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| 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:
- Abatacept (Orencia) SC is to be used in reducing the signs and symptoms and inhibiting the progression of structural damage in adults (greater than or equal to 18 years of age) with moderate to severe active rheumatoid arthritis; and
- Treatment with at least one non-biologic disease modifying anti-rheumatic drug (DMARD) (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, or cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated; and
- Treatment with at least two (2) of the preferred biologic products was ineffective or not tolerated, or all of these preferred products are contraindicated:
- Adalimumab (Humira)
- Etanercept (Enbrel)
- Tocilizumab (Actemra SC)
- Tofacitinib (Xeljanz, Xeljanz XR).
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:
- Abatacept (Orencia®) SC is to be used for reducing the signs and symptoms of moderately to severely active JIA/JRA in patients greater than or equal to two (2) years of age; and
- Treatment with at least one (1) preferred biologic product, adalimumab (Humira) or etanercept (Enbrel) has been ineffective or not tolerated, or both of these preferred products are contraindicated.
Psoriatic Arthritis (PsA)
- Abatacept (Orencia) SC may be considered medically necessary for the treatment of active psoriatic arthritis when the individual has a history of beneficial response to abatacept SC; or
- When ALL of the following are met:
- Abatacept (Orencia) SC is to be used in the treatment of adults with active psoriatic arthritis; and
- Treatment with at least one (1) nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, or cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated; and
- Treatment with at least two (2) of the following preferred products was ineffective or not tolerated, or all of these preferred products are contraindicated:
- Adalimumab (Humira)
- Etanercept (Enbrel)
- Ustekinumab (Stelara)
- Secukinumab (Cosentyx).
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)
- Abatacept (Orencia) IV 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 IV; or
- When ALL of the following are met:
- Abatacept (Orencia) IV is to be used in reducing the signs and symptoms and inhibiting the progression of structural damage in adults (greater than or equal to 18 years of age) with moderate to severe active rheumatoid arthritis; and
- Treatment with at least one non-biologic DMARD (e.g. methotrexate, leflunamide, sulfasalazine, hydroxychloroquine, or cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated; and
- Treatment with infliximab (Remicade) or golimumab (Simponi Aria) has been ineffective or not tolerated, or both of these preferred IV products are contraindicated.
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
- Abatacept (Orencia) IV is to be used for reducing the signs and symptoms of moderately to severely active JIA/JRA in individuals greater than or equal to six (6) years of age.
Psoriatic Arthritis (PsA)
- Abatacept (Orencia) IV may be considered medically necessary for the treatment of active psoriatic arthritis when the individual has a history of beneficial response to abatacept IV; or
- When ALL of the following are met:
- Abatacept (Orencia) IV is to be used for the treatment of adults with psoriatic arthritis; and
- When treatment with at least one (1) nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated; and
- Treatment with the preferred product, infliximab (Remicade) was ineffective or not tolerated, or is contraindicated
Not Medically Necessary
Abatacept (Orencia) is considered not medically necessary for an individual with ANY ONE of the following:
- Using abatacept in combination with tumor necrosis factor (TNF) antagonists or other biologic RA therapy, such as anakinra (Kineret); or
- Tuberculosis or other active serious infections or a history of recurrent infections; or
- Individual has not had a tuberculin skin test (TST) or Centers for Disease Control (CDC)-recommended equivalent to rule out latent tuberculosis; or
- The patient tests positive for the hepatitis B virus.
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.
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.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
09/2017, Coverage Criteria Revised for Abatacept (Orencia®)
03/2018, Coverage Criteria Revised for Abatacept (Orencia)
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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.
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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
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- Provides free language services to people whose primary language is not English, such as:
- Qualified interpreters
- Information written in other languages
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.
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