UnitedHealthcare Tremfya Prior Auth Coverage Update

Coverage Criteria for Tremfya (guselkumab)

Initial Therapy - Plaque Psoriasis

Initial therapy for moderate to severe plaque psoriasis — covered when ALL of the following are met

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

Severity or special-site involvement: (2)(a)(i) Greater than or equal to 3% body surface area involvement, or palmoplantar, facial, genital involvement, or severe scalp psoriasisBSA >= 3% or special-site involvement

Topical therapy failure: (2)(a)(ii) History of failure to one of the following topical therapies unless contraindicated or clinically significant adverse effects were experienced (document drug, date, and duration of trial): corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tarDocumented trial (drug, date, duration)

Methotrexate or prior targeted immunomodulator: (2)(b) Either: (i) History of failure to a 3 month trial of methotrexate at maximally indicated dose unless contraindicated (document date and duration), OR (ii) Prior treatment with a targeted immunomodulator FDA‑approved for plaque psoriasis documented by claims or medical records (document drug, date, duration)3 months for methotrexate

Concomitant therapy and prescriber: (3) Patient is not receiving Tremfya in combination with another targeted immunomodulator; AND (4) Prescribed by or in consultation with a dermatologist

Established users via sample/CarePath: Patients established on therapy via manufacturer supplied samples or Janssen CarePath assistance must meet initial authorization criteria as if new to therapy

Reauthorization - Plaque Psoriasis

Reauthorization for plaque psoriasis — covered when ALL of the following are met

Response: (1) Documentation of positive clinical response to Tremfya therapy

No combination therapy: (2) Patient is not receiving Tremfya in combination with another targeted immunomodulator

Initial Therapy - Psoriatic Arthritis

Initial therapy for psoriatic arthritis — covered when ALL of the following are met

Diagnosis: (1) Diagnosis of active psoriatic arthritis

Methotrexate or prior targeted immunomodulator or current therapy: (2) Either: (a) History of failure to a 3 month trial of methotrexate at the maximally indicated dose unless contraindicated (document date and duration); OR (b) Prior treatment with a targeted immunomodulator FDA‑approved for psoriatic arthritis documented by claims or medical records; OR (c) Current Tremfya therapy documented (and not established solely via manufacturer sample/CarePath)3 months for methotrexate

Concomitant therapy and prescriber: (3) Patient is not receiving Tremfya in combination with another targeted immunomodulator; AND (4) Prescribed by or in consultation with a rheumatologist or dermatologist

Established users via sample/CarePath:

Initial and Reauthorization - Ulcerative Colitis

Initial and continuation therapy for moderately to severely active ulcerative colitis — covered when specified criteria are met

Diagnosis: (1) Diagnosis of moderately to severely active ulcerative colitis

Loading dose or prior therapies: (2) Either: (a) Approved for loading dose of Tremfya under an active UnitedHealthcare medical benefit prior authorization; OR (b) One of the following: (i) Prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6‑mercaptopurine); OR (ii) Prior treatment with a targeted immunomodulator FDA‑approved for ulcerative colitis documented by claims or medical records

Established users via sample/CarePath: (2)(c) Current Tremfya therapy documented and not established solely via manufacturer sample or Janssen CarePath assistance

Concomitant therapy and prescriber: (3) Patient is not receiving Tremfya in combination with another targeted immunomodulator; AND (4) Prescribed by or in consultation with a gastroenterologist

Initial Therapy - Crohn's Disease

Initial therapy for moderately to severely active Crohn's disease — covered when ALL of the following are met

Diagnosis: (1) Diagnosis of moderately to severely active Crohn's disease

Loading dose or conventional therapy or prior biologic: (2) Either: (a) Patient has been approved for a loading dose of Tremfya under an active UnitedHealthcare medical benefit prior authorization; OR (b) One of the following: (i) History of failure to one of the following conventional therapies at up to maximally indicated doses unless contraindicated (corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate) documented with drug, date, and duration; OR (ii) Prior treatment with a targeted immunomodulator FDA‑approved for Crohn's disease documented by claims or medical records

Established users via sample/CarePath: (2)(c)(i) Current Tremfya therapy for Crohn's must be documented and not established solely via manufacturer supplied samples or Janssen CarePath assistance

Initial Therapy for Crohn's Disease (loading dose eligibility and alternatives)

Covered when ALL of the following are met:

Initial authorization core: (1) Patient meets baseline requirement per policy; AND (2) One of the following: (a) Patient has been approved for loading dose of Tremfya under an active UnitedHealthcare medical benefit for moderately to severely active Crohn's disease; OR (b.i) History of failure to one of the specified conventional therapies at maximally indicated doses unless contraindicated (corticosteroids, 6‑mercaptopurine, azathioprine, methotrexate) documented with drug, date, and duration; OR (b.ii) Prior treatment with an FDA‑approved targeted immunomodulator for Crohn's disease documented by claims or medical records; AND (3) Patient is not receiving Tremfya in combination with another targeted immunomodulator; AND (4) Prescribed by or in consultation with a gastroenterologist.

Patients established via manufacturer sample or Janssen CarePath assistance must meet initial authorization criteria as if new to therapy.

Reauthorization

Reauthorization approved when ALL of the following are met:

Reauthorization criteria: (1) Documentation of positive clinical response to Tremfya therapy; AND (2) Patient is not receiving Tremfya in combination with another targeted immunomodulator.

Use of Tremfya (guselkumab) in combination with another targeted immunomodulator is not permitted. Coverage for initiation or continuation requires that the patient is not receiving Tremfya in combination with another targeted immunomodulator as specified in the policy criteria.

Examples of prohibited combination targeted immunomodulators include, but are not limited to: Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, ustekinumab, Skyrizi (risankizumab), Cosentyx (secukinumab), Taltz (ixekizumab), Siliq (brodalumab), Ilumya (tildrakizumab), Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), Otezla (apremilast), Entyvio (vedolizumab), Omvoh (mirikizumab). Prescribers must ensure Tremfya is used as single‑agent targeted therapy; requests showing concurrent use with any of these agents will not meet the combination‑therapy requirement for coverage.

Initial Therapy - Drug-specific

Initial authorization per indication requires diagnosis plus specified prior therapy history or documentation of current therapy (with special rules for sample‑established users).

Plaque psoriasis initial (see details): See 'Initial Therapy - Plaque Psoriasis' criteria set

Psoriatic arthritis initial (see details): See 'Initial Therapy - Psoriatic Arthritis' criteria set

Ulcerative colitis initial (see details): See 'Initial and Reauthorization - Ulcerative Colitis' criteria set

Crohn's disease initial (see details): See 'Initial Therapy - Crohn's Disease' criteria set

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization and Approval Duration

Prior authorization is required for subcutaneous Tremfya for all covered indications. Approvals will be issued for 12 months.

Authorization duration: 12 months
For CT, KY, MS business only: a 30‑day trial requirement applies

Denial Risk

Triggers for Denial

Coverage may be denied if there is no documented diagnosis or if prior treatment history is not provided. Authorization may also be denied if Tremfya is prescribed in combination with another targeted immunomodulator.

Triggers for denial include: lack of documented diagnosis, absence of required prior trial or treatment documentation, or concurrent use with another targeted immunomodulator

Step Therapy Requirements and Documentation

Indication	Required prior trials / step	Documentation required
Plaque psoriasis
(1) ≥3% body surface area involvement or involvement of palmoplantar, facial, genital, or severe scalp psoriasis; AND (2) History of failure to one topical therapy (e.g., corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar) unless contraindicated; OR prior treatment with a targeted immunomodulator FDA‑approved for plaque psoriasis; OR current Tremfya therapy (with restrictions on establishment via manufacturer sample)
Document drug name, dates, and duration of topical trial(s) or prior targeted immunomodulator therapy, or claims/medical records showing current Tremfya use (include date and duration).

Indication	Required prior trials / step	Documentation required
Psoriatic arthritis
History of failure to a 3‑month trial of methotrexate at maximally indicated dose unless contraindicated; OR prior treatment with a targeted immunomodulator FDA‑approved for psoriatic arthritis; OR current Tremfya therapy (not established solely via manufacturer sample)
Document methotrexate trial (date and duration) or prior targeted immunomodulator (drug, date, duration) via claims history or submission of medical records.

Initial Therapy — Indication-Specific Requirements

Initial Therapy - Drug-specific

Initial authorization per indication requires diagnosis plus specified prior therapy history or documentation of current therapy (with special rules for sample‑established users).

Plaque psoriasis initial: See coverage criteria set 'Initial Therapy - Plaque Psoriasis'

Psoriatic arthritis initial: See coverage criteria set 'Initial Therapy - Psoriatic Arthritis'

Ulcerative colitis initial: See coverage criteria set 'Initial and Reauthorization - Ulcerative Colitis'

Continuation and Reauthorization Criteria

Continuation / Reauthorization

Reauthorization/continuation requirements across indications

General reauth: Documentation of positive clinical response to Tremfya therapy AND patient is not receiving Tremfya in combination with another targeted immunomodulator

Reauthorization / Continuation

Reauthorization and continuation rules

Continuation approval: Documentation of positive clinical response and no concurrent targeted immunomodulator use required for reauthorization. Authorization will be issued for 12 months (state‑specific exceptions may apply).

For Connecticut, Kentucky, and Mississippi business a 30‑day trial requirement applies instead of standard reauthorization duration.

Site of Care and Coding Considerations

Note

Supply limits, site-of-care programs, and use of claims/automated approvals

Supply limits and site-of-care programs may apply. UnitedHealthcare may use claims/medication history and automated approval processes which vary by program; automated approval logic and supply limits can affect approvals for site-of-care settings (e.g., infusion center).

UnitedHealthcare may use claim/medication history, diagnosis codes, and claim logic for automated approvals
Supply limits and site-of-care program rules may apply

Definitions and Background

inv-20: Tremfya (guselkumab) — drug definition and indications

Drug classInterleukin-23 inhibitor (guselkumab)

Brand / genericTremfya (guselkumab)

Approved indicationsModerate-to-severe plaque psoriasis; active psoriatic arthritis; moderately to severely active ulcerative colitis; moderately to severely active Crohn's disease

Formulation coveredSubcutaneous (prior authorization required)

Prescriber requirementsFor IBD indications, prescribed by or in consultation with a gastroenterologist

inv-21: Targeted immunomodulator — examples listed

OpenPayer

Prior Authorization / Medical Necessity - Tremfya (guselkumab)