Casimersen (Amondys-45)

Policy ID: I-236-004

Section: Injections

Effective Date: March 15, 2021

Revised Date: September 15, 2021

Revision Effective Date: October 01, 2021

Last Reviewed: September 12, 2023

Applies To: Commercial Only

Description

Casimersen (Amondys-45) is an antisense oligonucleotide designed to bind to exon 45 of dystrophin pre-mRNA resulting in exclusion of this exon during mRNA processing in individuals with genetic mutations that are amenable to exon 45 skipping. Exon 45 skipping is intended to allow for production of an internally truncated dystrophin protein in individuals with genetic mutations that are amenable to exon 45 skipping. Casimersen (Amondys-45) is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in treated individuals.

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.

Casimersen (Amondys-45) is considered experimental/investigational and therefore non-covered as there is a lack of conclusive evidence confirming clinical efficacy.

Procedure Code

J1426

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Not Applicable for this policy

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 3-17-2021 Adopted policy - Effective 3-15-2021

Internal Medical Policy Committee 7-22-2021 Coding update - Effective 7-1-2021

Added new code C9075 to policy

Internal Medical Policy Committee 9-21-2021 Coding update - Effective 10-1-2021

Added new code J1426 to policy, and
Removed code C9075

Internal Medical Policy Committee 9-28-2022 Annual Review-no changes in criteria

Internal Medical Policy Committee 9-12-2023 Annual review, no clinical content change

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.

Policy ID: I-236-002

Section: Injections

Effective Date: March 15, 2021

Revised Date: May 27, 2021

Revision Effective Date: July 01, 2021

Last Reviewed: July 22, 2021

Archived Date: September 30, 2021

Applies To: Commercial Only

Description

Criteria

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

Casimersen (Amondys-45) is considered experimental/investigational and therefore non-covered as there is a lack of conclusive evidence confirming clinical efficacy.

Procedure Codes

J3490

J3590

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Outpatient HCPCS (C Codes)

C9075

Diagnosis Codes

Not Applicable for this policy

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 3-17-2021 Adopted policy effective 3-15-2021

Internal Medical Policy Committee 7-22-2021 Added new code C9075 to policy effective 7-1-2021

Links

References (PDF)

Disclaimer

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Medical Policies Quick Search

Casimersen (Amondys-45)

Description

Criteria

Procedure Code

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Codes

Outpatient HCPCS (C Codes)

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer