Tocilizumab - PA, NF

Indications for Prior Authorization

Actemra IV & SC (tocilizumab), Tofidence IV (tocilizumab-bavi), Tyenne IV & SC (tocilizumab-aazg)
  • For diagnosis of Rheumatoid arthritis (RA)
    Indicated for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

  • For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)
    Indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

  • For diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA)
    Indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

  • For diagnosis of Giant Cell Arteritis (GCA)
    Indicated for the treatment of giant cell arteritis (GCA) in adult patients.

Actemra SC (tocilizumab)
  • For diagnosis of Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
    Indicated for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Tyenne SC (tocilizumab-aazg)
  • For diagnosis of Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
    Tocilizumab SC has been used for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Actemra IV (tocilizumab), Tofidence IV (tocilizumab-bavi)
  • For diagnosis of Coronavirus Disease 2019 (COVID-19)
    Indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Tyenne IV (tocilizumab-aazg)
  • For diagnosis of Coronavirus Disease 2019 (COVID-19)
    Tocilizumab IV has been used for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) [1].

Actemra IV (tocilizumab)
  • For diagnosis of Cytokine Release Syndrome
    Indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older.

Tofidence IV (tocilizumab-bavi), Tyenne IV (tocilizumab-aazg)
  • For diagnosis of Cytokine Release Syndrome
    Tocilizumab IV has been used for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older [1].

Criteria

Actemra IV or SC, Tofidence IV, Tyenne IV or 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
    AND
  • Both of the following: (Applies to Tofidence IV, Tyenne IV or SC only)
    • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 6-month trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Actemra IV or SC, Tofidence IV, Tyenne IV or 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
Tofidence IV, Tyenne IV or 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

Non Formulary

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

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of moderately to severely active rheumatoid arthritis
  • AND
  • Prescribed by or in consultation with a rheumatologist
  • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a 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:
    • Paid claims or submission of medical records (e.g., chart notes) confirming a 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
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy
      • AND
      • 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
    AND
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 6-month trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Actemra IV or SC, Tofidence IV, Tyenne IV or 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 active polyarticular juvenile idiopathic arthritis
  • AND
  • Minimum duration of a 6-week trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [5]:
    • leflunomide
    • methotrexate
    AND
  • Prescribed by or in consultation with a rheumatologist
  • 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 therapy, defined as no more than a 45-day gap in therapy
    AND
  • Both of the following: (Applies to Tofidence IV, Tyenne IV or SC only)
    • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 6-month trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Actemra IV or SC, Tofidence IV, Tyenne IV or 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, 5]:
    • Reduction in the total active (swollen and tender) joint count from baseline
    • Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
Tofidence IV, Tyenne IV or 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

Non Formulary

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

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of active polyarticular juvenile idiopathic arthritis
  • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 6-week trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [5]:
    • leflunomide
    • methotrexate
    AND
  • Prescribed by or in consultation with a rheumatologist
  • AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming a 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
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy
      • AND
      • 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, inflammation) from baseline
    AND
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 6-month trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Actemra IV or SC, Tofidence IV, Tyenne IV or SC

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA)

  • Diagnosis of active systemic juvenile idiopathic arthritis
  • AND
  • Prescribed by or in consultation with a rheumatologist
  • AND
  • Trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [4]:
    • Minimum duration of a 3-month trial and failure of methotrexate
    • Minimum duration of a 1-month trial of nonsteroidal anti-inflammatory drug (NSAID) (e.g., ibuprofen, naproxen)
    • Minimum duration of a 2-week trial of systemic glucocorticoid (e.g., prednisone)
    AND
  • Both of the following: (Applies to Tofidence IV, Tyenne IV or SC only)
    • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 6-month trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Actemra IV or SC, Tofidence IV, Tyenne IV or SC

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA)

  • Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [4]:
    • Reduction in the total active (swollen and tender) joint count from baseline
    • Improvement in clinical features or symptoms (e.g., pain, fever, inflammation, rash, lymphadenopathy, serositis) from baseline
Tofidence IV, Tyenne IV or SC

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of active systemic juvenile idiopathic arthritis
  • AND
  • Prescribed by or in consultation with a rheumatologist
  • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [4]:
    • Minimum duration of a 3-month trial and failure of methotrexate
    • Minimum duration of a 1-month trial of nonsteroidal anti-inflammatory drug (NSAID) (e.g., ibuprofen, naproxen)
    • Minimum duration of a 2-week trial of systemic glucocorticoid (e.g., prednisone)
    AND
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 6-month trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Actemra IV or SC, Tofidence IV, Tyenne IV or SC

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Giant Cell Arteritis (GCA)

  • Diagnosis of giant cell arteritis
  • AND
  • Prescribed by or in consultation with a rheumatologist
  • AND
  • Trial and failure, contraindication, or intolerance to a glucocorticoid
  • AND
  • Both of the following: (Applies to Tofidence IV, Tyenne IV or SC only)
    • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 6-month trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Actemra IV or SC, Tofidence IV, Tyenne IV or SC

