Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: I-90-019
Topic: Abatacept (Orencia)
Section: Injections
Effective Date: May 28, 2018
Issue Date: May 28, 2018
Last Reviewed: February 2018

Abatacept (Orencia®) is a selective co-stimulation modulator that inhibits T cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes, implicated in the pathogenesis of rheumatoid arthritis. Activated T lymphocytes are found in the synovium of patients with rheumatoid arthritis.

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 circumstances may warrant individual consideration, based on review of applicable medical records.

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

Subcutaneous (SC) Injection

Rheumatoid Arthritis (RA)
Abatacept (Orencia) SC may be considered medically necessary for the treatment of moderately to severely active RA when the individual has a history of beneficial response to abatacept (Orencia) SC; or

When ALL of the following indications are met:

Juvenile Idiopathic Arthritis (JIA)/Juvenile Rheumatoid Arthritis (JRA)
Abatacept (Orencia) SC may be considered medically necessary for the treatment of moderately to severely active JIA/JRA when the individual has a history of beneficial response to abatacept SC; or

When ALL of the following indications are met:

Psoriatic Arthritis (PsA)

Intravenous (IV) Injection

Abatacept (Orencia) IV injection may be considered medically necessary for the treatment of ANY ONE of the following conditions:

Rheumatoid Arthritis (RA)

Juvenile Idiopathic Arthritis (JIA)/Juvenile Rheumatoid Arthritis (JRA)
Abatacept (Orencia) IV may be considered medically necessary for the treatment of moderately to severely active JIA/JRA when the individual has a history of beneficial response to abatacept IV; or

Psoriatic Arthritis (PsA)

Not Medically Necessary
Abatacept (Orencia) is considered not medically necessary for an individual with ANY ONE of the following:

Abatacept (Orencia) is considered experimental/investigational for ALL other indications not listed in this policy and therefore non-covered.  Scientific evidence does not support its use for any other indications. 

Procedure Codes
J0129


NOTE: Dosage recommendations per the FDA label.



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of Abatacept (Orencia®) IV and SC 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


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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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.

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: 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.

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.