CurrentNeighborhood Health Plan of Rhode IslandPolicy 2156-A

Guselkumab (Tremfya) — Prior Authorization and Coverage Criteria

This policy defines prior authorization, clinical criteria, documentation, prescriber specialty, and renewal requirements for guselkumab (Tremfya) for adults with plaque psoriasis, psoriatic arthritis, or moderately to severely active ulcerative colitis under Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGuselkumab (Tremfya) — Prior Authorization and Coverage Criteria

Policy CodePolicy 2156-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of indication-specific criteria and a negative TB test for biologic‑naïve patients.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

>=10% BSApsoriasis coverage threshold

TB test within 6 monthsTB screening requirement

Specialty restrictedprescriber requirement

14references cited

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria by Indication

Initial and renewal coverage criteria by indication

Covered when the FDA-approved indication is present and ALL relevant indication-specific criteria are met.

Indication and general requirements

Indication-specific paths: See child nodes for Psoriasis, Psoriatic arthritis, and Ulcerative colitis criteria

Plaque psoriasis criteria

Prior biologic or targeted synthetic therapy: Member has previously received a biologic or targeted synthetic drug indicated for moderate to severe plaque psoriasis (e.g., Sotyktu, Otezla).
Reference prior‑use pathway
Crucial body areas affected: Crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas) are affected.
>=10% BSA: >= 10% of body surface area (BSA) is affected.>= 10% BSA
3% BSA plus additional requirement
- Inadequate response to phototherapy or systemic agents: Member has had an inadequate response or intolerance to phototherapy (e.g., UVB, PUVA) OR to pharmacologic treatment with methotrexate, cyclosporine, or acitretin.
  Document prior therapies and response
- Clinical reason to avoid systemic agents: Member has a clinical reason to avoid pharmacologic treatment with methotrexate, cyclosporine, or acitretin.
  See Appendix for acceptable clinical reasons

Psoriatic arthritis criteria

Prior biologic or targeted synthetic therapy: Member has previously received a biologic or targeted synthetic drug indicated for active psoriatic arthritis (e.g., Rinvoq, Otezla).
Reference prior‑use pathway
Inadequate response to conventional synthetic DMARD: Member has mild to moderate disease and has had an inadequate response to methotrexate, leflunomide, or another conventional synthetic drug (e.g., sulfasalazine) administered at an adequate dose and duration.
Document dose and duration
Intolerance or contraindication to conventional DMARD: Member has an intolerance or contraindication to methotrexate, leflunomide, or another conventional synthetic drug (e.g., sulfasalazine).
Document clinical reason
Enthesitis: Member has enthesitis.

Ulcerative colitis criteria: Authorization may be granted for 12 months for adults with moderately to severely active ulcerative colitis when treatment goals are remission or maintenance of a positive clinical response as evidenced by improvement from baseline in clinical measures.

Improvements may include stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, mucosal appearance on imaging/endoscopy, or validated disease activity scores (e.g., UCEIS, Mayo)

Any indications for guselkumab (Tremfya) that are not among the FDA‑approved uses — moderate to severe plaque psoriasis, active psoriatic arthritis, or moderately to severely active ulcerative colitis in adults — are considered experimental/investigational and are not covered under this policy.

This document contains confidential and proprietary information of CVS Caremark and may not be reproduced, distributed, or printed without written permission. Brand names and trademarks referenced (including prescription drug trademarks) are the property of their respective manufacturers and are not affiliated with CVS Caremark.

Use of guselkumab for non–FDA‑approved indications is considered not medically necessary and will not be authorized through this policy.

Drug and Coding References

Drug referencedmixed

Tremfya

guselkumab (brand name listed in document)

Body Surface Area (BSA) threshold — inv-06

Primary BSA thresholdAt least 10% of body surface area (BSA) affected for coverage

Alternative lower BSA pathwayAt least 3% BSA affected PLUS either inadequate response/intolerance to phototherapy (e.g., UVB, PUVA) or to methotrexate, cyclosporine, or acitretin, or a clinical reason to avoid those agents

Authorization duration when criteria metAuthorization of 12 months may be granted when PsO criteria (including BSA thresholds) are met

Prior Authorization, Documentation, and Screening Requirements

Prior Authorization

Prior authorization duration and general requirement

Authorization of 12 months may be granted when clinical criteria for the specific indication are met (psoriasis, psoriatic arthritis, ulcerative colitis). Prior authorization may be granted for 12 months for adult members who have previously received a biologic or targeted synthetic drug indicated for the relevant condition.

Authorization duration: 12 months when criteria met
Includes prior biologic/targeted synthetic exposure criteria where specified

Note

Prior authorization — administrative note

No specific prior authorization submission instructions or billing codes are provided in this section. Providers should follow standard PA submission processes and include required documentation described elsewhere in the policy.

Drug Background and Indications

Guselkumab (Tremfya) is approved for three adult indications: moderate to severe plaque psoriasis (PsO) in patients who are candidates for systemic therapy or phototherapy, active psoriatic arthritis (PsA), and moderately to severely active ulcerative colitis (UC). The policy aligns authorization and renewal with these FDA‑approved indications and specifies that any other uses are considered experimental/investigational and not medically necessary.

Key Definitions and Clinical Terms

Crucial body areas — inv-20

Listed crucial body areasHands, feet, face, neck, scalp, genitals/groin, and intertriginous areas

Use in criteria logicPresence of involvement in any of these crucial areas qualifies for authorization under plaque psoriasis criteria

Documentation requirementChart notes or medical record documentation of affected area(s) and BSA required for initial requests

Positive clinical response / improvement — inv-21

Psoriasis — measurable improvementReduction in body surface area (BSA) affected from baseline

Psoriasis — symptom improvement examplesImprovement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling, burning, cracking, pain)

Policy Revision History

2024-09reference_updateLatest

Package insert for Tremfya (guselkumab) dated September 2024 cited in references.

2024copyright

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGuselkumab (Tremfya) — Prior Authorization and Coverage Criteria

Policy CodePolicy 2156-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of indication-specific criteria and a negative TB test for biologic‑naïve patients.

SourceLink

On This Page

Severe disease: Member has severe psoriatic arthritis.

Step Therapy

Prior treatment / step requirements

For plaque psoriasis and psoriatic arthritis, coverage may require prior use of conventional systemic therapy or a biologic/targeted synthetic agent as detailed under the indication-specific criteria. For psoriasis, prior phototherapy or treatment with methotrexate, cyclosporine, or acitretin (or documented clinical reason to avoid them) may be required when BSA criteria are met. For psoriatic arthritis, prior use of methotrexate, leflunomide, or another conventional synthetic agent (or documented intolerance/contraindication) may be required.

Psoriasis: prior phototherapy or methotrexate/cyclosporine/acitretin unless contraindicated or clinically inappropriate
PsA: prior methotrexate, leflunomide, or another conventional synthetic agent unless contraindicated or clinically inappropriate

Note

Step therapy — absence note

No formal step therapy program is specified in this section (no multi-step mandatory sequencing or administrative step edits are provided). The policy describes prior treatment considerations within indication-specific medical criteria but does not define a separate step therapy requirement.

Documentation Required

Documentation requirements by indication

Initial and continuation documentation requirements vary by indication. For plaque psoriasis initial requests: include chart notes or medical record documentation of affected area(s) and Body Surface Area (BSA) and documentation of prior therapies tried or clinical reasons to avoid them. For psoriatic arthritis initial requests: include chart notes, medical record documentation, or claims history supporting previous medications tried or reasons to avoid them. For ulcerative colitis continuation requests: provide chart notes or medical record documentation supporting a positive clinical response or remission.

Psoriasis initial: affected areas and BSA; prior medications tried or reason to avoid
Psoriasis continuation: documentation of decreased BSA and/or symptom improvement
PsA initial: prior medications tried or reason to avoid; PsA continuation: documentation of positive clinical response
UC continuation: documentation of clinical response or remission

Note

References

This section contains reference citations only; see the References list for clinical guidelines, product labeling, and consensus statements that inform the criteria.

Primary references include the Tremfya package insert and relevant guideline publications (AAD-NPF, EULAR, AGA, ACG, GRAPPA).

Denial Risk

TB screening and concomitant therapy restrictions

For all indications, a negative TB test (TST or IGRA) within 6 months is required for patients naïve to biologic or targeted synthetic drugs; if testing is positive, further evaluation to exclude active disease (e.g., chest x-ray) is required and latent TB must be treated prior to initiating therapy. Also, the requested medication must not be used concomitantly with another biologic or targeted synthetic drug for the same indication.

Negative TB test within 6 months for biologic/targeted synthetic–naïve patients
If TB test positive: additional testing to exclude active TB; do not administer if active TB; treat latent TB prior to therapy
No concomitant use with another biologic or targeted synthetic drug for the same indication

Psoriatic arthritis — response criteriaImprovement from baseline in number of swollen or tender joints, dactylitis, enthesitis, skin and/or nail involvement, functional status, or C-reactive protein (CRP)

Guideline and trial references — inv-22

Product labelingTremfya [package insert]. Janssen Biotech, Inc.; September 2024

Dermatology guidelinesAAD-NPF joint guidelines and related AAD sections for psoriasis and biologic use (Menter et al., 2009; 2011; 2019) cited

Psoriasis randomized trialsVOYAGE 1 & 2 randomized controlled trials assessing guselkumab versus adalimumab (Reich et al.; Blauvelt et al.)

Rheumatology and PsA guidanceEULAR, ACR, GRAPPA recommendations for management of psoriatic arthritis cited (Gossec et al.; Singh et al.; Coates et al.)