WHA

ORENCIA (abatacept)

Self-Administration - subcutaneous (SC) injection

Office-Administration - intravenous (IV) infusion

 

Indications for Prior Authorization:

 

Orencia (abatacept IV) or Orencia (abatacept SC) 

Rheumatoid Arthritis (RA): Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. Limitations of Use: The concomitant use of Orencia with other potent immunosuppressants (e.g., biologic disease-modifying antirheumatic drugs [DMARDs], Janus kinase [JAK] inhibitors) is not recommended. 

Polyarticular Juvenile Idiopathic Arthritis (PJIA): Indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA). Limitations of Use: The concomitant use of Orencia with other potent immunosuppressants (e.g., biologic DMARDs, JAK inhibitors) is not recommended. 

Psoriatic Arthritis (PsA): Indicated for the treatment of adult patients with active psoriatic arthritis (PsA). Limitations of Use: The concomitant use of Orencia with other potent immunosuppressants (e.g., biologic DMARDs, JAK inhibitors) is not recommended. 

 

Orencia (abatacept IV) only

Prophylaxis for Acute Graft versus Host Disease (aGVHD): Indicated for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor. Limitations of Use: The concomitant use of Orencia with other potent immunosuppressants (e.g., biologic DMARDs, JAK inhibitors) is not recommended.

 

Coverage Criteria:

 

For diagnosis of Rheumatoid Arthritis (RA):

  • Documented diagnosis of moderately to severely active RA; AND
  • Prescribed by or in consultation with a rheumatologist; AND
  • Minimum duration of a 3-month trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses: 
    • methotrexate 
    • leflunomide 
    • sulfasalazine
    • hydroxychloroquine; AND
  • One of the following: 
    • Trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*:
      • Cimzia (certolizumab pegol) 
      • Enbrel (etanercept) 
      • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
      • Rinvoq (upadacitinib) 
      • Simponi (golimumab) 
      • Xeljanz/XR (tofacitinib/ER) 
    • For continuation of prior Orencia therapy, defined as no more than a 45-day gap in therapy.

 

For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA):

  • Documented diagnosis of active PJIA; AND  
  • Prescribed by or in consultation with a rheumatologist; AND
  • Minimum duration of a 6-week trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses: 
    • methotrexate 
    • leflunomide 
    • sulfasalazine; AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*:
      • Enbrel (etanercept) 
      • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz 
      • Xeljanz (tofacitinib) (IR tablet or oral solution only**)
    • For continuation of Orencia therapy, defined as no more than a 45-day gap in therapy.

 

For diagnosis of psoriatic arthritis (PsA):

  • Documented diagnosis of active PsA; AND
  • One of the following:
    • actively inflamed joints 
    • dactylitis 
    • enthesitis 
    • axial disease 
    • active skin and/or nail involvement; AND
  • Prescribed by or in consultation with a rheumatologist or dermatologist; AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to TWO of the following: 
      • Cimzia (certolizumab pegol)
      • Enbrel (etanercept)
      • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
      • Simponi (golimumab)
      • Stelara (ustekinumab)
      • Tremfya (guselkumab)
      • Skyrizi (risankizumab-rzaa)
      • Rinvoq (upadacitinib)
      • Xeljanz/XR (tofacitinib/ER)
    • For continuation of prior Orencia therapy, defined as no more than a 45-day gap in therapy

 

For diagnosis of prophylaxis for Acute Graft versus Host Disease (aGVHD):

  • Used for prophylaxis of acute graft versus host disease (aGVHD); AND
  • Patient is 2 years of age or older; AND
  • Request is for the intravenous (IV) formulation of Orencia; AND
  • Patient will receive hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor; AND
  • Recommended antiviral prophylactic treatment for Epstein-Barr Virus (EBV) reactivation (e.g., acyclovir) will be administered prior to Orencia and continued for six months after HSCT; AND
  • Orencia will be used in combination with BOTH of the following:
    • calcineurin inhibitor (e.g., cyclosporine, tacrolimus) 
    • methotrexate 

 

* Includes attestation that a total of two TNF inhibitors have already been tried in the past, and the patient should not be made to try a third TNF inhibitor.

