Coverage Policy Manual
Policy #: 2024037
Category: Pharmacy
Initiated: December 2024
Last Review: August 2025
  Certolizumab pegol (e.g., Cimzia)
Description:
Certolizumab pegol (e.g., Cimzia) is a recombinant, humanized antibody Fab’ fragment, with specificity for human tumor necrosis factor alpha (TNFα). Certolizumab pegol selectively neutralizes TNFα. TNFα stimulates the production of downstream inflammatory mediators, including interleukin-1, prostaglandins, platelet activating factor, and nitric oxide. Elevated levels of TNFα have been implicated in the pathology of Crohn’s disease and rheumatoid arthritis. Certolizumab pegol binds to TNFα, inhibiting its role as a key mediator of inflammation (Cimzia, 2022).
 
Regulatory Status
 
Certolizumab pegol was approved by the U.S. Food and Drug Administration (FDA) for the following dates and indications:
 
On April 22, 2008, for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult individuals with moderately to severely active disease who have had an inadequate response to conventional therapy.
 
On May 13, 2009, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
 
On September 27, 2013, for the treatment of adult individuals with active psoriatic arthritis (PsA).
 
On October 17, 2013, for the treatment of adults with active ankylosing spondylitis (AS).
 
On March 29, 2019, for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
 
On May 25, 2018, for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
 
Certolizumab has a Black Box Warning of serious infections and malignancies.  It indicates that there is an increased risk of developing serious infections that may lead to hospitalization or death especially if certolizumab is being taken with concomitant immunosuppressants. Reported infections include active TB, including reactivation of latent TB, invasive fungal infections including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis etc. And bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.  Malignancies including lymphoma, some fatal, have been reported in children and adolescents treated with TNF blockers.  Certolizumab is not indicated for use in pediatric individuals.   
 
Certolizumab pegol (e.g., Cimzia) was approved by the U.S. Food and Drug Administration (FDA) on September 13, 2024, for the treatment of active polyarticular Juvenile Idiopathic Arthritis (pJIA) for individuals 2 years of age and older, and corresponding pediatric labeling updates pursuant to the Pediatric Research Equity Act (PREA).
 
 
Coding
 
See CPT/HCPCS Code section below.
Policy/
Coverage:
Prior approval is required for Certolizumab pegol (e.g., Cimzia).
 
The use of certolizumab pegol (e.g., Cimzia) prefilled syringe is not covered under the medical benefit. Please check the member’s pharmacy benefit for coverage.  
 
INITIAL AND CONTINUATION APPROVAL will be for duration of treatment course or 12 months (whichever comes first). Approval timeframes may differ for members/participants of Self-Insured plans.
 
Effective October 15, 2025
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Certolizumab pegol (e.g., Cimzia) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
 
CROHN’S DISEASE
 
INITIAL APPROVAL
 
1. Individual is greater than or equal to 18 years of age (Cimzia, 2024); AND
2. Individual has a diagnosis of moderate to severe Crohn’s disease (Cimzia, 2024) supported by the submitted medical records; AND
3. Individual has an active disease with documented inadequate response (trial of greater than or equal to 3 months) to at least one conventional therapy option (e.g., betamethasone, methylprednisolone, prednisolone, prednisone, budesonide, hydrocortisone, azathioprine, mercaptopurine, sulfasalazine, mesalamine, methotrexate) (Lichtenstein, 2018; Cimzia, 2024); OR
4. Individual has an active disease with intolerance or contraindication to at least one conventional therapy option (e.g., betamethasone, methylprednisolone, prednisolone, prednisone, budesonide, hydrocortisone, azathioprine, mercaptopurine, sulfasalazine, mesalamine, methotrexate) (Van Rheenen, 2021); OR
5. Individual has previously received a biologic (e.g., adalimumab, infliximab, certolizumab pegol, risankizumab, ustekinumab, natalizumab, vedolizumab) or Janus Kinase Inhibitor (e.g., upadacitinib) indicated for moderate to severe Crohn’s disease; OR
6. Individual has fistulizing disease (Feuerstein, 2021); AND
7. Individual is not using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, IL-36 inhibitor, integrin inhibitor, any other IL inhibitor, or Janus kinase inhibitor.
 
CONTINUATION OF THERAPY
 
1. Individual has met initial criteria for a diagnosis of Crohn’s disease; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor. 
 
PLAQUE PSORIASIS 
 
INITIAL APPROVAL
 
1. Individual is greater than or equal to 18 years of age(Cimzia, 2024); AND
2. Individual has a diagnosis of moderate to severe plaque psoriasis established by or in consultation with a dermatologist as indicated by one of the following (AAD, 2019):
a. Plaque psoriasis involving greater than or equal to 3% body surface area (BSA) (Reich, 2017); OR
b. Plaque psoriasis including areas that significantly impact daily function (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) (AAD, 2019); AND
3. Individual has an active disease with documented inadequate response (trial of greater than or equal to 3 months) to phototherapy (e.g., UVB, PUVA) or at least one oral systemic treatment (e.g., methotrexate, cyclosporine, apremilast, acitretin); OR
4. Individual has an active disease with documented intolerance/contraindication to phototherapy (e.g., UVB, PUVA) or at least one oral systemic treatment (e.g., methotrexate, cyclosporine, apremilast, acitretin); OR
5. Individual has previously received a biologic (e.g., etanercept, infliximab, ustekinumab, adalimumab, certolizumab pegol, brodalumab, tildrakizumab, risankizumab, secukinumab, ixekizumab, guselkumab, alefacept, bimekizumab) or oral tyrosine kinase inhibitor (e.g., deucravacitinib) indicated for plaque psoriasis (Menter, 2020); AND
6. Individual is not using the medication in combination with other biologic intended for treatment of plaque psoriasis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor.  
CONTINUATION OF THERAPY
 
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with other biologic intended for treatment of plaque psoriasis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor.
 
RHEUMATOID ARTHRITIS
 
INITIAL APPROVAL
 
1. Individual is greater than or equal to 18 years of age (Cimzia, 2024); AND
2. Individual has a diagnosis of moderate to severe rheumatoid arthritis (RA) supported by the submitted medical records (Cimzia, 2024); AND
3. Individual has an active disease with inadequate response (trial of greater than or equal to 3 months) to at least one conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine) (Fraenkel, 2021); OR
4. Individual has an active disease with documented intolerance or contraindication to at least one conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine) (Fraenkel, 2021); OR
5. Individual has previously received a biologic (e.g., etanercept, infliximab, adalimumab, certolizumab, tocilizumab, sarilumab, golimumab, abatacept, anakinra, rituximab) or synthetic DMARD (tofacitinib, baricitinib, upadacitinib) indicated for rheumatoid arthritis (Fraenkel, 2021); AND
6. Individual is not using the medication in combination with other biologic intended for treatment of rheumatoid arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor.
 
CONTINUATION OF THERAPY
 
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with other biologic intended for treatment of rheumatoid arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor.
 
PSORIATIC ARTHRITIS
 
INITIAL APPROVAL
 
1. Individual is greater than or equal to 18 years of age (Cimzia, 2024); AND
2. Individual has a diagnosis of moderate to severe psoriatic arthritis supported by the submitted medical records (Cimzia, 2024); AND
3. Individual has an active disease with documented inadequate response (trial of greater than or equal to 3 months) to at least one conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide) or phosphodiesterase 4 inhibitor (e.g., apremilast) (Ogdie, 2020); OR
4. Individual has an active disease with documented intolerance or contraindication to at least one conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide) or phosphodiesterase 4 inhibitor (e.g., apremilast) (Ogdie, 2020); OR
5. Individual has previously received a biologic (e.g., etanercept, infliximab, ustekinumab, adalimumab, golimumab, certolizumab pegol, abatacept, secukinumab, ixekizumab, guselkumab) or oral Janus kinase inhibitor (e.g., tofacitinib, upadacitinib) indicated for psoriatic arthritis (Ogdie, 2020); OR
6. Individual has axial disease that is not responsive to treatment with NSAIDs, physiotherapy or sacroiliac joint glucocorticoid injections (GRAPPA, 2022); AND
7. Individual is not using the medication in combination with other biologic intended for treatment of psoriatic arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor.
 
CONTINUATION OF THERAPY
 
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with other biologic intended for treatment of psoriatic arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor.  
ANKYLOSING SPONDYLITIS  
 
INITIAL APPROVAL
 
1. Individual is greater than or equal to 18 years of age(Cimzia, 2024); AND
2. Individual has a diagnosis of active ankylosing spondylitis (ACR, 2019; Cimzia, 2024); AND
3. Individual has an active disease with documented inadequate response (trial of greater than or equal to 3 months) to continuous treatment with at least two scheduled NSAIDs (e.g., indomethacin, naproxen, celecoxib) (Perrotta, 2022); OR
4. Individual has active disease with documented intolerance or contraindication to at least two NSAIDs (e.g., indomethacin, naproxen, celecoxib) (Perrotta, 2022); OR
5. Individual has previously received a biologic (e.g., infliximab, etanercept, adalimumab, golimumab, certolizumab pegol, ixekizumab, secukinumab) or Janus kinase inhibitor (e.g., tofacitinib, upadacitinib) indicated for active ankylosing spondylitis or active non-radiographic axial spondyloarthritis with objective signs of inflammation (ACR, 2019); AND
6. Individual will not be using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor.
 
CONTINUATION OF THERAPY
 
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with any other biologic indicated for ankylosing spondylitis, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor.
 
NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS 
 
INITIAL APPROVAL
 
1. Individual is greater than or equal to 18 years of age (Cimzia, 2024); AND
2. Individual has a diagnosis of active non-radiographic axial spondyloarthritis with objective signs of inflammation (Ward, 2019; Cimzia, 2024); AND
3. Individual has documented inadequate response (trial of greater than or equal to 3 months) to continuous treatment with at least two scheduled NSAIDs (e.g., indomethacin, naproxen, celecoxib); OR
4. Individual has active disease with documented intolerance/contraindication to at least two NSAIDs (e.g., indomethacin, naproxen, celecoxib); OR
5. Individual has previously received a biologic (e.g., infliximab, etanercept, adalimumab, golimumab, certolizumab pegol, ixekizumab, secukinumab) or Janus kinase inhibitor (e.g., tofacitinib, upadacitinib) indicated for active non-radiographic axial spondyloarthritis with objective signs of inflammation (Ward, 2019); AND
6. Individual will not be using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor.  
 
CONTINUATION OF THERAPY
 
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor.
 
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS
 
INITIAL APPROVAL
 
1. Individual is age 2 years or older; AND
2. Individual weights 10 kg or more; AND
3. Individual has a diagnosis of Juvenile Idiopathic Arthritis (JIA) as defined by 5 or more joints with active arthritis at baseline (NCT01550003); AND
4. Individual an active disease with documented inadequate response (trial of greater than or equal to 3 months) to scheduled NSAIDs (e.g., indomethacin, naproxen, celecoxib) or synthetic DMARDs (e.g., methotrexate) indicated for pJIA (Ringold, 2019); OR
5. Individual has an active disease with intolerance or contraindication to scheduled NSAIDs (e.g., indomethacin, naproxen, celecoxib) or synthetic DMARDs (e.g., methotrexate, sulfasalazine) indicated for pJIA (Ringold, 2019); OR
6. Individual has previously received a biologic (e.g., golimumab, abatacept, tocilizumab, certolizumab, adalimumab, sarilumab) or targeted synthetic drug (e.g., tofacitinib, upadacitinib) indicated for pJIA (Ringold, 2019); OR
7. Individual has disease involvement of high-risk joints (cervical spine, wrist, or hip) , high disease activity, and/or is at high risk of disabling joint damage as assessed by rheumatologist/immunologist (Kimura, 2021); AND
8. Individual is not using the medication in combination with other biologic intended for treatment of rheumatoid arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor.
 
CONTINUATION OF THERAPY
 
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor.
 
Does Not Meet Primary Coverage Criteria Or Is Not Covered For Contracts Without Primary Coverage Criteria
 
Certolizumab pegol (e.g., Cimzia), for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, certolizumab pegol (e.g., Cimzia), for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
POLICY GUIDELINES  
 
Prescriber is responsible for verification that Individual does not have latent tuberculosis or serious active infection before starting the treatment.
 
