CurrentcignaPolicy IP0652

Adalimumab Products Prior Authorization Policy

Prior authorization policy for multiple adalimumab products (reference list of brand and biosimilar formulations) governing medical and pharmacy benefit coverage for inflammatory and other supported indications; defines initial and continuation approval criteria, durations, prescriber specialty requirements, step/ preferred product requirements, non-covered uses, and applicable billing codes (partial document, part 1 of 2).

Policy Summary

Payercigna

PolicyAdalimumab Products Prior Authorization Policy

Policy CodePolicy IP0652

Change TypeCoding and product list updates; coverage/criteria revisions

Effective DateMar 15, 2026

Next Review Date

Key ActionSubmit prior authorization for any adalimumab product; initial approvals require specialist prescriber or consultation and meeting indication-specific criteria; approvals granted for specified durations (initial vs continuation).

SourceLink

POLICY UPDATE CHANGES

Added HCPCS codes C9399, J0139, J3490, J3590 to policy.

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

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

Adalimumab-bwwd added to policy and specific adalimumab products designated as Non-Covered for Employer Plans and Individual.

Ulcerative colitis and Crohn's disease initial therapy criteria were modified over 2025-03/2026 time period (removal of certain prior therapy options).

14+Indications listed (FDA-approved and supportive)

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.

Listed HCPCS/Codes in policy excerpt

5Products excluded for some plans (by NDC/brand)

5Initial approval durations (months) vary

03/15/2026Last substantive annual revision

Coverage Summary

This policy (part 1 of 2, effective 2026-03-15) implements prior authorization for multiple adalimumab products across both the medical and pharmacy benefits. Coverage is covered with indication-specific criteria: initial and continuation approval pathways, specialist prescriber or consultation requirements, and defined approval durations apply by indication. The policy requires use of preferred adalimumab products before approval of a requested non-preferred product (see respective Preferred Specialty Management policies). Certain products/NDCs are designated as not covered for Employer Plans and Individual and Family Plans (examples include adalimumab-bwwd; adalimumab-ryvk NDCs starting with 51759; Amjevita NDCs starting with 84612; Humira NDCs starting with 83457; Hyrimoz NDCs starting with 83457). Billing and HCPCS/J‑codes noted in the policy must be used when submitting claims.

Durations / Thresholds (key policy dates and approval durations)

Policy / PayerCigna Coverage Policy IP0652 (Adalimumab Products)

Policy effective date03/15/2026

Last review date03/15/2026

Established on therapy duration (continuation)Varies by indication: typically ≥ 3 months (Hidradenitis Suppurativa, Behcet's, Sarcoidosis), ≥ 4 months (Pyoderma Gangrenosum), or ≥ 6 months (most other indications) before continuation criteria apply

Initial approval durations (by indication)3 months: Hidradenitis Suppurativa, Plaque Psoriasis, Behcet's initial, Sarcoidosis; 4 months: Pyoderma Gangrenosum; 6 months: Ankylosing Spondylitis, Crohn's Disease, JIA, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Uveitis, Scleritis/Sterile Corneal Ulceration, Spondyloarthritis (other subtypes)

Notes on approval unitsApprovals provided in months; 1 month = 30 days

Non-covered product noteCertain adalimumab products/NDCs are not covered for Employer and Individual & Family plans (examples listed in policy) — see policy for specifics

Prior Authorization & Provider Requirements

General Prior Authorization Requirements

Prior authorization is required for adalimumab products. Approvals are contingent on specialist involvement, use of preferred products per product selection/multi-source (PSM) policies, and plan-specific exclusions for certain products/NDCs.

ALL of the following

Prior authorization is required for all adalimumab products for the covered indications listed in this policy.
Operational: submit a PA request prior to initiation when possible.
Prescriber requirement: initial requests must be written by, or include consultation from, an appropriate specialty provider (e.g., rheumatology, gastroenterology, dermatology, ophthalmology) familiar with the requested indication.
A documented specialist consultation is acceptable when the prescribing clinician is not a specialist.
Formulary and product selection: use of preferred adalimumab products and biosimilars is required when specified by the member's benefit plan and PSM (product selection/multi-source) policies; non-preferred products may require justification.

Initial Therapy Criteria (by indication)

FDA-Approved Indications - Ankylosing Spondylitis

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

A) Initial Therapy
- Duration: Approve for 6 months6 months
- Age: Patient is ≥ 18 years of age≥18
- Prescriber: Medication is prescribed by or in consultation with a rheumatologist

Continuation Therapy Criteria (by indication)

Continuation / Renewal Branches Across Indications

Continuation/renewal branches from each indication where 'Patient is Currently Receiving an Adalimumab Product' are defined. For each branch the established-on-therapy duration and response requirement are preserved.

Continuation / Renewal Branches

Ankylosing Spondylitis - continuation: Approve for 1 year; patient has been established on therapy for at least 6 months; response requirement: objective measure OR symptomatic improvementEstablished ≥6 months; Approve 1 year
Examples: ASDAS, BASDAI, CRP/ESR; symptom improvement e.g., pain, stiffness
Crohn's Disease - continuation: Approve for 1 year; patient has been established on therapy for at least 6 months; response requirement: objective measure (fecal markers, CRP, imaging, endoscopy, reduced steroid dose) OR symptomatic improvementEstablished ≥6 months; Approve 1 year

Other Uses with Supportive Evidence & Exclusions

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

Approve for the duration noted if the patient meets ONE of the following (A or B) for each respective condition; criteria vary by condition (examples below).

Behcet's Disease - A) Initial Therapy: Approve for 3 months; patient is > 2 years of age; patient has tried at least ONE conventional therapy OR has ophthalmic manifestations of Behcet's disease; medication prescribed by or in consultation with rheumatologist, dermatologist, ophthalmologist, gastroenterologist, or neurologist3 months; >2 years
Behcet's Disease - B) Currently Receiving: Approve for 1 year; established on therapy for at least 3 months; objective measure (dependent on organ involvement) AND symptomatic improvementEstablished ≥3 months; Approve 1 year

Applicable Codes

Considered Medically Necessary / Billing 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)

Products Not Covered for Employer and Individual and Family PlansNDC|mixedNot Covered

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

Considered Medically Necessary HCPCS/other drug codesHCPCS|otherCovered

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 certain commercial products (operational note)NDC|otherNot Covered

adalimumab-bwwd

Added to policy (03/01/2026) and designated as Non-Covered for Employer Plans and Individual (note references to NDC prefixes: -ryvk NDCs starting with 51759; Amjevita NDCs starting with 84612; Humira NDCs starting with 83457; Hyrimoz NDCs starting with 83457).

Clinical Evidence & Guidelines

Guideline and specialty society references cited in the policy include the American College of Rheumatology (ACR), American College of Gastroenterology (ACG), American Gastroenterological Association (AGA), American Academy of Ophthalmology (AAO), European League Against Rheumatism (EULAR), and other specialty guidance (dates and specific guideline versions vary by indication). Specialty society guidelines support use of TNF inhibitors in many listed indications, and the policy states that its criteria align with those guideline recommendations where cited.

9Listed HCPCS/Codes in policy excerpt

5Products excluded for some plans (by NDC/brand)

14+Indications listed (FDA-approved and supportive)

3-6 moCommon initial approval durations (varies by indication)

Background

Background: Adalimumab products are tumor necrosis factor (TNF) inhibitors approved for multiple inflammatory conditions (including ankylosing spondylitis, Crohn's disease, hidradenitis suppurativa, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, and uveitis). Specialty guidelines recommend TNFis in many of these conditions. This policy applies prior authorization with indication-specific initial and continuation criteria and defined approval durations to manage appropriate use and benefits coverage.

Definitions

Initial TherapyA patient who has received < specified months of therapy or is restarting therapy; reviewed under the Initial Therapy criteria for the applicable indication.

Patient is Currently Receiving an Adalimumab ProductContinuation/renewal pathway for patients established on therapy for the indication-specific minimum duration (commonly 3 or 6 months) with demonstrated benefit.

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

Revision History

11/01/2024material

New policy created and coding additions: Added HCPCS codes C9399, J0139, J3490, J3590.

01/01/2025material

Added Q-codes for adalimumab biosimilars effective 1/1/2025 (Q5140–Q5145) to policy coding list.

06/01/2025material

Selected revision: adalimumab-aaty (unbranded Yuflyma) was added to the policy; same criteria apply as other adalimumab subcutaneous products.

Policy Summary

Payercigna

PolicyAdalimumab Products Prior Authorization Policy

Policy CodePolicy IP0652

Change TypeCoding and product list updates; coverage/criteria revisions

Effective DateMar 15, 2026

Next Review Date

SourceLink

On This Page

See plan-specific PSM rules and the Coding section for preferred NDCs.

Plan exclusions: certain Cigna plans or lines of business exclude specific adalimumab products or NDCs. Requests for excluded products will be denied for members covered under those plans.

See Coding/Benefit Exclusions for the affected NDCs and plan lists.

Clinical / Safety Considerations and Restrictions

Contraindications and safety: adalimumab is contraindicated in patients with active serious infections, including tuberculosis; screen and document TB and other infection risk prior to initiation.
Follow local guidelines for latent TB screening and treatment before starting TNF inhibitors.
Vaccination: live vaccines should not be given concurrently with adalimumab; ensure appropriate immunizations are up to date prior to initiating therapy.
Document vaccine status in the PA submission when applicable.
Malignancy and demyelinating disease: use caution and provide justification for use in patients with history of malignancy or demyelinating disorders; document risk/benefit discussion.
Provide oncology/neurology consultation notes if applicable.
Pregnancy and lactation: document pregnancy status and counseling; consider specialty guidance when prescribing during pregnancy or breastfeeding.
Provide OB/GYN or maternal-fetal medicine input when indicated.

Prior Authorization

Prior authorization required

Submit a prior authorization (PA) for any adalimumab product. Initial approvals require a specialist prescriber or documented specialist consultation.

HCPCS/Q codes and NDCs as specified on the PA form and in the Coding section (include all adalimumab product codes when submitting).

Billing Rule

Use appropriate codes and NDCs

Use appropriate HCPCS/CPT and NDC codes when billing for adalimumab products. Claims submitted without covered diagnosis or procedure codes will be denied.

J3490, C9399, and applicable HCPCS/HCPCS-derived codes and NDCs listed in the Coding section.
Claims without a covered diagnosis/procedure code aligned to this policy will be denied as not covered.

Documentation Required

Documentation of prior therapies and response

Document prior therapies, reasons for discontinuation, and objective measures of response. For initial therapy provide trials of indicated prior treatments or justification for bypassing them; for continuation document established duration of benefit and ongoing response.

Document trials of prior conventional therapies (e.g., methotrexate, other DMARDs, corticosteroids) or objective reason they are contraindicated or not tolerated.
For continuation requests, document the duration of therapy and objective clinical benefit (e.g., symptom scores, imaging, endoscopic findings, physician assessment).
When applicable, document previous TNFi exposure and rationale for switching between TNFis.

Denial Risk

Non-covered uses and combinations

Claims for uses not meeting policy criteria or for concurrent use of adalimumab with another biologic/targeted synthetic DMARD will be denied.

Non-covered uses per this policy will be denied.
Concurrent administration of a biologic or targeted synthetic DMARD with adalimumab for the same inflammatory condition is not allowed and will be denied.
Reference excluded products/NDCs for some plans in the Coding section; use those lists to confirm coverage.

Documentation Required

Avoid concurrent biologic or targeted synthetic therapy

Prescribers must not administer adalimumab concurrently with another biologic or targeted synthetic therapy for inflammatory conditions. If conventional DMARDs are used concurrently (e.g., methotrexate), document the agents and dosing.

Codes: J0135, J0129, C9022, and other HCPCS/NDCs for biologic agents should not be billed concurrently for the same inflammatory indication.
Document any concurrent conventional synthetic DMARDs (methotrexate, sulfasalazine, leflunomide) when part of combination therapy.

Note

TNF inhibitors not recommended for PMR

TNF inhibitors are generally not recommended for polymyalgia rheumatica (PMR); PA requests for PMR are expected to be denied consistent with EULAR/ACR guidance.

B) Patient is Currently Receiving an Adalimumab Product

Duration: Approve for 1 year1 year
Established duration: Patient has been established on therapy for at least 6 months≥6 months
A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy.
Response requirement
- Objective measure: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, and/or serum markers [CRP, ESR])
- Symptomatic improvement: Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain or stiffness, or improvement in function or activities of daily living)

FDA-Approved Indications - Crohn's Disease

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

A) Initial Therapy
- Duration: Approve for 6 months6 months
- Age: Patient is ≥ 6 years of age≥6
- Prescriber: Medication is prescribed by or in consultation with a gastroenterologist
B) Patient is Currently Receiving an Adalimumab Product
- Duration: Approve for 1 year1 year
- Established duration: Patient has been established on therapy for at least 6 months≥6 months
  A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy.
- Response requirement
  - Objective measure: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: fecal markers [fecal lactoferrin, fecal calprotectin], serum markers [CRP], imaging [MRE, CTE], endoscopic assessment, and/or reduced dose of corticosteroids)

FDA-Approved Indications - Juvenile Idiopathic Arthritis (JIA)

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

A) Initial Therapy
- Duration: Approve for 6 months6 months
- Age: Patient is ≥ 2 years of age>=2
- Prior therapy / exceptions: Patient meets ONE of: tried one other systemic therapy (examples: methotrexate, sulfasalazine, leflunomide, or NSAID) OR will start adalimumab concurrently with methotrexate/sulfasalazine/leflunomide OR has absolute contraindication to those agents OR has aggressive disease as determined by prescriber; note a prior trial of one biologic other than requested also counts; biosimilar does not count
- Prescriber: Medication is prescribed by or in consultation with a rheumatologist
B) Patient is Currently Receiving an Adalimumab Product
- Duration: Approve for 1 year1 year
- Established duration: Patient has been established on therapy for at least 6 months≥6 months
  A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy.
- Response requirement: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: MD global, PGA, PDA, JDAS, cJDAS, JSpADA, serum markers [CRP, ESR], reduced corticosteroid dose) OR compared with baseline patient experienced improvement in at least one symptom (e.g., improved limitation of motion, less joint pain/tenderness, decreased morning stiffness or fatigue, improved function/ADLs)

FDA-Approved Indications - Hidradenitis Suppurativa

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

A) Initial Therapy
- Duration: Approve for 3 months3 months
- Age: Patient is ≥ 12 years of age>=12
- Prior therapy: Patient has tried at least ONE other therapy (examples: intralesional/oral corticosteroids, systemic antibiotics, or isotretinoin)
- Prescriber: Medication is prescribed by or in consultation with a dermatologist
B) Patient is Currently Receiving an Adalimumab Product
- Duration: Approve for 1 year1 year
- Established duration: Patient has been established on therapy for at least 3 months≥3 months
  A patient who has received < 3 months of therapy or who is restarting therapy is reviewed under Initial Therapy.
- Response requirement: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: Hurley staging, Sartorius score, Physician Global Assessment, Hidradenitis Suppurativa Severity Index) AND compared with baseline patient experienced improvement in at least one symptom (e.g., decreased pain or drainage of lesions, nodules, or cysts)

FDA-Approved Indications - Plaque Psoriasis

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

A) Initial Therapy
- Duration: Approve for 3 months3 months
- Age: Patient is ≥ 18 years of age>=18
- Prior therapy / exceptions: Patient meets ONE of: tried at least one traditional systemic agent for at least 3 months unless intolerant (examples: methotrexate, cyclosporine, acitretin; 3-month PUVA counts) OR prescriber states patient has contraindication to methotrexate; exception if prior trial of biologic (other than requested), Otezla/Otezla XR, or Sotyktu exempts trial of traditional systemic agent; biosimilar does not count
- Prescriber: Medication is prescribed by or in consultation with a dermatologist
B) Patient is Currently Receiving an Adalimumab Product
- Duration: Approve for 1 year1 year
- Established duration: Patient has been established on therapy for at least 3 months≥3 months
  A patient who has received < 3 months of therapy or who is restarting therapy is reviewed under Initial Therapy.
- Response requirement: 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; AND 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) Initial Therapy
- Duration: Approve for 6 months6 months
- Age: Patient is ≥ 18 years of age>=18
- Prescriber: Medication is prescribed by or in consultation with a rheumatologist or a dermatologist
B) Patient is Currently Receiving an Adalimumab Product
- Duration: Approve for 1 year1 year
- Established duration: Patient has been established on therapy for at least 6 months≥6 months
  A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy.
- Response requirement: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC enthesitis score, Leeds Dactylitis Instrument, MDA, PsAID-12, and/or serum markers [CRP, ESR]) OR compared with baseline patient experienced improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue; improved function/ADLs; 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) Initial Therapy
- Duration: Approve for 6 months6 months
- Age: Patient is ≥ 18 years of age>=18
- Prior therapy: 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
- Prescriber: Medication is prescribed by or in consultation with a rheumatologist
B) Patient is Currently Receiving an Adalimumab Product
- Duration: Approve for 1 year1 year
- Established duration: Patient has been established on therapy for at least 6 months≥6 months
  A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy.
- Response requirement: Patient experienced a beneficial clinical response when assessed by at least one objective measure (examples: CDAI, DAS28 [ESR or CRP], PAS-II, RAPID-3, SDAI) OR patient experienced improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, fatigue; improved function/ADLs; 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). Note: some initial-therapy options were modified across 2025-2026 (see Revision History).

A) Initial Therapy
- Duration: Approve for 6 months6 months
- Age: Patient is ≥ 5 years of age>=5
- Prescriber: Medication is prescribed by or in consultation with a gastroenterologist
B) Patient is Currently Receiving an Adalimumab Product
- Duration: Approve for 1 year1 year
- Established duration: Patient has been established on therapy for at least 6 months≥6 months
  A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy.
- Response requirement: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: fecal markers [fecal calprotectin], serum markers [CRP], endoscopic assessment, and/or reduced steroid dose) OR compared with baseline patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, rectal bleeding)

FDA-Approved Indications - Uveitis

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

A) Initial Therapy
- Duration: Approve for 6 months6 months
- Age: Patient is ≥ 2 years of age>=2
- Prior therapy: Patient has tried ONE of the following: periocular, intraocular, or systemic corticosteroids; immunosuppressives (examples: methotrexate, mycophenolate mofetil, azathioprine, cyclosporine). A trial of one biologic other than the requested medication also counts; biosimilar does not count
- Prescriber: Medication is prescribed by or in consultation with an ophthalmologist
B) Patient is Currently Receiving an Adalimumab Product
- Duration: Approve for 1 year1 year
- Established duration: Patient has been established on therapy for at least 6 months≥6 months
  A patient who has received < 6 months of therapy or who is restarting therapy is reviewed under Initial Therapy.
- Response requirement: When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: best-corrected visual acuity, assessment of chorioretinal/inflammatory retinal vascular lesions, anterior chamber cell grade, vitreous haze grade) OR compared with baseline patient experienced improvement in at least one symptom (e.g., decreased eye pain, redness, light sensitivity, blurred vision; or improvement in visual acuity)

JIA - continuation: Approve for 1 year; patient has been established on therapy for at least 6 months; response requirement: objective measure (MD global, PGA, JDAS, JSpADA, CRP/ESR, reduced steroid) OR symptomatic improvementEstablished ≥6 months; Approve 1 year

Hidradenitis Suppurativa - continuation: Approve for 1 year; patient has been established on therapy for at least 3 months; response requirement: objective measure (Hurley, Sartorius, HS Severity Index) AND symptomatic improvementEstablished ≥3 months; Approve 1 year

Plaque Psoriasis - continuation: Approve for 1 year; patient has been established on therapy for at least 3 months; response requirement: improvement in at least one of estimated BSA, erythema, induration/thickness, or scale AND symptomatic improvementEstablished ≥3 months; Approve 1 year

Psoriatic Arthritis - continuation: Approve for 1 year; patient has been established on therapy for at least 6 months; response requirement: objective measure (DAPSA, CPDAI, PsA DAS, MDA, CRP/ESR, etc.) OR symptomatic improvementEstablished ≥6 months; Approve 1 year

Examples: decreased joint pain, morning stiffness, improved function

Rheumatoid Arthritis - continuation: Approve for 1 year; patient has been established on therapy for at least 6 months; response requirement: objective measure (CDAI, DAS28, RAPID-3, SDAI) OR symptomatic improvementEstablished ≥6 months; Approve 1 year

Ulcerative Colitis - continuation: Approve for 1 year; patient has been established on therapy for at least 6 months; response requirement: objective measure (fecal calprotectin, CRP, endoscopy, reduced steroid dose) OR symptomatic improvementEstablished ≥6 months; Approve 1 year

Some initial-therapy options were modified across 2025-2026 (see Revision History).

Uveitis - continuation: Approve for 1 year; patient has been established on therapy for at least 6 months; response requirement: objective measure (best-corrected visual acuity, lesion assessment, anterior chamber cell grade, vitreous haze) OR symptomatic improvementEstablished ≥6 months; Approve 1 year

Other uses - continuation: Approve for 1 year; established durations vary by indication (Behcet's, Sarcoidosis, Pyoderma gangrenosum, Scleritis, Spondyloarthritis) as specified in respective initial/continuation criteria; require objective measure and symptomatic improvement per indicationEstablished per-indication (3,4,6 months) ; Approve 1 year

Pyoderma Gangrenosum - A) Initial Therapy: Approve for 4 months; patient is > 18 years of age; patient has tried one systemic corticosteroid OR one other immunosuppressant for at least 2 months or was intolerant; medication prescribed by or in consultation with a dermatologist4 months; >18 years

Pyoderma Gangrenosum - B) Currently Receiving: Approve for 1 year; established on therapy for at least 4 months; patient experienced beneficial clinical response (improvement in size, depth, and/or number of lesions) AND symptomatic improvementEstablished ≥4 months; Approve 1 year

Sarcoidosis - A) Initial Therapy: Approve for 3 months; patient is > 18 years of age; patient has tried at least one corticosteroid and at least one immunosuppressive medication; medication prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist3 months; >18 years

Sarcoidosis - B) Currently Receiving: Approve for 1 year; established on therapy for at least 3 months; objective measures (lung function, serum markers, imaging) AND symptomatic improvementEstablished ≥3 months; Approve 1 year

Scleritis or Sterile Corneal Ulceration - A) Initial Therapy: Approve for 6 months; patient is > 18 years of age; patient has tried one other therapy for this condition; medication prescribed by or in consultation with an ophthalmologist6 months; >18 years

Scleritis or Sterile Corneal Ulceration - B) Currently Receiving: Approve for 1 year; established on therapy for at least 6 months; objective measures (e.g., serum markers) OR symptomatic improvement (decreased eye pain, redness, tearing, improved visual acuity)Established ≥6 months; Approve 1 year

Spondyloarthritis, Other Subtypes - A) Initial Therapy: Approve for 6 months; patient is > 18 years of age; patient meets ONE of: (a) peripheral arthritis AND tried at least one conventional synthetic DMARD OR (b) axial disease with objective signs of inflammation (elevated CRP or sacroiliitis on MRI); medication prescribed by or in consultation with a rheumatologist6 months; >18 years

Spondyloarthritis, Other Subtypes - B) Currently Receiving: Approve for 1 year; established on therapy for at least 6 months; objective measure (ASDAS or serum markers) OR symptomatic improvementEstablished ≥6 months; Approve 1 year

Conditions Not Covered

Adalimumab products for any other use are considered not medically necessary, including the following specific exclusions:

Concurrent biologic/targeted synthetic prohibition: Concurrent use with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is not covered (combination therapy generally not recommended due to higher adverse events and lack of controlled additive efficacy data)
This does NOT exclude use of conventional synthetic DMARDs in combination.
Polymyalgia Rheumatica exclusion: Polymyalgia Rheumatica (PMR) is not covered (EULAR/ACR guidelines recommend against TNFis for PMR)

Clinical and safety restrictions include a prohibition on concurrent administration of adalimumab with another biologic or a targeted synthetic oral small molecule drug for an inflammatory condition due to higher adverse event risk and lack of evidence for additive efficacy; however, conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) are allowed in combination. The policy also cites guideline-based contraindications where applicable (for example, guideline recommendations strongly advising against TNFi use in polymyalgia rheumatica).

09/01/2025material

Selected revision: Plaque psoriasis initial-therapy note and exceptions updated (added Otezla XR/Sotyktu exception; modified methotrexate contraindication wording) as part of ongoing edits.

01/01/2026material

Selected revision entry (1/1/2026) recorded in change log as part of ongoing coding/administrative updates.

03/01/2026material

Adalimumab-bwwd was added to the policy and a note added designating specific products/NDC prefixes as Non‑Covered for Employer Plans and Individual and Family Plans (adalimumab-bwwd; -ryvk NDCs starting with 51759; Amjevita NDCs starting with 84612; Humira and Hyrimoz NDCs starting with 83457).

09/01/2025 - 03/15/2026material

Multiple selected and annual revisions between 09/01/2025 and 03/15/2026 modified initial therapy approval options for ulcerative colitis and Crohn's disease (removal of certain prior therapy/options across the 2025–03/2026 period).

03/15/2026materialLatest

Last substantive annual revision modified 03/15/2026; policy effective date set to 03/15/2026. Multiple edits finalized including changes to Crohn's Disease initial-therapy options and confirmation of non‑covered product designations.

Symptomatic improvement:

Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool)