HCPCS
J9204
1 mg = 1 unit
Phase 1
Identify what you're billing
Cycle 1 weekly → cycle 2+ q2w — the schedule change is the single biggest source of claim errors.
Dosing by cycle FDA label verified May 2026
Poteligeo has a single labeled dose (1 mg/kg) but two distinct schedules — weekly induction in cycle 1, then q2w maintenance. Both bill J9204 at the actual mg administered.
| Cycle | Dose | Schedule | Infusions/cycle | Infusion time | Notes |
|---|---|---|---|---|---|
| Cycle 1 (induction) | 1 mg/kg IV | Days 1, 8, 15, 22 | 4 infusions | ≥60 minutes | Premedicate before first infusion; observe for infusion reactions |
| Cycle 2+ (maintenance) | 1 mg/kg IV | Days 1, 15 of each 28-day cycle | 2 infusions per cycle | ≥60 minutes | Continue until progression or unacceptable toxicity |
Worked example — unit math (70 kg adult)
# Per-dose math — 1 mg/kg, 70 kg patient
Per-dose mg: 70 × 1 = 70 mg → bill 70 units of J9204 (JZ)
Vials drawn: 4 × 20 mg = 80 mg total → 10 mg discarded
Bill JW: 10 units on a separate line
Per-infusion drug units billed: 70 JZ + 10 JW = 80 units total drug
# Cycle 1 (4 weekly doses) — 70 kg patient
Cycle 1 J9204 units administered (JZ): 280 (70 × 4)
Cycle 1 JW waste: 40 units (10 × 4)
Cycle 1 drug-only cost (Q2 2026 ASP+6%): ~$70,970.76 (administered only; JW is not separately reimbursed but documents waste)
# Cycle 2+ (2 doses per 28-day cycle) — 70 kg patient
Per-cycle J9204 units: 70 × 2 = 140 units administered
Per-cycle JW waste: 20 units
Per-cycle drug-only cost (Q2 2026 ASP+6%): ~$35,485.38
Annualized (cycle 1 + ~12 maintenance cycles): roughly $496,795 drug spend
Per-dose mg: 70 × 1 = 70 mg → bill 70 units of J9204 (JZ)
Vials drawn: 4 × 20 mg = 80 mg total → 10 mg discarded
Bill JW: 10 units on a separate line
Per-infusion drug units billed: 70 JZ + 10 JW = 80 units total drug
# Cycle 1 (4 weekly doses) — 70 kg patient
Cycle 1 J9204 units administered (JZ): 280 (70 × 4)
Cycle 1 JW waste: 40 units (10 × 4)
Cycle 1 drug-only cost (Q2 2026 ASP+6%): ~$70,970.76 (administered only; JW is not separately reimbursed but documents waste)
# Cycle 2+ (2 doses per 28-day cycle) — 70 kg patient
Per-cycle J9204 units: 70 × 2 = 140 units administered
Per-cycle JW waste: 20 units
Per-cycle drug-only cost (Q2 2026 ASP+6%): ~$35,485.38
Annualized (cycle 1 + ~12 maintenance cycles): roughly $496,795 drug spend
Reconstitution & infusion
- Vial does not require reconstitution — supplied as 20 mg / 5 mL (4 mg/mL) solution
- Withdraw calculated dose volume; dilute in 0.9% NaCl to a final volume of 50–250 mL
- Gently invert to mix; do NOT shake
- Administer via IV infusion over at least 60 minutes through a low-protein-binding 0.22-micron in-line filter
- Do NOT administer as IV push or bolus; do NOT co-infuse with other drugs in the same line
- Diluted solution stable refrigerated up to 24 hours including infusion time; do not freeze
Premedication for first infusion
- Acetaminophen 650 mg PO + diphenhydramine 25–50 mg PO or IV approximately 30 minutes before first infusion
- Consider premedication for subsequent infusions if the patient had a prior infusion reaction
- Document the premedication in the chart at the same encounter as the infusion
NDC reference FDA NDC Directory verified May 2026
| NDC | Strength | Package Size | Units/Vial |
|---|---|---|---|
42747-761-50 (10-digit) / 42747-0761-50 (11-digit) |
20 mg / 5 mL (4 mg/mL) | Single-dose vial, 1 vial per carton | 20 units (1 mg = 1 unit) |
Single 20 mg SKU + 1 mg/kg dosing — waste is the norm. Any adult patient over 20 kg
produces partial-vial waste, and most adult doses require 3–5 vials with 5–15 mg of JW. Bill JW for
the discarded portion on every claim. CMS audits flag claims missing the JW line.
Use the carton-level NDC. Submit
42747-761-50 (10-digit) or
42747-0761-50 (11-digit, N4-qualified) on box 24A shaded area of the CMS-1500. Kyowa Kirin is the
sole U.S. manufacturer; there are no biosimilar versions.
Phase 2
Code the claim
Anti-CCR4 mAb — bills under chemotherapy admin codes per CPT classification.
Administration codes CPT verified May 2026
Poteligeo is billed under chemotherapy administration codes (CCR4-targeted mAb for hematologic malignancy). Standard 60-minute infusion fits within the 96413 window.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for Poteligeo. 60-minute infusion fits cleanly within the 1-hour window. Use this on every Poteligeo claim. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Add ONLY if infusion documented >60 minutes (e.g., slowed rate after a prior reaction). Most Poteligeo claims do not need 96415 because the labeled infusion time is 60 minutes minimum and rarely exceeds 90. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Poteligeo is an anti-CCR4 mAb for hematologic malignancy — chemo admin codes apply per CPT and most payer policies. |
Typical visit: 60-minute infusion = bill 96413 alone. If documentation supports a longer
infusion (e.g., 75 minutes after a mild prior reaction), 96413 + 96415 covers the second clock-hour. Document
infusion start and stop times in the chart on every encounter.
Modifiers CMS verified May 2026
JZ + JW — almost always both
Poteligeo is a fixed 20 mg single-dose vial dosed by weight — the math virtually never lands on a clean
20 mg multiple. Bill JZ on the units administered and JW on the discarded units on a
separate claim line.
Worked example — 70 kg adult, 1 mg/kg = 70 mg dose:
Vials drawn: 4 × 20 mg = 80 mg total
· Line 1:
· Line 2:
Both lines must appear on the same claim. Missing JW or JZ triggers automatic denial.
Vials drawn: 4 × 20 mg = 80 mg total
· Line 1:
J9204 × 70 units with JZ (administered)· Line 2:
J9204 × 10 units with JW (discarded)Both lines must appear on the same claim. Missing JW or JZ triggers automatic denial.
One of JZ or JW must be on every J9204 claim per CMS's July 2023 single-dose container policy. Use JZ when zero waste (uncommon — only at exact 20-mg-multiple doses); use JW for the discarded mg on the partial vial.
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 (e.g., new dermatologic toxicity assessment, infection workup). Routine pre-infusion clinical assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired Poteligeo, follow your MAC's current 340B modifier policy. Kyowa Kirin's billing materials do not provide 340B-specific instructions.
ICD-10-CM by CTCL subtype FY2026 verified May 2026
Poteligeo's label covers mycosis fungoides (MF) and Sézary syndrome (SS) in adults after ≥1 prior systemic therapy. Use the most specific CTCL code supported by encounter documentation; pair with Z51.11 on the admin claim.
| Indication | ICD-10 family | Specific codes (high-frequency) | Notes |
|---|---|---|---|
| Mycosis fungoides (MF) | C84.0x |
C84.00–C84.09 MF by site (0=unspec, 1=head/neck, 2=intrathoracic, 3=intra-abdominal, 4=axilla/upper limb, 5=inguinal/lower limb, 6=intrapelvic, 7=spleen, 8=multiple sites, 9=extranodal) |
Most common Poteligeo indication. Requires pathology + TNMB staging + ≥1 prior systemic therapy documented. |
| Sézary syndrome (SS) | C84.1x |
C84.10–C84.19 Sézary by site (same 5th-character anatomic-site scheme as C84.0x) |
Leukemic/erythrodermic variant; requires absolute Sezary cell count, flow cytometry, and TNMB staging on the PA. |
| Other CTCL variants | C84.A |
C84.A0–C84.A9 Other mature T/NK-cell lymphomas (incl. primary cutaneous ALCL when used in CTCL context) |
Off-label for Poteligeo — not on the FDA label. Verify coverage individually; most commercial payers will deny. |
| Encounter for chemotherapy | Z51.11 |
Z51.11 Encounter for antineoplastic chemotherapy |
Pair with primary CTCL diagnosis code on every admin claim line. |
Documentation depth, not the ICD-10 code, drives PA outcomes. Payers approve C84.0x and C84.1x
on the label, but the PA submission must include: pathology report confirming MF or SS, TNMB stage per
ISCL/EORTC, Sezary cell count (for SS), list of prior systemic therapies with start/stop dates and outcome,
baseline skin assessment, and a treatment-plan note. Missing any of these is the #1 denial driver.
Site of care & place of service Verified May 2026
Poteligeo's W&P profile (serious infusion reactions, SJS/TEN risk, autoimmune complications, infection) requires in-clinic monitoring. Hospital outpatient department (HOPD), freestanding oncology infusion suite, or oncology physician office are all acceptable. Home infusion is not appropriate for Poteligeo — the label's monitoring requirements (and the rate of cycle-1 infusion reactions) make home administration unsafe and uncovered.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Oncology physician office | 11 | CMS-1500 / 837P | Preferred for stable maintenance (cycle 2+) where on-site oncology backup is available |
| Freestanding infusion suite (AIC) | 49 | CMS-1500 / 837P | Acceptable for stable maintenance; ensure dermatology and emergency backup |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Common for cycle 1 and for patients with prior infusion reactions |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Acceptable; UHC/Aetna may steer to office/AIC after cycle 1 in stable patients |
| Oncology ASC | 24 | CMS-1500 / 837P | Less common; verify ASC capacity for CTCL biologic infusion |
| Patient home | 12 | — | NOT appropriate — monitoring requirements + cycle-1 reaction rate preclude home infusion |
Claim form field mapping Kyowa Kirin 2025
From Kyowa Kirin Patient Support coding & coverage guide.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 42747-0761-50 + ML + total volume drawn (mL across vials) |
| HCPCS J9204 + JZ (administered units) | 24D (drug line 1) | Mark JZ on the administered mg (e.g., 70 units for 70 kg patient at 1 mg/kg) |
| HCPCS J9204 + JW (waste units) | 24D (drug line 2) | Separate line for discarded mg from partial 20 mg vial (e.g., 10 units waste) |
| Drug units | 24G | Actual mg administered (line 1) + waste mg (line 2) |
| CPT 96413 (admin line) | 24D (admin line) | Primary chemo admin code (60-min infusion) |
| CPT 96415 (additional hour, if applicable) | 24D (admin line) | Only when documented infusion time exceeds 60 minutes |
| ICD-10 | 21 | Primary CTCL code (C84.0x for MF or C84.1x for SS) + Z51.11 |
| PA number | 23 | Required by all major payers |
| Premedication CPT (if billed) | 24D | 96374/96375 for IV diphenhydramine if administered separately; oral acetaminophen typically not billed |
Phase 3
Get paid
CTCL pathology, TNMB staging, Sezary cell count, and prior systemic therapy are the gating documentation.
Payer policy snapshot Reviewed May 2026
All major payers require PA. CTCL-specific documentation (pathology, TNMB stage, prior systemic therapy, Sezary cell count for SS) is the gating issue.
| Payer | PA? | Documentation focus | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Medication Clinical Coverage Policy |
Yes | Pathology MF/SS; TNMB stage; Sezary cell count for SS; ≥1 prior systemic therapy (bexarotene, MTX, IFN, HDACi, vorinostat, romidepsin, or brentuximab vedotin) | Yes — Optum-managed steering away from HOPD post-cycle 1–3 in stable patients |
| Aetna CPB + Medical Drug policies |
Yes | Aligned with NCCN T-cell lymphoma guidelines; CD4+/CD3+ documentation; prior systemic therapy required | Yes (separate Site-of-Care policy applies after cycle 1) |
| BCBS plans Vary by plan |
Yes | Generally NCCN-aligned; some plans require flow cytometry for SS workup | Plan-specific; many have CTCL-biologic site-of-care steering |
| Medicare (MAC LCDs) | Generally yes for HOPD; varies by MAC | Coverage for label indications; LCDs follow FDA label + NCCN T-cell compendium | HOPD packaging rules apply (no separate site-of-care UM) |
Step therapy
Generally required. Most commercial payers require failure or intolerance of at least one prior systemic therapy as a condition of label compliance. Common prior systemic therapies in CTCL include bexarotene, methotrexate, interferon alpha, HDAC inhibitors (vorinostat, romidepsin), and brentuximab vedotin (see Adcetris (J9042) for CD30+ CTCL). Document the prior therapy, dose, duration, and reason for discontinuation on the PA.
NCCN alignment
Poteligeo is NCCN Category 2A recommended for relapsed/refractory MF and SS in the NCCN Primary Cutaneous Lymphoma guidelines. Cite NCCN T-cell lymphoma compendium and the MAVORIC trial (Lancet Oncology 2018) on PA submissions.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9204
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions · Next update July 1, 2026 for Q3
ASP + 6%
$253.467
per mg / per unit
70 mg dose (1 mg/kg, 70 kg)
$17,742.69
70 units × ASP+6%
Cycle 1 (4 weekly doses, 70 kg)
$70,970.76
280 units × ASP+6%
Course-level cost (drug only, Q2 2026 ASP+6%, 70 kg patient):
Cycle 1 (4 weekly doses) ≈ $70,970.76; each subsequent 28-day cycle (2 doses) ≈
$35,485.38. After ~2% sequestration: ~ASP+4.3% actual paid. Therapy continues until progression
or unacceptable toxicity — no fixed cycle cap.
Coverage
No NCD specific to mogamulizumab-kpkc. Coverage falls under MAC LCDs for biologics and the generic drug-coverage framework. All MACs cover J9204 for FDA-approved on-label indications (R/R MF or SS) with appropriate ICD-10 and pathology documentation. Off-label use in non-CTCL T-cell malignancies is generally non-covered without case-by-case medical-necessity review.
Code history
- J9204 — permanent code "Injection, mogamulizumab-kpkc, 1 mg"; effective January 1, 2020 (per Healthcare Common Procedure Coding System file). Pre-permanent-code period (FDA approval August 2018 through end-2019) used unclassified code J3490 / J3590 / C9399.
Patient assistance — Kyowa Kirin Patient Support Kyowa Kirin verified May 2026
- Kyowa Kirin Patient Support (KKPS): 1-844-768-3544 / kkpatientsupport.com — benefits investigation, prior authorization assistance, appeals support, infusion-coverage research
- Poteligeo Co-Pay Assistance Program: commercial copay support for eligible commercially-insured patients (excludes Medicare, Medicaid, Tricare, VA/DOD, other federal programs); program limits posted on the KKPS website
- Kyowa Kirin Patient Assistance Program: free product for uninsured / underinsured patients meeting income requirements (typically <500% FPL; verify on enrollment)
- Foundations (Medicare and uninsured backup): Patient Advocate Foundation (PAF), HealthWell Foundation, CancerCare, Leukemia & Lymphoma Society (LLS) — verify open CTCL / lymphoma funds quarterly
- Web: poteligeo-hcp.com / kkpatientsupport.com
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and
OOP max? Run a CareCost Estimate — J9204 pre-loaded.
Phase 4
Fix problems
Pathology gaps, JW omission, premedication documentation, and skin-reaction grading are the recurring failures.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| MF/SS pathology + staging incomplete | PA submitted without pathology confirmation of MF or SS, Sezary cell count (SS), or TNMB stage per ISCL/EORTC | #1 denial driver. Submit dermatopathology report, peripheral blood flow cytometry (SS only), TNMB stage worksheet, and prior systemic therapy table. Most payers will reverse on resubmission once these are on file. |
| Prior systemic therapy not documented | PA missing documentation that the patient failed or did not tolerate ≥1 prior systemic therapy | Submit a prior-therapy table: drug name, start date, stop date, response/toxicity, and reason for discontinuation. Bexarotene, methotrexate, IFN-alpha, vorinostat, romidepsin, brentuximab vedotin are all accepted prior therapies. |
| Premedication not documented | Cycle 1 first infusion claim missing acetaminophen + antihistamine premedication in the chart | Add premed orders (acetaminophen 650 mg PO + diphenhydramine 25–50 mg PO/IV ≈30 min pre-infusion) to the encounter. Update chart note. Resubmit appeal with corrected documentation. |
| JW missing | Single 20 mg vial billed for weight-based dose without reporting waste | Add JW line for discarded units. JZ on administered units; JW on wasted units. Required on virtually every adult Poteligeo claim. |
| JZ missing | Single-dose vial claim without JZ | Resubmit with JZ on the administered-units line. Required since 7/1/2023. |
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413. Poteligeo is an anti-CCR4 mAb for hematologic malignancy — chemo admin per CPT classification. |
| Dermatologic toxicity workup missing | Mid-treatment claim denied because new rash documented but no grading or workup on file | Document grade (CTCAE), photo if possible, dermatology consult, and dose-modification decision. SJS/TEN is a labeled risk — document the negative workup. |
| Wrong NDC format | Vial-level NDC submitted in the wrong digit format | Use carton NDC: 42747-761-50 (10) / 42747-0761-50 (11) with N4 qualifier. |
| Site of care (HOPD) | HOPD administration after cycle 1–3 on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49) for stable patients. Submit medical-necessity letter if HOPD required (prior reaction, dermatologic toxicity, immunosuppression). |
| Off-label CTCL variant (C84.A) | PA submitted for primary cutaneous ALCL or other CTCL variant under C84.A | Poteligeo's label is MF and SS only. For pcALCL post-prior systemic therapy, consider Adcetris (J9042). Off-label Poteligeo will require peer-to-peer and medical-necessity letter. |
| Pediatric patient | PA submitted for patient under 18 | Poteligeo is adult-only on the FDA label. Pediatric coverage will require off-label review and is generally denied. |
| Pre-HSCT use without flag | Patient referred to allogeneic HSCT shortly after Poteligeo without label-required risk discussion documented | Use of Poteligeo before allogeneic HSCT increases severe acute GVHD risk; document risk-benefit discussion and stop date relative to conditioning. Some payers will pre-deny if the transplant referral is open at the time of PA. |
Frequently asked questions
Are mycosis fungoides and Sézary syndrome covered under the same J-code?
Yes. J9204 applies to both indications because they share the FDA label — relapsed or
refractory MF or SS after ≥1 prior systemic therapy. The clinical distinction matters for pathology and
prognosis (SS is the leukemic/erythrodermic variant of CTCL with circulating Sezary cells), but the J-code,
dose schedule, and admin codes are identical. Use C84.0x for MF and C84.1x for SS on
the claim; payer PA almost always asks for TNMB staging and Sezary cell quantification on the SS claim.
Why is cycle 1 weekly but cycle 2+ every 2 weeks?
Per the FDA label, Poteligeo is dosed at 1 mg/kg IV on Days 1, 8, 15, and 22 of cycle 1 (four weekly doses to achieve target CCR4 receptor saturation), then 1 mg/kg IV on Days 1 and 15 of each subsequent 28-day cycle. So cycle 1 = 4 infusions, cycle 2+ = 2 infusions per cycle. Bill each infusion as a separate encounter; J9204 mg units reflect actual mg administered at each visit. Treatment continues until disease progression or unacceptable toxicity.
What considerations apply if the patient is heading to allogeneic HSCT?
Poteligeo administration before allogeneic hematopoietic stem cell transplantation has been associated with increased severe acute GVHD, steroid-refractory GVHD, and transplant-related complications. The label warns to follow patients closely for early evidence of these complications. Document a risk-benefit discussion, the stop date relative to conditioning, and the transplant team's plan. Some payers will deny Poteligeo if an allogeneic transplant is imminent — verify with the transplant center first.
How do I bill a skin reaction (rash, drug eruption, SJS/TEN workup)?
New or worsening dermatologic toxicity is common with Poteligeo. Document the rash with a CTCAE grade and a skin biopsy when severity warrants it. Bill the dermatology consult under standard E/M (with modifier 25 if on the same day as infusion). Bill skin biopsy CPT 11102 (tangential) or 11104 (punch) plus pathology (88305) as appropriate. The Poteligeo infusion claim itself (J9204 + 96413) is unchanged — the workup adds separate E/M and procedure lines.
Is Poteligeo approved in pediatric patients?
No. The FDA label is adult-only (≥18 years). Pediatric CTCL is exceedingly rare; safety and effectiveness in pediatric patients have not been established. Off-label pediatric use will not have payer coverage and is outside FDA-labeled indications. NCCN T-cell lymphoma guidelines do not include pediatric Poteligeo use.
Can patients be re-treated after disease progression?
The label does not specify a re-treatment protocol. Per label, therapy continues until disease progression or unacceptable toxicity — meaning patients are discontinued at progression. Re-challenge with Poteligeo after progression is not a labeled use and would require case-by-case payer review; most commercial payers will deny re-initiation absent a clear interim non-CCR4 therapy and a new PA submission.
What is the premedication protocol?
Premedicate before the first infusion with acetaminophen (typically 650 mg PO) and an antihistamine (diphenhydramine 25–50 mg PO or IV) approximately 30 minutes before infusion. Consider continued premedication for subsequent infusions if the patient experienced a prior infusion reaction. Document the premedication orders and administration time in the chart at the same encounter as the Poteligeo infusion — missing premed documentation is a common cycle-1 denial driver.
What is the Medicare reimbursement for J9204?
For Q2 2026, the Medicare Part B payment limit for J9204 is $253.467 per mg (ASP + 6%). For a 70 kg patient at 1 mg/kg (70 mg dose), reimbursement is approximately $17,742.69 per infusion. Cycle 1 (4 weekly doses) totals $70,970.76, and each subsequent 28-day cycle (2 doses) totals $35,485.38. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- FDA — POTELIGEO prescribing information (BLA 761051)
- DailyMed — POTELIGEO (mogamulizumab-kpkc)
- Kim YH et al. — Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncology 2018;19(9):1192–1204.
- Kyowa Kirin Patient Support — POTELIGEO coding & coverage HCP resources
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J9204 reference
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna CPB — Oncology medical drugs (covers Poteligeo)
- NCCN — T-Cell Lymphomas Guidelines (covers MF/SS)
- POTELIGEO HCP site (Kyowa Kirin)
- 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, AMA CPT releases. |
| NDC, dosing, FDA label, indication list | Event-driven | Tied to manufacturer document version + FDA label revision date. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS, Kyowa Kirin
Patient Support, 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 (live). Manufacturer source: Kyowa Kirin Patient Support 2025. FDA label: original approval August 8, 2018 (BLA 761051); latest revision verified 2024. Two FDA-labeled indications covered (R/R MF, R/R SS). Cycle 1 weekly + cycle 2+ q2w dosing detailed. Pivotal MAVORIC trial cited (Kim YH et al., Lancet Oncology 2018). W&P-equivalent risks emphasized: infusion reactions, severe dermatologic reactions, infections, autoimmune complications, post-HSCT GVHD.
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 and NCCN T-cell lymphoma compendium. We do not paraphrase from billing-software vendor blogs.