HCPCS
J1628
1 mg = 1 unit
Phase 1
Identify what you're billing
Two routes, two formulations, four indications — route + indication drives everything.
IV induction vs SC maintenance — the key billing split FDA verified May 2026
Tremfya is dual-formulation. The 2024 IBD approval introduced the IV vial. Route + indication determines benefit, code, and administration CPT.
Until 2024, Tremfya was a pure subcutaneous biologic for psoriasis and PsA — almost always self-administered through the pharmacy benefit. The 2024 Crohn's disease and ulcerative colitis approvals added an intravenous induction phase using a new 200 mg / 20 mL single-dose vial, followed by SC maintenance using the existing 100 mg/mL prefilled syringe or One-Press autoinjector (200 mg = two SC injections).
| IV induction (Crohn's / UC) | SC maintenance / psoriasis / PsA | |
|---|---|---|
| HCPCS | J1628 (1 mg = 1 unit) | J1628 (1 mg = 1 unit) when clinic-administered |
| Formulation | 200 mg / 20 mL single-dose vial (10 mg/mL) | 100 mg / 1 mL prefilled syringe; 100 mg / 1 mL One-Press autoinjector |
| NDC | 57894-640-01 | 57894-642-02 (PFS) / 57894-641-02 (One-Press) |
| Dose | 200 mg at weeks 0, 4, 8 (3 induction doses) | 100 mg q8wk (psoriasis/PsA) or 100–200 mg q4–8wk (IBD maint) |
| Admin CPT | 96365 + 96366 (therapeutic IV, ~1 hr) | 96372 (therapeutic SC injection) |
| Benefit | Medical benefit (clinic buy-and-bill) | Pharmacy benefit when self-administered; medical benefit when clinic-administered |
| Modifier | JZ (single-dose vial, no waste) | JZ (single-dose syringe/autoinjector, no waste) |
| Site | Office (POS 11) / AIC (POS 49) / HOPD (POS 19/22) | Office (POS 11) / patient home (POS 12) |
| Indication | Crohn's, UC (induction phase only) | Plaque psoriasis, PsA, IBD maintenance |
Why this split matters: An IBD patient may receive 3 IV induction doses (medical benefit, J1628 +
96365/96366) and then transition to SC maintenance — which can run through pharmacy benefit (specialty
pharmacy, NDC-based) or remain medical benefit if the clinic continues administering. PA and benefit
verification need to be set up for both legs.
Self-administered SC for psoriasis/PsA usually does NOT bill J1628. When a psoriasis patient
picks up Tremfya from a specialty pharmacy and injects at home, the drug is dispensed under the pharmacy benefit
and billed by NDC, not via J1628. J1628 applies when the dose is clinic-administered (rare for psoriasis,
common for IBD).
Dosing by indication FDA label 2024 IBD revision
From FDA prescribing information — label revised 2024 to add Crohn's and UC indications.
| Indication | Loading | Maintenance | Route | Units / dose |
|---|---|---|---|---|
| Plaque psoriasis (≥18 yr) | 100 mg SC at weeks 0, 4 | 100 mg SC every 8 weeks | SC | 100 units |
| Psoriatic arthritis (≥18 yr) | 100 mg SC at weeks 0, 4 | 100 mg SC every 8 weeks | SC | 100 units |
| Crohn's disease (≥18 yr, 2024) | 200 mg IV at weeks 0, 4, 8 | 100 mg or 200 mg SC at week 16, then q4–8wk | IV induction → SC maint | 200 (IV) / 100–200 (SC) |
| Ulcerative colitis (≥18 yr, 2024) | 200 mg IV at weeks 0, 4, 8 | 100 mg or 200 mg SC at week 16, then q4–8wk | IV induction → SC maint | 200 (IV) / 100–200 (SC) |
Year-1 dose count by indication
- Plaque psoriasis / PsA: 2 loading doses (weeks 0, 4) + 6 maintenance doses (q8wk for ~48 weeks) = ~8 doses, ~800 units total
- Crohn's / UC: 3 IV induction doses (200 mg each = 600 units) + ~6 SC maintenance doses (100–200 mg q4–8wk) = 1,200–1,800 units year 1 depending on q4 vs q8 cadence
Worked example — first-year billing for Crohn's induction-to-maintenance
# IV induction phase (medical benefit)
Doses: 3 (weeks 0, 4, 8) × 200 mg
HCPCS: J1628 × 200 units × 3 doses = 600 units
Modifier: JZ · Admin: 96365 + 96366
Drug cost: 600 × $67.813 = $40,687.80 (Q2 2026 ASP+6%)
