ACTEMRA (tocilizumab)

Actemra (tocilizumab)

Self-Administration - subcutaneous (SC) injection (prefilled syringe or autoinjector)

Office Administration - intravenous (IV) infusion

 

Indication for Prior Authorization:

 

Actemra (tocilizumab IV) or Actemra (tocilizumab SC)

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).

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

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

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

 

Actemra (tocilizumab IV)

Cytokine Release Syndrome (CRS): 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.

 

Actemra (tocilizumab SC)

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).

 

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, or Brand Adalimumab-adaz
    • Rinvoq (upadacitinib)
    • Simponi (golimumab)
    • Xeljanz/XR (tofacitinib/ER)
  • For continuation of prior Actemra therapy, defined as no more than a 45-day gap in therapy.

* 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 diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA):

• Documented diagnosis of active SJIA; 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:
  • 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).

 

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, or Brand Adalimumab-adaz
    • Xeljanz (tofacitinib) (IR tablet or oral solution only**)
  • For continuation of Actemra therapy, defined as no more than a 45-day gap in therapy.

* 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.

 

For diagnosis of Giant Cell Arteritis (GCA) (also known as temporal arteritis):

• Documented diagnosis of GCA; AND 
• Prescribed by or in consultation with a rheumatologist; AND
• Trial and failure, contraindication, or intolerance to a glucocorticoid (e.g., prednisone, dexamethasone, methylprednisolone, etc.).

 

For diagnosis of Cytokine Release Syndrome (CRS):

• One of the following:
  • Patient will receive or is receiving chimeric antigen receptor (CAR) T-cell immunotherapy (i.e., Kymriah [tisagenlecleucel], Yescarta [axicabtagene ciloleucel], Breyanzi [lisocabtagene maraleucel], Tecartus [brexucabtagene autoleucel], etc.);
  • Patient has a diagnosis of refractory CRS caused by treatment with Blincyto (blinatumomab) (off-label use); AND 
• Request is for the intravenous (IV) formulation of Actemra; AND
• Prescribed by or in consultation with an oncologist or hematologist.

 

For diagnosis of Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD):

• Diagnosis of SSc-ILD as documented by the following:
  • 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
    • In patients subjected to a lung biopsy, both HRCT and surgical lung biopsy pattern revealing SSc-ILD or probable SSc-ILD; AND 
• Request is for the subcutaneous (SC) formulation of Actemra; AND
• Prescribed by or in consultation with a pulmonologist or rheumatologist

 

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 SJIA:

• 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 clinical features or symptoms (e.g., pain, fever, inflammation, rash, lymphadenopathy, serositis) from baseline.

 

For diagnosis of SSC-ILD, GCA:

• Documentation of positive clinical response to therapy.

 

Dosing:

 

RA (adults):

• IV infusion:
  • Starting dose: 4 mg/kg IV infusion every 4 weeks.
  • Increased to 8 mg/kg every 4 weeks based on clinical response. 
  • Doses exceeding 800 mg per infusion are not recommended in RA patients.
• SC self-administration:
  • Less than 100kg: up to 162 mg SC every other week.
  • May increase to 162 mg SC every week based on clinical response.
  • 100 kg or greater: up to 162 mg SC weekly.

 

PJIA (2 years of age and older):

• IV infusion:
  • Less than 30 kg: up to 10 mg/kg IV infusion every 4 weeks.
  • 30 kg or greater: up to 8 mg/kg IV infusion every 4 weeks.
• SC self-administration:
  • Less than 30 kg: up to 162 mg SC every 3 weeks.
  • 30 kg or greater: up to 162 mg SC every 2 weeks.

 

SJIA (2 years of age and older):

• IV infusion:
  • Less than 30 kg: up to 12 mg/kg IV infusion every 2 weeks.
  • 30 kg or greater: up to 8 mg/kg IV infusion every 2 weeks.
• SC self-administration:
  • Less than 30 kg: up to 162 mg SC every 2 weeks.
  • 30 kg or greater: up to 162 mg SC weekly.

 

GCA (adults):

• IV infusion:
  • 6 mg/kg IV infusion every 4 weeks.
  • Doses exceeding 600 mg per infusion are not recommended in GCA patients.
• SC self-administration:
  • Up to 162 mg SC weekly.

 

CRS (2 years of age and older):

• IV infusion:
  • Less than 30 kg: up to 12 mg/kg IV infusion for a total of 4 doses.
  • 30 kg or greater: up to 8 mg/kg IV infusion up to 800 mg per infusion for a total of 4 doses.

 

SSc-ILD:

• SC self-administration:
  • Up to 162 mg SC weekly.

 

Coverage Duration:

 

• Initial and reauthorization (RA, PJIA, SJIA, SSc-ILD, CGA): 1 year.
• CRS: 2 months (one-time authorization).

 

Review History:

 

• 02/18/2020 - annual review.
• 02/16/2021 - updated format; 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 requirement for one NSAID or systemic steroid for SJIA; added medical necessity guidance for reauthorization requests; added FDA approval to treat CGA and CRS; updated approval duration to 1 year.
• 04/20/2021: added coverage criteria for GCA and CRS.
• 11/16/2021 - Updated Juvenile Idiopathic Arthritis (JIA) oral disease-modifying anti-rheumatic drugs [DMARDs] criteria
• 01/01/2023 – Added criteria and dosing for new indication (SSc-ILD), updated PJIA step to two of Humira, Xeljanz, or Enbrel, updated RA step to include Enbrel, add minimum duration for trial of first line treatments prior to evaluating efficacy, add IV dosing for GCA.
• 09/01/2023 - Addition of Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred options for RA and PJIA. (P&T 08/15/2023)

 

References:

 

1. Actemra Prescribing Information. Genentech, Inc. South San Francisco, CA. June 2019.
2. 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
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. 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.
5. 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.
6. Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. 2013;65(10):2499-512.
7. 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.
8. 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.