Certolizumab pegol (Cimzia)

OFFICE ADMINISTRATION / SELF ADMINISTRATION

Indications for Prior Authorization:

  • Crohn’s Disease
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Psoriatic Arthritis

Patients must meet the following criteria for the indications above:

Crohn's Disease

  • Diagnosis of moderate to severe Crohn’s Disease confirmed by GI specialist
  • Patient does not have perforation, abscess, or obstruction AND
  • Patient must fail Anti-TNF therapy unless contraindicated. Failure is defined as:
    • patient not in remission
    • patient has failed adalimumab (Humira) and one to three doses of Remicade induction therapy
    • has failed Remicade Maintenance therapy (2 or more exacerbations requiring steroids)
    • has clinically significant adverse reaction to Remicade and Humira 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) AND
  • Patient must fail Anti-TNF therapy with adalimumab (Humira) and etanercept (Enbrel). Failure is defined as patient not in remission or has clinically significant adverse reaction to Enbrel and Humira

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 certolizumab

Do not administer live vaccines or attenuated vaccines concurrently with certolizumab.

Ankylosing Spondylitis

  • Diagnosis by Rheumatologist (the prescribing MD does not have to be a rheumatologist) AND
  • Inadequate response or intolerable side effect to two of the following biologic agents:
    • Humira, Enbrel, or Remicade, AND ONE of the following:
      • Inadequate response with a trial of any 2 NSAIDs OR
      • Intolerable GI adverse events 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) auranofin (Ridaura®), azathioprine (Imuran®), cyclosporine (Neoral®), methotrexate (Rheumatrex®), sulfasalazine (Azulfidine®), leflunomide (Arava®)] or medical rationale why sulfasalazine cannot be used

Psoriatic Arthritis

  • Psoriatic arthritis diagnosed by a rheumatologist AND
  • Age > 18 years AND
  • Inadequate response, intolerance, or contraindication to one or more DMARDs [Auranofin (Ridaura®), Azathioprine (Imuran®), Cyclosporine (Neoral®), Methotrexate (Rheumatrex®), sulfasalazine (Azulfidine®), Leflunomide (Arava®)] or has a medical reason why methotrexate, sulfasalazine, and leflunomide cannot be used AND
  • Inadequate response, intolerance, or contraindication to two of the following: Enbrel, Humira, or Remicade

Rheumatoid Arthritis (moderate to severe)

  • Diagnosis of moderate to severe 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). OR
  • Has a medical reason why Methotrexate, Hydroxychloroquine, and Sulfasalazine cannot be used AND
  • Patient must fail Anti-TNF therapy with adalimumab (Humira) and etanercept (Enbrel) or infliximab (Remicade). Failure is defined as patient not in remission or has clinically significant adverse reaction to Enbrel and Humira.

Dosing:

  • Certolizumab lyophilized powder should be administered by a health care professional
  • Certolizumab prefilled syringe may be self-administered.

Ankylosing spondylitis

  • Initial: 400 mg SubQ (given as two 200 mg injections)
  • Maintenance: 400 mg SubQ every 4 weeks

Crohn’s Disease

  • Initial: 400 mg (as 2 SubQ injections of 200 mg) at weeks 0, 2 and 4
  • Maintenance:400 mg SubQ every 4 weeks

Psoriatic arthritis

  • Up to 400 mg SubQ at weeks 0, 2, 4 followed by either:
  • 200 mg every other week OR
  • 400 mg every 4 weeks

Rheumatoid Arthritis

  • Initial:  400 mg (as 2 SubQ injections of 200 mg) at weeks 0, 2 and 4
  • Maintenance:  200 mg SubQ every other week OR 400 mg SubQ every 4 weeks

Approval:

  • Initial: 3 months to assess patient’s response
  • Renewal: one year if patient has clinical response (less than 2 exacerbations requiring steroid therapy)

 

Last review date: July 20, 2016