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Giant Cell Arteritis (GCA)

  • Patient demonstrates positive clinical response to therapy.
Tofidence IV, Tyenne IV or SC

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Giant Cell Arteritis (GCA)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of giant cell arteritis
  • AND
  • Prescribed by or in consultation with a rheumatologist
  • AND
  • Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to a glucocorticoid
  • AND
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 6-month trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Actemra SC, Tyenne SC [off-label]

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

  • Diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD) as documented by the following [6-8]:
    • Exclusion of other known causes of interstitial lung disease (ILD)
    • AND
    • One of the following:
      • In patients not subjected to surgical lung biopsy, the presence of idiopathic interstitial pneumonia (e.g., fibrotic nonspecific interstitial pneumonia [NSIP], usual interstitial pneumonia [UIP] and centrilobular fibrosis) pattern on high-resolution computed tomography (HRCT) revealing SSc-ILD or probable SSc-ILD
      • OR
      • In patients subjected to a lung biopsy, both HRCT and surgical lung biopsy pattern revealing SSc-ILD or probable SSc-ILD
    AND
  • Prescribed by or in consultation with a pulmonologist or rheumatologist
  • AND
  • Both of the following: (Applies to Tyenne SC only)
    • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 6-month trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Actemra SC, Tyenne SC [off-label]

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

  • Patient demonstrates positive clinical response to therapy.
Tyenne SC [off-label]

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD) as documented by the following [6-8]:
    • Exclusion of other known causes of interstitial lung disease (ILD)
    • AND
    • One of the following:
      • In patients not subjected to surgical lung biopsy, the presence of idiopathic interstitial pneumonia (e.g., fibrotic nonspecific interstitial pneumonia [NSIP], usual interstitial pneumonia [UIP] and centrilobular fibrosis) pattern on high-resolution computed tomography (HRCT) revealing SSc-ILD or probable SSc-ILD
      • OR
      • In patients subjected to a lung biopsy, both HRCT and surgical lung biopsy pattern revealing SSc-ILD or probable SSc-ILD
    AND
  • Prescribed by or in consultation with a pulmonologist or rheumatologist
  • AND
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 6-month trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Actemra IV, Tofidence IV, Tyenne IV [off-label]

Prior Authorization

Length of Approval: 14 Days [B]
For diagnosis of Coronavirus disease 2019 (COVID-19)

  • Diagnosis of COVID-19
  • AND
  • Patient is hospitalized
  • AND
  • Currently receiving systemic corticosteroids
  • AND
  • Patient requires one of the following:
    • Supplemental oxygen
    • Non-invasive mechanical ventilation
    • Invasive mechanical ventilation
    • Extracorporeal membrane oxygenation (ECMO)
    AND
  • Both of the following: (Applies to Tofidence IV and Tyenne IV only)
    • Paid claims or submission of medical records (e.g., chart notes) confirming a trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Tofidence IV, Tyenne IV [off-label]

Non Formulary

Length of Approval: 14 Days [B]
For diagnosis of Coronavirus disease 2019 (COVID-19)

  • Submission of medical records (e.g., chart notes) confirming a diagnosis of COVID-19
  • AND
  • Patient is hospitalized
  • AND
  • Currently receiving systemic corticosteroids
  • AND
  • Patient requires one of the following:
    • Supplemental oxygen
    • Non-invasive mechanical ventilation
    • Invasive mechanical ventilation
    • Extracorporeal membrane oxygenation (ECMO)
    AND
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming a trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Actemra IV, Tofidence IV [off-label], Tyenne IV [off-label]

Prior Authorization

Length of Approval: 2 Months [A]
For diagnosis of Cytokine Release Syndrome (CRS) Risk due to CAR T-Cell Therapy

  • Patient will receive or is receiving chimeric antigen receptor (CAR) T-cell immunotherapy (e.g., Kymriah [tisagenlecleucel], Yescarta [axicabtagene ciloleucel])
  • AND
  • Prescribed by or in consultation with an oncologist or hematologist
  • AND
  • Both of the following: (Applies to Tofidence IV and Tyenne IV only)
    • Paid claims or submission of medical records (e.g., chart notes) confirming a trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
Tofidence IV [off-label], Tyenne IV [off-label]

Non Formulary

Length of Approval: 2 Months [A]
For diagnosis of Cytokine Release Syndrome (CRS) Risk due to CAR T-Cell Therapy

  • Patient will receive or is receiving chimeric antigen receptor (CAR) T-cell immunotherapy (e.g., Kymriah [tisagenlecleucel], Yescarta [axicabtagene ciloleucel])
  • AND
  • Prescribed by or in consultation with an oncologist or hematologist
  • AND
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming a trial of Actemra (tocilizumab)
    • AND
    • Submission of medical records documenting why the covered product has not been effective
P & T Revisions

