Abatacept (Orencia®) is a fully human recombinant fusion protein categorized as a costimulatory or second-signal blocker of T cell activation. Abatacept (Orencia) disrupts the activation pathway of T cells causing a disturbance in key mechanisms of inflammation and progression joint destruction in inflammatory diseases. 

Abatacept (Orencia) for Intravenous (IV) Use

Abatacept (Orencia) IV injection may be considered medically necessary when an individual meets the criteria for ANY ONE of the following indications:

·         Polyarticular Juvenile Idiopathic Arthritis (PJIA):

o    The individual is six (6) years of age and older with moderate to severe PJIA; and

o    Treatment with at least one (1) nonbiologic disease modifying anti-rheumatic drug (DMARD) (e.g. methotrexate, leflunomide, sulfasalazine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated; or

o    The individual requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage; or

·         Psoriatic Arthritis (PsA):

o    The individual is 18 years of age and older with active PsA; and

o    Treatment with at least one (1) nonbiologic DMARD was ineffective or not tolerated; and

o    Treatment with at least one (1) preferred IV biologic (infliximab [Remicade®], infliximab-dyyb [Inflectra®], or golimumab [Simponi Aria®]) was ineffective or not tolerated or all preferred IV biologics are contraindicated; or

·         Rheumatoid Arthritis (RA):

o    The individual is 18 years of age and older with moderately to severely active RA; and

o    Treatment with at least one (1) nonbiologic DMARD was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated; and

o    Treatment with at least one (1) preferred IV biologic (infliximab [Remicade], infliximab-dyyb [Inflectra], or golimumab [Simponi Aria]) was ineffective or not tolerated or all preferred IV biologics are contraindicated.

Abatacept (Orencia) for Subcutaneous (SC) Use

Abatacept (Orencia) SC injection may be considered medically necessary when an individual meets the criteria for ANY ONE of the following indications:

·         Polyarticular Juvenile Idiopathic Arthritis (PJIA):

o    The individual is two (2) years of age and older with moderate to severe PJIA; and

o    Treatment with at least one (1) nonbiologic DMARD was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated; or

o    The individual requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage; and

o    Treatment with two (2) of the following was ineffective or not tolerated:

§  Etanercept (Enbrel®)

§  Adalimumab (Humira®)

§  Tocilizumab (Actemra® SC); or

·         Psoriatic Arthritis (PsA):

o    Spinal or Axial PsA

§  The individual is 18 years of age or older with predominant spinal or axial PsA; and

§  Treatment with at least one (1) non-steroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated or all NSAIDs are contraindicated; and

§  Treatment with two (2) preferred biologic products (etanercept [Enbrel], adalimumab [Humira], apremilast [Otezla®], secukinumab [Cosentyx®], ustekinumab [Stelara®] SC or tofacitinib [Xeljanz®]) was ineffective or not tolerated; or

o    Psoriatic Arthritis without Spinal or Axial Disease

§  The individual is 18 years of age or older with active PsA; and

§  Treatment with at least one (1) non-biologic DMARD was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated; and

§  Treatment with two (2) preferred biologic products (etanercept [Enbrel], adalimumab [Humira], apremilast [Otezla], secukinumab [Cosentyx], ustekinumab [Stelara] SC or tofacitinib [Xeljanz]) was ineffective or not tolerated; or

o    Enthesitis and/or Dactylitis associated Psoriatic Arthritis

§  The individual is 18 years of age or older with active enthesitis and/or dactylitis associated with PsA; and

§  Treatment with at least one (1) NSAID or local glucocorticoid injection was ineffective or not tolerated or all NSAIDs and all local glucocorticoid injections are contraindicated; and

§  Treatment with two (2) preferred biologic products (etanercept [Enbrel], adalimumab [Humira], apremilast [Otezla], secukinumab [Cosentyx], ustekinumab [Stelara] SC or tofacitinib [Xeljanz]) was ineffective or not tolerated.

·         Rheumatoid Arthritis (RA):

o    The individual is 18 years of age and older with moderately to severely active RA; and

o    Treatment with at least one DMARD was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated; and

o    Treatment with two (2) preferred biologic products (tocilizumab [Actemra] SC), etanercept [Enbrel], adalimumab [Humira], upadacitinib [Rinvoq™], or tofacitinib [Xeljanz or Xeljanz XR®]) was ineffective or not tolerated.

The use of abatacept (Orencia) for any other indication is considered experimental/investigational and therefore, non-covered. Scientific evidence has not established the effectiveness for any other indication. 

Reauthorization Criteria

Continuation of therapy with abatacept (Orencia) may be considered medically necessary when the following criteria are met:

·         The individual has one of the above diagnoses; and

·        Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy; and

·         Reauthorization valid for 12 months.

Abatacept (Orencia) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.

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

• Using abatacept (Orencia) 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 individual tests positive for the hepatitis B virus.

The use of abatacept (Orencia) for any other indication is considered experimental/investigational and, therefore, non-covered. Scientific evidence has not established the effectiveness for any other indication. 

Abatacept (Orencia) 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 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 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 will be considered not medically necessary if administered in an unapproved hospital outpatient setting when an approved site of care is a viable option for treatment.

Note: If an individual has already had a trial of at least one biologic agent, they are not required to “step back” and try a non-biologic agent.

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.

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.