Pegcetacoplan (Empaveli)

Policy ID: I-9013-003

Section: Injections

Effective Date: July 01, 2021

Revised Date: November 14, 2023

Revision Effective Date: January 01, 2024

Last Reviewed: November 15, 2023

Applies To: Commercial Only

Description

Pegcetacoplan (Empaveli) is a complement inhibitor that binds to complement protein C3 and its activation fragment C3b, thus regulating the cleavage of C3 and the generation of downstream effectors of complement activation.

Pegcetacoplan (Empaveli) is a self-administered subcutaneous injection and may be covered on the pharmacy benefit.

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.

Pegcetacoplan (Empaveli) Initial Criteria

Pegcetacoplan (Empaveli) may be considered medically necessary when an individual meets ALL of the following criteria:

Paroxysmal Nocturnal Hemoglobinuria (PNH)

ONE of the following:
- The individual has a diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH) as confirmed by flow cytometry with at least two (2) independent flow cytometry reagents on at least two (2) cell lineages (e.g., RBCs and WBCs) demonstrating that the individual's peripheral blood cells are deficient in glycosylphosphatidylinositol (GPI) - linked proteins (lab tests required); and
- The individual has another FDA approved indication for the requested agent; and
ONE of the following:
- The individual's age is within FDA labeling for the requested indication for the requested agent; or
- The prescriber has provided information in support of using the requested agent for the patient's age for the requested indication; and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., hematologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual will NOT be using pegcetacoplan (Empaveli) in combination with Soliris (eculizumab) (NOTE: if the individual is switching from Soliris, Soliris should be continued for the first four (4) weeks after starting the requested agent and then Soliris should be discontinued); and
The individual will NOT be using pegcetacoplan (Empaveli) in combination with Ultomiris (ravulizumab-cwvz).

The use of pegcetacoplan (Empaveli) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J3490

Pegcetacoplan (Empaveli) Reauthorization Criteria

Continuation of pegcetacoplan (Empaveli) may be medically necessary when an individual meets ALL of the following criteria:

The individual was previously approved for pegcetacoplan (Empaveli) through Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had improvements or stabilization with pegcetacoplan (Empaveli) (e.g., decreased requirement of RBC transfusions, stabilization/improvement of hemoglobin, reduction of lactate dehydrogenase (LDH), stabilization/improvement of symptoms) (medical records required); and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., hematologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
The individual will NOT be using the requested agent in combination with Soliris (eculizumab) or Ultomiris (ravulizumab-cwvz).

Procedure Code

J3490

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 Code

D59.5

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-22-2021 - Effective July 01, 2021

Adopted new precertification drug policy

Internal Medical Policy Committee 11-23-2021 Added note 'pegcetacoplan (Empaveli) is a self-administered subcutaneous injection and may be covered on the pharmacy benefit.'

Internal Medical Policy Committee 11-29-2022 - Effective January 01, 2023

Removed FDA labeled contraindications criteria from the policy, and
Updated experimental/investigational statement

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

Updated initial criteria including other FDA approved indication and age criteria

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-9013-002

Section: Injections

Effective Date: July 01, 2021

Revised Date: November 23, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 29, 2022

Archived Date: December 31, 2023

Applies To: Commercial Only

Description

Pegcetacoplan (Empaveli) is a self-administered subcutaneous injection and may be covered on the pharmacy benefit.

Criteria

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

Pegcetacoplan (Empaveli) Initial Criteria

Pegcetacoplan (Empaveli) may be considered medically necessary when an individual meets ALL of the following criteria:

Paroxysmal Nocturnal Hemoglobinuria (PNH)

The individual has a diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH) as confirmed by flow cytometry with at least 2 independent flow cytometry reagents on at least 2 cell lineages (e.g., RBCs and WBCs) demonstrating that the individual’s peripheral blood cells are deficient in glycosylphosphatidylinositol (GPI) – linked proteins (lab tests required); and
The individual is 18 years of age or older; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., hematologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
The individual will NOT be using pegcetacoplan (Empaveli) in combination with Soliris (eculizumab) (NOTE: if the individual is switching from Soliris, Soliris should be continued for the first 4 weeks after starting the requested agent and then Soliris should be discontinued); and
The individual will NOT be using pegcetacoplan (Empaveli) in combination with Ultomiris (ravulizumab-cwvz); and
The individual does NOT have any FDA labeled contraindications to pegcetacoplan (Empaveli).

Pegcetacoplan (Empaveli) for any other indication not listed within this policy will be considered experimental/investigational and, therefore, not-covered. Scientific evidence does not support its efficacy or safety for any other indications.

Procedure Codes

J3490

Pegcetacoplan (Empaveli) Reauthorization Criteria

Continuation of pegcetacoplan (Empaveli) may be medically necessary when an individual meets ALL of the following criteria:

The individual was previously approved for pegcetacoplan (Empaveli) through Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had improvements or stabilization with pegcetacoplan (Empaveli) (e.g., decreased requirement of RBC transfusions, stabilization/improvement of hemoglobin, reduction of lactate dehydrogenase (LDH), stabilization/improvement of symptoms) (medical records required); and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., hematologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
The individual will NOT be using the requested agent in combination with Soliris (eculizumab) or Ultomiris (ravulizumab-cwvz).

Pegcetacoplan (Empaveli) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Codes

J3490

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.

Diagnosis Code

D59.5

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-22-2021 - Effective July 01, 2021

Adopted new precertification drug policy

Internal Medical Policy Committee 11-23-2021 Added note "pegcetacoplan (Empaveli) is a self-administered subcutaneous injection and may be covered on the pharmacy benefit."

Internal Medical Policy Committee 11-29-2022 - Effective January 01, 2023

Removed FDA labeled contraindications criteria from the policy, and
Updated experimental/investigational statement

Medical Policies Quick Search

Pegcetacoplan (Empaveli)

Description

Criteria

Procedure Code

Pegcetacoplan (Empaveli) Reauthorization Criteria

Procedure Code

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Codes

Procedure Codes

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer