CurrentcignaPolicy IP0652

Adalimumab Products Prior Authorization Policy

Prior authorization policy for multiple adalimumab products (brands and biosimilars) for inflammatory conditions; defines FDA-approved and supported indications, initial vs continuation criteria, prescriber specialty requirements, approval durations, exclusions (not medically necessary uses), preferred-product requirement, and coding guidance. This is Part 1 of 2 and covers policy statements, criteria for many indications, and initial coding list.

Policy Summary

Payercigna

PolicyAdalimumab Products Prior Authorization Policy

Policy CodePolicy IP0652

Change TypeCoding and criteria revisions (2024-2026)

Effective DateMar 15, 2026

Next Review Date

Key ActionSubmit prior authorization with specialty prescriber requirement

SourceLink

POLICY UPDATE CHANGES

Removed certain initial therapy approval options for Ulcerative Colitis and Crohn's Disease (various prior therapy requirements removed across 2025-03-15 to 2026 revisions).

Note designating several adalimumab products as Non-Covered for Employer Plans and Individual (specific NDC prefixes listed).

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

Added HCPCS coding: C9399, J0139, J3490, J3590.

Added Q-codes effective 1/1/2025: Q5140, Q5141, Q5142, Q5143, Q5144, Q5145.

Adalimumab-bwwd was added to the policy.

14Listed adalimumab products/biosimilars

13FDA-approved and supported indications listed

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Summary

Policy requires prior authorization for multiple adalimumab products and biosimilars; FDA‑approved and other supported indications are covered when the specified clinical criteria are met (including specialist prescriber/consultation, indication‑specific initial vs continuation requirements, and objective or symptom improvement for continuation).

Use of plan preferred adalimumab products is required before approval of non‑preferred products per the respective Preferred Specialty Management policy.

This document is Part 1 of 2 and includes policy statements, indication‑specific criteria, and initial coding; coding and product coverage updates (including Q‑codes effective 1/1/2025 and other product additions) are noted in revisions.

Approval Durations Summary

Initial approval durations (examples)3-6 months depending on indication (3 months: hidradenitis suppurativa, Behcet's initial; 4 months: pyoderma gangrenosum; 6 months: ankylosing spondylitis, Crohn's disease, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, uveitis, scleritis, spondyloarthritis)

Continuation (established-on-therapy) durationTypically requires the patient to be established on therapy for the indication-specific minimum (usually ≥3 or ≥6 months) and continuation approvals are generally for 1 year

Established-on-therapy examplesExamples of established durations by indication: ≥3 months (HS, plaque psoriasis, Behcet's, sarcoidosis if applicable), ≥4 months (pyoderma gangrenosum), ≥6 months (AS, CD, JIA, PsA, RA, UC, uveitis, scleritis, spondyloarthritis)

Prior Authorization & Provider Requirements

Prior Authorization

Submit prior authorization with specialty prescriber requirement

Prior authorization is required for adalimumab products. Initial approvals require the prescription be from or include consultation with a specialty prescriber (e.g., rheumatology, gastroenterology, dermatology, ophthalmology) and selection of a plan‑preferred adalimumab product when available. Ensure PA submission includes specialty prescriber information and product requested.

Affected codes: HCPCS J0135 and applicable NDC(s) for the requested adalimumab product

Documentation Required

Provide objective measures or symptom improvement for continuation

For continuation (renewal) requests, document the duration of therapy to date and provide objective measures or clear clinical evidence of symptom improvement or disease control since initiation. Objective measures may include validated disease activity scores, endoscopic or imaging findings, laboratory markers, or documented functional/symptom improvement in the medical record.

Initial and Continuation Therapy Criteria (by indication)

General Prior Authorization Policy Statement

Prior Authorization is required for benefit coverage of adalimumab products. Initial approval requires prescription by or consultation with a specialist.

ALL of the following

Prior Authorization is required for adalimumab products.
Initial approval requires the agent to be prescribed by or in consultation with a physician who specializes in the condition being treated.
Use of preferred products is required before approval of a requested non-preferred adalimumab product; refer to respective Preferred Specialty Management Policy for plan-specific preferred product criteria.

FDA-Approved Indications - Ankylosing Spondylitis

Approve for the duration noted if the patient meets ONE of the following (A or B):

Applicable Codes

Considered Medically Necessary / Applicable HCPCS and Misc CodesmixedCovered

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)

Considered Medically Necessary HCPCS/Codes when criteria metHCPCSCovered

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 for Employer and Individual & Family Plans (by NDC / product)NDC|mixedNot Covered

adalimumab-bwwd	Not covered on pharmacy and medical benefits for Employer Plans and Individual and Family Plans
adalimumab-ryvk (NDCs starting with 51759)	Not covered
Amjevita (NDCs starting with 84612)	Not covered
Humira (NDCs starting with 83457)	Not covered
Hyrimoz (NDCs starting with 83457)	Not covered

Non-covered designation (Employer Plans and Individual) - products noted in revisionsNDC/brandNot Covered

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

Background & Clinical Evidence

Adalimumab products are tumor necrosis factor inhibitors (TNFis) used to treat multiple inflammatory conditions (examples include ankylosing spondylitis, Crohn’s disease, JIA, plaque psoriasis, PsA, RA, ulcerative colitis, and uveitis).

Specialty society guidelines prominently feature TNFis for many of these indications and the policy aligns coverage with FDA‑approved indications and cited guideline recommendations (ACR, ACG/AGA, AAO, EULAR, and others).

Per plan management, preferred‑product requirements apply: preferred adalimumab products must be used prior to approval of requested non‑preferred adalimumab products and certain products/NDCs are designated non‑covered for Employer and Individual plans.

Guideline and evidence sources referenced include ACR, ACG/AGA, AAO, EULAR and other specialty guidelines supporting use of TNFis in the listed conditions.

EULAR/ACR guidance (2015) specifically strongly recommends against use of TNFis for polymyalgia rheumatica (PMR), cited as a condition not covered due to lack of benefit and potential harm.

The policy also cites the Humira prescribing information (AbbVie, Feb 2024) as a source for FDA‑approved indications and product information.

Definitions

Established on therapyPatient has been receiving the adalimumab product for the specified minimum duration (usually at least 3 or 6 months depending on indication) prior to continuation review.

Conventional synthetic DMARDsExamples include methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine; permitted in combination with adalimumab per policy note.

Revision History

11/01/2024added

Added HCPCS coding: C9399, J0139, J3490, J3590.

01/01/2025added

Added Q-codes effective 1/1/2025: Q5140, Q5141, Q5142, Q5143, Q5144, Q5145.

06/01/2025revised

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

Documentation Required

Avoid concurrent biologic/targeted synthetic combination therapy

Concurrent use of two biologic or targeted synthetic immunomodulators (combination biologic/targeted synthetic therapy) is not recommended and poses safety risks. Do not initiate or continue overlapping biologic/targeted synthetic therapies. If combination therapy is being considered or has been used, document a clear clinical rationale, the treating specialist's justification, and a risk mitigation plan in the medical record for review.

If combination biologic/targeted synthetic therapy is attempted, include explicit rationale and specialist documentation

Denial Risk

Denial for non-covered indications and combination biologic therapy

Requests for uses that are not approved indications or are otherwise non‑covered (including some off‑label uses) are at high risk for denial. Use of adalimumab for polymyalgia rheumatica (PMR) is a non‑covered / unsupported indication and will generally be denied. Concurrent use of more than one biologic or a biologic plus a targeted synthetic DMARD is also a ground for denial unless exceptional justification is documented.

Denial risk for non‑covered indications, including polymyalgia rheumatica (PMR)
Denial risk for concurrent biologic or biologic + targeted synthetic combination therapy
Include covered diagnosis codes and supporting documentation with PA; lack of supported indication or concurrent biologic therapy may result in denial

A or B

A) Initial Therapy
- Approve for 6 months
- Patient is ≥ 18 years of age
- Medication is prescribed by or in consultation with a rheumatologist
B) Patient is Currently Receiving an Adalimumab Product
- Approve for 1 year
- Patient has been established on therapy for at least 6 months
- a or b
  - Objective measure shows beneficial clinical response from baseline (examples: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, or serum markers such as CRP/ESR)
  - Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness, improved function/ADLs)

FDA-Approved Indications - Crohn's Disease

Approve for the duration noted if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy
- Approve for 6 months
- Patient is ≥ 6 years of age
- Medication is prescribed by or in consultation with a gastroenterologist
B) Patient is Currently Receiving an Adalimumab Product
- Approve for 1 year
- Patient has been established on therapy for at least 6 months
- ANY of the following
  - Objective measure shows beneficial clinical response from baseline (examples: fecal markers, serum markers, imaging MRE/CTE, endoscopic assessment, and/or reduced corticosteroid dose)
  - Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, blood in stool)

FDA-Approved Indications - Juvenile Idiopathic Arthritis (JIA)

Approve for the duration noted if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy
- Approve for 6 months
- Patient is ≥ 2 years of age
- one of a-d
  - Patient has tried one other systemic therapy for this condition (examples: methotrexate, sulfasalazine, leflunomide, NSAID). A previous trial of one biologic other than requested medication also counts. Biosimilar does not count.
  - Patient will be starting adalimumab concurrently with methotrexate, sulfasalazine, or leflunomide
  - Patient has an absolute contraindication to methotrexate, sulfasalazine, or leflunomide (examples provided)
  - Patient has aggressive disease, as determined by the prescriber
- Medication is prescribed by or in consultation with a rheumatologist
B) Patient is Currently Receiving an Adalimumab Product
- Approve for 1 year
- Patient has been established on therapy for at least 6 months
- ANY of the following
  - Objective measure shows beneficial clinical response from baseline (examples: MD global, PGA, PDA, JDAS, cJDAS, JSpADA, serum markers, reduced corticosteroids)
  - Compared with baseline, patient experienced improvement in at least one symptom (e.g., improved motion, less joint pain/tenderness, decreased morning stiffness, improved ADLs)

FDA-Approved Indications - Hidradenitis Suppurativa

Approve for the duration noted if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy
- Approve for 3 months
- Patient is ≥ 12 years of age
- Patient has tried at least ONE other therapy (examples: intralesional/oral corticosteroids, systemic antibiotics, isotretinoin)
- Medication is prescribed by or in consultation with a dermatologist
B) Patient is Currently Receiving an Adalimumab Product
- Approve for 1 year
- Patient has been established on therapy for at least 3 months
- Objective measure shows beneficial clinical response from baseline (examples: Hurley staging, Sartorius score, PGA, Hidradenitis Suppurativa Severity Index)
- Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or drainage)

FDA-Approved Indications - Plaque Psoriasis

Approve for the duration noted if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy
- Approve for 3 months
- Patient is ≥ 18 years of age
- a or b
  - Patient has tried at least one traditional systemic agent for psoriasis for at least 3 months unless intolerant (examples: methotrexate, cyclosporine, acitretin). PUVA 3-month trial also counts. Exception if prior 3-month trial or intolerance to at least one biologic (other than requested), Otezla, or Sotyktu. Biosimilar does not count.
  - Prescriber states patient has a contraindication to methotrexate
- Medication is prescribed by or in consultation with a dermatologist
B) Patient is Currently Receiving an Adalimumab Product
- Approve for 1 year
- Patient has been established on therapy for at least 3 months
- Patient experienced a beneficial clinical response, defined as improvement from baseline in at least one of: estimated BSA affected, erythema, induration/thickness, and/or scale
- Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, itching, burning)

FDA-Approved Indications - Psoriatic Arthritis

Approve for the duration noted if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy
- Approve for 6 months
- Patient is ≥ 18 years of age
- Medication is prescribed by or in consultation with a rheumatologist or dermatologist
B) Patient is Currently Receiving an Adalimumab Product
- Approve for 1 year
- Patient has been established on therapy for at least 6 months
- ANY of the following
  - Objective measure shows beneficial clinical response from baseline (examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC, Leeds Dactylitis Instrument, MDA, PsAID-12, serum markers)
  - Compared with baseline, patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling)

