Tofersen (Qalsody) (ARCHIVED)

Policy ID: I-9032-004

Section: Injections

Effective Date: April 25, 2023

Revised Date: October 20, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-9032-004

Section: Injections

Effective Date: April 25, 2023

Revised Date: October 20, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Tofersen (Qalsody™) is an antisense oligonucleotide indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain observed in patients treated with tofersen (Qalsody). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial.

Policy Application

All claims submitted under this policy's section will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Tofersen (Qalsody) is considered experimental/investigational and therefore non-covered as there is a lack of conclusive evidence confirming clinical efficacy.

Procedure Code

J1304

Diagnosis Codes

Not Applicable for this policy

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-23-2023 Effective April 25, 2023

Adopted new experimental/investigational policy

Internal Medical Policy Committee 9-12-2023 Effective October 01, 2023

Added new code, C9157, to the policy

Internal Medical Policy Committee 11-15-2023 Effective January 01, 2024

Added new code J1304
Removed code C9157

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Our Partners in Health:
Members
Employers
Producers

Fargo (Headquarters)
4510 13th Ave. S.
Fargo, N.D., 58121

Medical Policies Quick Search