Cigna Cimzia Prior Auth Coverage Update | OpenPayer

Loading...

Cigna Cimzia Prior Auth Coverage Update | OpenPayer

Ankylosing Spondylitis

Covered when ONE of the following is met

Ankylosing Spondylitis — Initial or Continuation: A) Initial Therapy: Approve for 6 months if BOTH: i) patient is ≥ 18 years of age; AND ii) medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if BOTH: i) patient has been established on therapy for at least 6 months; AND ii) patient meets at least ONE of: a) beneficial clinical response by at least one objective measure (examples: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, and/or serum markers); OR b) improvement in at least one symptom (e.g., decreased pain or stiffness, improved function or ADLs).

Objective measures examples provided in policy.

Crohn's Disease

Covered when ONE of the following is met

Crohn's Disease — Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL: i) patient is ≥ 18 years of age; AND ii) patient meets ONE of: a) tried or is taking corticosteroids (or corticosteroids are contraindicated); OR b) tried one other conventional systemic therapy for Crohn's disease (examples: azathioprine, 6-mercaptopurine, methotrexate); OR c) has enterocutaneous or rectovaginal fistulas; OR d) had ileocolonic resection; AND iii) medication is prescribed by or in consultation with a gastroenterologist. Note: exception to prior steroid/conventional agent requirement if patient has already tried at least one biologic other than the requested drug; a biosimilar does not count; a trial of mesalamine does not count as a systemic agent. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if BOTH: i) patient has been established on therapy for at least 6 months; AND ii) patient meets at least ONE of: a) beneficial clinical response by at least one objective measure (examples: fecal markers, serum markers, imaging, endoscopy, or reduced steroid dose); OR b) improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool).

Examples of objective measures include fecal lactoferrin, fecal calprotectin, CRP, MRE/CTE, endoscopy, or reduced corticosteroid dose.

Juvenile Idiopathic Arthritis (JIA)

Covered when ONE of the following is met

JIA — Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL: i) patient is > 2 years of age; AND ii) patient meets ONE of: a) tried one other systemic medication for JIA (examples: methotrexate, sulfasalazine, leflunomide, or an NSAID) — a prior trial of one biologic other than the requested drug also counts (biosimilars do not count); OR b) starting concurrently with methotrexate, sulfasalazine, or leflunomide; OR c) absolute contraindication to methotrexate, sulfasalazine, or leflunomide; OR d) aggressive disease as determined by the prescriber; AND iii) medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if BOTH: i) patient has been established on therapy for at least 6 months; AND ii) patient meets at least ONE of: a) beneficial clinical response by at least one objective measure (examples: MD global, PGA, PDA, JDAS, cJDAS, JSpADA, CRP/ESR, or reduced corticosteroid dose); OR b) improvement in at least one symptom (e.g., less joint pain/tenderness, decreased morning stiffness or fatigue, improved function/ADLs).

Objective measure examples include juvenile arthritis activity scores and serum markers.

Non-radiographic Axial Spondyloarthritis

Covered when ONE of the following is met

Non-radiographic Axial Spondyloarthritis — Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL: i) patient is ≥ 18 years of age; AND ii) patient has objective signs of inflammation defined as at least ONE of: a) CRP elevated beyond the upper limit of normal for the reporting laboratory; OR b) sacroiliitis reported on MRI; AND iii) medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if BOTH: i) patient has been established on the requested drug for at least 6 months; AND ii) patient meets at least ONE of: a) beneficial clinical response by at least one objective measure (examples listed in policy); OR b) improvement in at least one symptom (e.g., decreased pain or stiffness, improved function).

Objective signs of inflammation defined in policy.

Plaque Psoriasis

Covered when ONE of the following is met

Plaque Psoriasis — Initial or Continuation: A) Initial Therapy: Approve for 3 months if ALL: i) patient is ≥ 18 years of age; AND ii) patient has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant (examples: methotrexate, cyclosporine, acitretin; a 3-month trial of PUVA also counts) or patient has a contraindication to methotrexate; AND iii) medication is prescribed by or in consultation with a dermatologist. Note: exception if patient has already had a 3-month trial or intolerance to at least one biologic other than the requested drug; a biosimilar does not count. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if ALL: i) patient has been established on the requested drug for at least 3 months; AND ii) patient experienced a beneficial clinical response defined as improvement in at least one of: estimated body surface area affected, erythema, induration/thickness, and/or scale; AND iii) improvement in at least one symptom (e.g., decreased pain, itching, burning) compared with baseline.

Exceptions when prior biologic trial exists; biosimilars do not count as the requested biologic.

Psoriatic Arthritis

Covered when ONE of the following is met

Psoriatic Arthritis — Initial or Continuation: A) Initial Therapy: Approve for 6 months if BOTH: i) patient is ≥ 18 years of age; AND ii) medication is prescribed by or in consultation with a rheumatologist or a dermatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if BOTH: i) patient has been established on the requested drug for at least 6 months; AND ii) patient meets at least ONE of: a) beneficial clinical response when assessed by at least one standardized measure (examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument, MDA, PsAID-12, and/or serum markers); OR b) improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling).

Standardized measures examples provided in policy.

Rheumatoid Arthritis

Covered when ONE of the following is met

Rheumatoid Arthritis — Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL: i) patient is ≥ 18 years of age; AND ii) patient has tried ONE conventional synthetic DMARD for at least 3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) unless an exception applies (exception if patient already had a 3-month trial of at least one biologic other than the requested drug; biosimilars do not count); AND iii) medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if BOTH: i) patient has been established on the requested drug for at least 6 months; AND ii) patient meets at least ONE of: a) beneficial clinical response when assessed by at least one objective measure (examples: CDAI, DAS28-ESR/CRP, PAS-II, RAPID-3, SDAI); OR b) improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, fatigue; improved function).

Exceptions if prior biologic trial exists; biosimilars do not count as the requested biologic.

Spondyloarthritis, Other Subtypes

Covered when ONE of the following is met

Other Spondyloarthritis — Initial or Continuation: A) Initial Therapy: Approve for 6 months if ALL: i) patient is ≥ 18 years of age; AND ii) patient has arthritis primarily in the knees, ankles, elbows, wrists, hands, and/or feet; AND iii) patient has tried at least ONE conventional synthetic DMARD (examples: methotrexate, leflunomide, sulfasalazine); AND iv) medication is prescribed by or in consultation with a rheumatologist. OR B) Patient is Currently Receiving Cimzia: Approve for 1 year if BOTH: i) patient has been established on the requested drug for at least 6 months; AND ii) patient meets at least ONE of: a) beneficial clinical response by at least one objective measure (examples: ASDAS, serum markers such as CRP/ESR); OR b) improvement in at least one symptom compared with baseline (e.g., decreased pain or stiffness, improved function/ADLs).

Examples of objective measures include ASDAS and serum markers.

Continuation therapy — FDA-approved indications

Covered when ALL of the following are met for patients currently receiving Cimzia:

Current therapy renewal: Patient has been established on the requested drug for at least 6 months>= 6 months

If <6 months or restarting, review under initial therapy

Clinical response: Patient meets at least ONE of: (a) beneficial clinical response by at least one objective measure (e.g., CDAI, DAS28-ESR/CRP, PAS-II, RAPID-3, SDAI); OR (b) improvement in at least one symptom such as decreased joint pain, morning stiffness, fatigue, improved function, or decreased soft tissue swelling

Examples of objective measures listed in policy

Prescriber requirement: Medication is prescribed by or in consultation with a rheumatologist

Initial therapy — Other spondyloarthritis subtypes

Approve initial therapy for 6 months when ALL of the following are met:

Age: Patient is ≥ 18 years of age>= 18 years

Added requirement for initial approvals

Arthritis distribution: Patient has arthritis primarily in the knees, ankles, elbows, wrists, hands, and/or feet

Prior conventional DMARD: Patient has tried at least ONE conventional synthetic DMARD (examples: methotrexate, leflunomide, sulfasalazine)1 agent

Prescriber requirement:

Continuation therapy — Other spondyloarthritis subtypes

Approve renewal for 1 year when ALL of the following are met for patients currently receiving Cimzia:

Established on therapy: Patient has been established on the requested drug for at least 6 months>= 6 months

If <6 months or restarting, review under initial therapy

Clinical response: Patient meets at least ONE of: (a) beneficial clinical response by at least one objective measure from baseline (e.g., ASDAS, CRP, ESR); OR (b) improvement in at least one symptom compared with baseline such as decreased pain or stiffness or improved function/ADLs

Examples of objective measures provided

A biosimilar of the requested biologic does not count as a trial of the requested biologic when documenting prior therapy. For Crohn’s disease specifically, a trial of mesalamine does not qualify as a systemic agent for purposes of meeting prior therapy requirements. Use the policy-specified exceptions (for example, prior trial of a different biologic may waive some stepping requirements) as noted in the indication-specific criteria.

Concurrent use of Cimzia with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is considered experimental, investigational, or unproven and is not covered. Requests for combination therapy with another biologic or targeted synthetic oral small molecule may be denied; this policy does not exclude combination with conventional synthetic DMARDs (for example, methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine).

Administration of Cimzia in combination with another biologic or a targeted synthetic oral small molecule agent for an inflammatory condition is considered not medically necessary/experimental and unproven. Combination therapy is generally not recommended because of a potentially higher rate of adverse events and lack of controlled data demonstrating additive efficacy; conventional synthetic DMARD co‑therapy is allowed per the policy.

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for prescription benefit coverage of Cimzia. Initial approvals are time-limited (commonly 3–6 months depending on indication) and continuation/renewal approvals are typically provided for 1 year. When approvals are described in months, 1 month = 30 days. Because of the specialized skills required for evaluation and diagnosis of patients treated with Cimzia and the monitoring required for adverse events and long-term efficacy, initial approval requires Cimzia to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., rheumatologist, gastroenterologist, or dermatologist as specified in the indication criteria).

