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.

Approval Period

Initial approval 3 months to assess patient’s response. Renew for one year if patient has clinical response (less than 2 exacerbations requiring steroid therapy)

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 Period

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

 

Reviewed and approved by Dr. Prindiville, UCD GI Specialist


Western Health Advantage Pharmacy and Therapeutics Committee

Approved:  September 2014 | Revised: July 2015

Last review date: July 20, 2016