Pharmacy Prior Authorization Criteria

Orencia (abatacept)

Indications for Prior Authorization

Orencia (abatacept) SC

• For diagnosis of 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.

• For diagnosis of 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.

• For diagnosis of Psoriatic Arthritis (PsA)
  Indicated for the treatment of patients 2 years of age and older 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

• For diagnosis of 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 DMARDs, JAK inhibitors) is not recommended.

• For diagnosis of 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.

• For diagnosis of 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.

• For diagnosis of 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.

Criteria

Orencia IV or Orencia SC

*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. ** For review process only: Refer to the table in the Background section for carrier-specific formulary products

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)

• Diagnosis of moderately to severely active rheumatoid arthritis
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 [2, 3]:
• 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*
• Cimzia (certolizumab pegol)
• Enbrel (etanercept)
• One formulary adalimumab product**
• Simponi (golimumab)
• Rinvoq (upadacitinib)
• Xeljanz/XR (tofacitinib/ER)
OR
• For continuation of prior therapy, defined as no more than a 45-day gap in therapy

Orencia IV or Orencia SC

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1-3]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline

Orencia IV or Orencia SC

* 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. ** For review process only: Refer to the table in the Background section for carrier-specific formulary products

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)

• Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis
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 [4]:
• leflunomide
• methotrexate
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)
• One formulary adalimumab product**
• Rinvoq/LQ (upadacitinib)
• Xeljanz (tofacitinib)
OR
• For continuation of prior therapy, defined as no more than a 45-day gap in therapy

Orencia IV or Orencia SC

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 4]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline

Orencia IV or Orencia SC

** For review process only: Refer to the table in the Background section for carrier-specific formulary products

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Diagnosis of active psoriatic arthritis (PsA)
AND
• One of the following [5]:
• Actively inflamed joints
• Dactylitis
• Enthesitis
• Axial disease
• Active skin and/or nail involvement
AND
• Prescribed by or in consultation with one of the following:
• Dermatologist
• Rheumatologist
AND
• One of the following:
• Trial and failure, contraindication, or intolerance to TWO of the following:
• Cimzia (certolizumab pegol)
• Enbrel (etanercept)
• One formulary adalimumab product**
• Simponi (golimumab)
• One formulary ustekinumab product**
• Taltz (ixekizumab)
• Skyrizi (risankizumab-rzaa)
• Tremfya (guselkumab)
• Rinvoq/LQ (upadacitinib)
• Xeljanz/XR (tofacitinib/ER)
OR
• For continuation of prior therapy, defined as no more than a 45-day gap in therapy

Orencia IV or Orencia SC

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 5]:
• 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

Orencia IV

Prior Authorization

Length of Approval: 2 Month(s)
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
• 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
• Used in combination with both of the following:
• calcineurin inhibitor (e.g., cyclosporine, tacrolimus)
• methotrexate

P & T Revisions

2024-12-04, 2024-12-04, 2024-07-03, 2024-06-24, 2024-05-30, 2024-04-24, 2024-04-04, 2024-03-06, 2024-01-03, 2023-12-06, 2023-06-30, 2023-04-05, 2023-01-31, 2022-10-23, 2022-04-10, 2022-03-01, 2022-02-03, 2021-09-27, 2021-05-21, 2021-04-08, 2020-12-03, 2020-09-02, 2020-03-18, 2019-10-23

References

1. Orencia prescribing information. Bristol-Myers Squibb Company. Princeton, NJ. October 2023.
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.

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Revision History

• 2024-12-04: Dec P&T: Added Cimzia as an additional preferred alternative for PJIA. Aug P&T: Update to remove manufacturer information from "one formulary adalimumab product"; changed "Stelara" to "one formulary ustekinumab product" and added Taltz as another preferred alternative for PsA; updated background tables
• 2024-12-04: Update to remove manufacturer information from "one formulary adalimumab product"; changed "Stelara" to "one formulary ustekinumab product" and added Taltz as another preferred alternative for PsA; updated background tables
• 2024-07-03: Addition of Rinvoq/Rinvoq LQ as additional preferred alternatives for PJIA; addition of Rinvoq LQ as an additional preferred alternative for PsA
• 2024-06-24: No criteria changes; updated background table to specify BI manufacturer for adalimumab-adbm
• 2024-05-30: Updated background table to include CalPERS formulary; no criteria changes
• 2024-04-24: Annual review - no criteria changes
• 2024-04-04: Annual review - no criteria changes
• 2024-03-06: Updated verbiage in the RA, PJIA, and PsA steps to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
• 2024-01-03: Updated SC indication section to include pediatric patients for PsA; no criteria changes
• 2023-12-06: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-06-30: Addition of Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred step options for RA, PJIA, and PsA
• 2023-04-05: Annual review - no criteria changes
• 2023-01-31: Addition of Amjevita as another preferred step option for RA, PJIA, and PsA
• 2022-10-23: Addition of Enbrel as another preferred step option for RA, PJIA, and PsA; updated the PJIA step to two of Enbrel, Humira, or Xeljanz; further clinical detail added for RA, PJIA, and PsA
• 2022-04-10: Annual review - no criteria changes; background updates
• 2022-03-01: Formulary strategy update for PsA to add Skyrizi, Rinvoq, and Xeljanz/XR as preferred step options.
• 2022-02-03: Addition of indication and criteria for prophylaxis of acute graft versus host disease (aGVHD)
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-08: Annual review - No clinical changes; indication, background, and reference updates
• 2020-12-03: Addition of attestation bypass verbiage to Humira step in PJIA.
• 2020-09-02: Addition of Tremfya as a preferred step option for psoriatic arthritis; formulary strategy update to remove Simponi Aria as a preferred step option for RA and PsA
• 2020-03-18: Annual review - no clinical changes; updated references
• 2019-10-23: Added Rinvoq (upadacitinib) as a step option for RA.

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