HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-238-006
Topic:
Evinacumab-dgnb (Evkeeza)
Section:
Injections
Effective Date:
July 10, 2023
Issued Date:
July 10, 2023
Last Revision Date:
May 2023
Annual Review:
September 2022
 
 

Evinacumab-dgnb (EvkeezaTM) 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. 

Policy Position

Preferred Products

Proprotein convertase substilisin kexin 9 (PCSK9) inhibitors are the preferred products required for members initiating new therapy for homozygous familial hypercholesterolemia. The non-preferred product [evinacumab-dgnb (Evkeeza)] will be considered when the member has a documented therapy failure after an adequate therapeutic trial of a preferred product, the preferred product has not been tolerated or is contraindicated or the individual does not meet minimum age requirements based on FDA approval for the preferred products.

Adequate therapeutic trial is defined as three (3) months following the injection series at Food and Drug Administration (FDA) or compendia based therapeutic doses of preferred product.

New therapy is defined as no previous utilization within the last 365 calendar days.


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 then seven (7) years old
  • Individual has failure of proprotein convertase substilisin 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); and
  • Initial authorization will be for 12 months.

Reauthorization Criteria

  • Documentation of LDL-C reduction from baseline; and
  • Reauthorization will be for a period of 12 months. 

 

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 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

 

Evinacumab-dgnb (Evkeeza) for any other indication is considered not medically necessary.

J1305

 

 

 

 

 

 




Evinacumab-dgnb (Evkeeza) may be considered medically necessary for individuals 18 years of age and older when applicable clinical criteria for individual medication policies are met and when administered in a physician’s office not affiliated with a hospital, specialized infusion centers not affiliated with a hospital or in the home.

Outpatient facility (Outpatient Hospital IV Infusion Department or Hospital-based Outpatient Clinical Level of Care) administration may be considered medically necessary if ANY of the following criteria are present to indicate the member is medically unstable for infusions in other than an outpatient facility setting:

  • Member’s home is considered unsuitable for care by the home infusion provider; or
  • Individual’s medical status requires enhanced monitoring beyond that which would routinely be needed for infusion therapy; or
  • Previous severe adverse reaction (including but not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure) during or following administration of prescribed medication despite standard pre-medication; or
  • Individual is receiving other medications that require close monitoring with a higher level of care (e.g., cytotoxic chemotherapy or blood products); or
  • Individual is at high risk for complications due to medication administration (e.g., at risk for post-transplant complications, increased risk of infusion reactions due to presence of circulating antibodies, unstable vascular access, cardiopulmonary condition at risk for severe adverse reactions, unstable renal function with inability to safely tolerate IV volume loads, etc.); or 
  • Individual is initiating therapy or re-initiating therapy after a period of at least 6 months with no therapy; or
  • Physically and/or cognitively impaired AND a home caregiver is not available to comply with the required treatment regimen and schedule.

Home health services may be considered medically necessary when utilized for the administration of home infusion therapy and when provided by licensed eligible provider. Each case will be addressed on an individual basis.

The medications identified in this policy will be considered not medically necessary if administered in an unapproved hospital outpatient setting when an approved site of care is a viable option for treatment.

J1305

 

 

 

 

 

 




Related Policies

Refer to Medical Policy I-151, Site of Care, for additional information.


E78.01

 

 

 

 

 

 



Place of Service: Outpatient - Home Infusion

Evidence based guidelines support the administration of this drug in alternative sites of care such as the home, office or outpatient ambulatory infusion centers. Administration of infusible drugs at alternate sites of care is based upon the professional judgment of the provider, and taken into account the clinical appropriateness for each individual patient.

Evidence-based guidelines support the administration of injectable medications in alternative sites of care such as the non-hospital physician’s office, non-hospital infusion center or in the home. Administration of the injectable medications subject to this policy at alternate sites of care is based upon the professional judgment of the provider, and takes into account the clinical appropriateness for each individual member. Requests for administration of any dose of the drugs listed in this policy received from a hospital-based facility, physician’s office or specialized infusion center will be assessed for meeting the policy exception criteria based on the clinical documentation provided by the requesting practitioner. is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.



The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.