Etanercept (Enbrel) - Coverage Criteria and Prior Authorization
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Clinical coverage and prior authorization criteria for Etanercept (Enbrel) for Delaware First Health Medicaid members, including initial and continuation therapy requirements across FDA‑approved indications.
Per July SDC: for all indications, added criteria requiring use of one adalimumab product and stating Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred.
2Q 2024 annual review: updated Appendix D with removal of Hidradenitis Suppurativa guideline supplemental information; added Bimzelx, Zymfentra, Omvoh, Sotyktu, Wezlana, and Velsipity to section III.B; references reviewed and updated.
2Q 2025 annual review: for pJIA removed minimum cJADAS-10 > 8.5 requirement and removed requirement to document baseline 10-joint cJADAS; removed requirement for evidence of response by decrease in cJADAS-10 from baseline in continued therapy.
Coverage and Approval Criteria
Initial Therapy: Ankylosing Spondylitis
Initial Approval Criteria — Ankylosing Spondylitis (must meet all):
See Appendix D for agent-specific notes and prior authorization requirements.
Initial Therapy: Plaque Psoriasis
Initial Approval Criteria — Plaque Psoriasis (must meet all):
Prior authorization may be required for listed comparator agents (e.g., adalimumab products, Taltz, ustekinumab).
Initial Therapy: Polyarticular Juvenile Idiopathic Arthritis
Initial Approval Criteria — Polyarticular Juvenile Idiopathic Arthritis (must meet all):
Prior authorization may be required for adalimumab products, Actemra, and Xeljanz/Xeljanz XR.
Initial Therapy: Psoriatic Arthritis
Initial Approval Criteria — Psoriatic Arthritis (must meet all):
Prior authorization may be required for adalimumab products, Otezla, Taltz, ustekinumab, and Xeljanz/Xeljanz XR.
Initial Therapy: Rheumatoid Arthritis
Initial Approval Criteria — Rheumatoid Arthritis (must meet all):
Prior authorization may be required for adalimumab products, Actemra, and Xeljanz/Xeljanz XR; see Appendices G/H for scoring details.
Initial Therapy — overall requirements
Initial approval requires diagnosis-specific prior therapy failures and prescriber specialty requirements as detailed by indication.
See individual indication sections for exact agent and duration requirements and Appendix references.
Initial Therapy — dosing by indication
Dosing regimens and maximum doses by indication:
RA dosing per Appendix I (chunk 33).
PsA dosing per Appendix I (chunk 33).
AS dosing per Appendix I (chunk 33).
pJIA dosing per Appendix I (chunk 33).
PsO dosing per Appendix I (chunk 33).
Initial therapy preference and redirection
Initial therapy preference and therapeutic redirection rules (SDC updates):
Per July and subsequent SDC entries (chunks 38–39).
See Coding Implications SDC summary (chunk 38).
Continued Therapy — general
Continued Therapy (All indications):
Approval duration: 12 months.
Continuation Therapy — operational requirements
Operational continuation requirements (what must be documented):
Approval duration: 12 months; providers must submit office notes, labs, or other clinical information to support response.
Continued Therapy / Response
Examples of clinical response and considerations supporting continued therapy:
These examples are illustrative and may be submitted as part of documentation of response.
pJIA continued therapy revisions
Revisions specific to pJIA continuation criteria (2Q 2025 annual review):
Change made during 2Q 2025 annual review as noted in Coding Implications.
The policy prohibits combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or potent immunosuppressants because of the risk of additive immunosuppression, increased neutropenia, and higher rates of serious infections. This restriction applies broadly to classes and agents listed in Section III and is reiterated in the continued-therapy and denial guidance sections; requests that document concurrent use with these agents may be denied for safety reasons.
Non‑FDA approved indications that are not addressed by this policy are not authorized unless there is sufficient documentation of efficacy and safety consistent with the payer’s off‑label use policies (see policies CP.PMN.53, CP.PMN.255, and CP.PMN.16). Providers must reference those off‑label/evidence‑of‑coverage processes when requesting coverage for indications outside the FDA‑labeled uses listed in this policy.
Combination use with the following specific agents is not authorized due to additive immunosuppression and higher risk of neutropenia and serious infections: Arcalyst, Bimzelx, Cosentyx, Ilaris, Ilumya, Kevzara, Kineret, Omvoh, Siliq, Skyrizi, Spevigo, Stelara (and its biosimilars), Taltz, Tremfya, Janus kinase inhibitors (e.g., Cibinqo, Olumiant, Rinvoq, Xeljanz/Xeljanz XR), anti‑CD20 monoclonal antibodies (e.g., Rituxan and its biosimilars), selective co‑stimulation modulators (Orencia), integrin receptor antagonists (Entyvio), tyrosine kinase 2 inhibitors (Sotyktu), and sphingosine 1‑phosphate receptor modulators (Velsipity).
The policy reiterates that etanercept must not be used in combination with other bDMARDs or JAK inhibitors. Combination therapy with those classes or the listed individual agents is not authorized and is a basis for medical necessity denial because of documented safety concerns.
Concurrent use of etanercept with the biologics, JAK inhibitors, anti‑CD20 antibodies, and other immunomodulators enumerated in Section III is expressly not authorized. Providers should not submit requests that propose simultaneous administration of etanercept with these listed agents; such requests will be considered not medically necessary due to additive immunosuppression and infection risk.
Initial Authorization Requirements
Initial Therapy — summary
Initial approval requires diagnosis‑specific prior therapy failures and appropriate prescriber specialty as detailed below.
Refer to each indication section for exact agent lists and durations.
Initial Therapy: Ankylosing Spondylitis (detailed)
Ankylosing Spondylitis — detailed initial criteria nodes:
Prior authorization may be required for adalimumab products, Taltz, and Xeljanz/Xeljanz XR (see Appendix D).
Initial Therapy: Plaque Psoriasis (detailed)
Plaque Psoriasis — detailed initial criteria nodes:
Prior authorization may be required for adalimumab, Taltz, and ustekinumab products.
Initial Therapy: Polyarticular Juvenile Idiopathic Arthritis (detailed)
Polyarticular JIA — detailed initial criteria nodes:
Prior authorization may be required for adalimumab products, Actemra, and Xeljanz/XR.
Initial Therapy: Psoriatic Arthritis (detailed)
Psoriatic Arthritis — detailed initial criteria nodes:
Prior authorization may be required for listed comparator agents.
Initial Therapy: Rheumatoid Arthritis (detailed)
Rheumatoid Arthritis — detailed initial criteria nodes:
See Appendices G/H for scoring and documentation details; prior authorization may be required for listed agents.
Initial Therapy — dosing (detailed)
Dosing regimens by indication (to accompany initial criteria):
Appendix I dosing table (chunk 33).
Appendix I dosing table (chunk 33).
Appendix I dosing table (chunk 33).
Initial therapy preference and redirection (SDC)
Initial therapy preference and redirection (SDC-added rules to appear alongside initial criteria):
Per Coding Implications SDC summaries (chunks 38–39).
See Coding Implications (chunk 38).
Continued Authorization Requirements
Continued Therapy — top level
Continued Therapy — top‑level criteria applicable to all indications:
Approval duration: 12 months.
Continuation Therapy — operational requirements
Operational continuation requirements (what must be submitted):
Providers must provide documentation to avoid denial; see Required documentation guidance.
Continued Therapy / Response — examples
Examples of clinical response that support continued therapy:
These examples are illustrative and acceptable forms of evidence for continued coverage.
pJIA continued therapy revisions
pJIA continuation criteria revisions (implementation note):
See Coding Implications (chunk 40) for revision context.
Step Edits and Therapeutic Alternatives
| Indication | Required prior therapy before Enbrel |
|---|---|
| Ankylosing spondylitis (adults) | Failure of at least TWO NSAIDs (each ≥4 weeks unless adverse effects/contraindicated or previously failed a biologic); AND failure of ALL of the following (each >3 months unless adverse effects/contraindicated): one adalimumab product (preferred examples listed) unless history of failure of two TNF blockers; Taltz; and if not responsive/intolerant to one or more TNF blockers, Xeljanz/Xeljanz XR (unless cardiovascular risk prohibits). Dose ≤50 mg/week. |
| Plaque psoriasis (≥4 years) | Failure of ≥3 month trial of methotrexate OR intolerance/contraindication to MTX plus failure of ≥3 month trial of cyclosporine or acitretin OR intolerance/contraindication to MTX/cyclosporine/acitretin and failure of phototherapy; for ≥18 years also failure of ONE adalimumab product (or history of failure of two TNF blockers) AND failure of Taltz (each ≥3 months). |
| Polyarticular juvenile idiopathic arthritis (≥2 years) | Failure of ≥3 month trial of methotrexate OR (if intolerant) ≥3 month trial of leflunomide or sulfasalazine, or for sacroiliitis failure of ≥4 week NSAID; AND failure of ALL of: ONE adalimumab product (preferred examples) unless history of failure of two TNF blockers; Actemra; and if not responsive/intolerant to TNF blockers, Xeljanz (each ≥3 months). |
| Psoriatic arthritis / juvenile PsA (≥2 years) | For ≥18 years: failure of ALL (each ≥3 months) — ONE adalimumab product (preferred examples) unless history of failure of two TNF blockers; Otezla/Otezla XR; Taltz; one ustekinumab product; and if not responsive/intolerant to TNF blockers, Xeljanz/Xeljanz XR (unless cardiovascular risk prohibits). Pediatric 6–17 have specified alternative requirements. |
| Rheumatoid arthritis (adults) | Failure of ≥3 month trial of methotrexate OR (if intolerant) ≥3 month trial of at least one conventional DMARD (e.g., sulfasalazine, leflunomide, hydroxychloroquine); AND failure of ALL (each ≥3 months): ONE adalimumab product (preferred examples) unless history of failure of two TNF blockers; Actemra; and if not responsive/intolerant to TNF blockers, Xeljanz/Xeljanz XR (unless cardiovascular risk prohibits). Dose ≤50 mg/week. |
| Therapeutic alternative | Notes / typical dosing or role |
|---|---|
| Methotrexate (MTX) | Conventional DMARD; typical trial ≥3 months at maximally indicated doses prior to biologic step for many indications (see indication sections). |
| Adalimumab products (e.g., Hadlima, Simlandi, Yusimry, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-fkjp) | Listed as preferred examples of adalimumab products in Appendix B; may be required as a prior trial or used for therapeutic redirection per payer SDC updates. Prior authorization may be required. |
| Taltz (ixekizumab) | Biologic alternative; listed as required prior therapy for several indications (e.g., PsO, AS, PsA) — typical maintenance dosing referenced in Appendix B. Prior authorization may be required. |
| Otezla / Otezla XR (apremilast) | Oral alternative listed for PsA and pediatric redirection in some cases; dosing regimens provided in Appendix B; may be required prior to Enbrel for PsA patients. |
| Ustekinumab products (e.g., Otulfi, Pyzchiva, Selarsdi, Steqeyma, Yesintek) | Interleukin-targeting biologics listed as therapeutic alternatives for PsO and PsA; specified products may be preferred per SDC updates and Appendix B dosing guidance. |
| Actemra (tocilizumab) | Non‑TNF biologic listed as a required prior therapy for some pediatric and adult indications (e.g., pJIA, RA) before Enbrel in certain scenarios. |
| Conventional agents (cyclosporine, acitretin, leflunomide, sulfasalazine, hydroxychloroquine, NSAIDs) | Listed in Appendix B as therapeutic alternatives or required conventional therapy trials depending on indication (e.g., MTX, cyclosporine, acitretin for PsO; NSAIDs for AS sacroiliitis). |
| SDC update / redirect | Effect on step therapy or preferred agent requirement |
|---|---|
| July SDC and subsequent SDC entries (adicap changes) | Per SDC updates, policy requires use of one preferred adalimumab product for multiple indications and lists specific preferred adalimumab products (Yusimry, Hadlima, unbranded adalimumab‑aaty, adalimumab‑adaz, adalimumab‑adbm, etc.) as redirection prior to or instead of etanercept. |
| SDC updates — indication‑specific redirections (Taltz, Xeljanz) | Applied redirection/step edits: Taltz and Xeljanz may be preferred or required in ankylosing spondylitis; Taltz preferred for plaque psoriasis; Otezla/Taltz/Xeljanz and other agents used for PsA and pediatric redirection per documented SDCs. |
| April/June/December SDCs and 2Q reviews | Multiple SDCs added or clarified preferred Stelara biosimilars and added adalimumab-adbm/Simlandi/unbranded adalimumab examples; updates adjust which agents are required or preferred before Enbrel across indications (see Coding Implications). |
Step therapy required before Enbrel for most indications
For most indications, authorization requires documented trial and inadequate response or intolerance to specified conventional therapies and/or other biologics (for example: an adalimumab product, Taltz, ustekinumab, Actemra, Otezla, MTX, NSAIDs, phototherapy) for the durations noted in the indication-specific criteria (commonly ≥3 months; NSAIDs in AS each ≥4 weeks).
- Failure or intolerance/contraindication to specified conventional DMARDs or biologics as listed per indication before Enbrel is authorized.
- Specified durations: commonly ≥3 months for DMARDs/biologics; NSAIDs in AS each ≥4 weeks.
Therapeutic alternatives listed; some agents may be preferred
Therapeutic alternatives are listed in Appendix B and may be preferred; listed agents (adalimumab products, Otezla, Taltz, ustekinumab, Actemra, Xeljanz, etc.) may require prior authorization and are included as alternatives or preferred agents in indication-specific step edits.
- Appendix B provides dosing and preferred/alternative listings for agents such as adalimumab products, Otezla (apremilast), Taltz (ixekizumab), ustekinumab products, Actemra, and Xeljanz.
- Alternatives may require prior authorization per the indication-specific criteria.
Step therapy and redirection updated by SDCs
Multiple SDC updates have applied step edits and redirection to preferred agents across indications (notably requiring use of one adalimumab product and listing preferred adalimumab products; adding preferred use of Taltz, Xeljanz, Actemra, Otezla, Kevzara, Olumiant in certain indications).
- July SDC added requirement to use one adalimumab product and named preferred adalimumab examples.
- SDC updates added indication-specific preferred agents (e.g., Taltz and Xeljanz for AS; Taltz for PsO; Actemra/Xeljanz for pJIA; Otezla/Taltz/Xeljanz for PsA; Actemra/Kevzara/Xeljanz/Olumiant for RA).
Provider Requirements, Documentation, and Billing
Prior authorization required
Prior authorization is required for etanercept and may also be required for certain comparator agents (examples: adalimumab products, Taltz, Actemra, Xeljanz/Xeljanz XR, ustekinumab, Otezla) as specified within the indication criteria.
- Prior authorization may be specifically required for adalimumab products, Xeljanz/Xeljanz XR, and Taltz per indication notes.
PA required and combination therapy prohibited
Prior authorization is required and etanercept must not be used in combination with other biologic DMARDs, JAK inhibitors, anti‑CD20 antibodies, or other specified immunomodulators; combination therapy is not authorized due to additive immunosuppression and infection risk.
- See Section III: coverage is NOT authorized for combination use with listed agents (e.g., other TNF antagonists, interleukin agents, JAK inhibitors, Rituxan and its biosimilars, Orencia, Entyvio, Sotyktu, Velsipity).
PA includes therapeutic redirection to preferred biologics
Prior authorization processes include therapeutic redirection/step edits requiring use of preferred biologic products or specified alternatives before etanercept in some indications per SDC updates.
- SDC-driven redirection examples: required use of one adalimumab product prior to enbrel in multiple indications; indication-specific redirection to Taltz, Otezla, Actemra, Xeljanz as noted.
Submit office notes, labs, and clinical records with PA requests
Submit supporting clinical documentation with the prior authorization request, such as office chart notes, laboratory results, and other clinical information demonstrating that the member meets all approval criteria.
- Examples of acceptable documentation include records of prior therapy trials, treatment durations, prescriber consultation notes, and relevant lab values.
Document clinical response to support continuation requests
Document evidence of clinical response when requesting continuation: acceptable examples include reduction in joint pain/swelling/tenderness, improvement in ESR/CRP, or improvements in activities of daily living.
- For RA continuation, decreased CDAI or RAPID3 from baseline is expected when available; other indications require clinical response documentation.
Denial triggers: insufficient documentation or disallowed combinations
Requests may be denied if documentation does not demonstrate the member has met all approval criteria, or if the request involves prohibited combination therapy or other policy exclusions.
- Insufficient documentation of prior trials or response is a common denial trigger.
- Requests for concurrent use with other bDMARDs, JAK inhibitors, or listed agents will be denied as not authorized.
Prohibited combination agents/classes (do not co-administer)
The policy explicitly prohibits concurrent use of etanercept with the listed biologics and classes (including other TNF antagonists, interleukin agents such as Taltz, Stelara and biosimilars, JAK inhibitors, anti‑CD20 antibodies, Orencia, Entyvio, Sotyktu, Velsipity) because of additive immunosuppression and increased infection/neutropenia risk.
- Examples of named agents/classes: Arcalyst, Bimzelx, Cosentyx, Ilaris, Ilumya, Kevzara, Kineret, Omvoh, Siliq, Skyrizi, Spevigo, Stelara and its biosimilars, Taltz, Tremfya, JAK inhibitors (Cibinqo, Olumiant, Rinvoq, Xeljanz/Xeljanz XR), Rituxan and its biosimilars, Orencia, Entyvio, Sotyktu, Velsipity.
Reference current coding guidance (HCPCS J1438 referenced)
Follow current professional coding guidance when submitting claims; the policy references HCPCS J1438 for etanercept 25 mg injection (note: J1438 may be used for Medicare when physician‑administered).
- Codes listed in the policy are informational only; verify up-to-date coding rules prior to claim submission.
Coding inclusion/exclusion does not guarantee coverage
Inclusion or exclusion of specific codes in this policy does not guarantee coverage; providers must verify that coding aligns with current professional guidance before submitting claims.
- Codes in the policy are for informational purposes only.
Use HCPCS J1438 for physician‑administered dosing in office/infusion center
When etanercept is administered under direct physician supervision in an office or infusion center (Medicare context), HCPCS J1438 may be used; J1438 is not appropriate when the drug is self‑administered.
- J1438 description: Injection, etanercept, 25 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self‑administered).
Billing Codes and Quantity Limits
| J1438 | Injection, etanercept, 25 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered) |
| J1438 | Injection, etanercept, 25 mg (code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug is self-administered) |
Administration Site and Biosimilar Direction
HCPCS J1438 use limited to physician‑administered settings
HCPCS J1438 may be used only when etanercept is administered under direct physician supervision (e.g., in an office or infusion center); it is not for use when the drug is self‑administered.
- Confirm site-of-care coding aligns with payer and Medicare rules before billing.
Preferred adalimumab products specified for redirection
SDC updates designate specific adalimumab products as preferred for redirection across indications (examples named include Yusimry, Hadlima, unbranded adalimumab‑fkjp, unbranded adalimumab‑adaz, adalimumab‑adbm, Simlandi, unbranded adalimumab‑aaty).
- July and subsequent SDCs added or expanded the list of preferred adalimumab products used for therapeutic redirection prior to etanercept.
Quick Actions and Denial Risks
Common denial reasons and required supporting documentation
Common denial reasons include insufficient documentation of required prior therapy trials or response, requests that involve prohibited combination therapy, and failure to meet indication‑specific criteria.
- Ensure submitted records show trial durations, reasons for discontinuation, prescriber specialty, and objective measures of response when applicable.
Billing reminder: verify coding (HCPCS J1438 cited)
Billing submissions should reference current professional coding guidance; HCPCS J1438 is cited in this policy for etanercept 25 mg injection but providers must confirm correct code use for the member’s situation.
- Codes referenced in the policy are informational; verify payer-specific and up-to-date coding rules prior to claim submission.
Definitions and Background
Etanercept (Enbrel) is a tumor necrosis factor (TNF) blocker used to treat multiple inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and moderate‑to‑severe plaque psoriasis. The policy ties authorization to prior trials of conventional DMARDs or specified biologics and includes dosing/administration details and safety considerations (e.g., infection risk) consistent with TNF‑blocker class guidance.
Policy Updates and Revision Timeline
July SDC added requirement for use of one adalimumab product across all indications and designated Yusimry, Hadlima, unbranded adalimumab-fkjp, and unbranded adalimumab-adaz as preferred; updated Appendix B (coding implications).
2Q 2024 annual review updated Appendix D (removed Hidradenitis Suppurativa guideline supplemental information) and added multiple agents to section III.B; references were reviewed and updated.
Per June/July SDCs, adalimumab-adbm and Simlandi were added to examples of preferred adalimumab products; unbranded adalimumab-aaty was also added to the preferred list.
2Q 2025 annual review revised pJIA criteria: removed minimum cJADAS-10 > 8.5 and baseline 10-joint cJADAS requirement from initial criteria and removed requirement to document response by decrease in cJADAS-10 in continued therapy; Appendix I updated with pJIA disease activity information per 2019 ACR guidance and section III.B updated.
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