There should be an absence of unacceptable toxicity resulting from the treatment such as serious infections including tuberculosis (TB), bacterial sepsis, invasive fungal infections (i.e., histoplasmosis), and infections due to other opportunistic pathogens.
 
Examples of Contraindications to Methotrexate: 
1. Alcoholism, alcoholic liver disease or other chronic liver disease
2. Breastfeeding
3. Blood dyscrasias (e.g., thrombocytopenia, leukopenia, significant anemia)
4. Elevated liver transaminases
5. History of intolerance or adverse event
6. Hypersensitivity
7. Interstitial pneumonitis or clinically significant pulmonary fibrosis
8. Myelodysplasia
9. Pregnancy or planning pregnancy (male or female)
10. Renal impairment
11. Significant drug interaction 
 
DOSAGE AND ADMINISTRATION
 
For FDA labeled indications, Certolizumab pegol (e.g., Cimzia) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified below.
 
Crohn’s Disease:
    •  The recommended dose of certolizumab pegol (e.g., Cimzia) is 400mg subcutaneously (SQ) initially and at Weeks 2 and 4. The recommended maintenance dose of certolizumab pegol (e.g., Cimzia) is 400mg every four weeks.
 
Rheumatoid Arthritis/Psoriatic Arthritis:
    •  The recommended dose of certolizumab pegol (e.g., Cimzia) is 400mg SQ initially and at Weeks 2 and 4, followed by 200 mg every other week. The recommended maintenance dosing of certolizumab pegol is 400mg every four weeks can be considered.
 
Ankylosing Spondylitis/Non-radiographic Axial Spondyloarthritis:
    •  The recommended dose of certolizumab pegol (e.g., Cimzia) is 400 mg SQ initially and at weeks 2 and 4. The recommended maintenance dosing of certolizumab pegol (e.g., Cimzia) is 200 mg every other week or 400 mg every 4 weeks.
 
Plaque Psoriasis:
    •  The recommended dose of certolizumab pegol (e.g., Cimzia) is 400 mg every other week.
 
Polyarticular Juvenile Idiopathic Arthritis:
    •  The recommended dose of certolizumab pegol (e.g., Cimzia) is:
      •  10 kg (22 lbs) to less than 20 kg (44 lbs): 100 mg initially and at Weeks 2 and 4, followed by 50 mg every other week;
      •  20 kg (44 lbs) to less than 40 kg (88 lbs): 200 mg initially and at Weeks 2 and 4, followed by 100 mg every other week;
      •  Greater than or equal to 40 kg (88 lbs): 400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week.
 
For some individuals (with body weight less than or equal to 90 kg), a dose of 400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week may be considered.
 
Certolizumab pegol (e.g., Cimzia) is available as a 200 mg lyophilized powder in a single-dose vial for reconstitution and a 200 mg single-dose prefilled syringe.
 
Certolizumab pegol (e.g., Cimzia) lyophilized vial should be administered subcutaneously by a healthcare professional.
 
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Effective January 29, 2025 to October 14, 2025
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Certolizumab pegol (e.g., Cimzia) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
 
CROHN’S DISEASE
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
1. Individual is greater than or equal to 18 years of age; AND
2. Individual has a diagnosis of moderate to severe Crohn’s disease supported by the submitted medical records; AND
3. Individual has an active disease with documented inadequate response (trial of greater than or equal to 3 months) to at least one conventional therapy option (e.g., betamethasone, methylprednisolone, prednisolone, prednisone, budesonide, hydrocortisone, azathioprine, mercaptopurine, sulfasalazine, mesalamine, methotrexate) (Lichtenstein, 2018); OR
4. Individual has an active disease with intolerance or contraindication to at least one conventional therapy option (e.g., betamethasone, methylprednisolone, prednisolone, prednisone, budesonide, hydrocortisone, azathioprine, mercaptopurine, sulfasalazine, mesalamine, methotrexate) (Van Rheenen, 2021); OR
5. Individual has previously received a biologic (e.g., adalimumab, infliximab, certolizumab pegol, risankizumab, ustekinumab, natalizumab, vedolizumab) or Janus Kinase Inhibitor (e.g., upadacitinib) indicated for moderate to severe Crohn’s disease; OR
6. Individual has fistulizing disease (Feuerstein, 2021); AND
7. Individual is not using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, IL-36 inhibitor, integrin inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
8. Must be dosed in accordance with the FDA label.  
 
CONTINUED APPROVAL for up to 1 year:
1. Individual has met initial criteria for a diagnosis of Crohn’s disease; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label.
 
PLAQUE PSORIASIS 
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months: 
1. Individual is greater than or equal to 18 years of age; AND 
2. Individual has a diagnosis of moderate to severe plaque psoriasis established by or in consultation with a dermatologist as indicated by one of the following (AAD, 2019):
a. Plaque psoriasis involving ≥3% body surface area (BSA) (Reich, 2017); OR
b. Plaque psoriasis including areas that significantly impact daily function (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) (AAD, 2019); AND
3. Individual has an active disease with documented inadequate response (trial of ≥3 months) to phototherapy (e.g., UVB, PUVA) or at least one oral systemic treatment (e.g., methotrexate, cyclosporine, apremilast, acitretin); OR
4. Individual has an active disease with documented intolerance/contraindication to phototherapy (e.g., UVB, PUVA) or at least one oral systemic treatment (e.g., methotrexate, cyclosporine, apremilast, acitretin); OR
5. Individual has previously received a biologic (e.g., etanercept, infliximab, ustekinumab, adalimumab, certolizumab pegol, brodalumab, tildrakizumab, risankizumab, secukinumab, ixekizumab, guselkumab, alefacept, bimekizumab) or oral tyrosine kinase inhibitor (e.g., deucravacitinib) indicated for plaque psoriasis (Menter, 2020); AND
6. Individual is not using the medication in combination with other biologic intended for treatment of plaque psoriasis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
7. Must be dosed in accordance with the FDA label. 
 
CONTINUED APPROVAL for up to 1 year:
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with other biologic intended for treatment of plaque psoriasis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label.  
 