2024-12-04, 2024-12-04, 2024-10-03, 2024-09-08, 2024-07-12, 2024-07-12, 2024-06-24, 2024-06-09, 2024-05-01, 2024-04-23, 2024-03-06, 2023-09-28, 2023-06-30, 2023-05-03, 2023-02-01, 2023-01-31, 2022-10-21, 2022-05-07, 2022-04-10, 2021-09-27, 2021-05-20, 2020-12-03, 2020-09-15, 2020-03-17, 2019-10-23, 2019-06-28

  1. Actemra Prescribing Information. Genentech, Inc. South San Francisco, CA. December 2022.
  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. Onel KB, Horton DB, Lovell DJ, et al. 2021 American College of Rheumatology guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for oligoarthritis, temporomandibular joint arthritis, and systemic juvenile idiopathic arthritis. Arthritis Rheumatol. 2022;74(4):553-569.
  5. 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.
  6. Khanna D, Lin CJF, Furst DE, et al. Tocilizumab in systemic sclerosis: a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2020;8:963–74.
  7. Fischer A, Swigris JJ, Groshong SD, et al. Clinically significant interstitial lung disease in limited scleroderma: histopathology, clinical features, and survival. Chest 2008; 134:601.
  8. UptoDate [internet database]. Waltham, MA. UpToDate, Inc. Clinical manifestations, evaluation, and diagnosis of interstitial lung disease in systemic sclerosis (scleroderma). Available by subscription at: https://www.uptodate.com. Accessed April 11, 2021.
  9. Tofidence Prescribing Information. Biogen MA Inc. Cambridge, MA. July 2024.
  10. Tyenne Prescribing Information. Fresenius Kabi USA, LLC. Lake Zurich, IL. March 2024.

  1. Patients should have Actemra on board for initial CAR T-cell therapy and be evaluated for signs and symptoms of CRS for at least 4 weeks after, up to a total of 4 doses of Actemra with at least 8 hours between doses. [1]
  2. The recommended dosage of Actemra for treatment of adult patients with COVID-19 is 8 mg/kg administered as a single 60-minute intravenous infusion. If clinical signs or symptoms worsen or do not improve after the first dose, one additional infusion of Actemra may be administered at least 8 hours after the initial infusion. [1]

  • 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"; updated background table
  • 2024-12-04: Update to remove manufacturer information from "one formulary adalimumab product"; updated background table
  • 2024-10-03: Addition of NF criteria for Tofidence and Tyenne
  • 2024-09-08: Updated indications and criteria section headings to reflect approval of Tofidence IV for GCA and COVID-19
  • 2024-07-12: Addition of Rinvoq/Rinvoq LQ as additional preferred alternatives for PJIA
  • 2024-07-12: Addition of Tyenne SC; combined Tofidence and Tyenne criteria with Actemra criteria
  • 2024-06-24: Addition of criteria for Tofidence and Tyenne; Updated background table to specify BI manufacturer for adalimumab-adbm
  • 2024-06-09: Addition of criteria for Tofidence and Tyenne
  • 2024-05-01: Annual review - no criteria changes
  • 2024-04-23: Updated verbiage in the RA and PJIA step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
  • 2024-03-06: Updated verbiage in the RA and PJIA step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
  • 2023-09-28: 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 and PJIA
  • 2023-05-03: Annual review - no criteria changes; background updates
  • 2023-02-01: Addition of criteria for COVID-19
  • 2023-01-31: Addition of Amjevita as another preferred step option for RA and PJIA
  • 2022-10-21: Addition of Enbrel as another preferred step option for RA; updated the PJIA step to two of Enbrel, Humira, or Xeljanz; further clinical detail added for RA, SJIA, and PJIA
  • 2022-05-07: Annual review - removed examples of exclusion of other known causes of ILD; background updates
  • 2022-04-10: Addition of IV formulation to the GCA criteria
  • 2021-09-27: Annual review - removed reference to drug name in reauth criteria; added methotrexate as another conventional step option for SJIA; background and reference updates
  • 2021-05-20: Annual review - removed reference to drug name in reauth criteria; added methotrexate as another conventional step option for SJIA; background and reference updates
  • 2020-12-03: Addition of attestation bypass verbiage to Humira step in PJIA.
  • 2020-09-15: Formulary strategy update to remove Simponi Aria as a preferred step option for RA
  • 2020-03-17: Annual review - no clinical changes; reference updates
  • 2019-10-23: Added Rinvoq (upadacitinib) as a step option for RA.
  • 2019-06-28: Update per PA escalation to remove "(i.e. prednisone)" from the giant cell arteritis criteria. Since the criteria asks for "a glucocorticoid," the intent is to allow for any glucocorticoid, not prednisone specifically. Criteria update aligns with the criteria enhancement being made for Part D. AJL 6/28/19

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