Adalimumab (Humira)


Indications for Prior Authorization:

  • Moderate to Severe Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Ankylosing Spondylitis
  • Crohn’s Disease
  • Psoriasis
  • Hidradenitis
  • Ulcerative Colitis

Humira is a preferred biologic agent for treatment of the following indications when all criteria below are met for specific indications:

  • Rheumatoid Arthritis
  • Ankloysing Spondylitis
  • Juvenile Idiopathic Arthritis
  • Psoriatic Arthritis
  • Plaque psoriasis
  • Crohn's Disease
  • Ulcerative Colitis

Patients must meet the following criteria for RA

  • Diagnosis by Rheumatologist (the prescribing MD does not have to be a rheumatologist)
  • Inadequate response to one or more Disease Modifying Anti-Rheumatic Drugs (DMARDs): Auranofin (Ridaura), Azathioprine (Imuran), Gold sodium thiomalate (Aurolate), Hydroxychloroquine (Plaquenil, Methotrexate (Rheumatrex), D-penicillamine (Cuprimine), Sulfasalazine (Azulfidine) or has a medical reason why methotrexate, hydroxychloroquine, and sulfasalazine cannot be used.
  • Not used in conjunction with another anti-TNF drug or interleukin-1 receptor antagonist

For Juvenile Idiopathic Arthritis

  • Diagnosis of active juvenile idiopathic arthritis in pediatric patients at least 2 years of age or older confirmed by a rheumatologist, AND
  • Patient has tried and failed or had clinically significant adverse effects to methotrexate at doses of at least 10 mg/m2 per week for three months

For Crohn’s disease

  • Failed or have a documented intolerance or contraindication to one agent from either of the following classes: oral corticosteroids or immunosuppressants (azathioprine, mercaptopurine, methotrexate, or cyclosporine)
  • is not used in conjunction with another anti-TNF drug or interleukin-1 receptor antagonist

For Ankylosing Spondylitis

  • Diagnosis by Rheumatologist (the prescribing MD does not have to be a rheumatologist)
  • Inadequate response to two non-steroidal anti-inflammatory agents OR
  • Intolerable GI adverse effects after a trial of an NSAID in combination with a PPI OR
  • Unable to take NSAIDs due to history of GI bleed AND
  • In patients without axial disease:
    •  inadequate response or intolerable side effect to one disease modifying anti-rheumatic drug (DMARD) or medical rationale why sulfasalazine cannot be used.

Note:  in patients with axial disease:

  • Inadequate response or intolerable side effect to NSAIDs as stated above.  Methotrexate or other DMARDs are not required prior to Humira consideration [chart note documentation is required as supporting information for prior authorization approval consideration].

For Psoriasis

  • Diagnosis of chronic moderate to severe plaque psoriasis confirmed by dermatologist or rheumatologist psoriasis; affects 10% or more of the body; psoriasis involves hands, feet, head, and neck or genitalia AND
  • Prescribed by dermatologist or rheumatologist AND
  • Patient has tried and failed topical therapy (e.g. Dovenox, Tazorac, other topical steroids) AND
  • Documented failure or clinically significant adverse effects to one of the following therapies alone or in combination, unless contraindicated methotrexate (doses up to 15-20 mg per week)or (if methotrexate is contraindicated) cyclosporine, acitretin, or a trial with PUVA or UVB

For Psoriatic Arthritis

  • Diagnosis of active psoriatic arthritis made at baseline prior to initiation of DMARD therapy confirmed by rheumatologist or dermatologist
    • Need copy of ESR or CRP labs
    • Number of swollen joints
    • Number of painful/tender joints
    • Duration of morning stiffness, AND
  • Patient has failed to respond, or had clinically significant adverse effects to methotrexate unless contraindicated

For Hidradenitis

  • Approved for diagnosis [chart notes must be provided with prior authorization documentation].

For Ulcerative Colitis (FDA approved indication on 9/28/2012)

  • Diagnosis is Moderate to Severe Ulcerative Colitis AND
  • One of the following conditions is met:
    • Patient is steroid-refractory or steroid-dependent OR
    • Patient has experienced an inadequate response or intolerance to an immunomodulatory agent (i.e., azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, etc.)

Coverage period:

  • Initial authorization:  8 weeks
  • First re-authorization:  One year, based on attestation that patient achieved clinical remission by week 8.
  • Subsequent re-authorization:  Yearly based on continued response.

The following indications do not meet the criteria for use established by the Western Health Advantage Pharmacy and Therapeutics Committee:

Any condition not listed above in the indications section.


Recommended dose for ADULTS with Rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis:

  • 40 mg every other week as a subcutaneous injection.
  • Doses of 40 mg every week, for rheumatoid arthritis only, can be approved for monotherapy if the patient has intolerance or contraindication to methotrexate in combination with Humira.

Recommended dose for Juvenile Idiopathic Arthritis

  • 10 kg (22 lbs) to < 15 kg (33 lbs): 10 mg every other week
  • 15 kg (33 lbs) to < 30 kg (66 lbs): 20 mg every other week
  • 30 kg (66 lbs) or greater: 40 mg every other week

Recommended dose for Crohn’s Disease

  • Subcutaneous injection of 160 mg on day 1, or 80 mg on days 1 and 2
  • then 80 mg SubQ on Day 14
  • then 40 mg SubQ every other week starting on week 4 (day 28)
  • Pediatric patients 17 kg (37 lbs) to < 40 kg (88 lbs):  80 mg SubQ at week 0 (Day 1), 40mg SubQ at week 2 (Day 15), 20 mg SubQ every other week thereafter starting on week 4 (Day 29)

Recommended dose for Psoriasis

  • Subcutaneous injection of 80 mg on day 1
  • then 40 mg SubQ on Day 8 and every other week thereafter

Recommended dose for Hidradenitis

  • Initial dosage: 160mg subcutaneously on day 1 (four 40 mg injections on 1 day or two 40 mg injections per day for 2 consecutive days), followed by 80 mg subcutaneously 2 weeks later (day 15)
  • Maintenance dosage: 40 mg subcutaneously every week beginning on day 29 and thereafter

Recommended dose for Ulcerative Colitis

  • Subcutaneous injection of 160 mg at week 0 (Day 1) OR 80 mg SubQ on Days 1 & 2
  • then 80 mg SubQ on week 2 (Day 14)
  • then 40 mg SubQ every other week starting on week 4

Approval Period:

One year to assess patient’s response.

Risk of Tuberculosis:

Patients should be evaluated for latent tuberculosis infection with a TB skin test. Treatment of latent tuberculosis infection should be initiated prior to therapy with Humira.


Last review date: July 20, 2016

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