HCPCS
J9273
1 mg = 1 unit
Phase 1
Identify what you're billing
Confirm the right code, weight-based dose, and the boxed ocular toxicity protocol.
About Tivdak FDA verified May 2026
First tissue factor-targeted antibody-drug conjugate; first FDA-approved drug specifically for recurrent/metastatic cervical cancer post-chemo.
Tivdak (tisotumab vedotin-tftv) is a tissue factor (TF)-directed antibody-drug conjugate developed jointly by Genmab and Seagen (acquired by Pfizer in 2023). It pairs an anti-tissue factor monoclonal antibody with the cytotoxic agent monomethyl auristatin E (MMAE) via a protease-cleavable linker. Once internalized by tumor cells expressing tissue factor, MMAE is released and disrupts microtubules, triggering apoptosis.
FDA granted accelerated approval September 20, 2021 based on the single-arm innovaTV 204 phase 2 trial. Full traditional approval was granted April 29, 2024 based on the ENGOT-cx12/innovaTV 301 randomized phase 3 confirmatory trial, which demonstrated overall survival benefit vs investigator-choice chemotherapy. Tivdak is the first FDA-approved drug specifically indicated for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy — an area with no prior approved second-line standard of care.
Dosing & unit math FDA label Apr 2024
Weight-based 2 mg/kg q3w with a 200 mg per-dose cap. Bill the actual mg administered.
Adult dosing
- 2 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
- Maximum 200 mg per dose for patients weighing more than 100 kg
- Round dose to nearest mg per FDA label
- 1 mg = 1 unit of J9273; bill the actual mg administered (not vial size)
- Approximately 17 cycles per year on a strict q3w schedule (52 / 3)
Reconstitution & preparation
- Reconstitute each 40 mg vial with 8 mL Sterile Water for Injection → 5 mg/mL solution
- Withdraw calculated dose volume; further dilute in 0.9% NaCl IV bag
- Final concentration: 0.4–1.8 mg/mL
- Administer over 30 minutes via dedicated IV line with 0.2–0.22 micron in-line filter
- Single-dose vial — discard unused portion (never pool partial vials)
Worked example — 70 kg patient
# Dose calculation
70 kg × 2 mg/kg = 140 mg per dose
Vials needed: 140 / 40 = 3.5 → round up to 4 vials (160 mg drawn)
Discarded: 160 - 140 = 20 mg waste
# Claim lines
Drug administered: J9273 × 140 units (no modifier on this line; or JZ-equivalent)
Drug discarded: J9273 × 20 units with JW modifier
Admin: 96413 (30-min chemo IV)
# Cost (Q2 2026 ASP+6%)
Administered: 140 × $196.121 = ~$27,456.94
Wasted (also reimbursable): 20 × $196.121 = ~$3,922.42
Total drug cost per dose: ~$31,379.36
70 kg × 2 mg/kg = 140 mg per dose
Vials needed: 140 / 40 = 3.5 → round up to 4 vials (160 mg drawn)
Discarded: 160 - 140 = 20 mg waste
# Claim lines
Drug administered: J9273 × 140 units (no modifier on this line; or JZ-equivalent)
Drug discarded: J9273 × 20 units with JW modifier
Admin: 96413 (30-min chemo IV)
# Cost (Q2 2026 ASP+6%)
Administered: 140 × $196.121 = ~$27,456.94
Wasted (also reimbursable): 20 × $196.121 = ~$3,922.42
Total drug cost per dose: ~$31,379.36
Worked example — 110 kg patient (capped)
# Dose calculation
110 kg × 2 mg/kg = 220 mg → cap at 200 mg (max per dose)
Vials needed: 200 / 40 = exactly 5 vials — no waste
# Claim lines
Drug administered: J9273 × 200 units with JZ modifier (no waste)
Admin: 96413
110 kg × 2 mg/kg = 220 mg → cap at 200 mg (max per dose)
Vials needed: 200 / 40 = exactly 5 vials — no waste
# Claim lines
Drug administered: J9273 × 200 units with JZ modifier (no waste)
Admin: 96413
Dose modifications
- Ocular AE grade 2+: withhold until grade 1 or baseline; resume at same dose. Discontinue for grade 4 or recurrent grade 3.
- Peripheral neuropathy grade 2: withhold until grade 1; resume at reduced dose (1.3 mg/kg). Discontinue for grade 3+.
- Hemorrhage grade 2 (other than pulmonary/CNS): withhold until resolved. Discontinue for grade 3+ or any grade pulmonary/CNS hemorrhage.
- Pneumonitis grade 2: withhold + corticosteroids; resume at reduced dose. Discontinue for grade 3+.
