UnitedHealthcare Cimzia Prior Auth Policy Update

Coverage Criteria by Indication

Initial Therapy - Crohn's disease

Covered when ALL of the following are met

Crohn's disease initial: Diagnosis of moderately to severely active Crohn's disease

Prior therapy for Crohn's: One of: (a) History of failure to one conventional therapy at maximally indicated doses (document drug, date, duration) OR (b) Prior treatment with an FDA‑approved systemic targeted immunomodulator for Crohn's (document drug, date, duration) OR (c) Current Cimzia therapy documented by claims history or medical records

If current therapy was established via manufacturer sample or CIMplicity program, patient must meet initial criteria as if new to therapy

Concurrent therapy restriction: Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication (examples listed in policy)

Prescribing specialist: Prescribed by or in consultation with a gastroenterologist

Reauthorization - Crohn's disease

Covered when ALL of the following are met

Clinical response: Documentation of positive clinical response to Cimzia therapy

Concurrent therapy restriction: Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication

Initial Therapy - Rheumatoid arthritis

Covered when ALL of the following are met

RA diagnosis: Diagnosis of moderately to severely active rheumatoid arthritis

Prior therapy for RA: One of: (a) History of failure to a 3‑month trial of one non‑biologic DMARD at maximally indicated doses (document drug, date, duration) OR (b) Prior treatment with an FDA‑approved systemic targeted immunomodulator for rheumatoid arthritis (document drug, date, duration) OR (c) Current Cimzia therapy documented by claims history or medical records

If current therapy was established via manufacturer sample or CIMplicity program, patient must meet initial criteria as if new to therapy

Concurrent therapy restriction: Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication

Prescribing specialist: Prescribed by or in consultation with a rheumatologist

Reauthorization - Rheumatoid arthritis

Covered when ALL of the following are met

Clinical response: Documentation of positive clinical response to Cimzia therapy

Concurrent therapy restriction: Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication

Initial Therapy - Psoriatic arthritis

Covered when ALL of the following are met

PsA diagnosis: Diagnosis of active psoriatic arthritis

Prior therapy for PsA: One of: failure to specified conventional or non‑biologic therapies OR prior treatment with an FDA‑approved systemic targeted immunomodulator for psoriatic arthritis (document drug, date, duration) OR current Cimzia therapy documented by claims history or medical records

If current therapy was established via manufacturer sample or CIMplicity program, patient must meet initial criteria as if new to therapy

Concurrent therapy restriction: Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication

Prescribing specialist: Prescribed by or in consultation with a rheumatologist or dermatologist

Initial Authorization — Axial Spondyloarthritis/Ankylosing Spondylitis

Initial authorization for active ankylosing spondylitis or non-radiographic axial spondyloarthritis

Diagnosis of active ankylosing spondylitis or non-radiographic axial spondyloarthritis

Prior therapies: Either (a) Failure to two NSAIDs at maximally indicated doses, each used ≥4 weeks unless contraindicated; OR (b) Prior treatment with a systemic targeted immunomodulator FDA‑approved for ankylosing spondylitis (document drug, date, duration); OR (c) Currently on Cimzia with documentation and not established via manufacturer sample or CIMplicity assistance

Patients established via manufacturer sample or CIMplicity assistance must meet initial criteria as if new to therapy.

Concomitant therapy restriction: Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication (examples listed in policy)

Prescriber requirement: Prescribed by or in consultation with a rheumatologist

Reauthorization — Axial Spondyloarthritis/Ankylosing Spondylitis

Reauthorization for ankylosing spondylitis/non-radiographic axial spondyloarthritis

Clinical response: Documentation of positive clinical response to Cimzia therapy

Concomitant therapy restriction: Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication

Initial Authorization — Plaque Psoriasis

Initial authorization for moderate to severe plaque psoriasis

Diagnosis of moderate to severe plaque psoriasis

Severity or involvement: >=3% body surface area involvement, or palmoplantar, facial, genital, or severe scalp psoriasis

Prior therapies: Either (a) Failure to one topical therapy (documented) AND history of failure to a 3‑month trial of methotrexate at maximally indicated dose, unless contraindicated; OR (b) Prior treatment with a systemic targeted immunomodulator FDA‑approved for plaque psoriasis (document drug, date, duration)

Document drugs, dates, and duration of trials; patients started via manufacturer sample or CIMplicity assistance must meet initial criteria as new patients.

Concomitant therapy restriction: Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication

Reauthorization — Plaque Psoriasis

Reauthorization for plaque psoriasis

Clinical response: Documentation of positive clinical response to Cimzia therapy

Concomitant therapy restriction: Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication

Initial Authorization — Polyarticular Juvenile Idiopathic Arthritis

Initial authorization for active polyarticular juvenile idiopathic arthritis

Diagnosis of active polyarticular juvenile idiopathic arthritis

Concomitant therapy restriction: Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication

Prescriber requirement: Prescribed by or in consultation with a rheumatologist

Reauthorization — Polyarticular Juvenile Idiopathic Arthritis

Reauthorization for polyarticular juvenile idiopathic arthritis

Clinical response: Documentation of positive clinical response to Cimzia therapy

Concomitant therapy restriction: Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication

Reauthorization

Reauthorization will be approved when ALL of the following are met:

Reauthorization requirements: (1) Documentation of positive clinical response to Cimzia therapy

Supporting documentation such as medical records may be required

Concomitant therapy restriction: (2) Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for treatment of the same indication (examples: adalimumab, etanercept, baricitinib, abatacept, upadacitinib, golimumab, tofacitinib)

Combination use for same indication disqualifies reauthorization

Requests for Cimzia (certolizumab) will not be approved when the patient is receiving Cimzia in combination with another systemic targeted immunomodulator for treatment of the same indication. This concomitant use is an exclusion to coverage and applies to initial authorization and reauthorization requests.

Concomitant use of Cimzia with another systemic targeted immunomodulator for the same indication is not permitted. Examples of agents listed in the policy include, but are not limited to, adalimumab, etanercept, secukinumab, abatacept, upadacitinib, golimumab, risankizumab, ixekizumab, guselkumab, tofacitinib, apremilast, and others; any combination therapy for the same indication may result in denial of coverage.

Use of Cimzia in combination with another systemic targeted immunomodulator for the same clinical indication is not allowed. Providers must ensure that patients are not receiving overlapping targeted therapies for the same condition when submitting authorization or reauthorization requests.

Initial Authorization Rules

Initial therapy rules (all indications)

Initial authorization criteria per indication

Diagnosis: Appropriate diagnosis for the indication (e.g., moderately to severely active disease as specified)

Prior therapy options: Require failure of specified conventional therapies at maximally indicated doses OR prior use of an FDA‑approved systemic targeted immunomodulator for that indication OR current documented Cimzia use

Document drug, date, duration of trials; manufacturer sample/CIMplicity program does not establish current user status for initial authorization

Specialist prescriber: Prescribed by or in consultation with the appropriate specialist (e.g., gastroenterologist for Crohn's; rheumatologist for RA and PsA; rheumatologist or dermatologist for PsA)

Initial Therapy — Axial Spondyloarthritis/Ankylosing Spondylitis

Reauthorization and Continuation

Reauthorization/Continuation

Reauthorization requirements

Continuation response: Documentation of positive clinical response to Cimzia therapy

No concurrent targeted therapy: Patient is not receiving Cimzia in combination with another systemic targeted immunomodulator for the same indication

Continuation/Reauthorization — Reauthorization requires documentation of ongoing benefit

Reauthorization requires documentation of ongoing benefit

Positive response: Documentation of positive clinical response to Cimzia therapy

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial authorization will be approved only when all indication‑specific criteria are met, including diagnosis and documentation of prior therapy or current Cimzia use as specified below. Authorization will be issued for 12 months unless otherwise noted.

Initial authorization: Member must meet all indication‑specific criteria (diagnosis and prior therapy requirements).
Document drug name, dates, and duration of prior trials or current therapy when stating prior treatment; submission of claims history or medical records may be required.

