UnitedHealthcare Enbrel prior auth Policy Update

Coverage Criteria by Indication

Initial Therapy - Rheumatoid Arthritis

Covered when ALL of the following are met

RA initial: (1) Diagnosis of moderately to severely active rheumatoid arthritis

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Prior therapy: One of: (a) Failure of a 3 month trial of one non-biologic DMARD at maximally indicated doses unless contraindicated; OR (b) Prior treatment with an FDA‑approved systemic targeted immunomodulator for rheumatoid arthritis as documented; OR (c) Current Enbrel user with documentation (claims or medical records) and no manufacturer sample/assistance used to establish current use3 months for DMARD trial

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Concomitant therapy: (3) Patient is not receiving Enbrel in combination with another systemic targeted immunomodulator for treatment of the same indication

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Prescriber: (4) Prescribed by or in consultation with a rheumatologist

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Reauthorization - Rheumatoid Arthritis

Covered when ALL of the following are met

Reauth RA: (1) Documentation of positive clinical response to Enbrel therapy

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Concomitant therapy: (2) Patient is not receiving Enbrel in combination with another systemic targeted immunomodulator for treatment of the same indication

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Initial Therapy - PJIA

Covered when ALL of the following are met

PJIA initial: (1) Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis

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Concomitant therapy: (2) Patient is not receiving Enbrel in combination with another systemic targeted immunomodulator for treatment of the same indication

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Prescriber: (3) Prescribed by or in consultation with a rheumatologist

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Reauthorization - PJIA

Covered when ALL of the following are met

Reauth PJIA: (1) Documentation of positive clinical response to Enbrel therapy

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Concomitant therapy: (2) Patient is not receiving Enbrel in combination with another systemic targeted immunomodulator for treatment of the same indication

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Initial Therapy - Psoriatic Arthritis

Covered when ALL of the following are met

PsA initial diagnosis: (1) Diagnosis of active psoriatic arthritis

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Prior therapy or established use: One of: (a) History of failure to a 3 month trial of methotrexate at maximally indicated dose unless contraindicated; OR (b) Prior treatment with an FDA‑approved systemic targeted immunomodulator for psoriatic arthritis as documented; OR (c) Current Enbrel user with documentation (claims or medical records) and no manufacturer sample/assistance used to establish current use3 months for methotrexate trial

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Concomitant therapy: (3) Patient is not receiving Enbrel in combination with another systemic targeted immunomodulator for treatment of the same indication

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Reauthorization - Psoriatic Arthritis

Covered when ALL of the following are met

Reauth PsA: (1) Documentation of positive clinical response to Enbrel therapy

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Concomitant therapy: (2) Patient is not receiving Enbrel in combination with another systemic targeted immunomodulator for treatment of the same indication

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Initial Therapy - Plaque Psoriasis

Covered when ALL of the following are met

Plaque psoriasis initial: (1) Diagnosis of chronic moderate to severe plaque psoriasis

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Initial Therapy - Plaque Psoriasis (expanded)

Covered when ALL of the following are met for initial plaque psoriasis:

Plaque psoriasis initial: (1) Diagnosis of chronic moderate to severe plaque psoriasis

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One of the following: (2) One of: (a) All topical therapy and methotrexate requirements met; OR (b) Prior systemic targeted immunomodulator treatment documented; OR (c) Current Enbrel user with documentation and no manufacturer sample/assistance used to establish current use

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Topical + methotrexate option: i. >=3% body surface area involvement or palmoplantar/facial/genital/severe scalp involvement; ii. Failure to one topical therapy (document drug, date, duration); iii. Failure of a 3 month trial of methotrexate at maximally indicated dose unless contraindicated3 months for methotrexate trial

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Reauthorization - Plaque Psoriasis

Covered when ALL of the following are met for reauthorization of plaque psoriasis:

Reauthorization plaque psoriasis: (1) Documentation of positive clinical response to Enbrel therapy; (2) Patient is not receiving Enbrel in combination with another systemic targeted immunomodulator for treatment of the same indication

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Initial Therapy - Ankylosing Spondylitis

Covered when ALL of the following are met for initial ankylosing spondylitis:

Ankylosing spondylitis initial: (1) Diagnosis of active ankylosing spondylitis

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One of the following: (2) One of: (a) History of failure to two NSAIDs at maximally indicated doses, each used for at least 4 weeks; OR (b) Prior treatment with an FDA‑approved systemic targeted immunomodulator for ankylosing spondylitis as documented; OR (c) Current Enbrel user with documentation and no manufacturer sample/assistance used to establish current useeach NSAID >= 4 weeks

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Prescriber requirement: (3) Prescribed by or in consultation with a rheumatologist

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Reauthorization - Ankylosing Spondylitis

Covered when ALL of the following are met for reauthorization of ankylosing spondylitis:

Reauthorization ankylosing spondylitis: (1) Documentation of positive clinical response to Enbrel therapy; (2) Patient is not receiving Enbrel in combination with another systemic targeted immunomodulator for treatment of the same indication

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Requests for Enbrel (etanercept) will be denied when the patient is receiving Enbrel in combination with another systemic targeted immunomodulator for treatment of the same indication. Examples of excluded concomitant agents include, but are not limited to, adalimumab; certolizumab (Cimzia); abatacept (Orencia); upadacitinib (Rinvoq); golimumab (Simponi); tofacitinib (Xeljanz/XR), and additional biologic or targeted therapies listed in the policy. Authorization is conditioned on the patient not concurrently receiving these agents for the same diagnosis.

Coverage for Enbrel is explicitly contingent on the patient not receiving Enbrel in combination with another systemic targeted immunomodulator for the same indication. The policy provides a non‑exhaustive list of examples (e.g., adalimumab; certolizumab; bimekizumab; secukinumab; abatacept; apremilast; upadacitinib; golimumab; risankizumab; ixekizumab; guselkumab; tofacitinib; ustekinumab). Reauthorizations and initial authorizations both require absence of concurrent therapy with these agents.

Initial Therapy — Aggregated

Initial Therapy - All Indications

Initial authorization per indication

RA initial: See RA initial criteria: diagnosis, prior DMARD trial or prior targeted therapy, documentation, no combination therapy, rheumatologist involvement

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PJIA initial: See PJIA initial criteria: diagnosis, no combination therapy, rheumatologist involvement

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PsA initial: See PsA initial criteria: diagnosis, methotrexate trial or prior targeted therapy or current documented user, no combination therapy, prescriber rheumatologist or dermatologist3 months for methotrexate trial

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Reauthorization / Continuation Criteria

Continuation/Reauthorization

Reauthorization rules

Positive response: Documentation of positive clinical response to Enbrel therapy is required for reauthorization

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Concomitant therapy: Patient must not be receiving Enbrel in combination with another systemic targeted immunomodulator for treatment of the same indication

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Reauthorization / Continuation

Reauthorization requirements

Continuation: Documentation of positive clinical response to Enbrel therapy; patient is not receiving Enbrel in combination with another systemic targeted immunomodulator for treatment of the same indication

Provider Requirements and Documentation

Prior Authorization

Rheumatoid arthritis — Initial authorization requirements

Initial authorization for rheumatoid arthritis requires documentation of diagnosis of moderately to severely active rheumatoid arthritis and prior therapy. Provider must document either: (a) history of failure to a 3-month trial of one non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) at maximally indicated doses unless contraindicated or adverse effects (document drug, date, and duration of trial); OR (b) prior treatment with a systemic targeted immunomodulator FDA‑approved for rheumatoid arthritis documented by claims history or medical records (document drug, date, and duration). For patients currently on Enbrel, submit claims history or medical records showing date and duration of therapy and confirm the patient did not establish therapy solely via manufacturer-provided samples or Amgen Enbrel Support assistance. Patient must not be receiving Enbrel in combination with another systemic targeted immunomodulator for the same indication. Prescriber must be a rheumatologist or consult with one.

Document drug, date, and duration of prior DMARD or biologic therapy
Do not approve if Enbrel is used in combination with another systemic targeted immunomodulator for the same indication
For patients established on Enbrel via samples/support program, initial authorization criteria apply as if new to therapy

Prior Authorization

Key Coding & Trial Duration Values

Methotrexate trial duration

Requirement>= 3 months at maximally indicated dose

ApplicabilityRequired for methotrexate trial when used as prior therapy option for plaque psoriasis and psoriatic arthritis (unless contraindicated)

DocumentationDocument date and duration of the methotrexate trial

NSAID trial duration

RequirementEach NSAID trial >= 4 weeks at maximally indicated doses

Number of trialsHistory of failure to two NSAIDs required as one prior-therapy option for ankylosing spondylitis

Step Therapy and Preferred Product Notes

Drug	Date(s) of trial	Duration of trial
Non-biologic DMARD (e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine)	Document drug and dates of therapy (claims or medical records)	3 months at maximally indicated doses (unless contraindicated or intolerable adverse effects)
Methotrexate (for psoriatic arthritis or plaque psoriasis where specified)	Document date and duration of trial (claims or medical records)	3 months at maximally indicated dose (unless contraindicated or intolerable adverse effects)
Prior systemic targeted immunomodulator (e.g., adalimumab, certolizumab, secukinumab, etc.)	Document drug and dates of therapy (claims or medical records)	Duration per prior therapy as documented; classify as prior targeted immunomodulator use rather than duration-based step when applicable

Note	Action / Reference
Step therapy and preferred-product edits have changed historically; specific current preferred step medications are maintained in the full policy.	See full policy for current step/preferred product details and historical change log (references and change control listed).

Definitions and Drug Information

Enbrel (etanercept) — drug description and labeled indications/age ranges

Drug classTumor necrosis factor (TNF) blocker (etanercept)

IndicationsRheumatoid arthritis; polyarticular juvenile idiopathic arthritis (patients >= 2 years); psoriatic arthritis (patients >= 2 years); ankylosing spondylitis; plaque psoriasis (patients >= 4 years)

Proprietary nameEnbrel (etanercept)

Failure — definition and documentation expectations

DefinitionFailure = documented lack of efficacy or intolerable adverse effects after a trial of the specified therapy

Required documentationDocument drug, date, and duration of the trial (or provide claims/medical records)

Background and Scope

Enbrel (etanercept) is a tumor necrosis factor (TNF) blocker approved for multiple inflammatory indications, including rheumatoid arthritis; polyarticular juvenile idiopathic arthritis (patients ≥2 years); psoriatic arthritis (patients ≥2 years); ankylosing spondylitis; and plaque psoriasis (patients ≥4 years). The policy uses these labeled indications to define covered uses and to set indication‑specific prior authorization and reauthorization requirements.

Quantity Limits and Supply

Enbrel (etanercept) — Supply limits

Policy noteSupply limits may be in place for Enbrel (etanercept)

Authorization impactSupply limits do not replace clinical coverage criteria; approvals may still require meeting prior-therapy and documentation rules

OperationalUnitedHealthcare may apply automated approval or claim-history–based processes; supply limits are a separate program control

Policy Revision History

2021-09step_therapy_update

Revised step requirements for rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis; updated background and references.

2022-06step_therapy_update

Added Rinvoq and Xeljanz as step therapy options for ankylosing spondylitis and psoriatic arthritis.

2022-11step_therapy_update

Removed step requirement through preferred products and added continuation of therapy for RA, PsA, and AS.

OpenPayer

Enbrel (etanercept) prior authorization

Coverage Criteria by Indication

Initial Therapy — Aggregated

Reauthorization / Continuation Criteria

Provider Requirements and Documentation

Key Coding & Trial Duration Values

Step Therapy and Preferred Product Notes

Definitions and Drug Information

Background and Scope

Quantity Limits and Supply

Policy Revision History