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This policy governs prior authorization, dosing limits, initial approval, and renewal requirements for intravenous or subcutaneous Tremfya (guselkumab) for plaque psoriasis, adult or juvenile psoriatic arthritis, ulcerative colitis, and Crohn's disease.
No material clinical or coverage changes in this revision.
5Covered disease indications
11 weeksInitial authorization for Crohn's disease or ulcerative colitis induction
12 monthsStandard renewal period
J1628HCPCS billing code
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3
Induction doses before maintenance
Initial and Renewal Coverage Criteria
Universal Initial Approval Criteria
Covered when ALL of the following universal criteria are met:
ALL of the following
Member is at least 18 years of age, unless otherwise specified by the applicable indication.
Physician has assessed baseline disease severity utilizing an objective measure or tool.
Provider confirms that the member is up to date with all age-appropriate vaccinations in accordance with current vaccination guidelines prior to initiating therapy.
Member has been evaluated and screened for latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for TB during treatment.
Member does not have an active infection, including clinically important localized infections.
Provider confirms that the member will not receive live vaccines during therapy.
Member is not receiving concurrent treatment with another biologic therapy or targeted synthetic therapy.
Baseline liver enzymes and bilirubin levels have been obtained prior to initiating therapy.
Adult Psoriatic Arthritis Initial Therapy
Covered when ALL applicable criteria are met:
ALL of the following
Member has documented moderate to severe active psoriatic arthritis.
ONE of the following treatment pathways
For predominantly axial disease or enthesitis: failure of at least a 4-week trial of ONE non-steroidal anti-inflammatory drug (NSAID), unless use is contraindicated.
For peripheral arthritis or dactylitis: failure of at least a 3-month trial of ONE conventional synthetic disease-modifying antirheumatic drug (csDMARD), such as methotrexate, azathioprine, sulfasalazine, leflunomide, or hydroxychloroquine.
Member is already established on biologic or targeted synthetic therapy for treatment of psoriatic arthritis.
Juvenile Psoriatic Arthritis Initial Therapy
Covered when ALL applicable criteria are met:
ALL of the following
Member is at least 6 years of age and weighs at least 40 kg.
Member has documented moderate to severe active polyarticular juvenile psoriatic arthritis.
Tremfya may be used as a single agent or in combination with a csDMARD, such as methotrexate.
ONE of the following treatment pathways
Member has had at least a 1-month trial and failure, unless contraindicated or intolerant, of previous therapy with either oral NSAIDs or csDMARDs, such as methotrexate, leflunomide, or sulfasalazine.
Ulcerative Colitis Initial Therapy
Covered when ALL applicable criteria are met:
ALL of the following
Member has documented moderate to severe active ulcerative colitis.
ONE of the following treatment pathways
Documented failure or ineffective response to a minimum 3-month trial of conventional therapy, including aminosalicylates, corticosteroids, or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate, at maximum tolerated doses, unless contraindicated or intolerant.
Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of a TNF modifier, such as adalimumab, golimumab, or infliximab.
Member is already established on biologic or targeted synthetic therapy for treatment of ulcerative colitis.
Crohn's Disease Initial Therapy
Covered when ALL applicable criteria are met:
ALL of the following
Member has documented moderate to severe active Crohn's disease.
ONE of the following treatment pathways
Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of corticosteroids or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate.
Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of a TNF modifier, such as adalimumab, certolizumab, or infliximab.
Member has evidence of high-risk disease for which corticosteroids or immunomodulators are inadequate and biologic therapy is necessary.
Continuation Therapy
Covered for renewal when ALL applicable criteria are met:
ALL of the following
Member continues to meet the universal and other indication-specific applicable criteria identified in the initial approval criteria.
There is an absence of unacceptable toxicity from the drug, including clinically important infections, severe hypersensitivity reactions, hepatotoxicity, or other unacceptable toxicity.
