Pharmacy Prior Authorization Criteria

Cimzia (certolizumab pegol)

Indications for Prior Authorization

Cimzia (certolizumab pegol)

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

• For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)
  Indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older.

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

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

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

• For diagnosis of 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.

• For diagnosis of 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.

Criteria

Cimzia

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)

• Diagnosis of moderately to severely active rheumatoid arthritis (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 [2, 3]:
• methotrexate
• leflunomide
• sulfasalazine

Cimzia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1-3]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline

Cimzia

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)

• Diagnosis of active polyarticular juvenile idiopathic arthritis (PJIA)
AND
• Prescribed by or in consultation with a rheumatologist
AND
• Minimum duration of a 6-week trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [4]:
• leflunomide
• methotrexate

Cimzia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 4]:
• Reduction in the total active (swollen and tender) joint count from baseline
• Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline

Cimzia

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Diagnosis of active psoriatic arthritis (PsA)
AND
• One of the following [5]:
• actively inflamed joints
• dactylitis
• enthesitis
• axial disease
• active skin and/or nail involvement
AND
• Prescribed by or in consultation with one of the following:
• Dermatologist
• Rheumatologist

Cimzia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 5]:
• 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

Cimzia

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Plaque Psoriasis (PsO)

• Diagnosis of moderate to severe plaque psoriasis (PsO)
AND
• One of the following [6]:
• Greater than or equal to 3% body surface area involvment
• 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 [7]:
• corticosteroids (e.g., betamethasone, clobetasol)
• vitamin D analogs (e.g., calcitriol, calcipotriene)
• tazarotene
• calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
AND
• Prescribed by or in consultation with a dermatologist

Cimzia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Plaque Psoriasis (PsO)

• Patient demonstrates positive clinical response to therapy as evidenced by ONE of the following [1, 6]:
• Reduction in the body surface area (BSA) involvement from baseline
• Improvement in symptoms (e.g., pruritus, inflammation) from baseline

Cimzia

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)

• Diagnosis of active ankylosing spondylitis (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) at maximally tolerated doses [8]

Cimzia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)

• Patient demonstrates positive clinical response to therapy as evidenced by improvement from baseline for at least one of the following [1, 8]:
• 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

Cimzia

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Non-radiographic Axial Spondyloarthritis (nr-axSpA)

• Diagnosis of active non-radiographic axial spondyloarthritis (nr-axSpA)
AND
• Patient has objective signs of inflammation (e.g., C-reactive protein [CRP] levels above the upper limit of normal and/or sacroiliitis on magnetic resonance imaging [MRI], indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints.) [1, 8]
AND
• Prescribed by or in consultation with a rheumatologist
AND
• Minimum duration of one month trial and failure, contraindication, or intolerance to two different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses [8]

Cimzia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-radiographic Axial Spondyloarthritis (nr-axSpA)

• Patient demonstrates positive clinical response to therapy as evidenced by improvement from baseline for at least one of the following [1, 8]:
• 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

Cimzia

Prior Authorization (Initial Authorization)

Length of Approval: 16 Weeks [A]
For diagnosis of Crohn’s disease (CD)

• Diagnosis of moderately to severely active Crohn’s disease (CD)
AND
• One of the following [9, 10]:
• 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
• Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies [9, 10]:
• 6-mercaptopurine
• Azathioprine
• Corticosteroids (e.g., prednisone)
• Methotrexate
AND
• Prescribed by or in consultation with a gastroenterologist

Cimzia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Crohn’s disease (CD)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 9, 10]:
• 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

P & T Revisions

2024-11-08, 2024-09-15, 2024-04-03, 2023-09-05, 2023-04-10, 2022-10-21, 2022-04-24, 2021-05-25, 2021-04-08, 2020-04-08

References

1. Cimzia Prescribing Information. UCB. Smyrna, GA. September 2024.
2. 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.
3. 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.
4. Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis. Arthritis Rheumatol. 2019;71(6):846-863.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.

---

End Notes

1. The recommended initial adult dose of Cimzia is 400 mg (given as two subcutaneous injections of 200 mg) initially, and at Weeks 2 and 4. In patients who obtain a clinical response, the recommended maintenance regimen is 400 mg every four weeks.

---

Revision History

• 2024-11-08: Addition of criteria for PJIA
• 2024-09-15: Removed anthralin and coal tar as topical step options for PsO
• 2024-04-03: 2024 Annual Review - no changes
• 2023-09-05: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-04-10: 2023 Annual Review - updated references
• 2022-10-21: Further clinical detail and criteria added
• 2022-04-24: Annual review - no criteria changes; GPI Reclassification
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-08: Annual review - No clinical changes; background updates
• 2020-04-08: Annual review - Added objective measures to the psoriasis reauthorization criteria; updated references

---