CurrentcignaPolicy IP0652

Adalimumab Products Prior Authorization Policy

Cigna prior authorization policy (IP0652) governing coverage, clinical criteria, prescriber specialty requirements, approval durations, preferred-product requirements, and exclusions for adalimumab products (including multiple branded and biosimilar formulations) across specified inflammatory indications. This is Part 1 of 2 and includes FDA-approved indications, other supported uses, conditions not covered, and coding guidance present in this part.

Policy Summary

Payercigna

PolicyAdalimumab Products Prior Authorization Policy

Policy CodePolicy IP0652

Change TypeCoding, product additions, non-covered designations, criteria revisions (2024–2026)

Effective DateMar 15, 2026

Next Review Date

Key ActionPrior Authorization required for all adalimumab products; initial approvals require specialist prescriber or consultation and adherence to preferred-product step requirements per referenced PSM policies.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS/Codes: C9399, J0139, J3490, J3590.

Added Q-codes Q5140-Q5145 effective 1/1/2025 for adalimumab biosimilars.

Adalimumab-aaty (Yuflyma) and adalimumab-bwwd were added to the policy at later revisions.

Designated specific NDC-starting products as Non-Covered for Employer Plans and Individual.

Annual revisions removed several initial therapy approval options for Ulcerative Colitis and Crohn's Disease (various criteria removed) as of 03/15/2026.

Plaque Psoriasis initial therapy exceptions modified to allow 3-month trial or intolerance to apremilast/Otezla XR or deucravacitinib as exception to trial of traditional systemic agent.

Annual review entries noted 'No criteria changes' for certain revision dates.

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Coverage Summary

Scope: This policy (IP0652) is a Cigna prior authorization policy for adalimumab products governing coverage, clinical criteria, prescriber specialty requirements, approval durations, preferred-product requirements, coding guidance, and exclusions across multiple inflammatory and autoimmune indications. This document is Part 1 of 2 and addresses FDA‑approved indications, other supported uses, conditions not covered, and coding guidance; product‑preference rules and legacy/plan-specific preferred‑product criteria and exceptions are detailed in the referenced Preferred Specialty Management (PSM) policies (e.g., PSM003, PSM013, PSM014).

Coverage stance: Covered with criteria — prior authorization is required; initial approvals generally require prescription by or consultation with a specialist in the condition being treated and use of preferred products before approval of non‑preferred adalimumab products per the referenced PSM policies.

Policy effective date: 2026-03-15. Last review: 2026-03-15.

General Prior Authorization & Prescriber Requirement

Prior Authorization is required; initial approval requires specialist prescribing or consultation and preferred-product use prior to non-preferred product approval as noted.

ALL of the following

Prior Authorization is required for benefit coverage of adalimumab products.
Initial approval requires the agent to be prescribed by or in consultation with a physician who specializes in the condition being treated.
Preferred product must be used before approval of a requested non-preferred adalimumab product per referenced Preferred Specialty Management Policies (PSM003, PSM013, PSM014).
Refer to respective PSM policy for legacy/plan-specific preferred product criteria and exceptions.

Indication-specific Approval Criteria

FDA-Approved Indications - Uveitis

Approve if ONE of (A) Initial Therapy or (B) Currently Receiving is met:

ANY of the following

A) Initial Therapy
- Approve for 6 months
- Patient is ≥ 2 years of age
- Patient has tried ONE of: periocular, intraocular, or systemic corticosteroids; immunosuppressives (examples: methotrexate, mycophenolate mofetil, azathioprine, cyclosporine). A trial of one biologic other than requested medication also counts.
- Medication prescribed by or in consultation with an ophthalmologist

Applicable Codes

Considered Medically Necessary / Covered HCPCS/J-codes and relatedmixedCovered

C9399	Unclassified drugs or biologicals
J0139	Injection, adalimumab, 1 mg
J3490	Unclassified drugs
J3590	Unclassified biologics
Q5140	Injection, adalimumab-fkjp, biosimilar, 1 mg (Code effective 1/1/2025)
Q5141	Injection, adalimumab-aaty, biosimilar, 1 mg (Code effective 1/1/2025)
Q5142	Injection, adalimumab-ryvk biosimilar, 1 mg (Code effective 1/1/2025)
Q5143	Injection, adalimumab-adbm, biosimilar, 1 mg (Code effective 1/1/2025)
Q5144	Injection, adalimumab-aacf (idacio), biosimilar, 1 mg (Code effective 1/1/2025)
Q5145	Injection, adalimumab-afzb (abrilada), biosimilar, 1 mg (Code effective 1/1/2025)

Products Not Covered (by product/NDC guidance)NDC|mixedNot Covered

adalimumab-bwwd	product name (not covered on pharmacy and medical benefits for Employer Plans and Individual and Family Plans)
adalimumab-ryvk (NDCs starting with 51759)	product/NDC restriction (not covered for Employer and Individual & Family Plans)
Amjevita (NDCs starting with 84612)	not covered for Employer and Individual & Family Plans
Humira (NDCs starting with 83457)	not covered for Employer and Individual & Family Plans
Hyrimoz (NDCs starting with 83457)	not covered for Employer and Individual & Family Plans

Covered HCPCS / J-codes / miscellaneous drug codes when medically necessaryHCPCSCovered

C9399	Unclassified drugs or biologicals.
J0139	Injection, adalimumab, 1 mg.
J3490	Unclassified drugs.
J3590	Unclassified biologics.
Q5140	Injection, adalimumab-fkjp, biosimilar, 1 mg (Code effective 1/1/2025).
Q5141	Injection, adalimumab-aaty, biosimilar, 1 mg (Code effective 1/1/2025).
Q5142	Injection, adalimumab-ryvk biosimilar, 1 mg (Code effective 1/1/2025).
Q5143	Injection, adalimumab-adbm, biosimilar, 1 mg (Code effective 1/1/2025).
Q5144	Injection, adalimumab-aacf (idacio), biosimilar, 1 mg (Code effective 1/1/2025).
Q5145	Injection, adalimumab-afzb (abrilada), biosimilar, 1 mg (Code effective 1/1/2025).

Non-covered designation for select products (Employer Plans and Individual)NDC/mixedNot Covered

adalimumab-bwwd	Designated as Non-Covered product for Employer Plans and Individual (policy note).
adalimumab-ryvk (NDCs starting with 51759)	Designated as Non-Covered product for Employer Plans and Individual (policy note).
Amjevita (NDCs starting with 84612)	Designated as Non-Covered product for Employer Plans and Individual (policy note).
Humira (NDCs starting with 83457)	Designated as Non-Covered product for Employer Plans and Individual (policy note).
Hyrimoz (NDCs starting with 83457)	Designated as Non-Covered product for Employer Plans and Individual (policy note).

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required for benefit coverage of adalimumab products. Affected billing codes include: J0139, Q5140–Q5144, C9399, J3490, J3590. Initial approvals require the agent to be prescribed by or in consultation with a physician who specializes in the condition being treated; preferred-product requirements per the referenced Preferred Specialty Management (PSM) policies must be met before approval of a requested non-preferred adalimumab product.

J0139
Q5140
Q5141
Q5142
Q5143
Q5144
C9399
J3490
J3590

Background & Clinical Evidence

Background: Adalimumab products are tumor necrosis factor inhibitors (TNFis) approved and used across multiple inflammatory and autoimmune disorders (examples listed include ankylosing spondylitis, Crohn's disease, hidradenitis suppurativa, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, and uveitis). The policy references guideline recommendations that prominently feature TNFis for many of these indications and provides indication‑specific prior authorization requirements, prescriber specialty requirements, and durations for initial and continuation approvals.

This part (Part 1) includes the FDA‑approved indications and other supported uses with criteria and approval durations; prescribing information is cited (Humira prescribing information, AbbVie; February 2024) and multiple professional guidelines are referenced (examples: ACR, AGA, ACG, AAO, EULAR) to support recommended use and policy exclusions.

Evidence summary: Guideline sources cited in the policy include the American College of Rheumatology (ACR) guideline updates (e.g., ankylosing spondylitis, rheumatoid arthritis, JIA), American Gastroenterological Association (AGA) and American College of Gastroenterology (ACG) guidelines for Crohn's disease and ulcerative colitis, American Academy of Ophthalmology (AAO) guidance for ocular inflammatory disorders, and EULAR recommendations (e.g., Behçet's).

Prescribing information: The Humira prescribing information (AbbVie; February 2024) is cited as the product PI reference for clinical and labeling details.

Guideline‑based limitations: The policy explicitly notes the EULAR/ACR (2015) recommendation that TNFis are strongly recommended against for polymyalgia rheumatica (PMR), which is listed among conditions not covered. Guideline recommendations inform the policy's indication‑specific PA requirements, step/previous therapy expectations, specialist prescribing requirements, and duration/continuation criteria.

Definitions & Key Thresholds

Revision History

11/01/2024material

New policy published (IP0652); HCPCS/J-code additions: C9399, J0139, J3490, J3590.

01/01/2025material

Q-codes for adalimumab biosimilars added and effective 1/1/2025: Q5140–Q5145 (Q5145/Abrilada included in code list).

06/01/2025material

Adalimumab-aaty (Yuflyma) added to the policy; same criteria apply as other adalimumab products.

Policy Summary

Payercigna

PolicyAdalimumab Products Prior Authorization Policy

Policy CodePolicy IP0652

Change TypeCoding, product additions, non-covered designations, criteria revisions (2024–2026)

Effective DateMar 15, 2026

Next Review Date

SourceLink

On This Page

Other Uses with Supportive Evidence (Behcet's, Pyoderma Gangrenosum, Sarcoidosis, Scleritis, Spondyloarthritis, etc.)

Each condition has Initial Therapy and Currently Receiving branches; approvals and requirements vary by condition as detailed below.

ALL of the following

Behcet's Disease: Initial Therapy: Approve for 3 months if patient is > 2 years of age AND patient has tried at least ONE conventional therapy OR has ophthalmic manifestations; medication prescribed by or in consultation with an appropriate specialist (rheumatologist, dermatologist, ophthalmologist, gastroenterologist, or neurologist). Currently Receiving: Approve for 1 year if patient has been established on therapy ≥ 3 months and has objective beneficial response and symptom improvement.
Pyoderma Gangrenosum: Initial Therapy: Approve for 4 months if patient is > 18 years of age AND patient has tried one systemic corticosteroid OR one other immunosuppressant; medication prescribed by or in consultation with a dermatologist. Currently Receiving: Approve for 1 year if patient has been established on therapy ≥ 4 months and has objective beneficial response and symptom improvement.
Sarcoidosis: Initial Therapy: Approve for 3 months if patient is > 18 years of age AND patient has tried at least one corticosteroid and at least one immunosuppressive; medication prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist. Currently Receiving: Approve for 1 year if patient has been established on therapy ≥ 3 months and has objective beneficial response and symptom improvement.
Scleritis or Sterile Corneal Ulceration: Initial Therapy: Approve for 6 months if patient is > 18 years of age AND patient has tried one other therapy for this condition; medication prescribed by or in consultation with an ophthalmologist. Currently Receiving: Approve for 1 year if patient has been established on therapy ≥ 6 months and has objective beneficial response or symptom improvement.
Spondyloarthritis, Other Subtypes: Initial Therapy: Approve for 6 months if patient is > 18 years of age AND either (a) peripheral arthritis with trial of conventional synthetic DMARD OR (b) axial disease with objective signs of inflammation (elevated CRP or MRI sacroiliitis); medication prescribed by or in consultation with a rheumatologist. Currently Receiving: Approve for 1 year if patient has been established on therapy ≥ 6 months and has objective response or symptom improvement.

Conditions Not Covered

Adalimumab products for any other use are considered not medically necessary, including explicit exclusions below:

ANY of the following

Concurrent use with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is not covered (combination therapy).
Does not exclude use of conventional synthetic DMARDs in combination.
Polymyalgia Rheumatica (PMR) is not covered; TNFis are strongly recommended against per EULAR/ACR guidelines (2015).

General Coverage Limitations / Contraindications

These use limitations apply unless otherwise specified in the applicable policy statements:

ALL of the following

Concurrent use with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is not permitted.
Does NOT exclude concomitant use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine).
Use for polymyalgia rheumatica (PMR) is strongly recommended against per EULAR/ACR 2015 guidelines due to lack of evidence and potential harm.

Documentation Required

Document objective response for continuation

For continuation (1-year approvals) providers must document that the patient has been established on therapy for the required duration per indication and has experienced a beneficial clinical response from baseline by objective measures or symptom improvement. Required establishment durations and examples: Ankylosing spondylitis — established ≥6 months for 1-year approval; objective measures: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ‑S, serum markers (CRP, ESR). Crohn’s disease — established ≥6 months; objective measures: fecal markers (lactoferrin, calprotectin), CRP, imaging (MRE, CTE), endoscopy, reduced corticosteroid dose. Hidradenitis suppurativa — established ≥3 months; objective measures: Hurley staging, Sartorius score, Physician Global Assessment, Hidradenitis Suppurativa Severity Index. Juvenile idiopathic arthritis — established ≥6 months; objective measures: MD global, PGA, PDA, JDAS, cJDAS, JSpADA, CRP/ESR, reduced corticosteroid dose. (See respective indication criteria for full lists and thresholds.)

Documentation Required

Specialist prescribing requirement

Initial therapy requires the medication be prescribed by or in consultation with a physician who specializes in the condition being treated. Specialist-to-indication mappings in the policy include: rheumatologist (ankylosing spondylitis, JIA, psoriatic arthritis, rheumatoid arthritis, spondyloarthritis subtypes), gastroenterologist (Crohn's disease, ulcerative colitis), dermatologist (hidradenitis suppurativa, plaque psoriasis, pyoderma gangrenosum), ophthalmologist (uveitis, scleritis, sterile corneal ulceration), and pulmonologist (sarcoidosis where pulmonary involvement is present).

Documentation Required

Ensure policy-specific criteria met

Adalimumab products and listed billing codes (e.g., C9399, J0139, J3490, J3590, Q5140–Q5144, Q5145) are considered medically necessary only when the applicable policy-specific criteria in Part 1 are met for the patient's indication. Providers must document indication and prior therapy per the policy before using adalimumab or biosimilars; claims that do not meet those criteria may be denied.

C9399
J0139
J3490
J3590
Q5140
Q5141
Q5142
Q5143
Q5144
Q5145