** Xeljanz XR is not indicated for PJIA

 

Reauthorization Criteria:

 

For diagnosis of RA, PJIA:

  • Documentation of positive clinical response to therapy as evidenced by at least one of the following:
    • Reduction in the total active (swollen and tender) joint count from baseline
    • Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline

 

For diagnosis of PsA:

  • Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
    • Reduction in the total active (swollen and tender) joint count from baseline 
    • Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline 
    • Reduction in the body surface area (BSA) involvement from baseline 

 

Dosing:

 

RA, (adults): 

  • IV infusion:
    • Administer at 0, 2, and 4 weeks, and every 4 weeks thereafter per body weight categories.
      • Less than 60 kg: 500 mg (2 vials)
      • 60 to 100 kg: 750 mg (3 vials). 
      • More than 100 kg: 1,000mg (4 vials)
  • SC self-administration: 
    • Prior to the first subcutaneous dose, may administer an optional loading dose as a single intravenous infusion as per body weight categories above.
    • Administer 125 mg by subcutaneous injection once weekly (within a day of the intravenous infusion if infusion given).
    • Patients switching from intravenous use to subcutaneous use, administer first subcutaneous dose instead of next scheduled intravenous dose.

 

PsA, (adults): 

  • IV infusion:
    • Administer at 0, 2, and 4 weeks, and every 4 weeks thereafter per body weight categories.
      • Less than 60 kg: 500 mg (2 vials)
      • 60 to 100 kg: 750 mg (3 vials). 
      • More than 100 kg: 1,000 mg (4 vials)
  • SC self-administration: 
    • Administer 125 mg by subcutaneous injection once weekly without an intravenous loading dose.
    • Patients switching from intravenous use to subcutaneous use, administer first subcutaneous dose instead of next scheduled intravenous dose.

 

PJIA (pediatrics): 

  • IV infusion (6 years of age and older):
    • Administer at 0, 2, and 4 weeks, and every 4 weeks thereafter per body weight categories.
    • Less than 75 kg: 10 mg/kg
    • 75 kg and greater: use adult IV dosing regimen for RA (do not exceed a maximum dose of 1,000 mg). 
  • SC self-administration (2 years of age and older): 
    • Administer by subcutaneous injection once weekly without an intravenous loading dose.
    • 10 kg to less than 25 kg: 50 mg
    • 25 to less than 50 kg: 87.5 mg 
    • 50 kg or more: 125 mg

 

aGVHD (pediatrics and adults):

  • IV infusion (6 years of age and older):
    • 10 mg/kg dose (maximum dose 1,000 mg) as a 60-minute infusion on the day before transplantation, followed by a dose on Day 5, 14, and 28 after transplant.
  • IV infusion (2 to less than 6 years of age):
    • 15 mg/kg dose as a 60-minute infusion on the day before transplantation, followed by a 12 mg/kg dose as a 60-minute infusion on Day 5, 14, and 28 after transplant.

 

Coverage Duration:

 

aGVHD:

  • 2 months

RA, PsA, PJIA:

  • Initial: 1 year
  • Reauthorization: 1 year

 

Authorization is not covered for the following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee:

  • Crohn’s Disease
  • Ulcerative Colitis
  • Psoriasis
  • Irritable Bowel Disease

 

Additional Information:

 

Policy Updates:
  • 07/01/2020- Original review
  • 02/16/2021- Annual review. Criteria and format updated; P&T Ad Hoc review of PA guidelines: removed reference to chart note requirement; updated oral DMARD examples for RA and PJIA; removed TB testing requirements; added medical necessity guidance for reauthorization requests; updated approval duration to 1 year.
  • 11/16/2021 - Updated Juvenile Idiopathic Arthritis (JIA) oral disease-modifying anti-rheumatic drugs [DMARDs] criteria
  • 04/01/2022- Addition of Rinvoq, Skyrizi, and Xeljanz as preferred agents for PsA. New criteria for new indication for acute GVHD
  • 01/01/2023 – Update prerequisite drugs for RA; update use duration for prerequisite drugs; add symptom requirements for PsA; update reauthorization criteria with symptom requirements. (P&T 11/15/2022)
  • 09/01/2023 - Addition of Amjevita, Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred options for RA; Updated examples of TNF inhibitors to list generic names. (P&T 08/15/2023).
  • 11/14/2023 – Update Hyrimoz preferred agent to Sandoz manufacturer only.

 

References:
  1. Orencia prescribing information. Bristol-Myers Squibb Company. Princeton, NJ. December 2021.
  2. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2015;68(1):1-25.
  3. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. 2021;73(7):924-939. 
  4. Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis. Arthritis Rheumatol. 2019;71(6):846-863.
  5. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32.

Last review date: November 14, 2023