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Medical Policy Bulletin
Title:Abatacept (Orencia®)
Policy #:08.00.62c

The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.

Intent
The intent of this policy is to communicate the medical necessity criteria for abatacept (Orencia®).

For information on policies related to this topic, refer to the Cross References section in this policy.

Description
Abatacept (Orencia®) is a soluble fusion protein that is produced by recombinant deoxyribonucleic acid (DNA) technology. It is a selective costimulation modulator that consists of human cytotoxic T-lymphocyte-associated antigen-4 linked to a modified portion of human immunoglobulin G1 (IgG1).

The activation of T lymphocytes has been implicated in the pathogenesis of rheumatoid arthritis (RA). Since abatacept (Orencia®) interrupts T lymphocyte activation, it is frequently used in the management of adults and children with juvenile idiopathic arthritis.

Abatacept (Orencia®) is only available via intravenous administration.

Policy
ADULT RHEUMATOID ARTHRITIS (RA)

Abatacept (Orencia®) is considered medically necessary and, therefore, covered when used to reduce signs and symptoms, induce major clinical response, inhibit the progression of structural damage, and improve physical function in individuals who have moderately to severely active RA when all of the following inclusion criteria are met:
  • The individual has had an inadequate response after at least three months to one or more disease-modifying antirheumatic drugs (DMARDs) or tumor necrosis factor (TNF)-antagonists, or the use of all DMARDs or TNF-antagonists is contraindicated in the individual.
  • The drug is prescribed by a rheumatologist.
  • The individual is 18 years of age or older.

POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS

Abatacept (Orencia®) is considered medically necessary and, therefore, covered when used to reduce signs and symptoms in individuals who have moderately to severely active polyarticular juvenile idiopathic arthritis. Abatacept (Orencia®) may be used as monotherapy or concomitantly with methotrexate when all of the following inclusion criteria are met:
  • The individual has had an inadequate response after at least three months to one or more DMARDs or TNF-antagonists, or the use of all DMARDs or TNF-antagonists is contraindicated in the individual.
  • The drug is prescribed by a rheumatologist.
  • The individual is 6 years of age or older.


All other uses for abatacept (Orencia®) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics. Uses of abatacept (Orencia®) that are not supported in either this medical policy or the off-label coverage policy are considered experimental/investigational and, therefore, not covered.

The use of abatacept (Orencia®) with other TNF-antagonists (eg, adalimumab [Humira®], etanercept [Enbrel®], infliximab [Remicade®]) or interleukin-1 (IL-1) inhibitors (eg, anakinra [Kineret®]) is considered experimental/investigational and, therefore, not covered because the safety and/or efficacy of these regimens cannot be established by a review of the available published peer-reviewed literature.

PRECERTIFICATION OR PREAPPROVAL REQUIREMENTS

For most of the Company's products, abatacept (Orencia®) requires precertification or preapproval, regardless of place of service. Individual product requirements must be verified.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.




Guidelines
BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, abatacept (Orencia®) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.


MEDICARE

There is no Medicare coverage criteria addressing this service; therefore, the Company policy is applicable.

For Medicare Advantage members, certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when abatacept (Orencia®) is covered under a member's medical benefit. It does not address instances when abatacept (Orencia®) is covered under a member’s pharmacy benefit.


US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Initial FDA approval for abatacept (Orencia®) was granted on December 23, 2005. Supplemental approvals
for abatacept (Orencia®) have since been issued.


The following information was taken directly from the FDA-approved product labeling at the time this policy was developed:

PEDIATRIC USE

The safety and effectiveness of abatacept (Orencia®) in pediatric patients younger than six years of age have not been established. Therefore, abatacept (Orencia®) is not recommended for use in patients younger than six years of age.

The safety and efficacy of abatacept (Orencia®) in pediatric patients for uses other than juvenile idiopathic arthritis have not been established.

DRUG INTERACTIONS

Concurrent administration of a TNF-antagonist (eg, adalimumab [Humira®], etanercept [Enbrel®], infliximab [Remicade®]) with abatacept (Orencia®) has been associated with an increased risk of serious infections and no significant additional efficacy over use of the TNF-antagonists alone. Concurrent therapy with abatacept (Orencia®) and TNF-antagonists is not recommended.