Documentation Required

Initial Authorization Requirements

For initial requests, provide evidence of the diagnosis and one of the following per the indication: failure of specified conventional non‑biologic therapies (document drug, dates, duration), prior treatment with an FDA‑approved systemic targeted immunomodulator for the same indication (document drug, dates, duration), or documentation that the patient is currently on Cimzia (claims or medical records) and did not rely on manufacturer samples or CIMplicity program assistance to establish current use. Prescriptions should be by or in consultation with the specialty indicated for the condition (e.g., gastroenterologist for Crohn's disease).

Step Therapy Requirements and Bypass

Requirement	What to document
Failure of specified conventional therapies or non-biologic DMARDs (where required)	Document drug name, date, and duration of trial (e.g., corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate or a 3‑month trial of a non‑biologic DMARD)
Prior treatment with a systemic targeted immunomodulator (alternative to non‑biologic failure)	Document drug name, date, and duration of prior biologic or targeted therapy (claims history or medical records)
Current Cimzia therapy as an alternative pathway	Document date and duration of current Cimzia therapy via claims history or submission of medical records; note if therapy was established via manufacturer sample/CIMplicity (samples/CIMplicity do not establish current user status)
Manufacturer sample/CIMplicity assistance	Document that patient has not received a manufacturer supplied sample or CIMplicity assistance to establish current use (if applicable)

Indication-specific step	What to document
Axial spondyloarthritis/Ankylosing spondylitis: NSAID requirement	Document failure to two NSAIDs (e.g., ibuprofen, naproxen) used at maximally indicated doses for ≥4 weeks each (drug name, dates, duration)
Plaque psoriasis: topical + methotrexate pathway	Document topical therapy failure (drug, date, duration) and a 3‑month trial of methotrexate at maximally indicated dose (document date and duration), or prior systemic targeted immunomodulator (drug, date, duration)
Rheumatoid arthritis: non‑biologic DMARD requirement	Document a 3‑month trial of one non‑biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses (drug, date, duration)

Bypass scenario	Provider action
Previous or current biologic DMARD where claim history is not available	Submit medical records documenting previous or current biologic DMARD therapy (document drug, date, and duration) to allow bypass of non‑biologic step requirements
Documentation to establish current Cimzia use	If claims history is unavailable, submit medical records with dates and duration of Cimzia therapy; note that manufacturer samples/CIMplicity assistance do not establish current user status

Background and Drug Information

Cimzia (certolizumab) is a tumor necrosis factor (TNF) blocker approved for multiple inflammatory conditions, including Crohn's disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, non-radiographic axial spondyloarthritis with objective signs of inflammation, and polyarticular juvenile idiopathic arthritis in patients aged 2 years and older.

Definitions

Cimzia (certolizumab) — definition and indications

Drug classTumor necrosis factor (TNF) blocker

Indications (policy list)Crohn's disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, non-radiographic axial spondyloarthritis with objective inflammation, polyarticular juvenile idiopathic arthritis (>=2 years)

Primary useReducing signs and symptoms and maintaining clinical response in moderately to severely active disease for indicated conditions

Age note for pJIAApproved for polyarticular juvenile idiopathic arthritis in patients 2 years of age and older

Brand/genericCimzia (certolizumab)

systemic targeted immunomodulator — examples

Quantity and Supply Limits

Cimzia (certolizumab) — supply / quantity limits

Quantity limits noteSupply limits may be in place for Cimzia

Program variabilitySupply limits and additional clinical rules may vary by UnitedHealthcare program or therapeutic class

Use in automated approvalsUnitedHealthcare may approve initial and re-authorization based on previous claim/medication history and claim logic; supply limits still may apply

Site of Care and Authorization Duration

Note

Authorization duration and state/benefit plan impacts

Authorization duration is generally 12 months; state mandates and the member's specific benefit plan coverage may modify coverage criteria or duration, particularly for infusion center or site‑of‑care considerations.

Plan- or state-specific rules can change required documentation or approval duration — verify benefit details.
For CT/KY/MS business a 30‑day trial rule is noted in the policy footnote.

OpenPayer

Cimzia (certolizumab) prior authorization and medical necessity

Coverage Criteria by Indication

Initial Authorization Rules

Reauthorization and Continuation

Provider Requirements and Documentation

Step Therapy Requirements and Bypass

Background and Drug Information

Definitions

Quantity and Supply Limits

Site of Care and Authorization Duration