CurrentNeighborhood Health Plan of Rhode IslandPolicy 2008-A

Adalimumab (Humira) and biosimilars coverage

Defines medical necessity, documentation, prescriber specialty, and prior authorization requirements for adalimumab (Humira) and listed biosimilars across multiple indications for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdalimumab (Humira) and biosimilars coverage

Policy CodePolicy 2008-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with chart notes, prior medication history, and required labs/biomarkers to initiate review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsTypical authorization duration

2 yrsMinimum age for JIA

5-6 yrsPediatric IBD minimum age

manyBiosimilars referenced

measurableObjective response required

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 Criteria and Indications

inv-01: FDA-approved indications

Covered indications when approval criteria are met

FDA-approved indications: Includes RA; PsA; polyarticular JIA (>=2 years); AS; UC (>=5 years); CD (>=6 years); hidradenitis suppurativa (>=12 years); plaque psoriasis; and non-infectious intermediate, posterior, and panuveitis (>=2 years).

Limitations: effectiveness not established in patients who lost response to or were intolerant to other TNF blockers.

inv-02: Compendial indications

Compendial covered uses

Compendial indications: Non-radiographic axial spondyloarthritis; pyoderma gangrenosum; Behcet's disease; oligoarticular juvenile idiopathic arthritis; immune checkpoint inhibitor-related inflammatory arthritis.

All other indications are considered experimental/investigational and not medically necessary.

inv-03: Rheumatoid arthritis

Rheumatoid arthritis (adults) — authorization criteria

RA authorization: Authorization of 12 months may be granted when BOTH of the following are met: (1) biomarker testing as specified: either positive rheumatoid factor (RF) OR positive anti‑cyclic citrullinated peptide (anti‑CCP); and testing of RF, anti‑CCP, and CRP and/or ESR; AND (2) inadequate response to at least a 3‑month trial of methotrexate titrated to >=15 mg/week, or intolerance/contraindication to methotrexate.

Prior biologic or targeted synthetic therapy may affect authorization; see documentation requirements for labs.

inv-04: Articular juvenile idiopathic arthritis

Articular juvenile idiopathic arthritis (>=2 years) — authorization criteria

JIA authorization: Authorization of 12 months may be granted for members >=2 years who have previously received a biologic or targeted synthetic drug indicated for articular JIA; OR when any of the following are met: inadequate response to methotrexate or another conventional synthetic DMARD at adequate dose/duration; inadequate response to scheduled NSAIDs and/or intra‑articular glucocorticoids plus presence of risk factors for poor outcome (e.g., involvement of ankle/wrist/hip/SI/TMJ, erosive disease, enthesitis, elevated inflammatory markers, delay in diagnosis, symmetric disease); OR high‑risk joint involvement or other risk factors and high disease activity or judged high risk for disabling joint disease.age >=2

See Appendix B for risk factors; documentation of prior therapies and disease severity required.

inv-05: Initial Therapy (JIA)

Articular juvenile idiopathic arthritis (JIA) — initial authorization

Prior biologic: Authorization of 12 months may be granted for members >=2 years who have previously received a biologic or targeted synthetic drug indicated for moderately to severely active articular JIA.age >=2

Alternative initial criteria: Authorization of 12 months may be granted for members >=2 years when any of the following is met: inadequate response to methotrexate or another conventional synthetic drug at adequate dose/duration; inadequate response to scheduled NSAIDs and/or intra‑articular glucocorticoids and presence of specified risk factors for poor outcome; or high‑risk joint involvement with high disease activity or judged high risk for disabling joint disease.clinical risk factors present

Documentation of prior trials and risk factors required.

inv-06: Initial Therapy (Psoriatic arthritis)

Psoriatic arthritis (PsA) — initial authorization

Prior biologic: Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug indicated for active PsA.

Conventional therapy failure or specific features: Authorization of 12 months may be granted for adult members when either: inadequate response to methotrexate, leflunomide, or another conventional synthetic drug at adequate dose/duration; intolerance/contraindication to those agents; presence of enthesitis or predominantly axial disease; or severe disease.

inv-07: Initial Therapy (Ankylosing spondylitis / nr-axSpA)

Ankylosing spondylitis (AS) / non-radiographic axial spondyloarthritis (nr-axSpA) — initial authorization

Prior biologic: Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug indicated for active AS or nr‑axSpA.

NSAID trial: Authorization of 12 months may be granted for adult members when either: inadequate response to at least two NSAIDs; OR intolerance/contraindication to two or more NSAIDs.

inv-08: Initial Therapy — other indications

Other indications — initial authorization

Crohn's disease: Authorization of 12 months may be granted for treatment of moderately to severely active Crohn's disease.

Ulcerative colitis: Authorization of 12 months may be granted for treatment of moderately to severely active ulcerative colitis.

Plaque psoriasis: Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug; or when any of the following are met: crucial body areas affected; >=10% BSA involvement; inadequate response/intolerance to phototherapy or systemic agents; or >=3% BSA with clinical reason to avoid systemic agents.

Hidradenitis suppurativa: Authorization of 12 months may be granted for members >=12 years who have previously received a biologic; OR who have had inadequate response to an oral antibiotic for at least 90 days, or intolerance/contraindication to oral antibiotics.

inv-09: Continuation / Maintenance Therapy (all applicable indications)

Continuation / maintenance authorization (all indications where specified)

Rheumatoid arthritis continuation: Authorization of 12 months may be granted for adult members using the medication for moderately to severely active RA who achieve or maintain a positive clinical response evidenced by disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability.

JIA continuation: Authorization of 12 months may be granted for members >=2 years using the medication for articular JIA who achieve or maintain a positive clinical response evidenced by low disease activity or improvement in number of active joints, limitation of movement, or functional ability from baseline.

PsA continuation: Authorization of 12 months may be granted for adult members using the medication for PsA who achieve/maintain positive clinical response evidenced by improvement in swollen/tender joints, dactylitis, enthesitis, axial disease, skin/nail involvement, functional status, or CRP.

inv-10: Plaque psoriasis — continuation/authorization

Authorization of 12 months may be granted for adults using the medication for moderate to severe plaque psoriasis who achieve or maintain a positive clinical response when ALL of the following are met:

Plaque psoriasis response criteria: Member demonstrates reduction in body surface area (BSA) affected from baseline OR improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain).N/A

Authorization period = 12 months if met

inv-11: Hidradenitis suppurativa — continuation/authorization

Authorization of 12 months may be granted for members age >=12 years using the medication for moderate to severe hidradenitis suppurativa who achieve or maintain a positive clinical response when ANY of the following are met:

Hidradenitis response criteria: Reduction in abscess and inflammatory nodule count from baseline; decrease in frequency of inflammatory lesions from baseline; reduced formation of new sinus tracts and scarring; reduction in pain from baseline; improvement in frequency of relapses from baseline; reduction in suppuration from baseline; improvement in quality of life from baseline; improvement on a disease severity assessment tool from baseline.N/A

Authorization period = 12 months if any are met

inv-12: Non-infectious uveitis (intermediate, posterior, panuveitis) — continuation/authorization

Authorization of 12 months may be granted for members age >=2 years using the medication for non‑infectious intermediate, posterior, and panuveitis who achieve or maintain a positive clinical response when ANY of the following are met:

Uveitis response criteria: Reduced frequency of disease flares compared to baseline; stability or improvement in vitreous haze (VH) grade; stability or improvement in anterior chamber (AC) cell grade; stability or improvement in visual acuity; no new active inflammatory chorioretinal and/or inflammatory retinal vascular lesions relative to baseline; reduction in glucocorticoid requirements from baseline.N/A

Authorization period = 12 months if any are met

inv-13: Immune checkpoint inhibitor–related inflammatory arthritis — continuation/authorization

Authorization of 12 months may be granted for members using the medication for immunotherapy‑related inflammatory arthritis who achieve or maintain a positive clinical response as evidenced by low disease activity or symptom improvement.

ICI-related arthritis response: Member demonstrates low disease activity or improvement in signs and symptoms compared to baseline.N/A

Authorization period = 12 months if met

inv-14: Other covered indications — continuation/authorization

Authorization of 12 months may be granted for other indications outlined in the coverage criteria when members using the medication achieve or maintain a positive clinical response as evidenced by low disease activity or symptom improvement compared to baseline.

Other indications response: Member achieves or maintains clinical improvement/low disease activity per the condition‑specific measures described in the coverage criteria.N/A

Authorization period = 12 months if met

All uses that are not listed as FDA‑approved indications or supported compendial uses are considered experimental/investigational and not medically necessary. Examples of compendial uses explicitly accepted by the policy include non‑radiographic axial spondyloarthritis, pyoderma gangrenosum, Behcet's disease, oligoarticular juvenile idiopathic arthritis, and immune checkpoint inhibitor–related inflammatory arthritis; any indication outside those FDA‑approved or compendial listings may be denied as investigational.

Do not administer the requested medication to members with active tuberculosis infection. For persons who are biologic‑naive or targeted‑synthetic‑naive, the member must have a documented negative TB screening test (TST or IGRA) within 12 months prior to initiating therapy. If TB screening is positive, additional testing (for example, chest X‑ray) must be performed to exclude active disease; latent TB must be treated before starting the requested medication.

