HN Logo
Prior Authorization Protocol
ACTEMRAR (tocilizumab)

NATL
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
    • Treatment of patients 2 years of age and older with active systemic juvenile idiopathic arthritis (SJIA).
    • Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
  2. Health Net Approved Indications and Usage Guidelines:
    • Laboratory documentation of ALL of the following is provided, along with date performed within the last 3 months:
      • Absolute neutrophil count (ANC) at least 2000/mm3
      • Platelet count at least 100,000/mm3 (100 x 109/L, 10 x 108/L 100,000/ml, 100 K/5L)
      • Transaminases (ALT, AST) not greater than 1.5x ULN
    AND

    Rheumatoid Arthritis (IV and SC formulations)
    • Diagnosis of rheumatoid arthritis
    AND
    • Confirmed by a Rheumatologist
    OR
    • Defined at baseline prior to disease modifying anti-rheumatic drug (DMARD) treatment initiation by the American College of Rheumatology (ACR) criteria (refer to General Information for ACR criteria)
    AND
    • For intravenous Actemra only - failure or clinically significant adverse effects to a trial of RemicadeR, unless contraindicated

    Systemic Juvenile Idiopathic Arthritis (IV formulation only)
    • Diagnosis of Systemic Juvenile Idiopathic Arthritis

    AND

    • Confirmed by a Rheumatologist

    AND

    • Failure or clinically significant adverse effects to methotrexate at least 10 mg/m2 per week for 3 months. [only one DMARD required since MTX is the only DMARD with extensive pediatric safety data]
    Polyarticular Juvenile Idiopathic Arthritis (IV formulation only)
    • Diagnosis of active Polyarticular Juvenile Idiopathic Arthritis confirmed by a Rheumatologist
    AND
    • Failure or clinically significant adverse effects to methotrexate for 3 months
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
    • Combination use with biological DMARDs such as TNF antagonists [Cimzia, Enbrel, Humira, Simponi, Remicade], interleukin-1 receptor (IL-1R) antagonists [Kineret], anti-CD20 monoclonal antibodies [Rituxan] and selective co-stimulation modulators [Orencia] because of the possibility of increased immunosuppression, neutropenia and increased risk of infection.
  4. General Information:
    • ACR Classification criteria for RA (score-based algorithm: add score of categories A-D; a score of >/= 6/10 is needed for classification of a patient as having definite RA).
    A. Joint involvement (swollen or tender)
      • 1 large joint, score = 0
      • 2-10 large joints, score = 1
      • 1-3 small joints (with or without involvement of large joints), score = 2
      • 4-10 small joints (with or without involvement of large joints), score = 3
      • >10 joints (at least 1 small joint), score = 5
    B. Serology (at least 1 test result is needed for classification)
      • Negative RF and negative ACPA (anti-citrullinated protein antibody), score = 0
      • Low-positive RF or low-positive ACPA, score = 2
      • High-positive RF or high-positive ACPA, score = 3
    C. Acute-phase reactants (at least 1 test result is needed for classification)
      • Normal CRP and normal ESR, score = 0
      • Abnormal CRP or normal ESR, score = 1
    D. Duration of symptoms
      • < 6 weeks, score = 0
      • >/= 6 weeks, score = 1
    • This agent is immunosuppressive and has the potential to increase the risk of infection and reactivate latent, chronic infections. It should not be administered to patients with a clinically important infection. Caution should be used in patients with chronic infections or history of recurrent infection. If patient develops a serious infection this agent should be discontinued.
    • Treatment with Actemra was associated with a higher incidence of neutropenia, a reduction in platelet counts, and a higher incidence of transaminase elevations. Increased frequency and magnitude of transaminase elevations were observed when potentially hepatotoxic drugs (e.g., MTX) were used in combination with Actemra. It is not recommended to initiate Actemra treatment in patient with an ANC less than 2000/mm3, a platelet count below 100,000/mm3 and elevated transaminases greater than 1.5x ULN. In patients who develop an ANC less than 500/mm3, a platelet count less than 50,000/mm3 or elevated ALT or AST greater than 5x ULN, treatment is not recommended. Neutrophils, platelets, and transaminases should be monitored every 4 to 8 weeks with dose modifications based on laboratory results if necessary.
    • Actemra has not been studied and its use should be avoided in combination with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators because of the possibility of increased immunosuppression and increased risk of infection.
    • Subcutaneous administration of Actemra has not been FDA approved for systemic juvenile idiopathic arthritis or polyarticular juvenile idiopathic arthritis.

  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    RheumatrexR (methotrexate)

    Rheumatoid Arthritis
    7.5 mg/week PO or 2.5 mg PO Q12 hr for 3 doses/week

    Juvenile Idiopathic Arthritis

    10-15 mg/m2/week

    Adults: 30 mg/week

    Children: 15 mg/m2/week

    AzulfidineR (sulfasalazine)

    Rheumatoid Arthritis
    2 gm/day PO in divided doses

    3 gm/day

    PlaquenilR (hydroxychloroquine)

    Rheumatoid Arthritis
    Initial dose:
    400-600 mg/day PO
    Maintenance dose:
    200-400 mg/day PO

    600 mg/day

    ImuranR (azathioprine)

    Rheumatoid Arthritis
    1 mg/kg (50-100 mg) PO given as a single dose or twice daily

    2.5 mg/kg/day

    Enbrel (etanercept)*

    Rheumatoid Arthritis
    25 mg SC twice weekly or 50 mg SC once weekly
    Juvenile Idiopathic Arthritis
    0.8 mg/kg SC per week given as single injection
    Rheumatoid Arthritis
    50 mg twice weekly
    Juvenile Idiopathic Arthritis
    50 mg per week

    Humira (adalimumab)*

    Rheumatoid Arthritis
    40 mg SC every other week
    Juvenile Idiopathic Arthritis
    Dosed by weight for pediatric patients age 4-17 years:
    15 kg to less than 30 kg = 20 mg every other week; greater than or equal to 30 kg = 40 mg every other week.

    40 mg per week

    Cimzia (certolizumab pegol)*

    Rheumatoid Arthritis
    400 mg SC initially and at Weeks 2 and 4
    Maintenance dose:
    200 mg SC every other week or 400 mg SC every 4 weeks

    Initial:
    1200 mg/month
    Maintenance:
    400 mg/month

    Simponi (golimumab)*

    Rheumatoid Arthritis
    50 mg SC every month

    50 mg/month

    KineretR (anakinra)*

    Rheumatoid Arthritis
    100 mg/day SC

    100 mg/day

    Remicade (infliximab)*

    Rheumatoid Arthritis
    3 mg/kg IV initially and at weeks 2 and 6, then every 8 weeks.

    For incomplete response dosing adjustments up to 10 mg/kg or treating every 4 weeks can be considered.

    10 mg/kg every 8 weeks

    OrenciaR (abatacept)*

    Rheumatoid Arthritis
    IV infusion
    500 mg-1000 mg (weight-based dosing) at 2 and 4 weeks
    after the first dose and then every 4 weeks thereafter
    For SC administration
    After a single IV infusion as a loading dose (as per body weight categories),
    125 mg administered by a SC injection should be given within a day,
    followed by 125 mg SC once a week. Patients who are unable to receive
    an infusion may initiate weekly SC injections of Orencia without an IV loading dose.
    Patients transitioning from Orencia IV therapy to SC administration should
    administer the first SC dose instead of the next scheduled IV dose.

    For IV use
    1000 mg every 4 weeks
    For SC use
    125 mg once per week

    CuprimineR (d-Penicillamine)
    Rheumatoid Arthritis
    Initial dose:
    125-250 mg PO daily
    Maintenance dose:
    500-1500 mg PO daily

    1500 mg/day

    RidauraR (auranofin)

    Rheumatoid Arthritis
    3 mg PO BID or 6 mg PO once daily

    9 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit
    Actemra
    Rheumatoid Arthritis
    Intravenous
    4 mg/kg by IV infusion every 4 weeks,
    followed by an increase to 8 mg/kg based on clinical response
    Subcutaneous
    Under 100 kg weight: 162 mg SC every other week,
    followed by an increase to every week based on clinical response
    100 kg or greater weight: 162 mg SC every week
    When transitioning from Actemra IV therapy to SC administration,
    administer the first subcutaneous dose instead of the next scheduled intravenous dose.
    Dose reductions or interruptions may be necessary based on laboratory results
    for ANC, platelet count, and transaminases.

    Systemic Juvenile Idiopathic Arthritis
    Patients less than 30 kg: 12 mg/kg by IV infusion every 2 weeks
    Patients at or above 30 kg: 8 mg/kg by IV infusion every 2 weeks

    Polyarticular Juvenile Idiopathic Arthritis
    Patients less than 30 kg: 10 mg/kg by IV infusion every 2 weeks
    Patients at or above 30 kg: 8 mg/kg by IV infusion every 2 weeks
    Rheumatiod Arthritis
    Pharmacy:
    3 months initial trial
    Continued treatment will be approved up to one
    year with documentation of response to therapy.
    Medical:
    6 months or to member's renewal period, whichever is sooner.

    Systemic Juvenile Idiopathic Arthritis
    Pharmacy:
    3 months initial trial
    Continued treatment will be approved up to one
    year with documentation of response to therapy.
    Medical:
    6 months or to member's renewal period, whichever is sooner

    Polyarticular Juvenile Idiopathic Arthritis
    Pharmacy:
    3 months initial trial
    Continued treatment will be approved up to one
    year with documentation of response to therapy.
    Medical:
    6 months or to member's renewal period, whichever is sooner
  7. Product Availability:
    Single-use vials (20 mg/mL): 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL
    Single-use prefilled syringes: 162 mg/0.9 mL
  8. References:
    1. Actemra [Prescribing information]. South San Francisco, CA: Genentech, Inc; October 2013.
    2. Singh JA, et al. 2012 Update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care & Research. May 2012;64(5):625-39.
    3. Thomson Micromedex Web site. Available at: http://www.thomsonhc.com/home/dispatch. Accessed June 2014
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.