FDA-Approved Indications - Rheumatoid Arthritis

Approve for the duration noted if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy
- Approve for 6 months
- Patient is ≥ 18 years of age
- Patient has tried ONE conventional synthetic DMARD for at least 3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine). Exception if patient already had 3-month trial with at least one biologic other than requested (biosimilar does not count).
- Medication is prescribed by or in consultation with a rheumatologist
B) Patient is Currently Receiving an Adalimumab Product
- Approve for 1 year
- Patient has been established on therapy for at least 6 months
- ANY of the following
  - Objective measure shows beneficial clinical response (examples: CDAI, DAS28-ESR/CRP, PAS-II, RAPID-3, SDAI)
  - Patient experienced an improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, fatigue; improved function; decreased soft tissue swelling)

FDA-Approved Indications - Ulcerative Colitis

Approve for the duration noted if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy
- Approve for 6 months
- Patient is ≥ 5 years of age
- Medication is prescribed by or in consultation with a gastroenterologist
B) Patient is Currently Receiving an Adalimumab Product
- Approve for 1 year
- Patient has been established on therapy for at least 6 months
- ANY of the following
  - Objective measure shows beneficial clinical response (examples: fecal calprotectin, CRP, endoscopic assessment, reduced corticosteroid dose)
  - Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, rectal bleeding)

FDA-Approved Indications - Uveitis (noninfectious intermediate, posterior, panuveitis)

Approve for the duration noted if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy
- Approve for 6 months
- Patient is ≥ 2 years of age
- Patient has tried ONE of the following therapies: periocular, intraocular, or systemic corticosteroids; immunosuppressives (examples provided). A trial of one biologic other than requested medication also counts.
- Medication is prescribed by or in consultation with an ophthalmologist
B) Patient is Currently Receiving an Adalimumab Product
- Approve for 1 year
- Patient has been established on therapy for at least 6 months
- ANY of the following
  - Objective measure shows beneficial clinical response (examples: best-corrected visual acuity, chorioretinal/inflammatory retinal vascular lesions assessment, anterior chamber cell grade, vitreous haze grade)
  - Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased eye pain, redness, light sensitivity, blurred vision; or improved visual acuity)

Other Uses with Supportive Evidence (select examples)

Approve for the duration noted if the patient meets ONE of the following (A or B) per indication-specific criteria:

Behcet's Disease

A) Initial Therapy
- Approve for 3 months
- Patient is > 2 years of age
- ANY of the following
  - Patient has tried at least ONE conventional therapy (examples provided). Trial of one biologic other than requested counts.
  - Patient has ophthalmic manifestations of Behcet's disease
- Medication is prescribed by or in consultation with a rheumatologist, dermatologist, ophthalmologist, gastroenterologist, or neurologist
B) Currently Receiving
- Approve for 1 year
- Patient has been established on therapy for at least 3 months
- Objective measure shows beneficial clinical response (examples depend on organ involvement)
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or improved visual acuity if ophthalmic manifestations)

Pyoderma Gangrenosum

A) Initial Therapy
- Approve for 4 months
- Patient is > 18 years of age
- ANY of the following
  - Patient has tried one systemic corticosteroid
  - Patient has tried one other immunosuppressant for at least 2 months or was intolerant
- Medication is prescribed by or in consultation with a dermatologist
B) Currently Receiving

Sarcoidosis

A) Initial Therapy
- Approve for 3 months
- Patient is > 18 years of age
- Patient has tried at least one corticosteroid
- Patient has tried at least one immunosuppressive medication (examples provided)
- Medication is prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist
B) Currently Receiving

Spondyloarthritis, Other Subtypes

A) Initial Therapy
- Approve for 6 months
- Patient is > 18 years of age
- ANY of the following
  - Patient has arthritis primarily in peripheral joints and has tried at least one conventional synthetic DMARD
  - Patient has axial spondyloarthritis AND objective signs of inflammation (CRP elevated or sacroiliitis on MRI)
- Medication is prescribed by or in consultation with a rheumatologist
B) Currently Receiving

Clinical Exclusions / Combination Therapy

These use restrictions are part of the safety/clinical criteria for use of this medication:

ALL of the following

Concurrent use with another biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition is not recommended (combination therapy generally not recommended due to potentially higher adverse events and lack of controlled data).
Use for Polymyalgia Rheumatica (PMR) is strongly recommended against per EULAR/ACR 2015 guidelines due to lack of evidence for benefit and potential for harm.