# SC maintenance phase (medical or pharmacy benefit)
Doses: 6–7/year (100 mg q8wk) or 12–13/year (100 mg q4wk)
Lower-bound: 6 × 100 = 600 units · 6 × $6,781.30 = $40,687.80
Upper-bound (200 mg q4wk): 13 × 200 = 2,600 units · ~$176,313
# Year-1 totals (clinic-administered, mid-range)
Total drug units: ~1,200–1,800
Total drug cost: ~$81,000–$122,000 Year 1 (Medicare ASP+6%)
Doses: 3 (weeks 0, 4, 8) × 200 mg
HCPCS: J1628 × 200 units × 3 doses = 600 units
Modifier: JZ · Admin: 96365 + 96366
Drug cost: 600 × $67.813 = $40,687.80 (Q2 2026 ASP+6%)
# SC maintenance phase (medical or pharmacy benefit)
Doses: 6–7/year (100 mg q8wk) or 12–13/year (100 mg q4wk)
Lower-bound: 6 × 100 = 600 units · 6 × $6,781.30 = $40,687.80
Upper-bound (200 mg q4wk): 13 × 200 = 2,600 units · ~$176,313
# Year-1 totals (clinic-administered, mid-range)
Total drug units: ~1,200–1,800
Total drug cost: ~$81,000–$122,000 Year 1 (Medicare ASP+6%)
TB screening required pre-initiation
Per FDA label, evaluate patients for TB infection prior to initiating Tremfya. Treat latent TB before starting therapy. Monitor for active TB during and after treatment. This is a payer PA hard requirement — document the negative TB test in the PA submission.
NDC reference FDA NDC Directory verified May 2026
| NDC (10 / 11-digit) | Package | Route | Use |
|---|---|---|---|
57894-640-01 / 57894-0640-01 |
200 mg / 20 mL single-dose vial (10 mg/mL) | IV | IBD induction (Crohn's, UC) — weeks 0, 4, 8 |
57894-642-02 / 57894-0642-02 |
100 mg / 1 mL prefilled syringe (PFS) | SC | Psoriasis, PsA, IBD maintenance — clinician-administered or self-injected |
57894-641-02 / 57894-0641-02 |
100 mg / 1 mL One-Press patient-controlled injector | SC | Psoriasis, PsA, IBD maintenance — self-administration preferred device |
Match NDC to formulation precisely. Submitting the SC NDC (57894-642-02 or 57894-641-02) on
an IV induction claim will trigger an NDC mismatch denial. The 200 mg IV vial NDC is unique to the IBD
induction protocol — verify it is on the claim line for any 96365/96366 admin.
200 mg SC maintenance dose: when an IBD patient receives 200 mg SC, that's two
100 mg PFS or One-Press devices (each 1 mL). Bill 200 units total but document both NDC units and the second
injection on the claim.
IBD biologic class comparison Reviewed May 2026
Tremfya joins a crowded biologic landscape for moderate-to-severe Crohn's and UC. Mechanism, code, and admin pathway vary materially.
| Drug | HCPCS | Class / Target | Induction | Maintenance | Manufacturer |
|---|---|---|---|---|---|
| Tremfya (guselkumab) | J1628 |
IL-23 (anti-p19) | 200 mg IV wk 0/4/8 | 100–200 mg SC q4–8wk | Janssen |
| Skyrizi (risankizumab) | J2327 |
IL-23 (anti-p19) — same class | 600 mg IV wk 0/4/8 | 180 or 360 mg SC q8wk | AbbVie |
| Stelara (ustekinumab) | J3358 |
IL-12/23 (anti-p40, different epitope) | Weight-based IV (260/390/520 mg) | 90 mg SC q8wk | Janssen |
| Entyvio (vedolizumab) | J3380 |
Anti-α4β7 integrin (gut-selective) | 300 mg IV wk 0/2/6 | 300 mg IV q8wk or 108 mg SC q2wk | Takeda |
| Humira / biosimilars (adalimumab) | J0135 |
Anti-TNF | 160 mg SC wk 0, 80 mg wk 2 | 40 mg SC q2wk (qweekly possible) | AbbVie / multi |
| Remicade / biosimilars (infliximab) | J1745 |
Anti-TNF | 5 mg/kg IV wk 0/2/6 | 5–10 mg/kg IV q8wk | Janssen / multi |
Tremfya vs Skyrizi (head-to-head): both are anti-p19 IL-23 inhibitors with very similar IBD billing
patterns (IV induction → SC maintenance). Pricing per mg is comparable. Differentiators include dose
magnitude (Skyrizi induction is 600 mg vs Tremfya's 200 mg), maintenance cadence options, and manufacturer
contracting (CVS Cordavis / ESI Quallent PBM private-label arrangements often steer toward one). Step therapy
from anti-TNF (Humira/Remicade) is common before either IL-23.