Uses that fall outside the document's enumerated FDA‑approved indications and the specified compendial uses are considered not medically necessary and may be denied.

Concomitant administration of the requested medication with any other biologic drug or targeted synthetic drug for the same indication is not permitted. Concurrent use for the same therapeutic indication may result in denial of the request.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of therapy. Submit a complete prior authorization request to initiate review.

All indications require prior authorization before coverage is considered.
Prior authorization duration: typically 12 months for approved indications.

Prior Authorization

12-month Prior Authorization with Prior-Therapy Requirements

Initial prior authorization requests must include documentation of prior therapies when required by the indication. Documentation should show medication names, doses, dates of use, and clinical response or reason for discontinuation.

Provide chart notes, medical record documentation, or claims history supporting prior medications tried and response to therapy.
If a step therapy agent is medically inappropriate, include clinical rationale or documentation supporting avoidance (see Appendix A).

Prior Authorization

12-month Prior Authorization for Responders

Continuation (renewal) prior authorization requests must document sustained clinical response. Authorizations for responders may be granted for 12 months when improvement or low disease activity is demonstrated.

Submit chart notes or medical record documentation supporting positive clinical response or maintenance of low disease activity.
Examples of response measures vary by indication (e.g., tender/swollen joint counts, BSA for psoriasis, CDAI for Crohn's/UC, reduced abscess count for HS).

Step Therapy

Step Therapy / Prior Treatment Requirements

Step therapy and prior-treatment trials are required for many diagnoses before a biologic or targeted agent will be authorized. Requests must document adequate trials and inadequate response, intolerance, or contraindication to required prior agents.

Rheumatoid arthritis: documented inadequate response to at least a 3-month trial of methotrexate at adequate dosing (≥15 mg/week) unless intolerance/contraindication.
Psoriatic arthritis/Psoriasis: inadequate response or intolerance to conventional systemic agents (e.g., methotrexate, leflunomide, cyclosporine, acitretin) or phototherapy as applicable.
Ankylosing spondylitis/nr-axSpA: inadequate response to ≥2 NSAIDs or intolerance/contraindication to ≥2 NSAIDs.
Juvenile idiopathic arthritis: inadequate response to methotrexate or another conventional synthetic DMARD, or trial of NSAIDs/intra-articular steroids plus high-risk features per criteria.

Documentation Required

Reasons to Avoid Certain Systemic Agents (Appendix A)

If a required systemic agent is being bypassed, include clear clinical reasons. Acceptable reasons include documented intolerance, contraindication, or other clinical concerns preventing safe use.

See Appendix A for examples of acceptable reasons to avoid methotrexate, cyclosporine, acitretin, or leflunomide (e.g., pregnancy or planning pregnancy, breastfeeding, chronic liver disease or alcohol use disorder, significant comorbidity, drug interactions, hypersensitivity, history of severe adverse event).
When claiming intolerance or contraindication, provide specific chart documentation (e.g., adverse event description, lab abnormalities, specialist recommendations).

Referenced Products, Codes, and Key Measures

Referenced products (brand and biosimilars)mixed

Humira	adalimumab (brand)
Abrilada	adalimumab-afzb
Amjevita	adalimumab-atto
Cyltezo	adalimumab-adbm
Hadlima	adalimumab-bwwd
Hulio	adalimumab-fkjp
Hyrimoz	adalimumab-adaz
Idacio	adalimumab-aacf
Simlandi	adalimumab-ryvk
Yuflyma	adalimumab-aaty

1–10 of 12

1/2

inv-22: Body surface area (BSA) threshold for plaque psoriasis

BSA threshold (primary)>= 10% body surface area (BSA) involvement

BSA threshold (alternate)>= 3% BSA when the member has a clinical reason to avoid systemic agents (see Appendix A)

Crucial body areasCoverage may be granted when crucial body areas are affected (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

Prior therapy requirementIn many cases authorization is for members who previously received a biologic or targeted synthetic drug or who had inadequate response/intolerance to phototherapy or systemic agents

inv-23: TB screening timing — TST or IGRA within 12 months for biologic‑naive persons

Required TB test timingDocumented negative TST or IGRA within 12 months prior to initiating therapy for persons naive to biologic or targeted synthetic drugs

Positive TB screen follow-upIf screening is positive, further testing (eg, chest X‑ray) must exclude active disease before initiation

Latent TB managementIf latent TB is identified, TB treatment must be started before initiating the requested medication

Background and Scope

Adalimumab (Humira) and the listed biosimilars are TNF inhibitors used to treat multiple immune‑mediated inflammatory conditions. The policy covers both FDA‑approved indications (including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, and non‑infectious uveitis) and selected compendial uses (for example non‑radiographic axial spondyloarthritis, pyoderma gangrenosum, Behcet's disease, oligoarticular JIA, and immune checkpoint inhibitor–related inflammatory arthritis). Uses not listed as FDA‑approved or compendial are treated as experimental/investigational and not medically necessary.

Definitions and Clinical Measures

inv-39: Compendial uses — examples considered covered

Non-radiographic axial spondyloarthritisRecognized compendial use considered covered

Pyoderma gangrenosumRecognized compendial use considered covered

Behcet's diseaseRecognized compendial use considered covered

Oligoarticular juvenile idiopathic arthritisRecognized compendial use considered covered

Immune checkpoint inhibitor-related inflammatory arthritisRecognized compendial use considered covered

inv-40: Positive clinical response / maintenance — definition and examples

DefinitionPositive clinical response or maintenance = improvement or low disease activity from baseline demonstrated by condition‑specific measures

Examples — psoriasisReduction in BSA affected or improvement in signs/symptoms (eg, itching, redness, flaking, scaling, burning, cracking, pain)

Examples — joint diseasesImprovement in tender/swollen joint counts, number of active joints, limitation of movement, functional ability, pain, or validated disease activity scores

Examples — hidradenitis suppurativa and uveitisReduction in abscess/inflammatory nodule count, decreased lesion frequency, improved VH/AC cell grade, reduced flare frequency, or improved visual acuity

inv-41: Positive clinical response — condition-specific measures (psoriasis BSA, abscess/nodule counts, joint counts)

Psoriasis measureReduction in body surface area (BSA) affected from baseline or improvement in signs/symptoms (eg, itching, redness, flaking, scaling, burning, cracking, pain)

Hidradenitis suppurativa measuresReduction in abscess and inflammatory nodule count, decreased lesion frequency, reduced formation of new sinus tracts/scarring, pain reduction, fewer relapses, reduced suppuration, or improvement on a disease severity tool

Joint disease measuresImprovement in number of active joints, tender/swollen joint counts, limitation of movement, functional ability, or other joint count–based measures from baseline

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAdalimumab (Humira) and biosimilars coverage

Policy CodePolicy 2008-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with chart notes, prior medication history, and required labs/biomarkers to initiate review.

SourceLink

On This Page

Uveitis (non-infectious): Authorization of 12 months may be granted for members >=2 years who have previously received a biologic; OR who have had inadequate response to corticosteroids or immunosuppressive therapy, or intolerance/contraindication to those therapies.

Behcet's disease: Authorization of 12 months may be granted when member has had an inadequate response to at least one non‑biologic medication for Behcet's disease (e.g., azathioprine, colchicine, cyclosporine, systemic corticosteroids).

Pyoderma gangrenosum: Authorization of 12 months may be granted when member has had an inadequate response to corticosteroids or immunosuppressive therapy, or has intolerance/contraindication to those therapies.

Immune checkpoint inhibitor-related toxicity: Authorization of 12 months may be granted for moderate or severe immunotherapy‑related inflammatory arthritis when member has had an inadequate response to corticosteroids or a conventional synthetic DMARD, or has intolerance/contraindication to those therapies.

AS/nr-axSpA continuation:

Authorization of 12 months may be granted for adult members using the medication for AS or nr‑axSpA who achieve/maintain positive clinical response evidenced by improvement in functional status, total spinal pain, swollen/tender joints, morning stiffness/inflammation, or CRP.

Crohn's disease continuation: Authorization of 12 months may be granted for members using the medication for moderately to severely active Crohn's disease who achieve/maintain remission or improvement in abdominal pain/tenderness, diarrhea, weight, abdominal mass, hematocrit, mucosal appearance on endoscopy/CTE/MRE/intestinal ultrasound, or CDAI score.

Ulcerative colitis continuation: Authorization of 12 months may be granted for members using the medication for moderately to severely active UC who achieve/maintain remission or improvement in stool frequency, urgency, rectal bleeding, CRP, fecal calprotectin, endoscopic scores (e.g., UCEIS, Mayo), or mucosal appearance on imaging/endoscopy.

Plaque psoriasis continuation: Authorization of 12 months may be granted for adult members using the medication for moderate to severe plaque psoriasis who achieve/maintain a positive clinical response evidenced by reduction in BSA affected or improvement in signs and symptoms (itching, redness, flaking, scaling, burning, cracking, pain) from baseline.

Hidradenitis suppurativa continuation: Authorization of 12 months may be granted for members >=12 years using the medication for moderate to severe HS who achieve/maintain a positive clinical response evidenced by reduction in abscess/inflammatory nodule count, decreased lesion frequency, reduced new sinus tracts/scarring, pain reduction, fewer relapses, reduced suppuration, improved quality of life, or improvement on a disease severity tool.