RHEUMATOID ARTHRITIS
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
1. Individual is greater than or equal to 18 years of age; AND
2. Individual has a diagnosis of moderate to severe rheumatoid arthritis (RA) supported by the submitted medical records; AND
3. Individual has an active disease with inadequate response (trial of greater than or equal to 3 months) to at least one conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine) (Fraenkel, 2021); OR
4. Individual has an active disease with documented intolerance or contraindication to at least one conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine) (Fraenkel, 2021); OR
5. Individual has previously received a biologic (e.g., etanercept, infliximab, adalimumab, certolizumab, tocilizumab, sarilumab, golimumab, abatacept, anakinra, rituximab) or synthetic DMARD (tofacitinib, baricitinib, upadacitinib) indicated for rheumatoid arthritis (Fraenkel, 2021); AND
6. Individual is not using the medication in combination with other biologic intended for treatment of rheumatoid arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
7. Must be dosed in accordance with the FDA label.
 
CONTINUED APPROVAL for up to 1 year:
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with other biologic intended for treatment of rheumatoid arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label.
 
PSORIATIC ARTHRITIS
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
1. Individual is greater than or equal to 18 years of age; AND
2. Individual has a diagnosis of moderate to severe psoriatic arthritis supported by the submitted medical records; AND
3. Individual has an active disease with documented inadequate response (trial of ≥3 months) to at least one conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide) or phosphodiesterase 4 inhibitor (e.g., apremilast) (Ogdie, 2020); OR
4. Individual has an active disease with documented intolerance or contraindication to at least one conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide) or phosphodiesterase 4 inhibitor (e.g., apremilast) (Ogdie, 2020); OR
5. Individual has previously received a biologic (e.g., etanercept, infliximab, ustekinumab, adalimumab, golimumab, certolizumab pegol, abatacept, secukinumab, ixekizumab, guselkumab) or oral Janus kinase inhibitor (e.g., tofacitinib, upadacitinib) indicated for psoriatic arthritis (Ogdie, 2020); OR
6. Individual has axial disease that is not responsive to treatment with NSAIDs, physiotherapy or sacroiliac joint glucocorticoid injections (GRAPPA, 2022); AND
7. Individual is not using the medication in combination with other biologic intended for treatment of psoriatic arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
8. Must be dosed in accordance with the FDA label.
 
CONTINUED APPROVAL for up to 1 year:
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with other biologic intended for treatment of psoriatic arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label. 
 
ANKYLOSING SPONDYLITIS  
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
1. Individual is greater than or equal to 18 years of age; AND
2. Individual has a diagnosis of active ankylosing spondylitis (ACR, 2019); AND
3. Individual has an active disease with documented inadequate response (trial of ≥3 months) to continuous treatment with at least two scheduled NSAIDs (e.g., indomethacin, naproxen, celecoxib) (Perrotta, 2022); OR
4. Individual has active disease with documented intolerance or contraindication to at least two NSAIDs (e.g., indomethacin, naproxen, celecoxib) (Perrotta, 2022); OR
5. Individual has previously received a biologic (e.g., infliximab, etanercept, adalimumab, golimumab, certolizumab pegol, ixekizumab, secukinumab) or Janus kinase inhibitor (e.g., tofacitinib, upadacitinib) indicated for active ankylosing spondylitis or active non-radiographic axial spondyloarthritis with objective signs of inflammation (ACR, 2019); AND 
6. Individual will not be using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor; AND
7. Must be dosed in accordance with the FDA label. 
 
CONTINUED APPROVAL for up to 1 year:
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with any other biologic indicated for ankylosing spondylitis, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label.  
 
NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS 
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
1. Individual is greater than or equal to 18 years of age; AND
2. Individual has a diagnosis of active non-radiographic axial spondyloarthritis with objective signs of inflammation (Ward, 2019); AND
3. Individual has documented inadequate response (trial of ≥3 months) to continuous treatment with at least two scheduled NSAIDs (e.g., indomethacin, naproxen, celecoxib); OR
4. Individual has active disease with documented intolerance/contraindication to at least two NSAIDs (e.g., indomethacin, naproxen, celecoxib); OR
5. Individual has previously received a biologic (e.g., infliximab, etanercept, adalimumab, golimumab, certolizumab pegol, ixekizumab, secukinumab) or Janus kinase inhibitor (e.g., tofacitinib, upadacitinib) indicated for active non-radiographic axial spondyloarthritis with objective signs of inflammation (Ward, 2019); AND
6. Individual will not be using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor; AND
7. Must be dosed in accordance with the FDA label. 
 
CONTINUED APPROVAL for up to 1 year:
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label.  
 
Policy Guidelines  
 
Prescriber is responsible for verification that Individual does not have latent tuberculosis or serious active infection before starting the treatment.
 
Examples of Contraindications to Methotrexate: 
1. Alcoholism, alcoholic liver disease or other chronic liver disease 
2. Breastfeeding 
3. Blood dyscrasias (e.g., thrombocytopenia, leukopenia, significant anemia) 
4. Elevated liver transaminases 
5. History of intolerance or adverse event 
6. Hypersensitivity 
7. Interstitial pneumonitis or clinically significant pulmonary fibrosis 
8. Myelodysplasia 
9. Pregnancy or planning pregnancy (male or female) 
10. Renal impairment 
11. Significant drug interaction 
 
Dosage and Administration
Dosing per FDA Guidelines
 
Crohn’s Disease:
    • The recommended dose of certolizumab pegol (e.g., Cimzia) is 400mg subcutaneously (SQ) initially and at Weeks 2 and 4. The recommended maintenance dose of certolizumab pegol (e.g., Cimzia) is 400mg every four weeks.
 
Rheumatoid Arthritis/Psoriatic Arthritis:
    • The recommended dose of certolizumab pegol (e.g., Cimzia) is 400mg SQ initially and at Weeks 2 and 4, followed by 200 mg every other week. The recommended maintenance dosing of certolizumab pegol is 400mg every four weeks can be considered.
 
Ankylosing Spondylitis/Non-radiographic Axial Spondyloarthritis:
    • The recommended dose of certolizumab pegol (e.g., Cimzia) is 400 mg SQ initially and at weeks 2 and 4. The recommended maintenance dosing of certolizumab pegol (e.g., Cimzia) is 200 mg every other week or 400 mg every 4 weeks.
 
Plaque Psoriasis:
    • The recommended dose of certolizumab pegol (e.g., Cimzia) is 400 mg every other week
 
For some individuals (with body weight ≤ 90 kg), a dose of 400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week may be considered.
 
Certolizumab pegol (e.g., Cimzia) is available as a 200 mg lyophilized powder in a single-dose vial for reconstitution and a 200 mg single-dose prefilled syringe.
 
Certolizumab pegol (e.g., Cimzia) lyophilized vial should be administered subcutaneously by a healthcare professional.
 
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Certolizumab pegol (e.g., Cimzia), for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, certolizumab pegol (e.g., Cimzia), for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective December 1, 2024 to January 28, 2025
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Certolizumab pegol (e.g., Cimzia) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:
 
CROHN’S DISEASE
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
1. Individual is greater than or equal to 18 years of age; AND
2. Individual has a diagnosis of moderate to severe Crohn’s disease supported by the submitted medical records; AND
3. Individual has an active disease with documented inadequate response (trial of greater than or equal to 3 months) to at least one conventional therapy option (e.g., betamethasone, methylprednisolone, prednisolone, prednisone, budesonide, hydrocortisone, azathioprine, mercaptopurine, sulfasalazine, mesalamine, methotrexate) (Lichtenstein, 2018); OR
4. Individual has an active disease with intolerance or contraindication to at least one conventional therapy option (e.g., betamethasone, methylprednisolone, prednisolone, prednisone, budesonide, hydrocortisone, azathioprine, mercaptopurine, sulfasalazine, mesalamine, methotrexate) (Van Rheenen, 2021); OR
5. Individual has previously received a biologic (e.g., adalimumab, infliximab, certolizumab pegol, risankizumab, ustekinumab, natalizumab, vedolizumab) or Janus Kinase Inhibitor (e.g., upadacitinib) indicated for moderate to severe Crohn’s disease; OR
6. Individual has fistulizing disease (Feuerstein, 2021); AND
7. Individual is not using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, IL-36 inhibitor, integrin inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
8. Individual does not have latent tuberculosis or serious active infection; AND
9. Must be dosed in accordance with the FDA label.  
 
CONTINUED APPROVAL for up to 1 year:
 
1. Individual has met initial criteria for a diagnosis of Crohn’s disease; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label.
 
PLAQUE PSORIASIS 
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months: 
 
1. Individual is greater than or equal to 18 years of age; AND 
2. Individual has a diagnosis of moderate to severe plaque psoriasis established by or in consultation with a dermatologist as indicated by one of the following (AAD, 2019):
a. Plaque psoriasis involving ≥3% body surface area (BSA) (Reich, 2017); OR
b. Plaque psoriasis including areas that significantly impact daily function (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) (AAD, 2019); AND
3. Individual has an active disease with documented inadequate response (trial of ≥3 months) to phototherapy (e.g., UVB, PUVA) or at least one oral systemic treatment (e.g., methotrexate, cyclosporine, apremilast, acitretin); OR
4. Individual has an active disease with documented intolerance/contraindication to phototherapy (e.g., UVB, PUVA) or at least one oral systemic treatment (e.g., methotrexate, cyclosporine, apremilast, acitretin); OR
5. Individual has previously received a biologic (e.g., etanercept, infliximab, ustekinumab, adalimumab, certolizumab pegol, brodalumab, tildrakizumab, risankizumab, secukinumab, ixekizumab, guselkumab, alefacept, bimekizumab) or oral tyrosine kinase inhibitor (e.g., deucravacitinib) indicated for plaque psoriasis (Menter, 2020); AND
6. Individual is not using the medication in combination with other biologic intended for treatment of plaque psoriasis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
7. Individual does not have latent tuberculosis or serious active infection; AND
8. Must be dosed in accordance with the FDA label. 
 
CONTINUED APPROVAL for up to 1 year:
 
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with other biologic intended for treatment of plaque psoriasis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label.  
 
RHEUMATOID ARTHRITIS
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
1. Individual is greater than or equal to 18 years of age; AND
2. Individual has a diagnosis of moderate to severe rheumatoid arthritis (RA) supported by the submitted medical records; AND
3. Individual has an active disease with inadequate response (trial of greater than or equal to 3 months) to at least one conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine) (Fraenkel, 2021); OR
4. Individual has an active disease with documented intolerance or contraindication to at least one conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine) (Fraenkel, 2021); OR
5. Individual has previously received a biologic (e.g., etanercept, infliximab, adalimumab, certolizumab, tocilizumab, sarilumab, golimumab, abatacept, anakinra, rituximab) or synthetic DMARD (tofacitinib, baricitinib, upadacitinib) indicated for rheumatoid arthritis (Fraenkel, 2021); AND
6. Individual is not using the medication in combination with other biologic intended for treatment of rheumatoid arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
7. Individual does not have latent tuberculosis or serious active infection; AND
8. Must be dosed in accordance with the FDA label.
 
CONTINUED APPROVAL for up to 1 year:
 
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with other biologic intended for treatment of rheumatoid arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label.
 
PSORIATIC ARTHRITIS
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
1. Individual is greater than or equal to 18 years of age; AND
2. Individual has a diagnosis of moderate to severe psoriatic arthritis supported by the submitted medical records; AND
3. Individual has an active disease with documented inadequate response (trial of ≥3 months) to at least one conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide) or phosphodiesterase 4 inhibitor (e.g., apremilast) (Ogdie, 2020); OR
4. Individual has an active disease with documented intolerance or contraindication to at least one conventional synthetic DMARDs (e.g., methotrexate, sulfasalazine, leflunomide) or phosphodiesterase 4 inhibitor (e.g., apremilast) (Ogdie, 2020); OR
5. Individual has previously received a biologic (e.g., etanercept, infliximab, ustekinumab, adalimumab, golimumab, certolizumab pegol, abatacept, secukinumab, ixekizumab, guselkumab) or oral Janus kinase inhibitor (e.g., tofacitinib, upadacitinib) indicated for psoriatic arthritis (Ogdie, 2020); OR
6. Individual has axial disease that is not responsive to treatment with NSAIDs, physiotherapy or sacroiliac joint glucocorticoid injections (GRAPPA, 2022); AND
7. Individual is not using the medication in combination with other biologic intended for treatment of psoriatic arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
8. Individual does not have latent tuberculosis or serious active infection; AND
9. Must be dosed in accordance with the FDA label.
 
CONTINUED APPROVAL for up to 1 year:
 
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with other biologic intended for treatment of psoriatic arthritis, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label. 
 
ANKYLOSING SPONDYLITIS  
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
1. Individual is greater than or equal to 18 years of age; AND
2. Individual has a diagnosis of active ankylosing spondylitis (ACR, 2019); AND
3. Individual has an active disease with documented inadequate response (trial of ≥3 months) to continuous treatment with at least two scheduled NSAIDs (e.g., indomethacin, naproxen, celecoxib) (Perrotta, 2022); OR
4. Individual has active disease with documented intolerance or contraindication to at least two NSAIDs (e.g., indomethacin, naproxen, celecoxib) (Perrotta, 2022); OR
5. Individual has previously received a biologic (e.g., infliximab, etanercept, adalimumab, golimumab, certolizumab pegol, ixekizumab, secukinumab) or Janus kinase inhibitor (e.g., tofacitinib, upadacitinib) indicated for active ankylosing spondylitis or active non-radiographic axial spondyloarthritis with objective signs of inflammation (ACR, 2019); AND 
6. Individual will not be using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor; AND
7. Individual does not have latent tuberculosis or serious active infection; AND
8. Must be dosed in accordance with the FDA label. 
 
CONTINUED APPROVAL for up to 1 year:
 
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with any other biologic indicated for ankylosing spondylitis, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label.  
 
NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS 
 
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
 
1. Individual is greater than or equal to 18 years of age; AND
2. Individual has a diagnosis of active non-radiographic axial spondyloarthritis with objective signs of inflammation (Ward, 2019); AND
3. Individual has documented inadequate response (trial of ≥3 months) to continuous treatment with at least two scheduled NSAIDs (e.g., indomethacin, naproxen, celecoxib); OR
4. Individual has active disease with documented intolerance/contraindication to at least two NSAIDs (e.g., indomethacin, naproxen, celecoxib); OR
5. Individual has previously received a biologic (e.g., infliximab, etanercept, adalimumab, golimumab, certolizumab pegol, ixekizumab, secukinumab) or Janus kinase inhibitor (e.g., tofacitinib, upadacitinib) indicated for active non-radiographic axial spondyloarthritis with objective signs of inflammation (Ward, 2019); AND
6. Individual will not be using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor; AND
7. Individual does not have latent tuberculosis or serious active infection; AND
8. Must be dosed in accordance with the FDA label. 
 
CONTINUED APPROVAL for up to 1 year:
 
1. Individual has met criteria for initial approval; AND
2. Individual has experienced a documented positive clinical response; AND
3. Individual is not using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, any IL inhibitor, or Janus kinase inhibitor; AND
4. Must be dosed in accordance with the FDA label.  
 
Policy Guidelines  
 
Examples of Contraindications to Methotrexate: 
1. Alcoholism, alcoholic liver disease or other chronic liver disease 
2. Breastfeeding 
3. Blood dyscrasias (e.g., thrombocytopenia, leukopenia, significant anemia) 
4. Elevated liver transaminases 
5. History of intolerance or adverse event 
6. Hypersensitivity 
7. Interstitial pneumonitis or clinically significant pulmonary fibrosis 
8. Myelodysplasia 
9. Pregnancy or planning pregnancy (male or female) 
10. Renal impairment 
11. Significant drug interaction 
 
Dosage and Administration
Dosing per FDA Guidelines
 
Crohn’s Disease:   
    • The recommended dose of certolizumab pegol (e.g., Cimzia) is 400mg subcutaneously (SQ) initially and at Weeks 2 and 4. The recommended maintenance dose of certolizumab pegol (e.g., Cimzia) is 400mg every four weeks.
 
Rheumatoid Arthritis/Psoriatic Arthritis:
    • The recommended dose of certolizumab pegol (e.g., Cimzia) is 400mg SQ initially and at Weeks 2 and 4, followed by 200 mg every other week. The recommended maintenance dosing of certolizumab pegol is 400mg every four weeks can be considered.
 
Ankylosing Spondylitis/Non-radiographic Axial Spondyloarthritis:  
    • The recommended dose of certolizumab pegol (e.g., Cimzia) is 400 mg SQ initially and at weeks 2 and 4. The recommended maintenance dosing of certolizumab pegol (e.g., Cimzia) is 200 mg every other week or 400 mg every 4 weeks.
 
Plaque Psoriasis:
    • The recommended dose of certolizumab pegol (e.g., Cimzia) is 400 mg every other week
For some individuals (with body weight ≤ 90 kg), a dose of 400 mg initially and at Weeks 2 and 4, followed by 200 mg every other week may be considered.
 
Certolizumab pegol (e.g., Cimzia) is available as a 200 mg lyophilized powder in a single-dose vial for reconstitution and a 200 mg single-dose prefilled syringe.
 
Certolizumab pegol (e.g., Cimzia) lyophilized vial should be administered subcutaneously by a healthcare professional.
 
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Certolizumab pegol (e.g., Cimzia), for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, certolizumab pegol (e.g., Cimzia), for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
The efficacy and safety of certolizumab pegol for Crohn’s disease was studied in two double-blind, randomized, placebo-controlled trials in patients aged 18 years of age or older with moderately to severely active Crohn’s disease.
 
Study 1 included 662 patients with active Crohn’s disease who were administered certolizumab pegol or placebo at Weeks 0, 2, 4 and then every four weeks to Week 24. Clinical response was defined as at least a 100-point reduction in Crohn’s Disease Activity Index (CDAI) score compared to baseline. Clinical remission was defined as an absolute CDAI score of 150 points or lower. At Week 26 37% of certolizumab pegol patients and 27% of placebo patients received a clinical response. At Week 26 29% of certolizumab pegol patients were in clinical remission and 18% of placebo patients were in clinical remission.
 
Study 2 included 428 patients with active Crohn’s disease. All patients entered in the study were initially given certolizumab pegol 400mg at Weeks 0, 2, and 4. They were assessed for clinical response at Week 6. At Week 6, the clinical responders were randomized to receive either certolizumab pegol 400mg or placebo, every four weeks starting at Week 8, as maintenance therapy through Week 24. At Week 26 48% of patients in the certolizumab pegol group were in clinical remission and 29% of patients in the placebo group were in clinical remission.
 
The efficacy and safety of certolizumab pegol for rheumatoid arthritis was assessed in four randomized, placebo-controlled, double-blind studies. Patients were included if they were 18 years of age or older with moderately to severely active rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria. Certolizumab pegol was administered subcutaneously with methotrexate at stable doses of at least 10mg weekly in three of the studies. Certolizumab pegol was administered monotherapy in one study.
 
Study 1 and Study 2 evaluated patients who had received methotrexate for at least 6 months prior to the study but had an incomplete response to methotrexate alone. In both studies patients were treated with a loading dose of certolizumab pegol400mg at Weeks 0, 2, 4 or placebo followed by either 200mg or 400mg of certolizumab pegol or placebo every other week. These patients continued to receive their dose of methotrexate. Study 1 went for 52 weeks. Study 2 went for 24 weeks.
 
Study 3 evaluated 247 patients who had active rheumatoid arthritis despite receiving methotrexate for 6 months prior. Patients received 400mg of certolizumab pegol every four weeks for 24 weeks.
 
Study 4 evaluated 220 patients who had failed at least one disease modifying antirheumatic drug. 400mg of Certolizumab pegol or placebo was given every 4 weeks for 24 weeks.
 
The efficacy and safety of certolizumab pegol for psoriatic arthritis was assessed in a multi-center, randomized, double-blind, placebo-controlled trial. 409 patients were enrolled who were 18 years of age and older with active psoriatic arthritis despite disease modifying antirheumatic drug therapy or prior anti-TNF biologic therapy. 400mg of certolizumab pegol or placebo was given at Weeks 0, 2, and 4. This was followed by 200mg of certolizumab pegol every other week or 400mg certolizumab pegol in the treatment groups or placebo every other week. Patients were evaluated at weeks 12 and 24. ACR20 response rates at Weeks 12 and 24 were higher for each certolizumab pegol group relative to placebo. Response rate at Week 12 for placebo was 24%, 200 mg of certolizumab pegol was 58%, and 400mg of certolizumab pegol was 52%. At week 24 response rate for placebo was 24%, 200mg of certolizumab pegol was 64%, and 400mg of certolizumab pegol was 56%. ACR50 response rates at Weeks 12 and 24 were also higher for each certolizumab pegol group relative to placebo. Response rates at Week 12 for placebo was 11%, 200 mg of certolizumab pegol was 36%, and 400mg of certolizumab pegol was 33%. At week 24 response rate for placebo was 13%, 200mg of Certolizumab pegol was 44%, and 400mg of certolizumab pegol was 40%. ACR70 response rates at Weeks 12 and 24 were again higher for each certolizumab pegol group relative to placebo. Response rate at Week 12 for placebo was 3%, 200 mg of certolizumab pegol was 25%, and 400mg of certolizumab pegol was 13%. At week 24 response rate for placebo was 4%, 200mg of certolizumab pegol was 28%, and 400mg of certolizumab pegol was 24%.
 
The efficacy and safety of certolizumab pegol for ankylosing spondylitis was assessed in a multicenter, randomized, double-blind, placebo-controlled trial. Patients enrolled in the study were 18 years of age or older with adult-onset active axial spondyloarthritis for at least 3 months who were intolerant to or had an inadequate response to at least one NSAID. Patients were given a loading dose of 400mg certolizumab pegol at Weeks 0, 2, and 4 or placebo followed by either 200mg of certolizumab pegol every 2 weeks, 400mg of certolizumab pegol every 4 weeks, or placebo. Patients were allowed to continue NSAID use. At 12 weeks ASAS20 response was 37% in the placebo group, 57% in the 200mg of certolizumab pegol, and 64% in the 400mg certolizumab pegol. At 24 weeks ASAS20 response was 33% in the placebo group, 68% in the 200mg of certolizumab pegol, and 70% in the 400mg certolizumab pegol. At 12 weeks ASAS40 response was 19% in the placebo group, 40% in the 200mg of certolizumab pegol, and 50% in the 400mg certolizumab pegol. At 24 weeks ASAS40 response was 16% in the placebo group, 48% in the 200mg of certolizumab pegol, and 59% in the 400mg Certolizumab pegol.
 
The efficacy and safety of certolizumab pegol for non-radiographic axial spondyloarthritis was assessed in a multicenter, randomized, double-blind, placebo-controlled study. 317 patients who were 18 years of age or older with adult-onset active axial spondyloarthritis for at least 12 months were enrolled in the study. Patients must have had signs of inflammation indicated by C-reactive protein levels above the upper limit of normal and/or sacroiliitis on magnetic resonance imaging. Patients must have also been intolerant to or had an inadequate response to at least two NSAIDS. Patients were given a loading dose of 400mg of Certolizumab pegol at Weeks 0, 2, and 4 or placebo followed by 200mg of certolizumab pegol every 2 weeks or placebo. Patients were allowed to continue concomitant medications such as NSAIDS, DMARDS, corticosteroids, or opioids. The primary endpoint was the proportion of patients achieving an Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) response at Week 52. At Week 52 MSDAS-MI was 7% for the placebo patients and 47% for the Certolizumab pegol patients.
 
The efficacy and safety of certolizumab pegol for plaque psoriasis was studied in three multicenter, randomized, double-blind studies. Patients were enrolled if they were 18 years of age or older with moderate to severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Patients had a Physician Global Assessment (PGA) of ≥ 3 for severity, a Psoriasis Area, and Severity Index (PASI) score ≥ 12, and body surface area (BSA) involvement of ≥10%. Study 1 (234 patients) and Study 2 (227 patients) randomized subjects to placebo, certolizumab pegol 200mg every other week (following a loading dose of certolizumab pegol 400mg at Weeks 0, 2, 4), or certolizumab pegol 400mg every other week. Study 3 (559 patients) randomized subjects to receive placebo, certolizumab pegol 200mg every other week (following a loading dose of certolizumab pegol 400mg at Weeks 0, 2, 4), certolizumab pegol 400mg every other week up to Week 16, or a biologic comparator. Of the 850 patients randomized, 29% were naïve to prior psoriasis treatment, 47% had received phototherapy or chemo phototherapy, and 30% has received prior biologic therapy for the treatment of psoriasis. In Study 1 the average PGA was decreased 4% in the placebo group, 45% in the 200mg of certolizumab pegol, and 55% in the 400mg of certolizumab pegol. In Study 2 the aver PGA was decreased 3% in the placebo group, 61% in the 200mg of certolizumab pegol, and 65% in the 400mg certolizumab pegol. In Study 3 PGA was decreased 4% in the placebo group, 52% in the 200mg of certolizumab pegol, and 62% in the 400mg certolizumab pegol.
 
