WHA

CIMZIA (certolizumab pegol)

Self-Administration – Subcutaneous (SC) injection using certolizumab pegol prefilled syringe.

Office-Administration – Subcutaneous (SC) injection using certolizumab pegol lyophilized powder in vials is administered by a health care professional only. HCPCS code: J0717 (per 1 mg).

 

Indications for Prior Authorization:

Rheumatoid Arthritis (RA): Indicated for the treatment of adults with moderately to severely active rheumatoid arthritis.

Psoriatic Arthritis (PsA): Indicated for the treatment of adult patients with active psoriatic arthritis (PsA).

Plaque Psoriasis (PsO): Indicated for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

Ankylosing Spondylitis (AS): Indicated for the treatment of adults with active ankylosing spondylitis.

Non-radiographic Axial Spondyloarthritis (nr-axSpA): Indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

Crohn’s Disease (CD): Indicated for reducing signs and symptoms of Crohn's disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

 

Coverage Criteria:

 

For diagnosis of Rheumatoid Arthritis (RA):

  • Documented diagnosis of moderately to severely active RA; AND
  • Prescribed by or in consultation with a rheumatologist; AND
  • Minimum duration of a 3-month trial and failure, contraindication, or intolerance to ONE of the following conventional therapies at maximally tolerated doses:
    • methotrexate
    • leflunomide
    • sulfasalazine
    • hydroxychloroquine

 

For diagnosis of psoriatic arthritis (PsA):

  • Documented diagnosis of active PsA; AND
  • One of the following:
    • actively inflamed joints
    • dactylitis
    • enthesitis
    • axial disease
    • active skin and/or nail involvement; AND
  • Prescribed by or in consultation with a dermatologist or rheumatologist.

 

For diagnosis of plaque psoriasis (PsO):

  • Documented diagnosis of moderate to severe PsO; AND
  • One of the following:
    • Greater than or equal to 3% body surface area involvement
    • Severe scalp psoriasis
    • Palmoplantar (i.e., palms, soles), facial, or genital involvement; AND
  • Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies:
    • corticosteroids (e.g., betamethasone, clobetasol)
    • vitamin D analogs (e.g., calcitriol, calcipotriene)
    • tazarotene
    • calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
    • anthralin
    • coal tar; AND
  • Prescribed by or in consultation with a dermatologist or rheumatologist.

 

For diagnosis of ankylosing spondylitis (AS):

  • Documented diagnosis of active AS; AND
  • Prescribed by or in consultation with a rheumatologist; AND
  • Minimum duration of one-month trial and failure, contraindication, or intolerance to TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, indomethacin, meloxicam, diclofenac) at maximally tolerated doses.

 

For diagnosis of Non-radiographic Axial Spondyloarthritis (nr-axSpA):

  • Documented diagnosis of active nr-axSpA; AND
  • Prescribed by or in consultation with a rheumatologist; AND
  • Patient has objective signs of inflammation (e.g. C-reactive protein [CRP] levels above the upper limit of normal, or sacroiliitis on magnetic resonance imaging [MRI], indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints); AND
  • Minimum duration of one-month trial and failure, contraindication, or intolerance to TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, indomethacin, meloxicam, diclofenac) at maximally tolerated doses.

 

For diagnosis of Crohn’s disease (CD):

  • Documented diagnosis of moderately to severely active CD; AND
  • One of the following:
    • Frequent diarrhea and abdominal pain
    • At least 10% weight loss
    • Complications such as obstruction, fever, abdominal mass
    • Abnormal lab values (e.g., C-reactive protein [CRP])
    • CD Activity Index (CDAI) greater than 220; AND
  • Prescribed by or in consultation with a gastroenterologist; AND
  • Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies:
    • 6-mercaptopurine
    • azathioprine
    • corticosteroids (e.g., prednisone, methylprednisolone)
    • methotrexate

 

Reauthorization Criteria:

 

For diagnosis of RA:

  • Documentation of positive clinical response to therapy as evidenced by at least ONE of the following:
    • Reduction in the total active (swollen and tender) joint count from baseline.
    • Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline.

 

For diagnosis of PsA:

  • Documentation of positive clinical response to therapy as evidenced by at least ONE of the following:
    • Reduction in the total active (swollen and tender) joint count from baseline.
    • Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline.
    • Reduction in the body surface area (BSA) involvement from baseline.

 

For diagnosis of PsO:

  • Documentation of positive clinical response to therapy as evidenced by ONE of the following:
    • Reduction the body surface area (BSA) involvement from baseline.
    • Improvement in symptoms (e.g., pruritus, inflammation) from baseline.