Disease-modifying antirheumatic drugs (DMARDs) may include, but are not limited to:
  • Azathioprine (Imuran®)
  • Cyclosporine (Neoral®)
  • Gold (intramuscular or oral) (Myochrysine®, Auranofin®)
  • Hydroxychloroquine (Plaquenil®)
  • Leflunomide (Arava®)
  • Methotrexate (Trexall®)
  • Minocycline (Dynacin®)
  • Sulfasalazine (Azulfidine®)

TNF-antagonists may include, but are not limited to:
  • Adalimumab (Humira®)
  • Etanercept (Enbrel®)
  • Infliximab (Remicade®)
  • Golimumab (Simponi®)


OTHER BIOLOGIC RHEUMATOID ARTHRITIS THERAPY

There is insufficient data to assess the safety and efficacy of abatacept (Orencia®) administered concurrently with other biologic rheumatoid arthritis therapy, such as anakinra (Kineret®). Therefore, such use is not recommended.

References
American College of Rheumatology. Arthritis in children. [American College of Rheumatology Web site]. June 2008. Available at: .http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/juvenilearthritis.asp Accessed February 23, 2010.

Barclay L. American College of Rheumatology updates: Rheumatoid arthritis guidelines. [Medscape Web site]. 06/05/08. Available at: http://www.medscape.com/viewarticle/575597?src=mp&spon=36&uac=91078FZ [via subscription only]. Accessed January 25, 2010.

Matsumoto AK, Bathon J, Bingham CO 3rd. Rheumatoid arthritis treatment. Abatacept (Orencia®) [The Johns Hopkins Arthritis Center Web site]. Available at: http://www.hopkins-arthritis.org/arthritis-info/rheumatoid-arthritis/rheum_treat.html#tcell. Accessed January 25, 2010.

Monthly Prescribing Reference (MPR). Orencia gains JIA indication. [MPR Web site]. 04/09/08. Available at: http://www.empr.com/Orencia-gains-JIA-indication/article/122517/. Accessed January 25, 2010.

Orencia® (abatacept). American Hospital Formulary Service (AHFS). Drug Information 2009. [STAT!Ref Web site]. January 2009. Available at: http://online.statref.com/ [via subscription only]. Accessed January 25, 2010.

Orencia® (abatacept). Micromedex® Healthcare Series.[Micromedex® Web site]. Last modified: 01/04/10. Available at: http://www.thomsonhc.com [via subscription only]. Accessed January 25, 2010.

Orencia® (abatacept) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb; 2008. Available at: http://packageinserts.bms.com/pi/pi_orencia.pdf. Accessed January 25, 2010.

Saag KA, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. [American College of Rheumatology Web site]. 06/15/08. Available at:http://www.rheumatology.org/practice/clinical/guidelines/recommendations.pdf Accessed February 23, 2010.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Abatacept (Orencia®) [prescribing information]. [FDA Web site]. 08/25/09. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125118s0086lbl.pdf. Accessed January 25, 2010.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Abatacept (Orencia®). Supplemental biologics license approval letter. [FDA Web site]. 04/07/08. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125118s045ltr.pdf. Accessed January 25, 2010.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Abatacept (Orencia®). Supplemental biologics license approval letter for revisions to package insert. [FDA Web site]. 08/25/09. Available at:http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125118s0086ltr.pdf. Accessed January 25, 2010.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Drug details: Abatacept (Orencia®). [FDA Web site]. 04/07/08. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist. Accessed January 25, 2010.

Coding Table

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

Code SystemCode Number(s) and Narrative(s)
CPTN/A
ICD ProcedureN/A
ICD Diagnosis714.0: Rheumatoid arthritis

714.1: Felty's syndrome

714.2: Other rheumatoid arthritis with visceral or systemic involvement

714.30: Polyarticular juvenile rheumatoid arthritis, chronic or unspecified

714.31: Polyarticular juvenile rheumatoid arthritis, acute
HCPCS Level IIJ0129: Abatacept (Orencia®)
Revenue CodesN/A

Cross References

Cross Reference Policies




Version Effective Date: 04/07/2009


The Policy Bulletins on this web site were developed to assist AmeriHealth and its subsidiaries ("AmeriHealth") in administering the provisions of the respective benefit programs, and do not constitute a contract. If you are an AmeriHealth member, please refer to your specific benefit program for the terms, conditions, limitations and exclusions of your coverage. AmeriHealth does not provide health care services, medical advice or treatment, or guarantee the outcome or results of any medical services/treatments. The facility and professional providers are responsible for providing medical advice and treatment. Facility and professional providers are independent contractors and are not employees or agents of AmeriHealth. If you have a specific medical condition, please consult with your doctor. AmeriHealth reserves the right at any time to change or update its Policy Bulletins. ©2010 AmeriHealth, Inc. All Rights Reserved.  Current Procedural Terminology ©2010 American Medical Association. All Rights Reserved.

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