2025 Update
The efficacy of CIMZIA in pediatric patients with pJIA is based on pharmacokinetic exposure and extrapolation of the established efficacy of CIMZIA in RA patients.
 
The efficacy of CIMZIA was also assessed in a multi-center, open-label study NCT01550003 in 193 patients 2 to 17 years of age with JIA with active polyarthritis with an inadequate response or intolerance to at least 1 DMARD (nonbiologic or biologic). Of those, 105 received the recommended dose. The patients had the following subtypes of JIA: polyarthritis rheumatoid factor-positive (20.0%), polyarthritis rheumatoid factor-negative (44.8%), extended oligoarthritis (13.3%), juvenile psoriatic arthritis (4.8%), and enthesitis-related arthritis (19.0%). Patients could be on stable methotrexate, glucocorticoids, and/or NSAIDs. Efficacy was assessed as secondary endpoints through Week 24. The efficacy was generally consistent with responses in patients with RA. (Cimzia, 2024)
CPT/HCPCS:
J0717Injection, certolizumab pegol, 1 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)
References: ACIP(2025) Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention www.cdc.gov/acip/index.html

Cimzia(2022) package insert Smyrna, GA; UCB, 2022.

Cimzia(2024) package insert Smyrna, GA; UCB, 2024.

Clinical Trial(2025) Pediatric Arthritis Study of Certolizumab Pegol (PASCAL). ClinicalTrials.gov identifier: NCT01550003. Updated October 23, 2024. Accessed July 29, 2025.

Coates LC, Soriano ER, Corp N, Bertheussen H, Callis Duffin K, Campanholo CB, Chau J, Eder L, Fernández-Ávila DG, FitzGerald O, Garg A.(2022) Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nature Reviews Rheumatology. 2022 Aug;18(8):465-79.

Deodhar, A., et al.(2019) A Fifty-Two–Week, Randomized, Placebo-Controlled Trial of Certolizumab Pegol in Nonradiographic Axial Spondyloarthritis. Arthritis & Rheumatology, 71(7), pp.1101-1111.

Elmets CA, Korman NJ, Prater EF, Wong EB, Rupani RN, Kivelevitch D, Armstrong AW, Connor C, Cordoro KM, Davis DM, Elewski BE.(2021) Elmets CA, Korman NJ, Prater EF, Wong EB, Rupani RN, Kivelevitch D, Armstrong AW, Connor C, Cordoro KM, Davis DM, Elewski BE Journal of American Academy of Dermatology. 2021 Feb 1; 84(2):432-70

Feuerstein JD, Ho EY, Shmidt E, Singh H, Falck-Ytter Y, Sultan S, Terdiman JP, Sultan S, Cohen BL, Chachu K, Day L.(2021) AGA clinical practice guidelines on the medical management of moderate to severe luminal and perianal fistulizing Crohn’s disease. Gastroenterology. 2021 Jun 1:160(7):2496-508.

Fraenkel L, Bathon JM, England BR, St. Clair EW, Arayssi T, Carandang K, Deane KD, Genovese M, Huston KK, Kerr G, Kremer J.(2021) American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis & Rheumatology. 2021 Jul; 73(7): 1108-23.

Gottlieb, A., et al.(2018) Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). Journal of the American Academy of Dermatology, 79(2), pp.302-314.

Helliwell PS, Taylor WJ.(2015) Classification and diagnostic criteria for psoriatic arthritis. Ann Rheum Dis 2005;64 Suppl 2:ii3-8.

Lichtenstein, Gary R, et al. (2018) ACG Clinical Guideline: Management of Crohn’s Disease in Adults. American Journal of Gastroenterology, 113(4) 2018, pp. 481–517.

Mease, P., et al.(2013) Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomized placebo-controlled study (RAPID-PsA). Annals of the Rheumatic Diseases, 73(1), pp.48-55.

Menter A, Gelfand JM, Connor C, et al.(2020) Joint AAD-NPF guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445-1486.

Menter A, Strober BE, Kaplan DH, Kivelevitch D, Prater EF, Stoff B, Armstrong AW, Connor C, Cordoro KM, Davis DM, Elewski BE.(2019) Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. Journal of the American Academy of Dermatology. 2019 Apr 1;80(4):1029-72.

Ogdie A, Coates LC, Gladman DD.(2020) Treatment guidelines in psoriatic arthritis. Rheumatology. 2020 Mar 1:59(Supplement_1_:i37-46.

Perrotta FM, Scriffignano S, Ciccia F, Lubrano E.(2022) Perrotta FM, Scriffignano S, Ciccia F, Lubrano E. Open Access Rheumatology: Research and Reviews. 2022 Apr 19:57-66.

Singh, Jasvinder A, et al.(2015) American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis & Rheumatology, 68(1), 2015, pp.1-26.

Singh, Jasvinder A, et al.(2018) American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis & Rheumatology, 71(1), 2018, pp. 5–32. 

van der Heijde D, Ramiro S, Landewe R, et al.(2017) Update of the international ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis 2017;0:1-14

Van Rheenen PF, Aloi M, Assa A, Bronsky J, Escher JC, Fagerberg UL, Gasparetto M, Gerasimidis K, Griffiths A, Henderson P, Koletzko S.(2021) The medical management of paediatric Crohn’s disease: an ECCO-ESPGHAN guideline update. Journal of Crohn’s and Colitis. 2021 Feb 1; 15(2):171-94

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 (1): 1599-1613. Doi:10.1002/145.41042

Ward, M, 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 & Rheumatology, 71(10), pp.1599-1613. 

Weiss PF, MD.(2025) Polyarticular juvenile idiopathic arthritis: Treatment and prognosis. UpTo Date, Conner RF (Ed), Wolters Kluwer, Accessed July 29, 2025. Subscription required.
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants.
CPT Codes Copyright © 2025 American Medical Association.