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Modifiedharvard pilgrim health carePolicy N/A

Adalimumab products prior authorization

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Defines Harvard Pilgrim Health Care prior authorization and medical necessity criteria for coverage of adalimumab products (multiple biosimilars and brands) across specified inflammatory indications for commercial and specified public plan products.

Policy Summary

Payerharvard pilgrim health care

PolicyAdalimumab products prior authorization

Policy CodePolicy N/A

Change TypeCoverage placement and authorization interval revisions

Effective DateMar 1, 2026

Last ReviewJun 10, 2025

Next Review DateMar 1, 2026

Key ActionDocument prior therapy trials (drug name, dates, duration) including required Simlandi trial and failures to listed adalimumab products where applicable.

SourceLink

POLICY UPDATE CHANGES

For hidradenitis suppurativa, plaque psoriasis and psoriatic arthritis, initial approvals limited to 6 months with annual reauthorization coverage criteria added and disease severity and nonbiologic prerequisite requirements added.

For ankylosing spondylitis, Crohn's disease, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, ulcerative colitis and uveitis, approvals limited to 12 months with reauthorization coverage criteria added and nonbiologic prerequisites added.

Simlandi (adalimumab-ryvk) moved from non-preferred to preferred status and Humira moved from preferred to non-preferred status.

Requirement to document history of failure to multiple adalimumab biosimilars/products prior to Humira unless contraindicated.

multipleFDA indications listed

SimlandiPreferred product

requiredPrior trials required

6 monthsInitial approval (HS/psoriasis/psA)

12 monthsReauth interval (many indications)

>=6 monthsPsoriasis reauth minimal therapy

Coverage Criteria for Adalimumab Products

The policy designates Simlandi (adalimumab-ryvk) as the preferred adalimumab product. This guidance means Simlandi is the plan’s preferred adalimumab formulation and is referenced as the preferred product requiring prior authorization; the coverage criteria do not enumerate additional product-specific exclusions in this section.

Initial Therapy - Ankylosing Spondylitis

Covered when ALL of the following are met

Ankylosing spondylitis initial: 1. Documented diagnosis of active ankylosing spondylitis

[[chunk 5]]

Age: 2. Patient is at least 18 years of age or older>=18 years

[[chunk 5]]

Prescriber specialty: 3. Prescribed by a rheumatologist

[[chunk 5]]

NSAID trial: 4. History of failure to one prescription-strength NSAID unless contraindicated (document drug, date and duration)1 agent failed

[[chunk 5]]

Therapeutic category failures: 5. History of failure to two of the listed medications from each therapeutic category (interleukin antagonists, JAK inhibitors, TNF agents) — only one required if only one option exists per category2 agents per listed categories

[[chunk 6]]

Simlandi trial: 6. History of failure to a minimum three-month supply of Simlandi unless contraindicated (document date and duration)>=3 months

[[chunk 6]]

No combination therapy: 7. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

[[chunk 6]]

Reauthorization - Ankylosing Spondylitis

Covered when ALL of the following are met

Duration established: 1. Patient has been established on the requested medication for at least 12 months>=12 months

[[chunk 7]]

Diagnosis: 2. Documented diagnosis of active ankylosing spondylitis

[[chunk 7]]

Age: 3. Patient is at least 18 years of age or older>=18 years

[[chunk 7]]

Prescriber:

Initial Therapy - Crohn's Disease

Covered when ALL of the following are met

Diagnosis: 1. Documented diagnosis of Crohn's disease

[[chunk 9]]

Age: 2. Patient is at least 6 years of age or older>=6 years

[[chunk 9]]

Prescriber: 3. Prescribed by a gastroenterologist

[[chunk 9]]

Conventional therapy failure: 4. History of failure to one of: corticosteroid, 5-ASA, 6-mercaptopurine, or methotrexate unless contraindicated (document drug, date, duration)1 agent failed