For plaque psoriasis or adult psoriatic arthritis, disease response is demonstrated
Plaque psoriasis: improvement in signs and symptoms compared with baseline, such as redness, thickness, scaliness, and/or reduced surface area involvement (total BSA involvement ≤ 1%), and/or improvement on a disease activity scoring tool such as PASI ≤ 3 or PGA ≤ 1.
Adult psoriatic arthritis: improvement in signs and symptoms compared with baseline, such as tender and swollen joint counts, C-reactive protein, patient global assessment, imaging findings on X-ray, ultrasound, or MRI, and/or a disease activity scoring tool.
Juvenile Psoriatic Arthritis Continuation
For renewal of juvenile psoriatic arthritis therapy, ALL applicable continuation criteria must be met:
ALL of the following
Member continues to meet the applicable universal and juvenile psoriatic arthritis criteria.
There is an absence of unacceptable toxicity from the drug.
Disease response is demonstrated by improvement in signs and symptoms compared with baseline, such as tender and swollen joint counts, C-reactive protein, patient global assessment, imaging findings on X-ray, ultrasound, or MRI, and/or improvement on a disease activity scoring tool, including at least 30% improvement from baseline in three of six variables on the ACR Pediatric (ACR-Pedi 30) or improvement on the Juvenile Arthritis Disease Activity Score (JADAS).
Ulcerative Colitis Maintenance Therapy
For ulcerative colitis maintenance therapy, ALL applicable criteria must be met:
ALL of the following
Member is starting maintenance therapy and has received three 200 mg intravenous or 400 mg subcutaneous induction doses at weeks 0, 4, and 8.
ONE of the following
Member has shown a beneficial disease response and/or no worsening of disease, with an absence of unacceptable toxicity, to the intravenous doses.
Member requires continuation of maintenance therapy.
Disease response is demonstrated by improvement in signs and symptoms compared with baseline, such as stool frequency, rectal bleeding, endoscopic activity, tapering or discontinuation of corticosteroid therapy, normalization of C-reactive protein (CRP) or fecal calprotectin (FC), and/or improvement on a disease activity scoring tool.
Crohn's Disease Maintenance Therapy
For Crohn's disease maintenance therapy, ALL applicable criteria must be met:
ALL of the following
Member is starting maintenance therapy and has received three 200 mg intravenous or 400 mg subcutaneous induction doses at weeks 0, 4, and 8.
ONE of the following
Member has shown a beneficial disease response and/or no worsening of disease, with an absence of unacceptable toxicity, to the induction doses.
Member requires continuation of maintenance therapy.
Disease response is demonstrated by improvement in signs and symptoms compared with baseline, such as endoscopic activity, number of liquid stools, abdominal pain, abdominal mass, body weight regain, hematocrit, extra-intestinal complications, use of antidiarrheal drugs, tapering or discontinuation of corticosteroid therapy, improvement in fecal calprotectin or serum C-reactive protein (CRP), and/or improvement on a disease activity scoring tool such as the Harvey-Bradshaw Index.
Coverage is excluded when the member is receiving concurrent treatment with another biologic therapy or targeted synthetic therapy.
Coverage is excluded when the member has an active infection, including a clinically important localized infection.
Coverage is excluded for live vaccine administration during therapy.
Renewal is excluded in the presence of unacceptable toxicity, including clinically important infection, severe hypersensitivity reactions, hepatotoxicity, or other unacceptable toxicity.
Tremfya 200 mg/2 mL single-dose prefilled pen or prefilled syringe
Intravenous NDCsNDC
57894-0650-xx
Tremfya 200 mg/20 mL (10 mg/mL) single-dose vial
Covered Diagnosis CodesICD-10Covered
K50.00
Crohn's disease of small intestine without complications.
K50.011
Crohn's disease of small intestine with rectal bleeding.
K50.012
Crohn's disease of small intestine with intestinal obstruction.
K50.013
Crohn's disease of small intestine with fistula.
K50.014
Crohn's disease of small intestine with abscess.
K50.018
Crohn's disease of small intestine with other complication.