Step therapy is the norm. Most major payers require failure or intolerance to anti-TNF
therapy (typically Humira or Remicade) before approving Tremfya for IBD. Some plans also require a trial
of Stelara (anti-p40, older mechanism) before allowing Tremfya. Document prior biologic exposure thoroughly
in the PA submission.
Phase 2
Code the claim
Therapeutic IV/SC codes — not chemo. Wrong admin code is the top denial.
Administration codes CPT verified May 2026
Tremfya is a non-chemotherapy biologic. Therapeutic infusion / injection codes apply — chemo admin codes do not.
| Code | Description | When to use |
|---|---|---|
96365 |
Therapeutic, prophylactic, or diagnostic IV infusion; up to 1 hour, single or initial substance/drug | Primary IV admin code for Tremfya induction (Crohn's/UC weeks 0, 4, 8). Standard ~1 hr infusion. |
96366 |
Therapeutic, prophylactic, or diagnostic IV infusion; each additional hour | Add-on to 96365 when infusion exceeds 1 hour. Document infusion start/stop times. |
96372 |
Therapeutic, prophylactic, or diagnostic injection; SC or IM | Primary SC admin code for clinic-administered Tremfya (psoriasis, PsA, IBD maintenance). |
96413 / 96415 |
Chemotherapy administration, IV infusion (initial / each additional hour) | NOT appropriate. Tremfya is non-chemo. CPT chemo admin codes do not apply to IL-23 inhibitors. |
96401 |
Chemotherapy administration, SC/IM; non-hormonal anti-neoplastic | NOT appropriate. Use 96372 for SC Tremfya. |
Why therapeutic and not chemo: CPT chemotherapy administration codes (96409–96425) apply to
complex anti-neoplastic regimens. Tremfya is a non-oncology biologic for inflammatory disease. Per AMA / CPT
Assistant guidance, IL-23 inhibitors and other non-oncology biologics use the therapeutic administration code
family (96365–96372). Pay-rate is materially lower than chemo admin codes — do not upcode.
Top denial fix: If a Tremfya IV claim was submitted with 96413/96415, resubmit with 96365 +
96366. Most MACs will recoup if 96413 is detected on a J1628 claim. Same for SC: if 96401 was billed,
resubmit with 96372.
Modifiers CMS verified May 2026
JZ — required on virtually every claim
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Both the Tremfya 200 mg IV vial and the 100 mg PFS / One-Press are single-dose and used in whole. JZ applies to virtually every Tremfya claim.
JW — rare for Tremfya
JW reports the discarded portion of a single-dose vial. Because Tremfya doses are full-vial (200 mg IV vial = 200 mg dose; 100 mg PFS = 100 mg dose), partial-vial waste is unusual. JW is only relevant if a clinical circumstance forces discarding part of a vial — e.g., contamination during reconstitution. Bill the discarded mg on a separate JW line. One of JZ or JW must be on every J1628 claim.
Modifier 25 — same-day E/M
Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion or injection. Routine pre-administration clinical assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired Tremfya, follow your MAC's current 340B modifier policy. Janssen's billing guide does not provide 340B-specific instructions for J1628.
ICD-10-CM by indication FY2026 verified May 2026
Four FDA-approved indications. Match the most specific ICD-10 supported by encounter documentation.
| Indication | ICD-10 family | Specific codes | Notes |
|---|---|---|---|
| Plaque psoriasis | L40.x |
L40.0 psoriasis vulgaris · L40.1 generalized pustular · L40.2 acrodermatitis continua · L40.3 palmoplantar pustulosis · L40.4 guttate · L40.50–L40.59 arthropathic · L40.8 other · L40.9 unspecified |
Most claims use L40.0 for plaque psoriasis |
| Psoriatic arthritis | L40.50–L40.59, M07.0x–M07.69 |
L40.50 arthropathic psoriasis unspec · L40.51 distal interphalangeal · L40.52 mutilans · L40.53 spondylitis · L40.54 juvenile · L40.59 other · M07.0x–M07.69 PsA with arthropathy by site |
Pair with appropriate site code (M07.6 etc.) when documented |
| Crohn's disease (2024) | K50.x |
K50.00–K50.019 small intestine · K50.10–K50.119 large intestine · K50.80–K50.819 both · K50.90–K50.919 unspecified (with/without complications) |
Use 5th/6th-character specificity for complications when documented |
| Ulcerative colitis (2024) | K51.x |
K51.00–K51.019 pancolitis · K51.20–K51.219 proctitis · K51.30–K51.319 rectosigmoiditis · K51.40–K51.419 pseudopolyposis · K51.50–K51.519 left-sided · K51.80–K51.919 other / unspecified |
Document active vs in-remission for line-of-therapy support |
Indication-specific PA criteria are the norm. Most payers require ICD-10 code, prior therapies,
line of therapy, AND severity documentation. The ICD-10 code alone is not sufficient for approval.
Site of care & place of service Verified May 2026
For Tremfya IV induction, UnitedHealthcare and Aetna run site-of-care UM steering biologic infusions out of HOPD into office or AIC settings. For SC maintenance, the question is more often medical vs pharmacy benefit rather than site of care.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician office | 11 | CMS-1500 / 837P | Preferred by commercial UM (IV + SC) |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM (IV induction) |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored after first IV induction; UM challenge likely |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored; site-of-care UM |
| Patient home (SC) | 12 | CMS-1500 / pharmacy benefit | Standard path for psoriasis/PsA SC self-administration |
SC maintenance benefit determination: for IBD patients transitioning from IV to SC maintenance,
verify whether the SC drug runs through medical benefit (clinic-administered, J1628) or pharmacy benefit
(specialty pharmacy dispensed, NDC-based). Failing to align benefit determination with patient circumstance
causes payment gaps and denials.
Claim form field mapping Janssen 2025
From Janssen CarePath HCP coding & coverage materials.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + NDC + ML + total volume (20 mL for IV vial; 1 mL for SC PFS / One-Press) |
| HCPCS J1628 + JZ | 24D (drug line) | Mark JZ on virtually every claim |
| Drug units | 24G | 100 (SC), 200 (IV induction or 200 mg SC) |
| CPT 96365 (+ 96366 if >1 hr) or 96372 | 24D (admin line) | 96365/96366 for IV; 96372 for SC. Not 96413/96415/96401. |
| ICD-10 | 21 | Indication-specific (L40.x / M07.x / K50.x / K51.x) |
| PA number | 23 | Required by all major payers |
Phase 3
Get paid
Step therapy from anti-TNF, TB screen, and benefit determination drive PA approval.
Payer policy snapshot + step therapy Reviewed May 2026
All major commercial payers require PA, indication-specific documentation, and step therapy from anti-TNF for IBD.
| Payer | PA? | Step therapy | Notes |
|---|---|---|---|
| UnitedHealthcare Med + Pharmacy Drug Policy |
Yes | Anti-TNF (Humira or Remicade) failure / intolerance for IBD; TNFi or other systemic for psoriasis/PsA | Strict TB screen documentation; 2024 IBD indication added to policy late 2024 |
| Aetna CPB + Medical Drug policies |
Yes | Anti-TNF for IBD; phototherapy or systemic for psoriasis | Site-of-care UM for IV induction; preferred biologic varies by employer plan |
| BCBS plans Vary by plan |
Yes | Generally aligned with AGA/AAD/ACR guidelines — anti-TNF first for IBD | Plan-specific preferred biologic; Skyrizi vs Tremfya parity in many plans |
| Medicare (LCDs) | No formal PA but indication review | Coverage follows FDA-approved indications + AGA/AAD guidelines | All MACs cover J1628 for on-label use; LCDs reference biologic-class hierarchy |
| CVS Cordavis / ESI Quallent | PBM private-label biologic programs | May steer to specific biologic by class | Watch for Tremfya vs Skyrizi steering in PBM-managed pharmacy benefit |
Step therapy — typical sequence
- Plaque psoriasis: topical → phototherapy or systemic (MTX, cyclosporine) → TNFi (Humira) → IL-23 (Tremfya / Skyrizi) or IL-17 (Cosentyx / Taltz)
- PsA: NSAID + DMARD (MTX) → TNFi → IL-23 / IL-17
- Crohn's / UC: 5-ASA / steroids / immunomodulator (Crohn's may skip 5-ASA) → TNFi (Humira/Remicade) → IL-23 (Tremfya / Skyrizi) or IL-12/23 (Stelara) or integrin (Entyvio)
Document anti-TNF failure precisely. Payers want specifics: which TNFi, doses tried, duration,
clinical response (or lack of), reason for discontinuation (loss of response, immunogenicity, intolerance,
adverse event). Vague "TNFi failed" notes get denied.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J1628
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$67.813
per mg / per unit
100 mg dose (SC)
$6,781.30
100 units × ASP+6%
200 mg dose (IV induction)
$13,562.60
200 units × ASP+6%
Annualized cost (Medicare ASP+6%):
Plaque psoriasis q8wk maintenance ≈ ~$47,500/year (7 doses + 2 loading).
Crohn's induction (3 IV doses) + SC maintenance year 1 ≈ ~$80,000–$120,000
depending on q4 vs q8 cadence and 100 vs 200 mg maintenance dose. After ~2% sequestration: subtract
~$1,000–$2,400 from year 1 paid.
Coverage
No NCD specific to guselkumab. Coverage follows MAC LCDs for biologics. All MACs cover J1628 for FDA-approved on-label indications (psoriasis, PsA, Crohn's, UC) with appropriate ICD-10 and clinical documentation.
Code history
- J1628 — permanent code for Tremfya (guselkumab), 1 mg per unit. Applies to both IV and clinic-administered SC formulations.
- 2024 IBD expansion (Crohn's, UC) added IV induction protocol — same J1628 HCPCS, new 200 mg/20 mL vial NDC.
Patient assistance — Janssen CarePath / Tremfya withMe Janssen verified May 2026
- Janssen CarePath: 1-877-CarePath (1-877-227-3728) — benefits investigation, PA assistance, appeal support, copay program
- Tremfya withMe: 1-844-639-7833 — brand-specific patient support program: nurse navigator, injection training, refill reminders
- Tremfya Savings Program: commercial copay support — eligible commercially-insured patients (excludes Medicare, Medicaid, federal program patients); pay as little as $5 per dose
- Janssen Patient Assistance Foundation: free product for uninsured / underinsured patients meeting income requirements (501(c)(3))
- Foundations (Medicare patients): refer to PAN Foundation, HealthWell, Good Days — verify open psoriasis / IBD funds quarterly
- Web: tremfya.com · janssencarepath.com/patient/tremfya
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J1628 pre-loaded.
Phase 4
Fix problems
Wrong admin code (96413), missing TB screen, and benefit-mismatch are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong admin code (96413/96415) | Chemo IV billed instead of therapeutic IV | Resubmit with 96365 + 96366. Tremfya is non-chemo — chemo admin codes do not apply. |
| Wrong admin code (96401) | Chemo SC billed instead of therapeutic SC | Resubmit with 96372. SC Tremfya is non-chemo therapeutic injection. |
| Step therapy not documented | PA submitted without anti-TNF failure/intolerance for IBD | Submit detailed prior biologic history: drug, dose, duration, clinical response, reason for discontinuation. |
| TB screen missing | PA submitted without baseline TB result | Document negative QuantiFERON/TST result before initiation. Hard PA requirement. |
| JZ missing on adult claim | Single-dose vial/syringe claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| NDC mismatch (IV vs SC) | SC NDC submitted on IV induction claim or vice versa | Match NDC to formulation: 57894-640-01 for IV; 57894-642-02/57894-641-02 for SC. |
| Benefit mismatch (medical vs pharmacy) | Self-administered SC billed under medical benefit; or clinic SC submitted to pharmacy | Verify benefit determination at start of therapy — especially for IBD patients transitioning IV induction (medical) to SC maintenance. |
| Site of care (HOPD) | HOPD IV induction on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required. |
| Indication-specific PA criteria not met | Severity (BSA, PASI, Mayo score) not documented; line of therapy unclear | Submit complete clinical history including disease severity scores, prior therapies, and current line of therapy. |
Frequently asked questions
What is the HCPCS code for Tremfya?
Tremfya (guselkumab) is billed under HCPCS J1628 — "Injection, guselkumab, 1 mg." Each
milligram equals one billable unit. The 100 mg SC maintenance dose is billed as 100 units; the 200 mg IV
induction dose (Crohn's/UC) is billed as 200 units. J1628 covers the medical-benefit IV induction for IBD
and any clinic-administered SC dose. Self-administered SC for psoriasis/PsA typically runs through the
pharmacy benefit.
How many units do I bill for a Tremfya dose?
Bill 100 units of J1628 per 100 mg SC dose (psoriasis, PsA, IBD maintenance);
bill 200 units per 200 mg IV induction dose (Crohn's/UC weeks 0/4/8). Some IBD maintenance
protocols use 200 mg SC q4–8wk — bill 200 units (= two 100 mg PFS or One-Press devices). Each
dose uses one or two single-dose vials/syringes with no waste.
What administration CPT do I use for Tremfya IV?
For IV induction (Crohn's/UC), bill CPT 96365 (therapeutic IV infusion, up to 1 hour, single/initial
substance) plus 96366 for each additional hour. Tremfya IV induction infuses over approximately
1 hour. Do NOT bill 96413/96415 — those codes are reserved for chemotherapy/complex
biologic administration and Tremfya is classified as a non-chemotherapy biologic. For SC administration in
clinic, use 96372 (therapeutic SC injection).
Do I bill JZ or JW for Tremfya?
Bill JZ on virtually every Tremfya claim. Both the 200 mg/20 mL IV vial and the 100 mg/mL SC
prefilled syringe / One-Press autoinjector are single-dose containers used in whole. JW only
applies in the unusual case of partial-vial waste. One of JZ or JW must be on every J1628 claim per CMS's
July 2023 single-dose container policy.
What is the Medicare reimbursement for J1628?
For Q2 2026, the Medicare Part B payment limit for J1628 is $67.813 per mg (ASP + 6%). The 100 mg SC dose reimburses at approximately $6,781.30; the 200 mg IV induction dose at approximately $13,562.60. Annualized cost (Medicare ASP+6%) for psoriasis q8wk maintenance is approximately $47,500. Crohn's induction (3 IV doses) plus SC maintenance is approximately $80,000–$120,000 in year one. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
What indications does Tremfya have?
Four FDA-approved adult indications: (1) moderate-to-severe plaque psoriasis (original 2017 approval); (2) active psoriatic arthritis (2020); (3) moderately-to-severely active Crohn's disease (2024); and (4) moderately-to-severely active ulcerative colitis (2024). The 2024 IBD expansion introduced IV induction (200 mg at weeks 0, 4, 8) followed by SC maintenance (100 mg or 200 mg q4–8wk) — the first time Tremfya used an IV formulation.
How does Tremfya compare to Skyrizi?
Both Tremfya (guselkumab, J2327 sister drug Skyrizi (risankizumab) = J2327, AbbVie) are IL-23 inhibitors targeting the p19 subunit. Both treat plaque psoriasis, PsA, Crohn's, and UC. Both use IV induction → SC maintenance for IBD. Pricing per mg is similar but dose schedules differ: Tremfya psoriasis is q8wk maintenance; Skyrizi psoriasis is q12wk maintenance. Payers often have step therapy preferring one over the other based on contracting.
Is Tremfya covered under medical or pharmacy benefit?
It depends on formulation and indication. IV induction for Crohn's/UC is medical benefit (clinic-administered, billed via J1628). SC maintenance is split: when self-administered at home for psoriasis/PsA, it runs through pharmacy benefit (NDC-billed via specialty pharmacy). When clinic-administered, J1628 may apply under medical benefit. The medical/pharmacy distinction is critical for IBD patients who may shift between settings.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- DailyMed — TREMFYA (guselkumab) Prescribing Information
- Tremfya HCP & patient site (Janssen Biotech)
- Janssen CarePath HCP — Tremfya coding & coverage
- CMS — Medicare Part B Drug ASP Pricing File
- AGA Clinical Guidelines — Crohn's disease & ulcerative colitis biologics
- ECCO IBD Guidelines — biologic positioning
- AAD Psoriasis Guidelines
- UnitedHealthcare — Medical & Pharmacy Drug Coverage Policies (guselkumab)
- Aetna — Clinical Policy Bulletins (psoriasis biologics + IBD biologics)
- FDA National Drug Code Directory
About this page
We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, indication list | Event-driven | Tied to manufacturer document version + FDA label revision date. 2024 IBD expansion was the most recent major event. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS,
manufacturer, payer documents — all linked above). Editorial review in progress. Until that review is complete, treat this as a draft reference and verify each cited
source for high-stakes claims.
Change log
- — Initial publication. ASP data: Q2 2026. Manufacturer source: Janssen 2025. FDA label: 2024 IBD revision. Four indications (psoriasis, PsA, Crohn's, UC). IV induction + SC maintenance dual formulation. Direct comparison to Skyrizi (J2327) included.
Methodology
Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list is verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.