 

For diagnosis of AS:

  • Documentation of positive clinical response to therapy as evidenced by improvement from baseline for least ONE of the following:
    • Disease activity (e.g., pain, fatigue, inflammation, stiffness)
    • Lab values (erythrocyte sedimentation rate, C-reactive protein level)
    • Function
    • Axial status (e.g., lumbar spine motion, chest expansion)
    • Total active (swollen and tender) joint count

 

For diagnosis of nr-axSpA:

  • Documentation of positive clinical response to therapy as evidenced by improvement from baseline for least ONE of the following:
    • Disease activity (e.g., pain, fatigue, inflammation, stiffness)
    • Function
    • Lab values (erythrocyte sedimentation rate, C-reactive protein level)
    • Axial status (e.g., lumbar spine motion, chest expansion)
    • Total active (swollen and tender) joint count

 

For diagnosis of CD:

  • Documentation of positive clinical response to therapy as evidenced by at least ONE of the following:
    • Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
    • Reversal of high fecal output state

 

Dosing:

 

RA (adults):

  • Initial: 400 mg (given as 2 SC injections of 200 mg) initially and at Weeks 2 and 4.
  • Maintenance: 200 mg SC injection given every 2 weeks; OR 400 mg SC injection given every 4 weeks.

PsA (adults):

  • Initial: 400 mg (given as two SC injections of 200 mg each) initially and at Weeks 2 and 4.
  • Maintenance: 200 mg SC every 2 weeks, OR 400 mg SC every 4 weeks.

PsO (adults):

  • 400 mg SC (given as two 200 mg injections) every 2 weeks.
  • For some patients (with body weight less than or equal to 90 kg) consider Cimzia 400 mg (given as two SC injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every other week.

AS (adults):

  • Initial: 400 mg (given as two subcutaneous [SC] injections of 200 mg each) initially and at Weeks 2 and 4.
  • Maintenance: 200 mg SC every 2 weeks, OR 400 mg SC every 4 weeks.

nr-axSpA (adults):

  • Initial: 400 mg (given as 2 SC injections of 200 mg) initially and at Weeks 2 and 4.
  • Maintenance: 200 mg SC injection given every 2 weeks; OR 400 mg SC injection given every 4 weeks.

CD (adults):

  • Initial: 400 mg (given as two SC injections of 200 mg each) initially and at Weeks 2 and 4.
  • Maintenance: 400 mg SC every 4 weeks.

 

Coverage Duration:

 

CD:

  • Initial: 6 months.
  • Reauthorization: 1 year.

All other indications (RA, PsA, PsO, AS, nr-axSpA):

  • Initial: 1 year.
  • Reauthorization: 1 year.

 

Authorization is Not Covered for the Following:

 

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

 

Additional Information:

 

  • Risk of Tuberculosis (TB): patients should be tested for latent TB (e.g. TB skin test, QuantiFERON TB Gold test, or chest x-ray) before Cimzia use and during therapy. Treatment for latent infection should be initiated prior to Cimzia use.
  • Do not administer live vaccines or attenuated vaccines concurrently with Cimzia.

 

Review History:
  • 02/18/2020 - Annual review.
  • 07/01/2020 - Alignment changes to immunomodulator policies.
  • 12/28/2020 - Add nr-axSpA to covered indications.
  • 02/16/2021 - updated format; P&T Ad Hoc review of PA guidelines: removed chart note requirements for all indications; removed oral TB test requirements for all indications; removed DMARD and updated NSAID requirements for AS; removed criteria for axial and non-axial AS; updated language for specialist involvement and conventional therapies for CD; removed requirements for BSA measurements, topical therapies, and DMARDs for PsO; removed requirement for DMARD for PsA; updated language for specialist involvement and DMARD therapies for RA; added medical necessity criteria for reauthorization requests; added FDA approval and dosing to treat nr-axSpA; updated approval duration to 1 year.
  • 04/20/2021 - added coverage criteria for nr-SpA. Removed reauthorization criteria for PsO requiring documented changes in BSA, pruritus, or inflammation symptoms.
  • 11/16/2021 - clarified language for diagnoses that require the use of NSAIDs.
  • 01/01/2023 – Updated prerequisite therapies for RA, PsO; added disease characteristics for PsA, PsO, CD; added treatment durations of prerequisite drugs for RA, PsO, AS, nr-axSpA; updated clinical requirements for reauthorization for RA, PsA, PsO, AS, nr-axSpA, CD.; changed initial treatment duration for CD (P&T meeting 11/15/2022).

 

References:
  1. Cimzia Prescribing Information. UCB. Smyrna, GA. September 2019.
  2. Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG clinical guideline: management of Crohn's disease in adults. Am J Gastroenterol. 2018;113:481-517.
  3. Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn's Disease. Gastroenterology. 2021;160(7):2496-2508.
  4. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2015;68(1):1-25.
  5. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. 2021;73(7):924-939.
  6. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32.
  7. Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/spondyloarthritis research and treatment network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613.
  8. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019;80:1029-72.
  9. Elmets CA, Korman NJ, Farley Prater E, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol 2021;84:432-70.
     

Last review date: November 29, 2021