CurrentColorado Rocky Mountain Health PlansPolicy CSOH2025D0123.E

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

Defines medical necessity coverage for Qalsody (tofersen) for Ohio members and describes applicable coding and reference to InterQual criteria; applies to requests evaluated under Ohio Administrative Code 5160-1-01.

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy CSOH2025D0123.E

Change TypeNo material change

Effective DateJuly 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization referencing the current InterQual Tofersen (Qalsody) guideline to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1HCPCS drug code listed

1Diagnosis code listed (ALS)

2025-07-01Effective date

InterQualPrimary clinical coverage reference

Coverage criteria and policy notes

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InterQual criteria: Member meets the current InterQual CP: Specialty Rx Non-Oncology, Tofersen (Qalsody) guideline requirements for treatmentrefer to InterQual

Specific clinical elements (diagnosis, genetic testing, functional status, etc.) are specified in the InterQual guideline; this policy references that external criteria.

Authorization, documentation, and denial triggers

Prior Authorization

InterQual-based prior authorization

Coverage decisions for Tofersen (Qalsody) are based on the current InterQual® guideline for Tofersen (Qalsody). Prior authorization is required before services are rendered.

Prior authorization required for Tofersen (Qalsody)
Refer to current InterQual® criteria for medical necessity

Step Therapy

Step therapy

No step therapy requirements are specified in this policy. Coverage determinations should follow the InterQual® criteria referenced above.

Documentation Required

Documentation and governing rules

When submitting requests, providers must reference and follow applicable federal, state (Ohio Administrative Code), or contractual requirements for benefit plan coverage. In the event of a conflict, federal, state (OAC), or contractual requirements govern. UnitedHealthcare may use third‑party tools such as InterQual® to assist in administering benefits.

Check applicable federal, state (OAC), or contractual requirements before submitting requests
UnitedHealthcare may modify policies; policy is informational and not medical advice

Denial Risk

Denial triggers

Requests for services that are described as unproven or that are subject to coverage or quantity limits will be evaluated using Ohio Administrative Code 5160-1-01 and may be denied if they do not meet medical necessity under that rule or the InterQual® criteria.

Services stated as unproven or subject to limits will be reviewed under OAC 5160-1-01
Denials may occur if medical necessity criteria are not met per InterQual® or applicable regulations

Initial therapy — InterQual requirements

Initial therapy

Initial approval criteria are those specified in the InterQual guideline.

Initial therapy per InterQual: Member meets InterQual initial therapy criteria for Tofersen (Qalsody)refer to InterQual

Policy directs to InterQual for the detailed clinical requirements.

Ongoing therapy — continuation rules

Continuation therapy

Continuation therapy coverage follows InterQual ongoing therapy rules.

Continuation per InterQual: Continued coverage requires meeting ongoing therapy criteria in the InterQual guideline for Tofersen (Qalsody)refer to InterQual

Policy references InterQual for specific continuation requirements.

Step	Requirement / Notes	Coverage Status
1	No internal step therapy sequence specified; coverage determinations are made by the current InterQual CP: Specialty Rx Non‑Oncology, Tofersen (Qalsody) guideline. Refer to InterQual for specific clinical requirements for initial and ongoing therapy.	Coverage determined by InterQual criteria

Site-of-care guidance

Note

No site-of-care restrictions specified

This policy does not impose site-of-care restrictions for administration of Qalsody (tofersen); providers should follow the plan, federal, and state rules when selecting the infusion center or other site of care.

If federal, state (OAC), or contractual requirements specify site-of-care rules, those requirements take precedence.

Clinical background

Qalsody (tofersen) is a therapy used in conditions associated with amyotrophic lateral sclerosis (ALS). Coverage and medical necessity determinations for Qalsody are made by applying the current InterQual® Specialty Rx Non‑Oncology, Tofersen (Qalsody) guideline; initial and ongoing approval must meet the InterQual criteria. Providers should follow applicable state and contractual rules when submitting requests.