CurrentUnitedHealthcarePolicy CSOH2025D0123.E

Qalsody (Tofersen) (Ohio) — Medical Benefit Drug Policy

This policy governs coverage and medical necessity determination for Qalsody (tofersen) under UnitedHealthcare's Medical Benefit Drug Policy for Ohio members. It applies to providers requesting coverage in the state of Ohio and references InterQual criteria for clinical decision-making.

Policy Summary

PayerUnitedHealthcare

PolicyQalsody (Tofersen) (Ohio) — Medical Benefit Drug Policy

Policy CodePolicy CSOH2025D0123.E

Change TypeRoutine review — no change

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization using current InterQual CP: Specialty Rx Non-Oncology, Tofersen criteria to document medical necessity.

SourceLink

POLICY UPDATE CHANGES

Routine review; no change to coverage guidelines.

1HCPCS code listed

1Diagnosis code listed

OhioState-specific applicability

InterQualExternal clinical criteria

Coverage and Medical Necessity

Policy Summary

PayerUnitedHealthcare

PolicyQalsody (Tofersen) (Ohio) — Medical Benefit Drug Policy

Policy CodePolicy CSOH2025D0123.E

Change TypeRoutine review — no change

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization using current InterQual CP: Specialty Rx Non-Oncology, Tofersen criteria to document medical necessity.

SourceLink

On This Page

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InterQual-based coverage criteria

Covered when ALL of the following are met per InterQual

InterQual-determined medical necessity: Use current InterQual CP: Specialty Rx Non-Oncology, Tofersen (Qalsody) guideline to determine if patient meets medical necessity for treatmentrefer to InterQual

Providers must follow InterQual criteria linked in policy

The listing of a procedure or diagnosis code in this policy is provided for reference only and does not imply that the service described by the code is a covered health service. Benefit coverage and payment are determined by applicable federal, state, or contractual requirements and laws, which may mandate coverage in some circumstances. The inclusion of a code in this document does not guarantee reimbursement or claim payment.

This policy underwent a routine review effective 07/01/2025 with no changes to coverage guidelines. Medical necessity determinations for Qalsody (tofersen) continue to be made using the referenced InterQual criteria; providers must follow those external clinical criteria when requesting authorization.

Applicable Codes

Applicable HCPCS CodesHCPCS

J1304

Injection, tofersen, 1 mg.

Applicable Diagnosis CodesICD-10

G12.21

Amyotrophic lateral sclerosis

Provider Requirements and Billing Guidance

Denial Risk

Denial Risk for Unproven or Limited Services

Denial risk: Requests for services that are unproven or otherwise limited by this policy may be denied. Medical necessity for such requests will be evaluated using the Ohio Administrative Code (OAC) 5160-1-01 and the current InterQual guideline referenced in this policy.

Evaluate unproven or limited services per OAC 5160-1-01 and InterQual prior to submission.
Ensure documentation demonstrates medical necessity according to InterQual and state rules.

Prior Authorization

Prior Authorization Required per InterQual

Prior authorization is required. Coverage decisions are based on the medical necessity criteria in the current InterQual® guideline for Qalsody (Tofersen).

Submit prior authorization requests referencing the InterQual CP: Specialty Rx Non-Oncology, Tofersen criteria.
Provide complete clinical documentation to support InterQual medical necessity determinations.

Step Therapy

Step Therapy per InterQual

Step therapy requirements apply as specified in the InterQual CP: Specialty Rx Non-Oncology, Tofersen guideline. Providers must meet any InterQual-defined step requirements before coverage will be approved.

Follow InterQual step therapy rules for Tofersen prior to requesting coverage.
Document prior treatments and reasons for failure/intolerance when requesting an exception to step therapy.

Billing Rule

Coding References for Submissions

Coding and billing: Use the applicable HCPCS and diagnosis codes when submitting authorizations and claims. Inclusion of a code in this policy is for reference only and does not guarantee coverage or payment; verify benefit coverage and payer requirements.

HCPCS: J1304 — Injection, tofersen, 1 mg.
ICD-10: G12.21 — Amyotrophic lateral sclerosis.
Include appropriate supporting documentation with prior authorization and claims to demonstrate medical necessity.

Clinical and Policy Background

Qalsody (tofersen) coverage is governed by external clinical decision support: use the current InterQual CP: Specialty Rx Non‑Oncology, Tofersen guideline to determine medical necessity for both initial and continuation therapy. UnitedHealthcare relies on InterQual criteria for the clinical review and prior authorization process; providers should follow the InterQual requirements and applicable federal, state, or contractual rules when submitting requests for coverage.

Key Definitions

G12.21 — Amyotrophic lateral sclerosis (ICD-10 term)

ICD-10 codeG12.21

DescriptionAmyotrophic lateral sclerosis

Usage noteListed for reference; inclusion does not guarantee coverage or payment — benefit coverage is subject to federal, state, or contractual requirements.

Initial Therapy

Initial therapy coverage is subject to InterQual CP criteria for Tofersen.

InterQual initial: Initial approval requires meeting InterQual specialty Rx non-oncology Tofersen criteriarefer to InterQual

Continuation Therapy

Continuation therapy requirements are determined by the InterQual criteria.

InterQual continuation: Continuation coverage contingent on meeting ongoing InterQual criteriarefer to InterQual

Step Therapy Requirements

Step	Requirement / Note
1	Any step therapy requirements are defined by the current InterQual CP: Specialty Rx Non‑Oncology, Tofersen (Qalsody) guideline; providers should refer to InterQual for specific step therapy rules.

Site-of-Care and Contractual Requirements

Note

Follow federal/state/contract terms for site‑of‑care

Site‑of‑care and coverage decisions must comply with applicable federal, state (Ohio Administrative Code), or contractual requirements, which may override standard benefit plan provisions; check those requirements before requesting coverage.

Federal, state (OAC), or contractual terms govern in the event of a conflict with this policy.