Evinacumab-dgnb (Evkeeza)

Policy ID: I-238-006

Section: Injections

Effective Date: May 15, 2021

Revised Date: May 17, 2023

Revision Effective Date: July 01, 2023

Last Reviewed: May 23, 2023

Applies To: Commercial Only

Description

Evinacumab-dgnb (Evkeeza ^TM ) is an angiopoietin-like protein 3 (ANGPTL3) inhibitor. ANGPTL3 is expressed primarily in the liver and plays a role in the regulation of lipid metabolism by inhibiting lipoprotein lipase and endothelial lipase. Inhibition of ANGPTL3 leads to a reduction in LDL-C, HDL-C and triglycerides.

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.

Evinacumab-dgnb (Evkeeza) may be considered medically necessary when the following criteria are met:

Individual is five (5) years of age or older; and
Evinacumab-dgnb (Evkeeza) will be prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist; and
The individual will continue on current lipid lowering treatment regimen in combination with evinacumab-dgnb (Evkeeza) based on age-appropriate FDA approved treatments; and
There is genetic confirmation or clinical documentation of homozygous familial hypercholesterolemia (see table 1 below); and
Individual has failure of or intolerance to statin therapy (see table 2 below); and
- Note: statin therapy is not FDA approved in individuals younger than seven (7) years old
Individual has failure of proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor (e.g., alirocumab or evolocumab based upon FDA approval for age) for at least three (3) months (see table 3 below).

Reauthorization Criteria

Documentation of LDL-C reduction from baseline.

Table 1

Documentation of Homozygous Familial Hypercholesterolemia (must meet either genetic confirmation or clinical confirmation column)

Genetic Confirmation

Clinical Documentation (ONE from each of the following)

Two (2) mutant alleles at the LDLR, ApoB, PCSK9, or LDLRAP1 gene locus

ONE of the following untreated lab values

Untreated total cholesterol of greater than 500 mg/dL

Untreated LDL-C of greater than 400 mg/dL

Attestation of ONE of the following

Cutaneous or tendon xanthoma before age 10 years

Evidence of heterozygous familial hypercholesterolemia in both parents

Table 2

Statin Therapy Failure (must meet either statin failure or statin intolerance column)

Statin Failure (ONE of the following)

Statin Intolerant (One of the following)

7 to 17 years of age or younger

LDL-C greater than 135 mg/dL, despite use of a maximally tolerated statin

Statin related rhabdomyolysis or skeletal-related muscle symptoms while receiving at least two (2) separate trials of different statins which resolved upon discontinuation of the statins

18 years of age or older

LDL-C greater than 100 mg/dL, despite use of a maximally tolerated statin

Creatinine kinase (CK) increase to 10 times upper limit of normal (ULN) during any one (1) course of statin therapy

Liver function tests (LFTs) increase to 3 times upper limit of normal (ULN) during any one (1) course of statin therapy

Hospitalization due to severe statin-related adverse event, such as rhabdomyolysis during any one (1) course of statin therapy

Table 3

PCSK9 Failure or Contraindication/Adverse Event (must meet either column)

PCSK9 Treatment Failure

PCSK9 Contraindication/Adverse Event

10 to17 years of age

LDL-C greater than 135 mg/dL, despite use of a PCSK9 inhibitor (evolocumab) for at least three (3) months

Contraindication to or adverse event from PCSK9 inhibitor therapy

18 years of age or older

LDL-C greater than 100 mg/dL, despite use of a PCSK9 inhibitor (alirocumab or evolocumab) for at least three (3) months

Evinacumab-dgnb (Evkeeza) 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

J1305

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

E78.01

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-20-2021 Effective May 15, 2021

Adopted new pre-certification drug policy

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

Added new code C9079 to policy

Internal Medical Policy Committee 9-21-2021 Effective October 01, 2021

Added new code J1305 to policy and
Removed C9079

Internal Medical Policy Committee 9-28-2022 Annual review, no clinical content change

Internal Medical Policy Committee 1-26-2023 Effective March 01, 2023

Updated experimental/investigational statement

Internal Medical Policy Committee 5-23-2023 - Effective July 01, 2023

Added reauthorization criteria
Updated minimum age requirements for drug and in the tables