Reauthorization - Crohn's Disease

Covered when ALL of the following are met

Duration established: 1. Patient has been established on the requested medication for at least 12 months>=12 months

[[chunk 11]]

Diagnosis severity: 2. Documented diagnosis of moderately to severely active Crohn's disease

[[chunk 11]]

Clinical response: 3. Documentation of clinically significant improvement or stabilization in signs and symptoms as determined by prescriber

[[chunk 11]]

No combination therapy: 4. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

Initial Therapy - Hidradenitis Suppurativa

Covered when ALL of the following are met

Diagnosis: 1. Documented diagnosis of moderate to severe hidradenitis suppurativa

[[chunk 13]]

Hurley stage: 2. Documentation of Hurley Stage II or III diseaseHurley II or III

[[chunk 13]]

Age: 3. Patient is at least 12 years of age or older>=12 years

[[chunk 13]]

Prescriber: 4. Prescribed by a dermatologist

Reauthorization - Hidradenitis Suppurativa

Covered when ALL of the following are met

Duration established: 1. Patient has been receiving the requested medication for at least six (6) months>=6 months

[[chunk 15]]

Diagnosis: 2. Documented diagnosis of moderate to severe hidradenitis suppurativa

[[chunk 16]]

Objective improvement: 3. Medical charts documenting beneficial clinical response defined as improvement from baseline in at least one objective measure (e.g., Hurley staging, Sartorius score, Physician Global Assessment, Hidradenitis Suppurativa Severity Index)>=1 objective measure improved

[[chunk 16]]

Initial Therapy - Plaque Psoriasis

Covered when ALL of the following are met

Diagnosis: 1. Documented diagnosis of moderate to severe chronic plaque psoriasis

[[chunk 17]]

Traditional systemic therapy failure: 2. Failure to a minimum three-month supply of at least one traditional systemic agent (methotrexate, cyclosporine, acitretin) or phototherapy unless contraindicated>=3 months

[[chunk 17]]

Therapeutic category failures: 3. History of failure to two of the listed medications from each therapeutic category (interleukin antagonists, PDE4 inhibitor, TNF agents) — only one required if only one is available per category2 agents

[[chunk 17]]

Reauthorization - Plaque Psoriasis

Covered when ALL of the following are met

Duration established: 1. Patient has been receiving the requested medication for at least six (6) months>=6 months

[[chunk 18]]

Diagnosis severity: 2. Documented diagnosis of moderately to severe plaque psoriasis

[[chunk 18]]

Clinical response - BSA: 3. Submission of medical charts documenting beneficial clinical response defined as reduction in body surface area affected from baseline

[[chunk 18]]

Symptom improvement: 4. Submission of medical charts documenting improvement in at least one symptom (itching, redness, flaking, scaling, burning, cracking, or pain) compared to baseline

Initial Therapy - Polyarticular Juvenile Idiopathic Arthritis

Covered when ALL of the following are met

Diagnosis: 1. Documented diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis

[[chunk 19]]

Age: 2. Patient is at least 2 years of age or older>=2 years

[[chunk 19]]

Prescriber: 3. Prescribed by a rheumatologist

[[chunk 19]]

Traditional DMARD failure: 4. Documentation of history of failure to one traditional DMARD unless contraindicated (document drug, date, duration)

inv cu-11: Initial authorization — polyarticular juvenile idiopathic arthritis (pJIA) — Covered when ALL of the following are met

Covered when ALL of the following are met

pJIA_initial_combined: 1. Documented diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis 2. Patient is at least 2 years of age or older 3. Prescribed by a rheumatologist 4. Documentation of history of failure to one (1) traditional DMARD unless contraindicated (document drug, date, duration) 5. Documentation of history of failure to two (2) listed medications from each therapeutic category (only one required if only available) 6. Documentation of failure to a minimum three (3) month supply of Simlandi unless contraindicated 7. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

Chunks 19-20 combined for complete logic

inv cu-12: Reauthorization — polyarticular juvenile idiopathic arthritis (pJIA) — Covered when ALL of the following are met

Covered when ALL of the following are met

pJIA_reauth: 1. Patient established on requested medication for at least 12 months 2. Documented diagnosis of active moderately to severely active polyarticular juvenile idiopathic arthritis 3. Documentation of clinically significant improvement or stabilization in clinical signs and symptoms as determined by the prescriber 4. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

[[chunk 21]][[chunk 22]]

inv cu-13: Initial authorization — psoriatic arthritis — Covered when ALL of the following are met

Covered when ALL of the following are met

psoriatic_arthritis_initial: 1. Documented diagnosis of active psoriatic arthritis 2. Documentation of one of: actively inflamed joints, dactylitis, enthesitis, axial disease, active skin/nail involvement 3. Patient is at least 18 years of age 4. Prescribed by a rheumatologist or dermatologist 5. Documentation of failure to a minimum three-month supply of at least one DMARD unless contraindicated 6. Documentation of failure to two listed medications from each therapeutic category (interleukin antagonists, JAK inhibitors, PDE4 inhibitors, selective T cell stimulators, TNF) — only one required if only available 7. Documentation of failure to a minimum three-month supply of Simlandi unless contraindicated 8. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

Chunks 23-24 combined

inv cu-14: Reauthorization — psoriatic arthritis — Covered when ALL of the following are met

Covered when ALL of the following are met

psoriatic_arthritis_reauth: 1. Patient has been receiving the requested medication for at least six (6) months 2. Documented diagnosis of active psoriatic arthritis 3. Patient is at least 18 years of age 4. Prescribed by a rheumatologist or dermatologist 5. Submission of medical charts documenting beneficial clinical response defined as improvement from baseline in at least one of: body surface area affected or total active joint count 6. Submission of medical charts documenting improvement in at least one symptom (joint pain, morning stiffness, fatigue, joint or tendon sheath swelling) compared to baseline 7. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

inv cu-15: Initial authorization — rheumatoid arthritis (RA) — Covered when ALL of the following are met

Covered when ALL of the following are met

RA_initial: 1. Documented diagnosis of moderately to severely active rheumatoid arthritis 2. Patient is at least 18 years of age 3. Prescribed by a rheumatologist 4. Documentation of history of failure to one traditional DMARD unless contraindicated (document drug, date, duration) 5. Documentation of history of failure to two listed medications from each therapeutic category (interleukin antagonists, JAK inhibitors, selective T cell stimulators, TNF) — only one required if only available 6. Documentation of failure to a minimum three-month supply of Simlandi unless contraindicated 7. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

Chunks 27-28 combined

inv cu-16: Reauthorization — rheumatoid arthritis (RA) — Covered when ALL of the following are met

Covered when ALL of the following are met

RA_reauth: 1. Member established on requested medication for at least 12 months 2. Documented diagnosis of moderately to severely active rheumatoid arthritis 3. Documentation of clinically significant improvement or stabilization in clinical signs and symptoms as determined by the prescriber 4. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

[[chunk 29]]

inv cu-17: Initial authorization — ulcerative colitis — Covered when ALL of the following are met

Covered when ALL of the following are met

UC_initial: 1. Documented diagnosis of moderately to severely active ulcerative colitis 2. Age and prescriber requirements vary by age (documented lines): patient at least 18 years and prescribed by a rheumatologist OR patient at least 5 years and prescribed by a gastroenterologist 3. Documentation of history of failure to one of: corticosteroid, 5-ASA, 6-mercaptopurine, methotrexate unless contraindicated (document drug, date, duration) 4. Documentation of history of failure to two listed medications from each therapeutic category 5. Documentation of failure to a minimum three-month supply of Simlandi unless contraindicated 6. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

Chunk 30 contains duplicated/conflicting prescriber/age lines; see source

inv cu-18: Reauthorization — ulcerative colitis — Covered when ALL of the following are met

Covered when ALL of the following are met

UC_reauth: 1. Patient established on requested medication for at least 12 months 2. Documented diagnosis of moderately to severely active ulcerative colitis 3. Documentation of clinically significant improvement or stabilization in clinical signs and symptoms as determined by the prescriber 4. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

[[chunk 32]]

inv cu-19: Initial and Reauthorization — uveitis (non-infectious intermediate, posterior or panuveitis) — Covered when ALL of the following are met

Covered when ALL of the following are met

uveitis_initial: Initial: Documented diagnosis of non-infectious intermediate, posterior or panuveitis; prescribed by an ophthalmologist, ocular immunologist, or rheumatologist; documentation of failure to conventional therapy (periocular, intraocular, systemic corticosteroids; immunosuppressants) unless contraindicated; documentation of failure to a minimum 3-month supply of Simlandi unless contraindicated; patient not receiving requested medication in combination with another biologic or targeted synthetic oral small molecule drug

Chunks 33-35 combined for initial and reauthorization; reauth requires 12 months established therapy and clinically significant improvement/stabilization

uveitis_reauth: Reauthorization: Patient established on requested medication for at least 12 months; documented diagnosis of non-infectious intermediate, posterior or panuveitis; prescribed by an ophthalmologist, ocular immunologist, or rheumatologist; documentation of clinically significant improvement or stabilization in signs and symptoms as determined by prescriber; patient not receiving requested medication in combination with another biologic or targeted synthetic oral small molecule drug

[[chunk 34]][[chunk 35]]

inv cu-20: Initial and Reauthorization Criteria — Coverage of Humira is provided when the following indication-specific and documentation criteria are met

Coverage of Humira is provided when the following indication-specific and documentation criteria are met

Prior therapy: Documented failure to listed adalimumab products (Adalimumab-aacf, -aaty, -adaz, -adbm, -fkjp, -ryvk, Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry) unless contraindicated; include drug names, dates, and duration of trials.

From policy Humira-specific requirement.

Age requirement: Patient is at least 2 years of age or older where specified.>=2 years

Referenced in document.

Authorization duration by indication: For ankylosing spondylitis, Crohn's disease, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, ulcerative colitis and uveitis, approvals are provided in 12-month intervals; for hidradenitis suppurativa, plaque psoriasis and psoriatic arthritis, initial approval is 6 months with reauthorization in 12-month intervals.

Samples, free goods, or similar offerings are not acceptable evidence of an established clinical response and will not be considered for prior authorization. Providers should supply formal clinical documentation (e.g., dated medication trials, chart notes, objective measures) rather than sample or free-product use when seeking authorization.

The policy explicitly excludes samples, free goods, or similar offerings as acceptable evidence of established clinical response. Documentation intended to demonstrate prior therapy or response must come from verifiable clinical records rather than provisioned samples or complimentary product supplies.

Documentation that a member is a social drinker does not, by itself, constitute a medically acceptable contraindication to methotrexate and therefore is insufficient to bypass methotrexate prerequisite therapy. Providers must document a true medical contraindication or clinically significant adverse effect to methotrexate if claiming exemption from methotrexate trial requirements.

Coding and Key Parameters

Humira / adalimumab alternatives requiring prior failuremixed

Adalimumab-aacf	Adalimumab-aacf (biosimilar)
Adalimumab-aaty	Adalimumab-aaty (biosimilar)
Adalimumab-adaz	Adalimumab-adaz (biosimilar)
Adalimumab-adbm	Adalimumab-adbm (biosimilar)
Adalimumab-fkjp	Adalimumab-fkjp (biosimilar)
Adalimumab-ryvk	Adalimumab-ryvk (biosimilar)
Abrilada	Abrilada
Amjevita	Amjevita
Cyltezo	Cyltezo
Hadlima	Hadlima

1–10 of 15

1/2

Named therapeutic agents referenced for step therapymixed

Actemra	Interleukin Antagonist (tocilizumab)
Bimzelx	Interleukin Antagonist (bimekizumab)
Skyrizi	Interleukin Antagonist (risankizumab)
Taltz	Interleukin Antagonist (ixekizumab)
Tremfya	Interleukin Antagonist (guselkumab)
Yesintek	Interleukin Antagonist (secukinumab)
Rinvoq	Janus Kinase Inhibitor (upadacitinib)
Xeljanz	Janus Kinase Inhibitor (tofacitinib)
Olumiant	Janus Kinase Inhibitor (baricitinib)
Orencia	Selective T Cell Costimulation/Stimulator (abatacept)

1–10 of 16

1/2

Codesmixed

None	No codes listed

Established therapy duration for reauthorization (psoriasis/psoriatic arthritis)

Reauthorization interval (psoriasis, psoriatic arthritis)>= 6 months on requested medication before reauthorization

Evidence requiredSubmission of medical charts documenting beneficial clinical response (e.g., reduction in BSA for plaque psoriasis; improvement in joint counts or BSA/active joint count for psoriatic arthritis)

Combination therapyDocumentation that the patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

Established therapy duration for reauthorization (most systemic indications)

Reauthorization interval (most systemic indications)>= 12 months on requested medication before reauthorization

Provider Requirements and Documentation

Prior Authorization

Prior authorization required

Prior authorization is required for adalimumab products for Harvard Pilgrim and affiliated commercial and specified public plan products; Simlandi is the preferred adalimumab product and also requires prior authorization. Clinicians must submit a prior authorization request per the plan's requirements before dispensing.

Prior Authorization

Indication-specific prior authorization requirements

Prior authorization requests must include the documented diagnosis, applicable age criteria, prescriber specialty as required for the indication, and documentation of required prior therapy trials as specified in the indication-specific criteria.

Prior Authorization

Humira-specific prior authorization

For Humira (adalimumab) requests, prior authorization must include documentation of history of failure to the listed adalimumab reference and biosimilar products unless contraindicated.

Background

Adalimumab is a tumor necrosis factor (TNF) blocker that is approved for multiple immune-mediated inflammatory diseases, including ankylosing spondylitis, Crohn's disease, hidradenitis suppurativa, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, and uveitis. The guideline lists multiple branded and biosimilar adalimumab products and identifies Simlandi as the preferred adalimumab product requiring prior authorization.

Definitions and Product List

Adalimumab products

Included adalimumab reference and biosimilar productsAdalimumab-aacf; Adalimumab-aaty; Adalimumab-adaz; Adalimumab-adbm; Adalimumab-fkjp; Adalimumab-ryvk

Named brands and biosimilarsAbrilada; Amjevita; Cyltezo; Hadlima; Hulio; Hyrimoz; Idacio; Yuflyma; Yusimry

Preferred product noteSimlandi (Adalimumab-ryvk) is designated the preferred adalimumab product in this guideline

Failure (therapy)

Definition of failure (therapy)Documented lack of adequate response, intolerance, contraindication, or clinically significant adverse effects to a named prior medication; include drug name, dates, and duration of trial

Documentation requirementProvide dates and duration of prior trials; if not trialed due to contraindication or adverse effect, document reason

Policy Revision History

2026-03-01coverage_placement_changeLatest

Simlandi (adalimumab-ryvk) moved from non-preferred to preferred and Humira moved from preferred to non-preferred.

2025-12-09coverage_placement_change

Simlandi moved from non-preferred to preferred and Humira moved from preferred to non-preferred (effective 03/01/2026).

2025-06-10committee_review

Policy Summary

Payerharvard pilgrim health care

PolicyAdalimumab products prior authorization

Policy CodePolicy N/A

Change TypeCoverage placement and authorization interval revisions

Effective DateMar 1, 2026

Last ReviewJun 10, 2025

Next Review DateMar 1, 2026

Key ActionDocument prior therapy trials (drug name, dates, duration) including required Simlandi trial and failures to listed adalimumab products where applicable.

SourceLink

On This Page

4. Prescribed by a rheumatologist

Clinical response: 5. Documentation of clinically significant improvement or stabilization in signs and symptoms as determined by prescriber

[[chunk 8]]

No combination therapy: 6. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

[[chunk 8]]

Therapeutic category failures: 5. History of failure to two of the listed medications from each therapeutic category (interleukin antagonists, JAK inhibitors, TNF) — only one required if only one is available per category2 agents

[[chunk 10]]

Simlandi trial: 6. History of failure to a minimum three-month supply of Simlandi unless contraindicated (document date and duration)>=3 months

[[chunk 10]]

No combination therapy: 7. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

[[chunk 10]]

Conventional therapy failures: 5. History of failure to three of listed conventional treatments (local hygiene, weight reduction if obese, soaps/antiseptics, warm compresses, laser hair removal, smoking cessation, medical anti-inflammatory/antiandrogen therapy), unless contraindicated3 treatments failed

[[chunk 13]]

Simlandi trial: 6. History of failure to a minimum three-month supply of Simlandi unless contraindicated>=3 months

[[chunk 14]]

No combination therapy: 7. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

[[chunk 14]]

Symptom improvement: 4. Charts documenting improvement in at least one symptom such as decreased pain or drainage of lesions, nodules, or cysts compared to baseline>=1 symptom improved

No combination therapy: 5. Documentation the patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

[[chunk 16]]

Simlandi trial: 4. History of failure to a minimum three-month supply of Simlandi unless contraindicated>=3 months

No combination therapy: 5. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

[[chunk 17]]

>=1 symptom improved

No combination therapy: 5. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

[[chunk 18]]

Therapeutic category failures: 5. Documentation of history of failure to two listed medications from each therapeutic category (interleukin antagonists, JAK inhibitors, selective T cell agents, TNF) — only one required if only available2 agents

[[chunk 20]]

Simlandi trial: 6. Documentation of failure to a minimum three-month supply of Simlandi unless contraindicated>=3 months

[[chunk 20]]

No combination therapy: 7. Patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule drug

[[chunk 20]]

Limits and intervals specified in limitations and revision history.

Indications referencedApplies to ankylosing spondylitis, Crohn's disease, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, ulcerative colitis, and uveitis

Documentation of clinical responseSubmission of medical charts documenting clinically significant improvement or stabilization as determined by the prescriber

Simlandi trial duration

Simlandi trial durationMinimum 3 months (history of failure to a minimum three-month supply of Simlandi must be documented)

Where requiredSimlandi 3-month trial is required for multiple indications including RA, psoriatic disease, plaque psoriasis, Crohn's disease, ulcerative colitis, uveitis, ankylosing spondylitis, hidradenitis suppurativa, and pJIA per indication criteria

Documentation specificsDocument date and duration of Simlandi trial in prior therapy history

Minimum age

Minimum age (where specified)2 years of age or older (minimum referenced age in policy)

pJIA age requirementPatient is at least 2 years of age for polyarticular juvenile idiopathic arthritis initial authorization

General noteAge thresholds vary by indication; refer to indication-specific criteria for exact age requirements

Prior Authorization

Prior authorization requirement

Prior authorization requires documentation of failure to the specified adalimumab biosimilars/products (listed in policy) unless contraindicated; approvals are time‑limited by indication per the limitations section.

Step Therapy

Step requirements / required prior trials

Many indications require documented prior failures of specified conventional agents and biologic/targeted categories and, where applicable, a minimum three‑month trial of Simlandi; include drug names, dates, and durations of each trial.

Step Therapy

Therapeutic category step requirements

Step therapy requires documented failure to agents across specified therapeutic classes (e.g., interleukin antagonists, JAK inhibitors, selective T‑cell agents, TNF inhibitors, PDE4 inhibitors, S1P modulators) with trials as described for each indication.

Step Therapy

Biosimilar/alternative step requirement

Prior to Humira, providers must document failure to multiple listed adalimumab products (Adalimumab‑aacf, ‑aaty, ‑adaz, ‑adbm, ‑fkjp, ‑ryvk, Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry) unless contraindicated.

Documentation Required

Required documentation

Providers must document the patient’s diagnosis, age, prescriber specialty, and the dates and duration of prior medication or treatment trials (including Simlandi where required).

Documentation Required

Clinical response documentation

Submit medical charts demonstrating baseline and subsequent clinical response for the indication (for example, reduction in body surface area for plaque psoriasis or improvement in joint counts/symptoms for psoriatic arthritis).

Documentation Required

Prior therapy documentation

Document prior drug trials including drug name, dates, and duration for required DMARDs, biologics, Simlandi, and other listed therapeutic agents; document contraindications or adverse effects if an agent was not trialed.

Documentation Required

Prescriber specialty

The prescription must be from the specialist(s) specified for the indication (for example, rheumatologist, dermatologist, gastroenterologist, ophthalmologist/ocular immunologist) as described in the indication criteria.

Documentation Required

Required documentation for Humira and reauthorization

Document prior trials of the listed adalimumab products with drug name, dates, and duration. For reauthorization, also submit documentation of clinical response and relevant labs/imaging if requested.

Documentation Required

Methotrexate contraindication documentation

When methotrexate is a prerequisite, documentation that methotrexate is contraindicated cannot be established solely by noting the member is a social drinker.

Denial Risk

Documentation and criteria noncompliance

Failure to document the required diagnosis, applicable age, prescriber specialty, or the required prior therapy trials (including dates and durations) may result in denial of authorization.

Denial Risk

Samples not accepted

Samples, free goods, or similar offerings will not be accepted as documentation of an established clinical response and may lead to denial of the prior authorization request.

Denial Risk

Humira prior failure requirement

For Humira requests, lack of documented failure to the specified adalimumab biosimilars or products listed in the policy may trigger denial of the request.

Denial Risk

Insufficient documentation — samples not accepted

Samples, free goods, or similar offerings do not qualify as documentation of established clinical response and will not be accepted for prior authorization determinations.

Denial Risk

Missing prior biologic failure documentation

Failure to document prior trials (drug name, dates, and duration) of the listed adalimumab products may result in denial of the Humira prior authorization request.

ScopeApplies to conventional agents, biologics, and listed adalimumab products (including Simlandi) where required by indication-specific criteria

Listed adalimumab products

Listed adalimumab products requiring trial prior to HumiraAdalimumab-aacf; Adalimumab-aaty; Adalimumab-adaz; Adalimumab-adbm; Adalimumab-fkjp; Adalimumab-ryvk (Simlandi); Abrilada; Amjevita; Cyltezo; Hadlima; Hulio; Hyrimoz; Idacio; Yuflyma; Yusimry

Requirement summaryDocumentation of history of failure to the listed adalimumab products is required for Humira requests unless contraindicated (include drugs, dates, durations)

Evidence standardPrior trials of these specific adalimumab products must be documented in the prior therapy history to support Humira coverage consideration

Policy reviewed by the Pharmacy & Therapeutics Committee (effective 09/01/2025); clarified reauthorization intervals and added nonbiologic prerequisite language for multiple indications.

2024-10-14criteria_revision

Provider requirements revised; initial approvals for hidradenitis suppurativa, plaque psoriasis, and psoriatic arthritis limited to 6 months with annual reauthorization and added disease severity and nonbiologic prerequisite requirements; several systemic indications set to 12-month approvals with reauthorization and nonbiologic prerequisites added.

prior_failure_requirement_added

Requirement added to document history of failure to multiple adalimumab biosimilars/products prior to Humira unless contraindicated (document drugs, dates, and duration).