HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-85-022
Topic:
Natalizumab (Tysabri)
Section:
Injections
Effective Date:
February 5, 2024
Issued Date:
February 5, 2024
Last Revision Date:
January 2024
Annual Review:
January 2024
 
 

Natalizumab (Tysabri®) and is a recombinant humanized IgG4k monoclonal antibody produced in murine myeloma cells. Natalizumab (Tysabri) contains human framework regions and the complementarity determining regions of a murine antibody that binds to a 4-integrin.

Natalizumab-sztn (Tyruko®) is the biosimilar to natalizumab (Tysabri).

Policy Position

Natalizumab (Tysabri) or natalizumab-sztn (Tyruko) may be considered medically necessary for EITHER of the following conditions:

Multiple Sclerosis (MS)

  • As monotherapy for relapsing forms of MS when ALL of the following are met:
    • A diagnosis of relapsing forms of MS as defined by an MRI of the brain showing abnormalities consistent with MS; and
    • Prescribed by or in consultation with a neurologist or provider who specializes in the treatment of MS; and
    • Individual has had anti-JCV antibody testing prior to initiating treatment; and
    • Not to be used in combination with any other MS therapies; and
    • In accordance with all the requirements set forth by their associated REMS program; and
    • Initial authorization will be for a period of 12 months; or

Crohn’s Disease (CD)

  • As therapy for inducing and maintaining clinical response and remission in individuals 18 years of age and older with moderately to severely active CD with evidence of inflammation when ALL of the following are met:
    • Diagnosis of CD; and
    • Individual has had an inadequate response to, or are unable to tolerate conventional CD therapies (e.g. oral corticosteroids or immunosuppressants); and
    • Individual has had an inadequate response to, or is unable to tolerate inhibitors of TNF-alpha; and
    • Natalizumab (Tysabri) or natalizumab-sztn (Tyruko) will not be used in combination with immunosuppressants or inhibitors of TNF-alpha; and
    • In accordance with all the requirements set forth by their associated REMS program.

Reauthorization Criteria

Continuation of natalizumab (Tysabri) or natalizumab-sztn (Tyruko) may be medically necessary for individuals when the following criteria are met:

  • Individual has previously received treatment with natalizumab Tysabri or natalizumab-sztn (Tyruko); an
  • Individual has experienced therapeutic benefit of CD by 12 weeks of induction therapy; or
  • Documentation of positive clinical response (e.g. low disease activity, confirmed delay or improvement of disability progression); and
  • Reauthorization will be for a period of 12 months.

The use of natalizumab (Tysabri) and natalizumab-sztn (Tyruko) not meeting the criteria as indicated in this policy is considered not medically necessary.

J2323

J3590

 

 

 

 

 

 


Natalizumab (Tysabri) and natalizumab-sztn (Tyruko) are not indicated for the treatment of chronic progressive multiple sclerosis.

Note: Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with natalizumab (Tysabri) or natalizumab-sztn (Tyruko).

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.

Covered Diagnosis Codes for Procedure Code J2323 and J3590

G35

K50.00

K50.10

K50.80

K50.90

K50.011

K50.012

K50.013

K50.014

K50.018

K50.019

K50.111

K50.112

K50.113

K50.114

K50.118

K50.119

K50.811

K50.812

K50.813

K50.814

K50.818

K50.819

K50.911

K50.912

K50.913

K50.914

K50.918

K50.919

 

 

 

 

 

 


Place of Service: Inpatient/Outpatient

The administration of natalizumab (Tysabri) 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, and subject to the applicable laws of your state.


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. 

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. 




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.