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-238-005

Section: Injections

Effective Date: May 15, 2021

Revised Date: January 10, 2023

Revision Effective Date: March 01, 2023

Last Reviewed: January 26, 2023

Archived Date: June 30, 2023

Applies To: Commercial Only

Description

Evinacumab-dgnb (Evkeeza^TM) is an angiopoietin-like protein 3 (ANGPTL3) inhibitor. ANGPTL3 is expressed primarily in the liver and plays a role in the regulation of lipid metabolism by inhibiting lipoprotein lipase and endothelial lipase. Inhibition of ANGPTL3 leads to a reduction in LDL-C, HDL-C and triglycerides.

Criteria

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

Evinacumab-dgnb (Evkeeza) may be considered medically necessary when the following criteria are met:

Individual is 12 years of age or older; and
Evinacumab-dgnb (Evkeeza) will be prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist; and
The individual will continue on current lipid lowering treatment regimen in combination with evinacumab-dgnb (Evkeeza); and
There is genetic confirmation or clinical documentation of homozygous familial hypercholesterolemia (see table 1 below); and
Individual has failure of or intolerance to statin therapy (see table 2 below); and
Individual has failure of proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor (e.g., alirocumab or evolocumab based upon FDA approval for age) for at least three (3) months (see table 3 below).

Table 1

Documentation of Homozygous Familial Hypercholesterolemia (must meet either genetic confirmation or clinical confirmation column)

Genetic Confirmation

Clinical Documentation (ONE from each of the following)

Two (2) mutant alleles at the LDLR, ApoB, PCSK9, or LDLRAP1 gene locus

ONE of the following untreated lab values

Untreated total cholesterol of greater than 500 mg/dL

Untreated LDL-C of greater than 400 mg/dL

Attestation of ONE of the following

Cutaneous or tendon xanthoma before age 10 years

Evidence of heterozygous familial hypercholesterolemia in both parents

Table 2

Statin Therapy Failure (must meet either statin failure or statin intolerance column)

Statin Failure (ONE of the following)

Statin Intolerant (One of the following)

17 years of age or younger

LDL-C greater than 135 mg/dL, despite use of a maximally tolerated statin

Statin related rhabdomyolysis or skeletal-related muscle symptoms while receiving at least two (2) separate trials of different statins which resolved upon discontinuation of the statins

18 years of age or older

LDL-C greater than 100 mg/dL, despite use of a maximally tolerated statin

Creatinine kinase (CK) increase to 10 times upper limit of normal (ULN) during any one (1) course of statin therapy

Liver function tests (LFTs) increase to 3 times upper limit of normal (ULN) during any one (1) course of statin therapy

Hospitalization due to severe statin-related adverse event, such as rhabdomyolysis during any one (1) course of statin therapy

Table 3

PCSK9 Failure or Contraindication/Adverse Event (must meet either column)

PCSK9 Treatment Failure

PCSK9 Contraindication/Adverse Event

13 to 17 years of age

LDL-C greater than 135 mg/dL, despite use of a PCSK9 inhibitor (evolocumab) for at least three (3) months

Contraindication to or adverse event from PCSK9 inhibitor therapy

18 years of age or older

LDL-C greater than 100 mg/dL, despite use of a PCSK9 inhibitor (alirocumab or evolocumab) for at least three (3) months

Procedure Codes

J1305

Diagnosis Codes

E78.01

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-20-2021 Effective May 15, 2021

Adopted new pre-certification drug policy

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

Added new code C9079 to policy

Internal Medical Policy Committee 9-21-2021 Effective October 01, 2021

Added new code J1305 to policy and
Removed C9079

Internal Medical Policy Committee 9-28-2022 Annual review, no clinical content change

Internal Medical Policy Committee 1-26-2023 Effective March 01, 2023

Updated experimental/investigational statement

Links

References (PDF)

Disclaimer

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Evinacumab-dgnb (Evkeeza)

Description

Criteria

Table 1

Procedure Code

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Table 1

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer