistent with intrathecal administration.
- Billing units: use HCPCS J1304 (1 mg per billable unit) for claims.
Renewal denial triggers
Renewal requests may be denied if evidence shows unacceptable toxicity, lack of biomarker improvement, or rapid clinical decline while on therapy.
- Unacceptable toxicity examples include serious myelitis/radiculitis, papilledema/elevated intracranial pressure, aseptic meningitis.
- No improvement in plasma NfL levels compared to baseline may lead to denial.
- Rapid disease progression on therapy or a cumulative ALSFRS‑R score ≤ 3 may result in denial of renewal.
Background
Qalsody (tofersen) is an intrathecal antisense oligonucleotide indicated for ALS due to pathogenic SOD1 mutations. This policy establishes coverage with criteria that define required diagnostic documentation (accepted ALS diagnostic criteria), baseline respiratory and functional thresholds (%SVC ≥ 65% and minimum ALSFRS‑R item scores of 2), and monitoring requirements such as baseline and on‑treatment plasma neurofilament light chain (NfL). Renewal decisions require continued meeting of initial criteria, absence of unacceptable toxicity, improvement in plasma NfL from baseline, and disease stability or slowed decline on ALSFRS‑R.
Definitions and Clinical Measures
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