Etanercept (Enbrel)

JCODE: J1438

Office/Home Health/Self Administration

Indications for Prior Authorization

  • Moderate to Severe active Rheumatoid Arthritis
  • Juvenile Polyarticular Arthritis (age 4-17)
  • Psoriatic Arthritis
  • Ankylosing Spondylitis
  • Plaque Psoriasis

Patients must meet the following criteria for the indications above:

Rheumatoid Arthritis

  • Diagnosis of moderate to severe active rheumatoid arthritis by Rheumatologist (the prescribing MD does not have to be a rheumatologist)

AND

  • 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).

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.

Juvenile Polyarticular Arthritis

  • Diagnosis of active Juvenile Polyarticular Arthritis in patients four-17 years old 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.

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

Ankylosing Spondylitis

  • Diagnosis of moderate to severe ankylosing spondylitis

AND

  • Patient has tried and failed or had clinically significant adverse reactions to at least two NSAIDs for at least three months at maximal recommended doses.

OR

  • Intolerable GI adverse events after a trial of prescription strength 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

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

  • CHF
  • Multiple Sclerosis
  • Recurrent miscarriage
  • Infertility
  • Crohn’s Disease
  • Graft vs. Host Disease
  • Interleukin-2 Toxicity
  • Cachexia
  • Nephrotic Syndrome
  • Prevention of Muromonab-CD3-Associated Acute Clinical Syndrome

Dosing

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

• 50 mg per week.

• Doses HIGHER than 50 mg per week are NOT recommended (per manufacturer)

Recommended dose for pediatric patients with JRA (four-17 years):

• 0.8 mg/kg per week (up to a maximum of 50 mg per week).

• For pediatric patients weight more than 31 kg, the total weekly dose should be administered as two SubQ injections, either on the same day or two or four days apart.

• For pediatric patients weight less than 31 kg, the dose administered should be a single SubQ injection weekly.

Recommended dose for adults with plaque psoriasis:

  • 50 mg twice a week (three or four days apart) for three months.
  • Then 50 mg once a week for maintenance.

Recommended dose for pediatric patients (2-17 years old) with plaque psoriasis:

  • Up to 0.8 mg/kg per week (up to a maximum of 50 mg per week).  Should be given as two injections for pediatric patients > 31 kg.

NOTE:  Enbrel should not be started in a patient with an active infection. Verify with the MD that they are aware of the "Dear Doctor" letter from the manufacturer regarding this warning.

Approval Period

For Psoriasis:

Induction Doses:

  • Initial approval for 12 weeks at 50 mg dose
  • For a 2nd 12-week induction course, approve for an additional 12 weeks if member:
    • Experienced a flare while on maintenance dose, OR
    • Was slow to respond to initial induction or maintenance dose, OR
    • Had an interruption in induction or maintenance therapy

 Maintenance Doses:

  • Initial maintenance dose authorization:  If member shows clinical improvement in the PASI score of at least 50% from baseline, cover maintenance dosing for up to one year.
  • Subsequent reauthorization:  Yearly based on continued response.

For all others:  One year to assess patient’s response.


Western Health Advantage Pharmacy and Therapeutics Committee

Approved:  September 2008 | Revised: July 2015  |  Reviewed:  July 2016

Last review date: July 20, 2016