CurrentCignaPolicy IP0673

Etanercept Products Prior Authorization Policy

Prior authorization policy for etanercept products (Enbrel and biosimilars) governing coverage criteria, required prescriber specialties, approval durations, FDA-approved and selected other supported indications, and conditions considered not medically necessary.

Policy Summary

PayerCigna

PolicyEtanercept Products Prior Authorization Policy

Policy CodePolicy IP0673

Change TypeSelected revisions and annual updates

Effective DateMar 15, 2026

Next Review Date

Key ActionSubmit prior authorization requests for etanercept products and document prior therapies, contraindications, objective measures, and treatment response per the policy; initial approvals require prescription by or consultation with an appropriate specialist.

SourceLink

POLICY UPDATE CHANGES

Examples of systemic medications added to Note for GVHD initial approvals (Imatinib, methotrexate, rezurock, Niktimvo, hydroxychloroquine, rituximab IV, ruxolitinib, ibrutinib, basiliximab, infliximab, sirolimus, pentostatin, tocilizumab IV, aldesleukin, vedolizumab).

For plaque psoriasis initial therapy, added a 3-month trial or prior intolerance to apremilast (Otezla/Otezla XR) or deucravacitinib (Sotyktu) as an exception to the requirement for a trial of one traditional systemic agent.

Modified contraindication language for methotrexate to 'according to the prescriber, the patient has a contraindication to methotrexate'.

Still's Disease was removed from 'Other Uses with Supportive Evidence'.

Otezla XR (apremilast extended-release tablets) was added to the Appendix under Oral Therapies/Targeted Synthetic Oral Small Molecular Drugs.

Policy creation noted: New policy dated 11/01/2024.

9Indications with explicit criteria covered

8Conditions listed as not medically necessary

multipleBiologic/targeted agents listed in appendix

3Notable revision dates included

IP0673Policy identifier

Coverage Summary & Policy Statement

This policy (Policy Number IP0673, effective 2026-03-15) covers etanercept products (Enbrel and biosimilars). Coverage is subject to prior authorization and indication-specific criteria; initial approvals require prescribing by or consultation with a specialist appropriate to the condition and approval durations are specified per indication.

Policy Statement / Prior Authorization Requirement

Prior Authorization is required and initial approval requires specialist prescribing or consultation; approval durations specified per indication.

ALL of the following

Prior Authorization required for benefit coverage of etanercept products.
Initial approval requires etanercept products to be prescribed by or in consultation with a physician who specializes in the condition being treated.
Approval durations are as noted in each indication; when expressed in months, 1 month = 30 days.

Initial Therapy — FDA-Approved Indications

Ankylosing Spondylitis (FDA-Approved Indication)

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

ANY of the following

A) Initial Therapy
- Approve for 6 months.
- Patient is > 18 years of age.
- The medication is prescribed by or in consultation with a rheumatologist.
B) Patient is Currently Receiving an Etanercept Product

Initial Therapy — Other Supported Indications

Continuation Therapy / Ongoing Authorization Criteria

Each indication's criteria group includes a continuation branch ("Patient is Currently Receiving an Etanercept Product") that requires objective measures and evidence of symptom improvement for continuation approvals. The policy defines 'Established on therapy' durations per indication; examples include 6 months for many adult indications, 3 months for plaque psoriasis, 4 months for pyoderma gangrenosum, and 1 month for graft-versus-host disease.

Continuation Therapy — by indication

Ankylosing Spondylitis — B) Patient is Currently Receiving an Etanercept Product

Approve for 1 year.
Patient has been established on therapy for at least 6 months.
ANY of the following

Provider Actions & Billing Guidance

Prior Authorization

Prior authorization required

Submit a prior authorization request for etanercept products. Initial approvals require the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated. Examples of appropriate specialists include rheumatologists, dermatologists, ophthalmologists, and oncologist/hematologist or transplant physicians (when relevant to the condition).

Initial approval requires specialist prescribing or consultation
Examples of specialists: rheumatologist, dermatologist, ophthalmologist, oncologist/hematologist/transplant physician

Documentation Required

Document prior therapies and response

Document prior therapy trials, any contraindications, objective measures used to assess response, and baseline symptoms when requesting continuation or renewal approvals. The policy lists specific examples of allowed prior therapies and objective measures by indication within the criteria (see indication-specific sections and notes).

Applicable Codes & Identifiers

Policy Identifiersmixed

IP0673

Coverage Policy Number (Etanercept Products Prior Authorization Policy)

Coverage Policy Numbermixed

IP0673

Coverage Policy Number listed multiple times in the appendix and footer

Clinical Evidence & References

Primary prescribing information — Enbrel prescribing information (Immunex/Amgen; October 2024). Guideline recommendations commonly support TNFi use for many of the listed inflammatory indications (see guideline summaries for ankylosing spondylitis, JIA, plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis).

Background & Definitions

Etanercept products are tumor necrosis factor inhibitors (TNFis) approved for multiple inflammatory conditions including ankylosing spondylitis, juvenile idiopathic arthritis (JIA), plaque psoriasis, psoriatic arthritis, and rheumatoid arthritis. Clinical guidelines frequently feature TNFis and commonly recommend them as treatment options for many of these conditions; other uses have supportive but variable evidence and are addressed with specific criteria in this policy.

Thresholds (compact operational references)

Established on therapy durationsvaries by indication: 3 months for plaque psoriasis; 4 months for pyoderma gangrenosum; 1 month for GVHD initial establishment; 6 months for many other indications

Age thresholdsJIA > 2 years; Psoriasis ≥ 4 years; Rheumatoid arthritis & Ankylosing spondylitis > 18 years; Graft-versus-host disease > 6 years; Pyoderma gangrenosum > 18 years; Psoriatic arthritis > 2 years

Objective inflammation for axial diseaseDefined as either CRP elevated beyond the reporting lab's upper limit of normal OR sacroiliitis reported on MRI

"Established on therapy" is defined per indication and examples of durations include: 6 months for many adult indications; 3 months for plaque psoriasis; 4 months for pyoderma gangrenosum; and 1 month for graft-versus-host disease.

Revision History & Change Log

11/01/2024policy_creation

Policy creation noted: New policy dated 11/01/2024.

10/15/2025annual_revision

Annual Revision (10/15/2025): Graft-versus-Host Disease: For initial approvals, modified requirement that patient has tried at least one conventional systemic treatment to at least one systemic treatment. Added examples of systemic medications to Note (Imatinib, methotrexate, Rezurock (belumosudil), Niktimvo (axatilimab-csfr), hydroxychloroquine, a rituximab IV product, ruxolitinib, ibrutinib, basiliximab, an infliximab IV product, sirolimus, pentostatin, a tocilizumab IV product, aldesleukin, and vedolizumab).

01/01/2026selected_revision

Policy Summary

PayerCigna

PolicyEtanercept Products Prior Authorization Policy

Policy CodePolicy IP0673

Change TypeSelected revisions and annual updates

Effective DateMar 15, 2026

Next Review Date

SourceLink

On This Page

Patient has been established on therapy for at least 6 months.

AND patient must meet at least one:

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, serum markers such as CRP or ESR).
Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, improved function or activities of daily living).

Juvenile Idiopathic Arthritis (JIA) (FDA-Approved Indication)

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

ANY of the following

A) Initial Therapy
- Approve for 6 months.
- Patient is > 2 years of age.
- AND patient meets ONE of
  - Patient has tried one other systemic medication for this condition (examples: methotrexate, sulfasalazine, leflunomide, NSAID). A previous trial of one biologic other than the requested drug also counts; a biosimilar of the requested biologic does not count.
  - Patient will be starting on therapy concurrently with methotrexate, sulfasalazine, or leflunomide.
  - Patient has an absolute contraindication to methotrexate, sulfasalazine, or leflunomide (examples: pregnancy, breastfeeding, alcoholic liver disease, immunodeficiency, blood dyscrasias).
  - Patient has aggressive disease, as determined by the prescriber.
- The medication is prescribed by or in consultation with a rheumatologist.
B) Patient is Currently Receiving an Etanercept Product
- Approve for 1 year.
- Patient has been established on therapy for at least 6 months.
- ANY of the following
  - When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: MD global, PGA, PDA, JDAS, cJDAS, JSpADA, serum markers (CRP, ESR), and/or reduced corticosteroid dosage).
  - Compared with baseline, patient experienced an improvement in at least one symptom (e.g., improved limitation of motion, less joint pain/tenderness, decreased morning stiffness or fatigue, improved function or activities of daily living).

Plaque Psoriasis (FDA-Approved Indication)

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

ANY of the following

A) Initial Therapy
- Approve for 3 months.
- Patient is ≥ 4 years of age.
- AND patient meets ONE of
  - Patient has tried at least one traditional systemic agent for psoriasis for at least 3 months, unless intolerant (examples: methotrexate, cyclosporine, acitretin). A 3-month trial of PUVA also counts. A biosimilar of the requested biologic does not count.
  - According to the prescriber, the patient has a contraindication to methotrexate.
- The medication is prescribed by or in consultation with a dermatologist.
B) Patient is Currently Receiving an Etanercept Product
- Approve for 1 year.
- Patient has been established on therapy for at least 3 months.
- Patient experienced a beneficial clinical response, defined as improvement from baseline in at least one of: estimated body surface area, erythema, induration/thickness, and/or scale.
- Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, itching, and/or burning).

Psoriatic Arthritis (FDA-Approved Indication)

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

ANY of the following

A) Initial Therapy
- Approve for 6 months.
- Patient is > 2 years of age.
- Medication prescribed by or in consultation with a rheumatologist or dermatologist.
B) Patient is Currently Receiving an Etanercept Product
- Approve for 1 year.
- Patient has been established on therapy for at least 6 months.
- ANY of the following
  - When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC enthesitis score, Leeds Dactylitis Instrument Score, Minimal Disease Activity, PsAID-12, serum markers like CRP/ESR).
  - Compared with baseline, patient experienced an improvement in at least one symptom (e.g., less joint pain, morning stiffness, fatigue; improved function or activities of daily living; decreased soft tissue swelling).

Rheumatoid Arthritis (FDA-Approved Indication)

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

ANY of the following

A) Initial Therapy
- Approve for 6 months.
- Patient is > 18 years of age.
- Patient has tried ONE conventional synthetic DMARD for at least 3 months (examples: methotrexate, leflunomide, hydroxychloroquine, sulfasalazine). Exception if patient has already had a 3-month trial of at least one biologic other than the requested drug; biosimilar does not count.
- Medication prescribed by or in consultation with a rheumatologist.
B) Patient is Currently Receiving an Etanercept Product
- Approve for 1 year.
- Patient has been established on therapy for at least 6 months.
- ANY of the following
  - Patient experienced a beneficial clinical response when assessed by at least one objective measure (examples: CDAI, DAS28-ESR or CRP, PAS-II, RAPID-3, SDAI).
  - Patient experienced an improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, fatigue; improved function or activities of daily living; decreased soft tissue swelling).

When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, serum markers such as CRP or ESR).

Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or stiffness, improved function or activities of daily living).

Juvenile Idiopathic Arthritis (JIA) — B) Patient is Currently Receiving an Etanercept Product

Approve for 1 year.
Patient has been established on therapy for at least 6 months.
ANY of the following
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: MD global, PGA, PDA, JDAS, cJDAS, JSpADA, serum markers such as CRP or ESR, and/or reduced corticosteroid dosage).
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., improved limitation of motion, less joint pain/tenderness, decreased morning stiffness or fatigue, improved function or activities of daily living).

Plaque Psoriasis — B) Patient is Currently Receiving an Etanercept Product

Approve for 1 year.
Patient has been established on therapy for at least 3 months.
Patient experienced a beneficial clinical response, defined as improvement from baseline in at least one of: estimated body surface area, erythema, induration/thickness, and/or scale.
Compared with baseline, patient experienced improvement in at least one symptom (e.g., decreased pain, itching, and/or burning).

Psoriatic Arthritis — B) Patient is Currently Receiving an Etanercept Product

Approve for 1 year.
Patient has been established on therapy for at least 6 months.
ANY of the following
- When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: DAPSA, CPDAI, PsA DAS, Grace Index, LEI, SPARCC enthesitis score, Leeds Dactylitis Instrument Score, Minimal Disease Activity, PsAID-12, serum markers like CRP/ESR).
- Compared with baseline, patient experienced an improvement in at least one symptom (e.g., less joint pain, morning stiffness, or fatigue; improved function or activities of daily living; decreased soft tissue swelling).

Rheumatoid Arthritis — B) Patient is Currently Receiving an Etanercept Product

Approve for 1 year.
Patient has been established on therapy for at least 6 months.
ANY of the following
- Patient experienced a beneficial clinical response when assessed by at least one objective measure (examples: CDAI, DAS28-ESR or CRP, PAS-II, RAPID-3, SDAI).
- Patient experienced an improvement in at least one symptom (e.g., decreased joint pain, morning stiffness, fatigue; improved function or activities of daily living; decreased soft tissue swelling in joints or tendon sheaths).

Other Uses — Combined B) Continuation Criteria

Graft-Versus-Host Disease: Approve for 3 months; patient established on therapy for at least 1 month; when assessed by at least one objective measure, patient experienced beneficial clinical response (examples: normalization of LFTs, RBC count, platelet count; resolution of fever or rash); or compared with baseline experienced improvement in symptoms (e.g., skin, oral mucosal, ocular, or GI).
Pyoderma Gangrenosum: Approve for 1 year; patient established on therapy for at least 4 months; experienced beneficial clinical response defined as improvement in size, depth, and/or number of lesions; or improvement in symptoms (e.g., decreased pain/tenderness).
Spondyloarthritis, Other Subtypes: Approve for 1 year; patient established on therapy for at least 6 months; when assessed by at least one objective measure, patient experienced beneficial clinical response (examples: ASDAS, serum markers such as CRP or ESR); or experienced improvement in at least one symptom (e.g., decreased pain or stiffness, improved function).

Document prior therapy trials and responses
Document contraindications and baseline symptoms
Document objective measures used to demonstrate benefit (examples provided per indication)

Billing Rule

Approval duration billing

Use the approval durations shown in the policy when authorizing coverage. When durations are expressed in months, 1 month = 30 days. Examples of approval durations by indication include: 1 month (graft-versus-host disease initial approvals), 3 months (plaque psoriasis initial approvals; some Other Uses initial approvals), 4 months (pyoderma gangrenosum initial approvals), 6 months (many initial adult indications such as ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, spondyloarthritis), and 1 year (renewal/established-on-therapy approvals for many indications).

1 month = 30 days (used for GVHD initial approval calculations)
3 months (e.g., plaque psoriasis initial therapy)
4 months (e.g., pyoderma gangrenosum initial therapy)
6 months (e.g., initial therapy for AS, PsA, RA, other adult indications)
1 year (typical duration for established-on-therapy renewals)

Documentation Required

Prescriber-determined contraindication to methotrexate

For initial therapy in plaque psoriasis, the policy permits that, according to the prescriber, the patient has a contraindication to methotrexate. Documentation supporting the prior prescriber determination should be provided in the request per the policy language.

Prescriber's determination that the patient has a contraindication to methotrexate is acceptable
Documentation should reflect the prescriber's determination per policy wording

Documentation Required

Prior systemic therapy requirement for GVHD

For graft-versus-host disease initial approvals, the policy requires that the patient has tried at least one systemic treatment (language was changed from 'conventional systemic treatment' to 'systemic treatment'). Document the prior systemic therapies tried; the policy provides an illustrative list of examples that may be applicable (e.g., systemic corticosteroids, antithymocyte globulin, cyclosporine, tacrolimus, mycophenolate mofetil, imatinib, methotrexate, belumosudil, axatilimab, hydroxychloroquine, rituximab IV, ruxolitinib, ibrutinib, basiliximab, infliximab IV, sirolimus, pentostatin, tocilizumab IV, aldesleukin IV, vedolizumab IV).

Requirement changed to trial of at least one systemic treatment (not limited to 'conventional' agents)
List the specific prior systemic therapies tried; examples are provided in the policy note

Selected Revision (01/01/2026): Plaque Psoriasis: For initial therapy, added a 3-month trial or prior intolerance to Otezla/Otezla XR (apremilast) or Sotyktu (deucravacitinib) as an exception to the requirement for a trial of one traditional systemic agent. Modified wording regarding contraindication to methotrexate to 'according to the prescriber, the patient has a contraindication to methotrexate'. Otezla XR added in Appendix under Oral Therapies.

03/15/2026selected_revisionLatest

Selected Revision (03/15/2026): Still's Disease: This condition of approval was removed from Other Uses with Supportive Evidence.

Revision Changes Summary — selected recent revisions: (1) Annual Revision (10/15/2025): For graft-versus-host disease initial approvals, the policy was revised to require trial of at least one systemic treatment and examples of systemic medications were added to the Note (e.g., imatinib, methotrexate, Rezurock, Niktimvo, hydroxychloroquine, rituximab IV, ruxolitinib, ibrutinib, basiliximab, infliximab IV, sirolimus, pentostatin, tocilizumab IV, aldesleukin IV, vedolizumab IV). (2) Selected Revision (01/01/2026): Plaque psoriasis initial-therapy note updated to allow a 3-month trial or prior intolerance to Otezla/Otezla XR (apremilast) or Sotyktu (deucravacitinib) as an exception to the trial of a traditional systemic agent; methotrexate contraindication wording clarified. (3) Selected Revision (03/15/2026): Still's Disease was removed from the "Other Uses with Supportive Evidence" section.