K50.019
Crohn's disease of small intestine with unspecified complications.
K50.10
Crohn's disease of large intestine without complications.
K50.111
Crohn's disease of large intestine with rectal bleeding.
K50.112
Crohn's disease of large intestine with intestinal obstruction.
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Plaque Psoriasis Body Surface Area
Initial approval thresholdAt least 3% body surface area (BSA) involvement may support initial approval for plaque psoriasis.
Renewal response thresholdA total BSA involvement of ≤ 1% may demonstrate disease response at renewal.
Disease durationModerate to severe plaque psoriasis must be documented for at least 6 months.
Psoriasis Area and Severity Index
Initial approval thresholdA Psoriasis Area and Severity Index (PASI) score of 10 or greater may support initial approval.
Authorization, Documentation, and Denial Rules
Prior Authorization
Authorization Duration
Initial prior authorization is valid for 11 weeks for Crohn’s disease or ulcerative colitis induction therapy and for 6 months for all other initial indications. Renewal may be granted every 12 months (365 days) for maintenance therapy.
Crohn’s disease or ulcerative colitis: 11-week initial authorization for 3 intravenous or subcutaneous induction doses.
All other indications: 6-month (180-day) initial authorization.
Renewals: every 12 months (365 days), subject to renewal criteria.
Documentation Required
Universal Initial Approval Requirements
Before initiating Tremfya, document that the member meets the universal age, objective baseline assessment, vaccination, infection, laboratory, and concurrent-therapy safety requirements.
Policy Background
Tremfya (guselkumab) is authorized for selected inflammatory dermatologic, rheumatologic, and gastrointestinal diseases, including plaque psoriasis, adult and juvenile psoriatic arthritis, ulcerative colitis, and Crohn's disease. Coverage requires documentation supporting the applicable diagnosis, disease severity, prior-treatment history or established biologic therapy, and relevant safety and response information.
Disease Response Definitions
Disease Response in Juvenile Psoriatic Arthritis
Joint findingsImprovement may include reductions in tender and swollen joint counts.
Laboratory measureReduction of C-reactive protein may demonstrate disease response.
Patient and imaging measuresImprovement may include patient global assessment or imaging findings from X-ray, ultrasound, or MRI.
Disease activity toolsImprovement on JADAS or ACR-Pedi 30 may demonstrate response; ACR-Pedi 30 is defined as at least 30% improvement from baseline in three of six variables.
Disease Response in Ulcerative Colitis
Clinical symptomsResponse may include improvement in stool frequency and rectal bleeding.
Gastrointestinal Maintenance Continuation
Ulcerative Colitis Continuation
Covered when the ulcerative colitis continuation requirements are met.
Ulcerative colitis continuation: Member requires continuation of maintenance therapy or has shown beneficial disease response and/or no worsening of disease with absence of unacceptable toxicity to the induction doses, and disease response is documented.
Three induction doses are required before maintenance therapy.
Crohn's Disease Continuation
Covered when the Crohn's disease continuation requirements are met.
Crohn's disease continuation: Member requires continuation of maintenance therapy or has shown beneficial disease response and/or no worsening of disease with absence of unacceptable toxicity to the induction doses, and disease response is documented.
Three induction doses are required before maintenance therapy.
Tremfya may be used as a single agent or in combination with a csDMARD, such as methotrexate.
Member is already established on biologic or targeted synthetic therapy for treatment of juvenile psoriatic arthritis.
Member is already established on biologic or targeted synthetic therapy for treatment of Crohn's disease.
Renewal response threshold
A PASI score of ≤ 3 may demonstrate disease response at renewal.
Role in response assessmentPASI is an example of a disease activity scoring tool used to assess improvement compared with baseline.
Physician Global Assessment
Renewal response thresholdA physician global assessment (PGA) score of ≤ 1 may demonstrate disease response at renewal.
Additional response measureA total BSA involvement of ≤ 1% may demonstrate renewal response.
Additional scoring measureA PASI score of ≤ 3 may demonstrate renewal response.
Juvenile Psoriatic Arthritis Response
Required responseJuvenile psoriatic arthritis disease response is demonstrated by improvement in signs and symptoms compared with baseline.
ACR-Pedi 30 pathwayResponse may be demonstrated by at least 30% improvement from baseline in three of six variables using ACR-Pedi 30.
Comparable assessmentComparable improvement on a disease activity scoring tool such as the Juvenile Arthritis Disease Activity Score (JADAS) may also demonstrate response.
ACR-Pedi 30 Response
Minimum improvementAt least 30% improvement from baseline is required for an ACR-Pedi 30 response.
Variables meeting thresholdThe improvement must occur in three of six variables.
Assessment basisResponse is evaluated by comparing disease findings with baseline, including joint counts, C-reactive protein, patient global assessment, imaging, or a disease activity score.
Member is at least 18 years of age unless an indication-specific criterion specifies otherwise.
Physician has assessed baseline disease severity using an objective measure or tool.
Member is up to date with age-appropriate vaccinations under current guidelines.
Member was evaluated and screened for latent tuberculosis, with ongoing TB monitoring during treatment.
Member has no active infection, including clinically important localized infection.
Member will not receive live vaccines during therapy.
Member is not receiving another biologic or targeted synthetic therapy concurrently.
Baseline liver enzymes and bilirubin levels were obtained before initiation.
Prior Authorization
Renewal Requirements
Renewal requests must show continued eligibility under the universal and applicable indication-specific criteria, no unacceptable toxicity, and an appropriate treatment response.
Document continued fulfillment of relevant universal and indication-specific criteria.
Document absence of unacceptable toxicity, including clinically important infection, severe hypersensitivity reaction, or hepatotoxicity.
Document improvement in disease signs, symptoms, objective measures, or disease activity scores compared with baseline.
For ulcerative colitis or Crohn’s disease maintenance, document the applicable induction-dose history and beneficial response, no worsening, or need for continued maintenance therapy.
Prior Authorization
Clinical Authorization Required
Clinical authorization is required for Tremfya. Submit indication-specific clinical documentation establishing the diagnosis, disease activity and severity, relevant manifestations, prior treatment history and outcomes, and any contraindications or intolerance supporting the requested therapy.
Include clinical findings and objective measures appropriate to the indication.
For inflammatory bowel disease, include induction history, response, and maintenance-therapy rationale when applicable.
Document contraindications, intolerance, or high-risk disease when these support an alternative to required prior therapy.
Note
NQTL Prior-Authorization Factors
For this medical-benefit drug, prior authorization was designed using indication and drug cost as factors. Safety and efficacy and potential misuse or abuse were not priority factors in applying the limitation.
Indication: considered for prior authorization.
Cost of drug: considered for prior authorization.
Safety and efficacy: prior authorization was not a priority factor.
Potential for misuse or abuse: prior authorization was not a priority factor.
Step Therapy
Plaque Psoriasis Prior Therapy
For plaque psoriasis, document the required prior treatment history unless the member is already established on biologic or targeted synthetic therapy or has greater than 10% body-surface-area involvement.
At least a 4-week trial of topical agents, with inadequate response or documentation that the member is not a candidate.
At least a 3-month trial of at least one non-biologic systemic agent, with inadequate response or documentation that the member is not a candidate.
At least a 3-month trial of phototherapy, such as PUVA or UVB with coal tar or dithranol, with inadequate response or documentation that the member is not a candidate.
Also document moderate to severe plaque psoriasis for at least 6 months and at least one severity feature: BSA involvement of at least 3%, PASI of at least 10, or incapacitating/serious emotional consequences from lesion location or intractable pruritus.
Step Therapy
Adult Psoriatic Arthritis Prior Therapy
For adult psoriatic arthritis, document the pathway-appropriate prior therapy based on the member’s disease presentation, unless the member is already established on biologic or targeted synthetic therapy.