Prior authorization required for initial and continuation therapy; approval durations vary by indication (initial therapy: commonly 3–6 months; continuation: typically 1 year).
Initial prescriptions must be by or in consultation with a specialty physician for the treated condition.

Documentation Required

Required Documentation Elements

Documentation must be submitted showing the patient meets the clinical criteria for the requested indication. Required documentation elements include patient age, specialty prescriber or documentation of consultation with the appropriate specialist, objective measures when applicable, and a clear record of prior therapy trials or documentation of intolerance/contraindication to required therapies.

Patient age (meets the age requirement for the specific indication).
Evidence the medication was prescribed by or in consultation with the relevant specialist (e.g., rheumatologist for spondyloarthritis/JIA/RA/PsA; gastroenterologist for Crohn's disease; dermatologist for psoriasis).
Objective measures when required by the indication (examples: CRP/ESR, ASDAS, BASDAI, BASFI, imaging such as MRI for sacroiliitis, fecal markers or endoscopy for Crohn's disease, disease activity scores for RA/PsA/JIA).
Clinical response documentation for continuation requests (beneficial response from baseline on an objective measure or improvement in symptoms/function).

Step Therapy

Conventional DMARD / Prior Therapy Trial Requirements

Initial approvals frequently require documented trials of one or more conventional synthetic DMARDs or other conventional systemic therapies (or documented intolerance/contraindication) before approving Cimzia for many indications. Examples of acceptable conventional synthetic DMARDs and systemic therapies are provided per indication.

Rheumatoid arthritis: trial of ONE conventional synthetic DMARD for ≥ 3 months (examples: methotrexate [oral or injectable], leflunomide, hydroxychloroquine, sulfasalazine). Exception: prior 3-month trial of a biologic other than the requested drug may substitute.
Psoriatic arthritis/JIA/other spondyloarthritis subtypes: trial(s) of conventional systemic agents as specified for the indication (examples include methotrexate, leflunomide, sulfasalazine).
Plaque psoriasis: trial of at least one traditional systemic agent for ≥ 3 months unless intolerant (examples: methotrexate, cyclosporine, acitretin; a 3-month PUVA course counts).
Crohn's disease: trial of corticosteroids or one other conventional systemic therapy (examples: azathioprine, 6-mercaptopurine, methotrexate), unless contraindicated; mesalamine does not count as a systemic agent for Crohn's disease.
Other spondyloarthritis subtypes (initial therapy): trial of at least ONE conventional synthetic DMARD (examples: methotrexate, leflunomide, sulfasalazine).

Key Terms and Definitions

TNFi — Tumor necrosis factor inhibitor

DefinitionTumor necrosis factor inhibitor (TNFi) — biologic class to which Cimzia (certolizumab pegol) belongs; TNFis are recommended as initial biologic options in specialty guidelines for axial spondyloarthritis and other inflammatory conditions.

Example indicationsCimzia (a TNFi) is indicated for ankylosing spondylitis, Crohn's disease, juvenile idiopathic arthritis, non‑radiographic axial spondyloarthritis, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis.

Mechanism contextTNFis target tumor necrosis factor, a proinflammatory cytokine implicated across multiple rheumatologic and inflammatory GI diseases; guidelines cite TNFis as primary biologic therapy choices.

Objective signs of inflammation (non-radiographic axial spondyloarthritis)

DefinitionObjective signs of inflammation for non‑radiographic axial spondyloarthritis are defined as at least ONE of: elevated C‑reactive protein (CRP) above the laboratory upper limit of normal, OR sacroiliitis reported on magnetic resonance imaging (MRI).

ApplicationRequired for initial therapy approval for non‑radiographic axial spondyloarthritis (patient must be ≥ 18 years and have one of these objective signs).

Evidence examplesSerum markers such as CRP and ESR are listed among objective measures referenced elsewhere in the policy as validated indicators of inflammation and response.

Established on therapy

DefinitionEstablished on therapy — patient has been receiving the requested drug for at least 6 months prior to renewal consideration.

Renewal implicationPatients established on therapy ≥ 6 months may be reviewed for continuation approvals (commonly approved for 1 year) rather than initial‑therapy criteria.

If <6 monthsPatients who have received < 6 months of therapy or who are restarting therapy are reviewed under initial‑therapy criteria rather than continuation criteria.

Concurrent biologic/targeted synthetic use

DefinitionConcurrent biologic/targeted synthetic use — administration of Cimzia together with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition.

Coverage stanceConcurrent use with another biologic or a targeted synthetic oral small molecule drug is considered experimental, investigational, or unproven and is not covered.

Rationale and exceptionCombination therapy is generally not recommended due to potentially higher adverse events and lack of controlled data; this does NOT exclude use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) with Cimzia.