HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-247-008
Topic:
Efgartigimod alfa-fcab (Vyvgart) and Efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo)
Section:
Injections
Effective Date:
September 2, 2024
Issued Date:
September 2, 2024
Last Revision Date:
August 2024
Annual Review:
August 2024
 
 

Efgartigmod alfa-fcab (Vygvart®) is an antibody fragment that binds to the neonatal Fc receptor (FcRn). The blockade of FcRn reduces IgG antibody levels, including the abnormal antiacetylcholine receptor (AChR) antibodies that are present in patients with generalized myasthenia gravis (gMG). In patients with myasthenia gravis who test positive for the antiacetylcholine receptor (AChR) antibody, the AChR antibodies interfere with communication between nerves and muscles, resulting in weakness.

Efgartigmod alfa and hyaluronidase-qvfc (Vyvgart® Hytrulo) is a combination of efgartigmod alfa and hyaluronidase. The hyaluronidase component increases the dispersion and absorption of efgartigmod alfa following subcutaneous administration by a healthcare professional. 

Policy Position

Myasthenia Gravis

Efgartigimod alfa-fcab (Vyvgart) or efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) may be considered medically necessary for the treatment of individuals 18 years of age or older with a diagnosis of generalized myasthenia gravis when ALL of the following criteria are met:

  • Individual is positive for antiacetylcholine receptor (AchR) antibodies; and
  • Individual meets Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV*; and
  • Individual has a Myasthenia Gravis-Specific Activities of Daily Living scale (MG-ADL) total score of five (5) or greater at initiation*; and
  • Individual has experienced therapeutic failure, intolerance, or contraindication to treatment with two (2) or more classes of agents (acetylcholinesterase inhibitor, steroids and non-steroidal immunosuppressants), used alone or in combination; and
  • Individual is not concurrently receiving eculizumab (Soliris), ravulizumab-cwvz (Ultomiris), zilucoplan (Zilbrysq) or immune globulin therapy; or
    • Individual transitioning to efgartigimod alfa-fcab (Vyvgart) should discontinue eculizumab (Soliris), ravulizumab-cwvz (Ultomiris), zilucoplan (Zilbrysq) or immune globulin therapy within four (4) weeks of starting efgartigimod alfa-fcab (Vyvgart); and
  • Initial authorization period will be for six (6) months.

Reauthorization Criteria

Continuation of efgartigimod alfa-fcab (Vyvgart) or efgartigimod alfa and hyaluronidase-gvfc (Vyvgart Hytrulo) may be medically necessary for individuals when the following criteria are met:

  • Individual demonstrates a clinically meaningful response regarding daily activities (greater than or equal to a two (2) point improvement in the MG-ADL from baseline) after initial therapy; and
  • Reauthorization will be for a period of six (6) months.

Efgartigmod alfa-fcab (Vyvgart) or efgartigmod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) not meeting the criteria as listed in this policy is considered not medically necessary. 

J9332

J9334

 

 

 

 

 




Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo) may be considered medically necessary for the treatment of individuals 18 years of age or older with a diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) with progressive symptoms for at least two (2) months when ALL of the following criteria are met:

  • Progressive or relapsing motor and/or sensory dysfunction of more than one (1) limb or a peripheral nerve nature, developing over at least two (2) months; and
  • Hypo- or areflexia (usually involving all four (4) limbs); and
  • Nerve conduction studies strongly supportive of demyelination with at least ONE of the following (consistent with EFNS/PNS guidelines further defined in Professional Statements and Societal Positions section below):
    • Motor distal latency prolongation in at least two (2) nerves; or
    • Reduction of motor conduction velocity in at least two (2) nerves; or
    • Prolongation of F-wave latency in at least two (2) nerves; or
    • Absence of F-waves in at least two (2) nerves; or
    • Motor conduction block in at least one (1) nerve; or
    • Abnormal temporal dispersion in at least two (2) nerves; or
    • Distal CMAP duration prolongation in at least one (1) nerve; and
  • Initial authorization will be for a period of 6 months.

Reauthorization Criteria

Continuation of efgartigimod alfa and hyaluronidase-gvtfc (Vyvgart Hytrulo) may be medically necessary for individuals when the following criteria are met:

  • Individual has demonstrated clinically meaningful response as indicated by documentation of stable or improved symptoms; and
  • Reauthorization will be for a period of 6 months.

J9334

 

 

 

 

 




Efgartigimod alfa-fcab (Vyvgart) 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 settings 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 six (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 are considered not medically necessary if administered in an unapproved hospital outpatient setting when an approved site of care is a viable option for treatment.

J9332

 

 

 

 

 

 




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. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits. 

*See Table Attachment for additional information.


Related Policies

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

Refer to Pharmacy Policy J-1361 Zilbrysq (zilucoplan) for additional information.


Professional Statements and Societal Positions Guidelines

Motor nerve conduction criteria per the European Academy of Neurology/ Peripheral Nerve Society:

(1) Strongly supportive of demyelination:

At least one of the following:

(a) Motor distal latency prolongation ≥50% above ULN in two nerves (excluding median neuropathy at the wrist from carpal tunnel syndrome), or

(b) Reduction of motor conduction velocity ≥30% below LLN in two nerves, or

(c) Prolongation of F-wave latency ≥20% above ULN in two nerves (≥50% if amplitude of distal negative peak CMAP <80% of LLN), or

(d) Absence of F-waves in two nerves (if these nerves have distal negative peak CMAP amplitudes ≥20% of LLN) + ≥1 other demyelinating parameter in ≥1 other nerve, or

(e) Motor conduction block: ≥30% reduction of the proximal relative to distal negative peak CMAP amplitude, excluding the tibial nerve, and distal negative peak CMAP amplitude ≥20% of LLN in two nerves; or in one nerve + ≥ 1 other demyelinating parameter except absence of F-waves in ≥1 other nerve, or

(f) Abnormal temporal dispersion: >30% duration increase between the proximal and distal negative peak CMAP (at least 100% in the tibial nerve) in ≥2 nerves, or

(g) Distal CMAP duration (interval between onset of the first negative peak and return to baseline of the last negative peak) prolongation in ≥1 nerve + ≥1 other demyelinating parameter in ≥1 other nerve

•  (LFF 2 Hz) median > 8.4 ms, ulnar > 9.6 ms, peroneal > 8.8 ms, tibial > 9.2 ms

•  (LFF 5 Hz) median > 8.0 ms, ulnar > 8.6 ms, peroneal > 8.5 ms, tibial > 8.3 ms

•  (LFF 10 Hz) median > 7.8 ms, ulnar > 8.5 ms, peroneal > 8.3 ms, tibial > 8.2 ms

•  (LFF 20 Hz) median > 7.4 ms, ulnar > 7.8 ms, peroneal > 8.1 ms, tibial > 8.0 ms

(2) Weakly supportive of demyelination

As in (1) but in only one nerve.


Covered Diagnosis Codes for Procedure Code J9332 

G70.00

G70.01

 

 

 

 

 

Covered Diagnosis Codes for Procedure Code J9334 

G61.81

G61.82

G70.00

G70.01

 

 

 

 

 

 



Place of Service: Outpatient-Infusion

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.



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.