Predominantly axial disease or enthesitis: failure of at least a 4-week trial of one NSAID, unless contraindicated.
Peripheral arthritis or dactylitis: failure of at least a 3-month trial of one conventional synthetic DMARD, such as methotrexate, azathioprine, sulfasalazine, leflunomide, or hydroxychloroquine.
Document moderate to severe active disease.
Tremfya may be used alone or with a conventional synthetic DMARD.
Step Therapy
Juvenile Psoriatic Arthritis Prior Therapy
For juvenile psoriatic arthritis, document moderate to severe active polyarticular disease and the required prior treatment trial, unless the member is already established on biologic or targeted synthetic therapy.
Member must be at least 6 years of age and weigh at least 40 kg.
Document at least a 1-month trial and failure of oral NSAIDs or a conventional synthetic DMARD, unless contraindicated or intolerant.
Tremfya may be used alone or with a conventional synthetic DMARD.
Unsupported block type: step_therapy
Unsupported block type: step_therapy
Documentation Required
Universal Baseline Documentation
The authorization request must include baseline information needed to evaluate eligibility and medical necessity, including age, objective disease severity, vaccination status, infection screening, laboratory results, and concurrent therapy.
Member age and, when applicable, weight.
Objective baseline disease-severity measure or assessment tool.
Confirmation of age-appropriate vaccination status and that live vaccines will be avoided during therapy.
Latent TB screening and plan for ongoing monitoring, infection assessment, baseline liver enzymes, and bilirubin.
Current biologic or targeted synthetic therapy status.
Documentation Required
Indication-Specific Medical Necessity
Document the indication-specific diagnosis and medical-necessity elements, including disease severity, manifestations, prior treatment outcomes, and relevant contraindications or intolerance.
Plaque psoriasis: duration, BSA/PASI or location-related impact, and required topical, phototherapy, systemic, or biologic treatment history.
Adult or juvenile psoriatic arthritis: active disease, age/weight when applicable, disease presentation, and NSAID or DMARD history.
Ulcerative colitis or Crohn’s disease: active disease severity, conventional or TNF-modifier treatment outcomes, contraindications/intolerance, high-risk disease when applicable, and established biologic or targeted synthetic therapy status.
Documentation Required
Renewal Documentation
Renewal documentation must address continued eligibility, toxicity, response to treatment, and any indication-specific maintenance requirement.
Confirm continued universal and applicable indication-specific eligibility.
Report unacceptable toxicity or its absence, including important infections, severe hypersensitivity, and hepatotoxicity.
Provide disease-response findings compared with baseline, including clinical signs and symptoms, laboratory or biomarker results, imaging, or validated disease-activity measures.
For ulcerative colitis or Crohn’s disease, document three induction doses at Weeks 0, 4, and 8 when starting maintenance and the required response, absence of worsening, or continued-maintenance rationale.
Billing Rule
Dose and Quantity Documentation
Document the requested Tremfya dose, administration schedule, indication, and corresponding HCPCS billable-unit quantity so the request can be evaluated against policy limits.
Plaque psoriasis or psoriatic arthritis: 100 billable units at Weeks 0 and 4, then every 56 days.
Crohn’s disease or ulcerative colitis: 400 billable units at Weeks 0, 4, and 8, then 200 billable units every 28 days.
Documentation Required
Disease Response Documentation
For renewal, provide objective evidence of disease response or stability appropriate to the treated condition, including clinical findings and laboratory, biomarker, imaging, or validated scoring results.
Psoriatic arthritis: tender/swollen joint counts, CRP, patient global assessment, imaging, or disease-activity scores; for juvenile disease, include measures such as JADAS or ACR-Pedi 30 improvement.
Ulcerative colitis: stool frequency, rectal bleeding, endoscopic activity, steroid tapering/discontinuation, CRP or fecal calprotectin, or disease-activity score.
Crohn’s disease: endoscopic activity, liquid stools, abdominal pain or mass, weight regain, hematocrit, extra-intestinal complications, antidiarrheal use, steroid tapering/discontinuation, CRP or fecal calprotectin, or disease-activity score.
