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Prior Authorization Protocol
CIMZIAR (certolizumab pegol), ENBRELR (etanercept), HUMIRAR (adalimumab), KINERETR (anakinra), SIMPONIR, SIMPONIR ARIATM (golimumab), STELARATM (ustekinumab), REMICADE (infliximab), COSENTYX (secukinumab), OTEZLA (apremilast), ORENCIA (abatacept), ACTEMRA (tocilizumab), ENTYVIO (vedolizumab), TYSABRI (natalizumab)



NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:

    AS
    CD
    UC
    NOMID
    pJIA
    sJIA
    PP
    PsA
    RA
    HS
    Cimzia
    x
    x
    x
    x
    Enbrel
    x
    x
    x
    x
    x
    Humira
    x
    x
    x
    x
    x
    x
    x
    x
    Kineret
    x
    x
    Simponi
    x
    x
    x
    x
    Simponi Aria
    x
    Stelara
    x
    x
    Remicade
    x
    x
    x
    x
    x
    x
    Actemra
    x (IV)
    x (IV)
    x
    Orencia
    x (IV)
    x
    Entyvio
    x
    x
    Cosentyx
    x
    x
    x
    Otezla
    x
    x
    Tysabri
    x

    AS=ankylosing spondylitis; CD=Crohns disease; UC=ulcerative colitis; NOMID=neonatal-onset multisystem inflammatory disease; pJIA=polyarticular juvenile idiopathic arthritis; sJIA=systemic juvenile idiopathic arthritis; PP=plaque psoriasis; PsA= psoriatic arthritis; RA=rheumatoid arthritis; HS=Hidradenitis Suppurativa
  2. Health Net Approved Indications and Usage Guidelines:
    Rheumatoid Arthritis [for, Enbrel, Humira, , Simponi, Simponi Aria, Remicade, Kineret, Cimzia, Orencia, Actemra]
    • Diagnosis of rheumatoid arthritis (RA)
    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
    • Failure or clinically significant adverse effects to methotrexate (MTX) in the last year for patients who are new to biologics
    OR
    • If patient is not a candidate for MTX (i.e., patient is a smoker [increased risk of MTX lung disease] or MTX is contraindicated), then failure or clinically significant adverse effect to sulfasalazine or 1 other DMARD
    AND [for Kineret, Cimzia, Orencia, Actemra, Enbrel ]
    • Failure or clinically significant adverse effects to a 3-month minimum trial of HumiraR AND either, RemicadeR or SimponiR)
    Psoriatic Arthritis [for Enbrel, Humira, Simponi, Stelara, Remicade, Cimzia, Otezla, Cosentyx]
    • Diagnosis of Active Psoriatic Arthritis
    AND
    • Confirmed by a Rheumatologist or Dermatologist
    AND
    • Failure or clinically significant adverse effects to MTX unless contraindicated
    AND [for Cimzia, Cosentyx, Enbrel]
    • Failure or clinically significant adverse effects to a 3-month minimum trial of HumiraR AND either, RemicadeR or StelaraR or SimponiR or Otezla)
    Ankylosing Spondylitis [for Enbrel, Humira, Simponi, Remicade, Cimzia, Cosentyx]
    • Diagnosis of active Ankylosing Spondylitis
    AND
    • Failure or clinically significant adverse effects to at least two NSAIDs for at least 1 month at maximal recommended or tolerated anti-inflammatory dose, unless contraindicated
    AND [for Cimzia, Enbrel, Cosentyx]
    • Failure or clinically significant adverse effects to a 3-month minimum trial of HumiraR AND either, RemicadeR or SimponiR)
    Crohn`s Disease [for Humira, Remicade, Cimzia, Entyvio, Tysabri]
    • Diagnosis of moderate to severe Crohn`s Disease
    AND
    • Confirmed by a gastroenterologist
    AND [for Cimzia, Entyvio, Tysabri]
    • Failure or clinically significant adverse effects to HumiraR AND RemicadeR
    Ulcerative Colitis [for Humira, Simponi, Remicade, Entyvio]
    • Diagnosis of moderate to severe ulcerative colitis
    AND
    • Confirmed by a gastroenterologist
    AND
    For Induction:
    • Patient is not in remission
    AND
    • Failure or clinically significant adverse effects to a one-month course of aminosalicylates (e.g. sulfasalazine, mesalamine) followed by corticosteroids such as prednisone.
    AND [for Entyvio]
    • Failure or clinically significant adverse effects to HumiraR AND RemicadeR or Simponi
    For maintenance:
    • Failure or clinically significant adverse effects to one of the following:
      • azathioprine
      • 6-mercaptopurine (6-MP)
      • aminosalicylates (e.g., sulfasalazine)
    Plaque Psoriasis [for Enbrel, Humira, Stelara, Remicade, Otezla, Cosentyx]
    • Diagnosis of chronic moderate to severe plaque psoriasis
    AND
    • Prescribed by a Dermatologist or Rheumatologist
    AND
    • Failure or clinically significant adverse effects to ONE of the following therapies either alone or in combination, unless contraindicated:
      • Methotrexate up to a dose of 15-20 mg/week
    OR
      • If methotrexate is contraindicated, failure or clinically significant adverse effects to PUVA Therapy or UVB, or cyclosporine or acitretin
    AND [for Enbrel]
    • Failure or clinically significant adverse effects to HumiraR AND either Stelara or RemicadeR or Otezla
    OR [for Cosentyx]
    • Failure or clinically significant adverse effects to Humira AND either Stelara or Remicade
    Polyarticular Juvenile Idiopathic Arthritis [for Enbrel, Humira, Orencia]
    • Diagnosis of Active Polyarticular Juvenile Idiopathic Arthritis
    AND
    • Confirmed by a Rheumatologist
    AND
    • Failure or clinically significant adverse effects to methotrexate for 3 months
    AND [for Orencia, Enbrel]
    • Failure or clinically significant adverse effects to HumiraR
    Neonatal-Onset Multisystem Inflammatory Disease (NOMID) [for Kineret only]
    • Diagnosis of Neonatal-onset multisystem inflammatory disease (NOMID) or chronic infantile neurological, cutaneous and articular syndrome (CINCA)
    Hidradenitis Suppurativa (HS) [for Humira, Enbrel]:
    • Diagnosis of Hidradenitis Suppurativa (HS)
    AND
    • Prescribed by a Dermatologist or Rheumatologist or gastroenterologist

    AND [for Enbrel]

    • Failure or clinically significant adverse effects to HumiraR
    Systemic juvenile idiopathic arthritis (SJIA) (for Actemra only):
    • Diagnosis of Systemic juvenile idiopathic arthritis

    AND

    • Prescribed by a Dermatologist or Rheumatologist or gastroenterologist
    Relapsing remitting multiple sclerosis (for Tysabri only):
    • RRMS confirmed by a neurologist

    AND

    • Failure or clinically significant adverse effects to two of the following: Aubagio, Tecfidera, Gilenya, Avonex, Betaseron, Copaxone, Rebif, or Plegridy

  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 Xeljanz or biological DMARDs such as TNF antagonists [Enbrel, Humira, Simponi, Remicade], interleukin-1 receptor (IL-1R) antagonists [Kineret], interleukin-6 receptor (IL-6R) antagonists [Actemra], 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 (rheumatoid factor) andnegative ACPA (anti-citrullinated protein antibody), score = 0
      • Low-positive RF orlow-positive ACPA, score = 2
      • High-positive RF orhigh-positive ACPA, score = 3
    C. Acute-phase reactants (at least 1 test result is needed for classification)
      • Normal CRP (C-reactive protein) andnormal ESR (erythrocyte sedimentation rate), score = 0
      • Abnormal CRP orabnormal ESR, score = 1
    D. Duration of symptoms
      • < 6 weeks, score = 0
      • >/= 6 weeks, score =
    • In RA, failure of MTX or DMARD is defined as a contraindication or < 50% decrease in swollen joint count, < 50% decrease in tender joint count, and < 50% decrease in ESR, or < 50% decrease in CRP, or contraindication to at least 3 months of therapy with MTX at doses up to 25 mg per week or maximum tolerated dose.
    • These agents are immunosuppressive and have the potential to increase the risk of infection and reactivate latent, chronic infections. They 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 these agents should be discontinued.
    • Several ankylosing spondylitis (AS) treatment guidelines call for a trial of 2 or 3 non-steroidal anti-inflammatory drugs (NSAID) prior to use of an anti-TNF agent. A two year trial showed that continuous NSAID use reduced radiographic progression of AS versus on demand use of NSAID.
    • Serious infections were seen in clinical studies with concurrent use of Kineret and another TNF-blocking agent, Enbrel, with no added benefit compared to Enbrel alone. Because of the nature of the adverse reactions with this combination therapy, similar toxicities may also result from combination of anakinra and other TNF blocking agents.
    • For Ulcerative Colitis maintenance therapy, failure is defined as having two or more exacerbations requiring steroid therapy.
    • Failure of MTX in PJIA is defined as disease activity remaining moderate to high despite treatment with MTX.
    • In PJIA, response to treatment is reflected by improvement of disease activity level and poor prognostic features including: reduction in the number of active joints, ESR or CRP, Physician global assessment, patient/parent global assessment, arthritis of the hip or cervical spine, positive RF or ACPA, radiographic damage.
    • Per prescribing information, Xeljanz should not be used in combination with biologic DMARDs [such as Kineret] or potent immunosuppressants such as azathioprine and cyclosporine. As stated in the black box warning, patients treated with Xeljanz are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as MTX or corticosteroids.
    • Stelara is for subcutaneous administration and is intended for use under the guidance and supervision of a physician. After proper training in subcutaneous injection technique, a patient may self inject with Stelara if a physician determines that it is appropriate. Patients should be instructed to follow the directions provided in the Medication Guide.
    • In the PHOENIX 2 trial, dosing intensification of Stelara to every 8 weeks did not result in greater efficacy compared with continuing treatment every 12 weeks.
    • Other names used for NOMID are as follows: chronic infantile neurological, cutaneous and articular syndrome (CINCA), chronic neurologic, cutaneous, and articular syndrome, infantile onset multisystem inflammatory disease, IOMID syndrome, and Prieur-Griscelli syndrome.
    • Off-label indications:. Graft vs. Host disease is listed in Micromedex as Class IIa and Enbrel is recommended in most cases.
    • Hidradenitis Suppurativa (HS) sometimes referred to as : "acne inversa, acne conglobata, apocrine acne, apocrinitis, Fox-den disease, hidradenitis axillaris, HS, pyodermia sinifica fistulans, Velpeaus disease, and Verneuils disease."
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    azathioprine (ImuranR)

    Crohn's
    100-250 mg PO daily

    Rheumatoid Arthritis

    1 mg/kg PO given as a QD or BID

    Crohn's
    2.5 mg/kg/day

    Rheumatoid Arthritis

    2.5 mg/kg/day

    Corticosteroids

    Crohn`s
    Prednisone 40 mg PO QD for 2 weeks or
    IV 50-100 mg Q6H for 1 week
    budesonide (Entocort ECR) 6-9 mg PO QD

    Varies

    EnbrelR (etanercept) *

    Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
    25 mg SC twice weekly or 50 mg SC once weekly

    Plaque Psoriasis
    25-50 mg SC twice weekly or 50 mg SC once weekly

    Polyarticular Juvenile Idiopathic Arthritis
    Less than 63 kg: 0.8 mg/kg SC per week given as single injection.
    63 kg or more: 50 mg SC per week

    Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Polyarticular Juvenile Idiopathic Arthritis
    50 mg per week

    HumiraR (adalimumab) *

    Rheumatoid Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Psoriatic Arthritis
    40 mg SC QOW

    Crohn`s, Ulcerative Colitis
    Induction: 160 mg (four 40 mg injections) SC at week 0 followed by 80 mg SC at week 2 (day 15) (160 mg can be given as 4 injections in one day or divided over 2 days)
    Maintenance: 40 mg every other week beginning at week 4 (day 29)

    Rheumatoid Arthritis
    40 mg/week

    Psoriatic Arhthritis, Ankylosing Spondylitis, Plaque Psoriasis
    40mg every other week

    Crohns Disease,Ulcerative Colitis
    Induction: 160 mg
    Maintenance: 40 mg every other week

    hydroxychloroquine (PlaquenilR)
    Rheumatoid Arthritis
    Initial dose:
    400-600 mg PO QD
    Maintenance dose:
    200-400 mg PO QD

    600 mg/day

    mercaptopurine (PurinetholR)

    Crohn's, Ulcerative Colitis
    75-125 mg PO QD

    1.5 mg/kg/day

    methotrexate (RheumatrexR)

    Rheumatoid Arthritis
    7.5 mg/week PO or 2.5 mg PO Q12hr for 3 doses/week
    Polyarticular Juvenile Arthritis
    10mg/m2 PO weekly
    Plaque Psoriasis
    10 to 25 mg/week, IM, IV or PO

    30 mg/week

    OrenciaR (abatacept) *

    Rheumatoid Arthritis
    For IV infusion:
    500-1000 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.

    Polyarticular Juvenile Idiopathic Arthritis
    < 75 kg: 10 mg/kg IV
    Dose as an adult for > 75 kg
    75  100 kg: 750 mg IV
    >100 kg: 1000 mg IV
    (maximum dose = 1,000 mg)
    Following initial administration, repeat dose at weeks 2 and 4, then every 4 weeks
    For IV use:
    1000 mg every 4 weeks
    For SC use:
    125 mg once per week

    PentasaR (mesalamine)

    Crohns Disease and Ulcerative Colitis
    1000 mg PO QID

    4000 mg/day

    RemicadeR (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 IV or treating every 4 weeks can be considered.
    Psoriatic Arthritis, Plaque Psoriasis, Crohns Disease, Ulcerative Colitis
    5 mg/kg IV at 0, 2 and 6 weeks then every 8 weeks
    Ankylosing Spondylitis
    5 mg/kg IV at 0, 2 and 6 weeks, then every 6 weeks

    Crohn`s
    10 mg/kg every 8 weeks
    Rheumatoid Arthritis
    10 mg/kg every 4 weeks
    Psoriatic Arthritis
    5 mg/kg every 6 weeks

    SimponiR (golilumab) *

    Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
    50 mg SC once a month
    Ulcerative Colitis
    200 mg SC at week 0, 100 mg SC at week 2, then 100 mg SC every 4 weeks

    Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
    50 mg/month
    Ulcerative Colitis
    Initial: 200mg
    Maintenance: 100mg/month

    sulfasalazine (AzulfidineR)

    Rheumatoid Arthritis
    2 gm/day PO in divided doses

    Ulcerative Colitis
    Initial dose is 3 to 4 gm/day PO; maintenance is 2gms/day PO
    Administer in evenly divided doses (not exceeding 8-hour intervals)

    4 gm/day

    StelaraR (ustekinumab) *

    Plaque Psoriasis, Psoriatic Arthritis
    Less than or equal to 100 kg: 45 mg SC initially and 4 weeks later, followed by 45 mg SC every 12 weeks. Greater than 100 kg: 90 mg SC initially and 4 weeks later, followed by 90 mg SC every 12 weeks

    90 mg initially and 4 weeks later, then 90 mg every 12 weeks

    Cimzia (certolizumab pegol)*

    Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
    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

    Crohns Disease
    Initial dose: 400 mg SC initially and at weeks 2 and 4. Maintenance dose: 400 mg SC every 4 weeks.

    Initial: 1200 mg
    Maintenance: 400 mg/month

    cyclosporine (Sandimmune, Neoral)

    Rheumatoid Arthritis, Plaque Psoriasis
    2.5  4 mg/kg/day PO divided BID

    4 mg/kg/day

    acitretin (Soriatane)

    Plaque Psoriasis
    25 or 50 mg PO daily

    50 mg/day

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    See next column

    Rheumatoid Arthritis:

    CIMZIA
    Initial dose: 400 mg SC initially and at Weeks 2 and 4
    Maintenance dose: 200 mg SC every other week (400 mg SC every 4 weeks can be considered)

    ENBREL
    50 mg SC once weekly

    HUMIRA
    40 mg SC every other week
    If not on concomitant methotrexate, may benefit from increasing the dosing frequency to 40 mg SC every week.

    KINERET
    100 mg/day by SC injection.

    SIMPONI
    50 mg SC once a month

    SIMPONI ARIA
    2 mg/kg IV infusion over 30 minutes at weeks 0 and 4, then every 8 weeks

    REMICADE
    3 mg/kg IV initially and at weeks 2 and 6, then Q8W

    ACTEMRA
    Patients less than 100 kg: 162 mg SC QOW
    Patients 100 kg or more: 162 mg SC Q Week
    Or
    4 mg/kg IV every 4 weeks followed by an increase to 8 mg/kg IV every 4 weeks based on clinical response

    ORENCIA
    Patients less than 60 kg: 500 mg
    Patients 75 kg to 100 kg: 750 mg
    Patients more than 100 kg: 1,000 mg
    IV initially then at weeks 2 and 4 then, Q 4 Weeks
    Or
    125 mg SC Q Week. May be used following an initial IV loading dose
    HNCA: 6 months or to members renewal date, whichever is longer

    Medical: 6 months or to member's renewal period, whichever is sooner.

    NATL:
    3 months initial trial.

    Continued treatment will be approved up to one year with documentation of response to therapy.

    Approval of Humira dose escalation to 40 mg weekly will require documentation of partial response to every other week dosing.

    See next column

    Ankylosing spondylitis:

    CIMZIA
    Initial dose: 400 mg SC initially and at Weeks 2 and 4
    Maintenance dose: 200 mg SC every other week (400 mg SC every 4 weeks can be considered)

    COSENTYX
    Initial dose: 150 mg SC at weeks 0, 1, 2, 3 and 4 (or option for no loading dose)
    Maintenance dose: 150 mg SC every 4 weeks

    ENBREL
    50 mg SC once weekly

    HUMIRA
    40 mg SC every other week

    SIMPONI
    50 mg SC once a month

    REMICADE
    5 mg/kg IV initially and at weeks 2 and 6, then Q8W

    HNCA: 6 months or to members renewal date, whichever is longer

    NATL:
    3 months initial trial.

    Continued treatment will be approved up to one year with documentation of response to therapy.

    See next column

    Psoriatic arthritis:

    CIMZIA
    Initial dose: 400 mg SC initially and at Weeks 2 and 4
    Maintenance dose: 200 mg SC every other week (400 mg SC every 4 weeks can be considered)

    COSENTYX
    Initial dose: 150 mg SC at weeks 0, 1, 2, 3 and 4 (or option for no loading dose)
    Maintenance dose: 150 mg SC every 4 weeks (can increase to 300 mg if needed)

    ENBREL
    50 mg SC once weekly

    HUMIRA
    40 mg SC every other week

    SIMPONI
    50 mg SC once a month

    STELARA
    45 mg SC initially and 4 weeks later, followed by 45 mg every 12 weeks
    With co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg:
    90 mg SC initially and 4 weeks later, followed by 90 mg SC every 12 weeks

    REMICADE
    5 mg/kg IV initially and at weeks 2 and 6, then Q8W

    HNCA: 6 months or to members renewal date, whichever is longer

    Medical: 6 months or to member's renewal period, whichever is sooner.

    NATL:
    3 months initial trial.

    Continued treatment will be approved up to one year with documentation of response to therapy.

    See next column

    Crohn`s Disease:

    CIMZIA

    Initial dose: 400 mg SC initially and at weeks 2 and 4
    Maintenance dose: In patients who obtain a clinical response,
    400 mg SC every 4 weeks

    HUMIRA
    Induction: 160 mg SC (four 40mg injections) day 1 followed by 80 mg SC 2 weeks later (day15). 160mg can be given as 4 injections in one day or divided over 2 days. Two weeks later (day 29) begin maintenance dose of 40mg SC every other week
    Maintenance: 40 mg SC every other week

    Pediatric Crohns Disease
    17 kg (37 lbs) to < 40 kg (88 lbs): Initial dose (Day 1): 80 mg (two 40 mg injections in one day) Second dose two weeks later (Day 15): 40 mg Two weeks later (Day 29): Begin a maintenance dose of 20 mg every other week.

    ≥ 40 kg (88 lbs): Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day) Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week.


    REMICADE
    5 mg/kg IV initially and at weeks 2 and 6, then Q8W

    ENTYVIO
    300 mg IV initially and at weeks 2 and 6, then Q8W

    TYSABRI
    300 mg IV Q4W

    HNCA: 6 months or to members renewal date, whichever is longer

    NATL:
    3 months initial trial.

    Continued treatment will be approved up to one year with documentation of response to therapy.

    See next column

    Ulcerative Colitis Induction:

    HUMIRA
     Initial dose (Day 1): 160 mg SC (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days)
     Second dose two weeks later (Day 15): 80 mg SC
     Two weeks later (Day 29): Begin a maintenance dose of 40 mg SC every other week.
    Maintenance:
    40 mg SC every other week

    SIMPONI
    200 mg SC at week 0, 100 mg SC at week 2, then 100 mg SC every 4 weeks

    REMICADE
    5 mg/kg IV initially and at weeks 2 and 6, then Q8W

    ENTYVIO
    300 mg IV initially and at weeks 2 and 6, then Q8W

    HNCA: 6 months or to members renewal date, whichever is longer

    NATL:
    3 months initial trial.

    Continued treatment will be approved up to one year with documentation of response to therapy.

    See next column

    Plaque Psoriasis:

    ENBREL
    Starting dose: 25 mg or 50 mg or SC twice weekly for 3 months
    Maintenance dose: 25 mg or 50 mg SC per week

    HUMIRA
    Initial dose of 80 mg SC followed by 40 mg SC every other week starting one week after the initial dose.

    STELARA
    Equal or less than 100 kg: 45 mg SC initially and 4 weeks later, followed by 45 mg every 12 weeks
    Greater than 100 kg: 90 mg SC initially and 4 weeks later, followed by 90 mg every 12 weeks

    COSENTYX
    300 mg SC at weeks 0, 1, 2, 3 and 4 followed by 300 mg SC every 4 weeks. For some patients, a dose of 150 mg may be acceptable.

    REMICADE
    5 mg/kg IV initially and at weeks 2 and 6, then Q8W

    HNCA: 6 months or to members renewal date, whichever is longer

    Medical: 6 months or to member's renewal period, whichever is sooner.

    NATL:
    3 months initial trial.

    Continued treatment will be approved up to one year with documentation of response to therapy.

    See next column

    Polyarticular Juvenile Idiopathic Arthritis:

    ENBREL
    Less than 63 kg: 0.8 mg/kg SC per week given as single injection. Maximum dose of 50 mg per week
    63 kg or more: 50 mg SC per week

    HUMIRA
    10 kg to <15 kg = 10 mg SC every other week
    15 kg to <30 kg = 20 mg SC every other week
    ≥30 kg = 40 mg SC every other week.

    ORENCIA
    Patients less than 75 kg: 10 mg/kg
    Patients 75 kg to 100 kg: 750 mg
    Patients more than 100 kg: 1,000 mg
    IV initially then at weeks 2 and 4 then, Q 4 Weeks

    ACTEMRA
    Patients less than 30 kg: 10 mg/kg IV Q 4 Weeks
    Patients 30 kg or more: 8 mg/kg IV Q 4 Weeks

    HNCA: 6 months or to members renewal date, whichever is longer

    NATL:
    3 months initial trial.

    Continued treatment will be approved up to one year with documentation of response to therapy.

    Systemic juvenile idiopathic arthritis (SJIA)

    ACTEMRA
    Patients less than 30 kg: 12 mg/kg IV Q 2 Weeks
    Patients 30 kg or more: 8 mg/kg IV Q 2 Weeks

    HNCA: 6 months or to members renewal date, whichever is longer

    NATL:
    3 months initial trial.

    Continued treatment will be approved up to one year with documentation of response to therapy.

    Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

    KINERET
    1-2 mg/kg/day by SC injection. Maximum of 8 mg/kg daily.
    Once daily administration is generally recommended, but the dose may be split into twice daily administrations.

    HNCA: 6 months or to members renewal date, whichever is longer

    NATL:
    3 months initial trial.

    Continued treatment will be approved up to one year with documentation of response to therapy.

    Hidradenitis Suppurativa (HS):

    HUMIRA
     Initial dose (Day 1): 160 mg SC (given as four 40 mg injections on Day 1 or as two 40 mg injections per day on Days 1 and 2)
     Second dose two weeks later (Day 15): 80 mg SC (two 40 mg injections in one day)
     Third (Day 29) and subsequent doses: 40 mg SC every week.

    HNCA: 6 months or to members renewal date, whichever is longer

    NATL:
    3 months initial trial.

    Continued treatment will be approved up to one year with documentation of response to therapy.

    Tysabri

    Multiple Sclerosis
    300 mg IV Q 4 Wks

    HNCA:
    6 months or to member's renewal period, whichever is later

    Medical:
    6 months or to member's renewal period, whichever is later

    NATL:
    3 months initial trial.

    Continued treatment will be approved up to one year with documentation of response to therapy.

    Otezla

    Plaque Psoriasis, Psoriatic Arthritis
    30 mg PO BID after initial titration dosing

    Length of benefit

  7. Product Availability:

    CIMZIA
    Vial: 200 mg lyophilized powder
    Single-use prefilled syringe: 200 mg/mL

    COSENTYX
    Vial: 150 mg lyophilized powder (for healthcare professional use only)
    Syringe: 150 mg/ml; carton of 1 or 2 syringes
    Pen: 150 mg/ml (SensoreadyR); carton of 1 or 2 pens

    ENBREL
    Multi-use vials: 25 mg
    Single-use pre-filled syringes: 25 and 50 mg
    Pre-filled SureClick Autoinjector: 50 mg

    HUMIRA
    Pre-filled Pen Carton: 2 dose trays. Each dose tray contains a single-use 40mg/0.8ml pen.
    Crohn`s Disease/Ulcerative Colitis Starter Package: 6 dose trays. Each dose tray contains a single-use 40mg/0.8ml prefilled pen.
    Psoriasis Starter Package: 4 dose trays. Each dose tray contains a single-use 40mg/0.8ml prefilled pen.
    Pre-filled Syringe Carton: 40mg: 2 dose trays. Each dose tray contains a single-use 40mg/0.8ml prefilled syringe.
    Pre-filled Syringe Carton: 20 mg: 2 dose trays. Each dose tray contains a single-use 20mg/0.4ml prefilled syringe.
    Pre-filled Syringe Carton: 10 mg: 2 dose trays. Each dose tray contains a single-use 10 mg/0.2 ml prefilled syringe.
    Pediatric Crohns Disease Starter Package: 3 dose trays or 6 dose trays. Each dose tray contains a single-use 40 mg/0.8 ml prefilled syringe.

    KINERET
    Prefilled glass syringe: 100 mg/0.67 ml (single-use)

    SIMPONI
    Single dose prefilled SmartJect autoinjector: 50 mg/0.5 mL and 100mg/1mL
    Single dose prefilled syringe: 50 mg/0.5 mL and 100mg/1mL

    SIMPONI ARIA
    Vial: 50 mg/4 mL (12.5 mg/ml)

    STELARA
    Single-use prefilled syringe: 45 mg/0.5 mL or 90mg/1mL
    Single-use glass vial: 45 mg/0.5 mL or 90 mg/1 mL

    REMICADE
    single use vial, 100 mg/20 mL

    ORENCIA
    single use vial, 250 mg/15 mL; 125 mg/1 mL prefilled syringe

    ACTEMRA
    single use vial, 80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL; 162 mg/0.9mL prefilled syringe

    OTEZLA
    30 mg tablet; 14 day and 28 day starter kits containing 10 mg, 20 mg and 30 mg tablets

    ENTYVIO
    single use vial, 300 mg/20 mL

    TYSABRI
    single use vial, 300 mg/15 mL

  8. References:

    1. Cosentyx [Prescribing information]. East Hanover, NJ: Novartis; January 2016.
    2. Enbrel [Prescribing information]. Thousand Oaks, CA: Immunex Corporation; March 2015.
    3. Humira [Prescribing information]. North Chicago, IL: AbbVie Inc; September 2015.
    4. Stelara [Prescribing information] Horsham, PA: Janssen Biotech Inc; March 2014.
    5. Cimzia [Prescribing Information] Smyrna, GA: UCB, Inc; October 2013.
    6. Simponi [Prescribing information]. Horsham, PA: Janssen Biotech Inc; December 2014.
    7. Simponi Aria [Prescribing information]. Horsham, PA: Janssen Biotech Inc; December 2014.
    8. Kineret [package insert]. Stockholm, Sweden: Swedish Orphan Biovitrum AB (publ). October 2013.
    9. Aletaha D, Neogi T, Silman AJ et al. 2010 Rheumatoid Arthritis Classification Criteria. Arthritis and Rheumatism September 2010;62(9):2569-2581.
    10. Zochling J, van der Heijde D, Burgos-Vargas, R, et al. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2006;65:442-452.
    11. Braun J, Davis J, Dougados M, et al. First update of the international ASAS consensus statement for the use of anti-TNF agents in patients with ankylosing spondylitis. Ann Rheum Dis. 2006;65:316-320.
    12. Boulos P, Dougados M, MacLeod SM, et al. Pharmacological Treatment of Ankylosing Spondylitis. Drugs. 2005; 65: 2111-2127.
    13. Colombel JF, Sandborn WJ, Rutgeerts P, et.al. Adalimumab for Maintenance of Clinical Response and Remission in Patients With Crohn`s Disease: The CHARM Trial. Gastroenterology 2007;132:52-65.
    14. Lichtenstein G, Hanauer S, Sandborn W, et al. Management of Crohn`s Disease in Adults. Am J Gastroenterol 2009;104:465-483.
    15. Menter A, Gottlieb A, Feldman SR, et al. American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58:826-850.
    16. Menter A, Gottlieb A, Feldman, SR, et al. American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol May 2008; 58(5): 826-50.
    17. Menter A, Korman, NJ, Elmets CA, et al. American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009;60:643-659.
    18. Menter A, Korman NF, Elmets cA, et al. American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 10.1016/j.jaad.2009.03.027
    19. Braun J, van den Berg R, Baraliako X, et al. 2010 Update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011; 70:896-904.
    20. Enbrel, Cimzia, Humira, Kineret, Simponi, Stelara. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 8, 2015.
    21. DRUGDEXR System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 8, 2015.
    22. Ward M, Deodhar A, Akl E, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Available at http://www.rheumatology.org. Accessed February 16, 2016.

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.