Documentation Required
Induction and Maintenance History
For ulcerative colitis or Crohn’s disease maintenance authorization, document completion of the three-dose induction course at Weeks 0, 4, and 8 and the subsequent response or clinical rationale for continuing maintenance.
Induction consists of three 200 mg intravenous or 400 mg subcutaneous doses at Weeks 0, 4, and 8.
For initial maintenance, document beneficial response or no worsening and absence of unacceptable toxicity from induction doses.
For continued maintenance, document ongoing disease response and the need to continue therapy.
Denial Risk
Universal Criteria Not Met
Requests may be denied when universal eligibility or safety requirements are not met or cannot be documented.
Member does not meet the applicable age requirement.
Baseline disease severity was not assessed with an objective measure or tool.
Vaccination, latent-TB screening/monitoring, infection, live-vaccine, concurrent-therapy, liver-enzyme, or bilirubin requirements are not satisfied.
An active infection, concurrent biologic or targeted synthetic therapy, or other specified safety concern is present.
Denial Risk
Indication-Specific Criteria Not Met
Requests may be denied or restricted when the indication-specific diagnosis, severity, age or weight, prior-treatment, contraindication, or response requirements are not met or documented.
The requested indication or required disease severity is not established.
Applicable age or weight requirements are not met.
Required topical, phototherapy, systemic, NSAID, DMARD, conventional, or TNF-modifier treatment history is absent, inadequate, or not appropriately excepted.
Required treatment response, contraindication, intolerance, high-risk disease, or established-therapy exception is not documented.
Denial Risk
Insufficient Response or Unacceptable Toxicity
Renewal may be denied when the member no longer meets eligibility criteria, has unacceptable toxicity, or has insufficient clinical response or worsening disease.
Universal or indication-specific renewal criteria are no longer met.
Unacceptable toxicity is present, including clinically important infection, severe hypersensitivity, or hepatotoxicity.
Objective signs, symptoms, laboratory or biomarker results, imaging, or disease-activity measures do not show adequate response or stability.
Denial Risk
Dosing Limits Exceeded
Claims or authorization requests may be denied or restricted when the requested quantity, dose, or dosing interval exceeds the policy’s maximum billable-unit limits.
Plaque psoriasis or psoriatic arthritis: maximum 100 billable units at Weeks 0 and 4, then every 56 days.
Crohn’s disease or ulcerative colitis: maximum 400 billable units at Weeks 0, 4, and 8, then 200 billable units every 28 days.
Denial Risk
Maintenance Criteria Not Met
Ulcerative colitis or Crohn’s disease maintenance authorization may be denied when the required induction course, response, absence of worsening, toxicity assessment, or ongoing maintenance rationale is not documented.
Three induction doses at Weeks 0, 4, and 8 were not completed or cannot be verified when required.
Beneficial response or no worsening and absence of unacceptable toxicity are not demonstrated for initiation of maintenance.
For continued maintenance, disease response or a valid need for ongoing maintenance therapy is not documented.
Endoscopic responseImprovement in endoscopic activity may demonstrate disease response.
Corticosteroid useTapering or discontinuation of corticosteroid therapy may demonstrate response.
Laboratory and disease activity measuresResponse may include normalization of C-reactive protein or fecal calprotectin, and/or improvement on a disease activity scoring tool.
Disease Response in Crohn's Disease
Endoscopic and symptom responseResponse may include improvement in endoscopic activity, the number of liquid stools, abdominal pain, or abdominal mass.
Weight and hematologic responseBody weight regain or improvement in hematocrit may demonstrate disease response.
Complications and medication useResponse may include improvement in extra-intestinal complications, reduced antidiarrheal use, or tapering or discontinuation of corticosteroid therapy.
Biomarkers and disease activityResponse may include improvement in fecal calprotectin or serum C-reactive protein, and/or improvement on a disease activity score such as the Harvey-Bradshaw Index.