NDC reference FDA NDC Directory verified May 2026
| NDC (10 / 11-digit) | Package | Use |
|---|---|---|
51144-040-01 / 51144-0040-01 |
40 mg lyophilized powder — 1 single-dose vial per carton | All adult cervical cancer dosing |
Single vial size only. Tivdak is supplied exclusively as 40 mg vials. Combined with
weight-based dosing, this guarantees partial-vial waste on most doses (only 60, 80, 120, 160, 200 mg
target doses can be hit exactly). Plan claim lines to include both administered (J9273) and wasted
(J9273 + JW) units.
Use 11-digit NDC on claim form. Pad the middle segment with a leading zero
(51144-040-01 → 51144-0040-01). Use N4 qualifier in the 24A shaded area of the CMS-1500 with
units of measure ML (8 mL per reconstituted vial × vial count) and total dose in mg on the 24G drug line.
Ocular toxicity — BOXED WARNING FDA label verified May 2026
The defining safety feature of Tivdak. Every infusion has an ophthalmic protocol attached to it.
BOXED WARNING. Tivdak can cause severe ocular adverse reactions including
changes in visual acuity, ulcerative keratitis, and conjunctival and corneal events.
In innovaTV 204, ocular adverse reactions occurred in approximately 60% of patients; severe (grade 3+)
in approximately 6%. Permanent visual impairment has been reported.
Mandatory ophthalmology workflow
- Baseline ophthalmologic exam by an eye care provider before the first dose, including visual acuity and slit-lamp examination
- Repeat exam before every cycle (q3w) and as clinically indicated for new or worsening symptoms
- Patient education at every visit: avoid contact lenses, use eye drops as prescribed, report any vision changes immediately
- Have a referral pathway to an eye care provider for grade 2+ events — do not wait for next scheduled cycle
Dose modification for ocular AEs
| Severity | Action |
|---|---|
| Grade 1 (mild) | Continue dosing; treat symptoms |
| Grade 2 | Withhold until grade 1 or baseline; resume at same dose |
| Grade 3 | Withhold until grade 1 or baseline; resume at reduced dose; permanently discontinue if recurrent grade 3 |
| Grade 4 / corneal perforation | Permanently discontinue |
Mandatory eye care protocol FDA label verified May 2026
Required at every infusion. Document each step in the chart for payer audits.
Per-infusion eye care checklist
- Pre-infusion (immediately before): Administer ophthalmic vasoconstrictor eye drops to both eyes per label (typically a single drop each eye 5–10 min before infusion).
- Pre-infusion (immediately before): Administer ophthalmic corticosteroid eye drops to both eyes per institutional protocol.
- During infusion: Apply cooling eye pads to both closed eyelids for the entire 30-minute infusion AND continue for approximately 30 minutes after infusion ends. Replace pads as needed to maintain cooling.
- During and after infusion: Continue ophthalmic corticosteroid drops as prescribed for the remainder of the cycle.
- Throughout therapy and 30 days after the last dose: Patient uses preservative-free ophthalmic lubricants 4–6 times daily in both eyes.
- Throughout therapy: NO contact lens use unless directed by an eye care provider.
- Every cycle: Ophthalmologist exam BEFORE infusion (visual acuity + slit-lamp). Document result in the chart.
Document everything. Payers (especially commercial UM programs) increasingly request
documentation of ophthalmology pre-treatment exam and the per-infusion eye care protocol as part of
Tivdak prior auth. Build an "eye care checklist" SmartPhrase or template into the infusion-day note so
nothing is missed and chart documentation is audit-ready.
Supply tip: Cooling eye pads, ophthalmic vasoconstrictor (e.g., brimonidine,
phenylephrine per institution), ophthalmic corticosteroid (e.g., loteprednol, dexamethasone), and
preservative-free lubricants should be stocked on the infusion floor before scheduling the first
Tivdak patient. Some sites work with the dispensing specialty pharmacy or ophthalmology partner to
pre-package an "ocular kit" per cycle.
ADC class comparison — Tivdak vs other antibody-drug conjugates FDA verified May 2026
Six FDA-approved ADCs share architecture (mAb + linker + cytotoxic payload) but differ by target, payload, and signature toxicity.
| ADC | HCPCS | Target | Payload | Lead indication | Class context |
|---|---|---|---|---|---|
| Tivdak | J9273 |
Tissue factor | MMAE (auristatin) | Recurrent/metastatic cervical cancer | First TF-targeted ADC; first drug specifically for cervical cancer post-chemo. Boxed ocular toxicity warning. |
| Adcetris | J9042 |
CD30 | MMAE (auristatin) | cHL, sALCL, PTCL, CTCL | Original FDA-approved ADC (2011 accelerated, 2017 full) |
| Polivy | J9309 |
CD79b | MMAE (auristatin) | DLBCL (Pola-R-CHP, R/R DLBCL) | Same payload as Tivdak; B-cell target |
| Padcev | J9177 |
Nectin-4 | MMAE (auristatin) | Urothelial carcinoma | Same payload; different solid-tumor target |
| Enhertu | J9358 |
HER2 | Deruxtecan (DXd, topoisomerase I inhibitor) | HER2+ breast, gastric, NSCLC | Different payload; signature ILD/pneumonitis toxicity |
| Trodelvy | J9317 |
Trop-2 | Govitecan (SN-38, topoisomerase I inhibitor) | TNBC, HR+/HER2- breast, urothelial | Different payload; severe diarrhea/neutropenia |
What's unique about Tivdak in the ADC class:
(1) Only ADC carrying a boxed ocular toxicity warning — the eye care protocol is unique to this drug;
(2) Only tissue factor-targeted ADC approved by the FDA;
(3) Only ADC approved specifically for recurrent or metastatic cervical cancer post-chemo — an
indication with no prior standard second-line agent;
(4) Shares MMAE-related peripheral neuropathy with Adcetris, Polivy, Padcev (class effect);
(5) Weight-based dosing (2 mg/kg) + fixed 40 mg vial size means JW partial-vial waste is the rule.
Phase 2
Code the claim
Chemo admin code + JW for waste on virtually every claim. Single ICD-10 family (C53.x).
Administration codes CPT verified May 2026
Tivdak is a complex monoclonal antibody-drug conjugate — bill under chemo admin codes.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for Tivdak. 30-minute infusion fits within 1-hour window. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Rarely needed (Tivdak monotherapy is 30 min). May apply if same-day combo regimen extends chair time beyond 1 hour. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Tivdak (MMAE-bearing ADC) is billed under chemo admin codes per AMA classification. 96365 will be denied/downcoded. |
Why chemo admin codes for an ADC: CPT chemotherapy administration codes (96409–96425)
apply to complex monoclonal antibodies and antibody-drug conjugates regardless of mechanism. The MMAE
cytotoxic payload further reinforces chemo classification. This pays materially more than 96365
therapeutic infusion.
Modifiers CMS verified May 2026
JW — required on virtually every Tivdak claim
Tivdak ships only as 40 mg single-dose vials, but dosing is weight-based at 2 mg/kg. Most patient weights produce a calculated dose that is not a perfect 40 mg multiple, so partial-vial waste is the rule. CMS requires the JW modifier on a separate claim line reporting the discarded units, and one of JZ or JW must be on every J9273 claim per the July 1, 2023 single-dose container policy.
JZ — only when calculated dose lands exactly on a 40 mg multiple
Use JZ only when no drug is discarded. For Tivdak that means the calculated 2 mg/kg dose is exactly 40, 80, 120, 160, or 200 mg — corresponding to patient weights of 20, 40, 60, 80, or 100+ kg (capped). Most adult patients will not hit those weights exactly.
| Patient weight | Calculated dose | Vials | Waste | Modifier(s) |
|---|---|---|---|---|
| 50 kg | 100 mg | 3 (120 mg) | 20 mg | JW (20 units) |
| 60 kg | 120 mg | 3 (120 mg) | 0 mg | JZ |
| 70 kg | 140 mg | 4 (160 mg) | 20 mg | JW (20 units) |
| 80 kg | 160 mg | 4 (160 mg) | 0 mg | JZ |
| 85 kg | 170 mg | 5 (200 mg) | 30 mg | JW (30 units) |
| >100 kg (capped) | 200 mg | 5 (200 mg) | 0 mg | JZ |
Common error: Forgetting to bill the JW waste line. Wasted Tivdak is reimbursable
but must be reported on a separate claim line with JW. Given the per-mg ASP of $196.121, a routine
20 mg waste is ~$3,922 of reimbursement left on the table per dose — ~$66,000/year for one patient.
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 infusion (e.g., toxicity assessment requiring management decisions). Routine pre-infusion clinical assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired Tivdak, follow your MAC's current 340B modifier policy. Pfizer's billing guide does not provide 340B-specific instructions.
ICD-10-CM — cervical cancer family FY2026 verified May 2026
Single indication: recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Use the most specific code supported by documentation.
| ICD-10 | Description | When to use |
|---|---|---|
C53.0 | Malignant neoplasm of endocervix | Tumor of the inner (endocervical) canal |
C53.1 | Malignant neoplasm of exocervix | Tumor of the outer (ectocervical) portion |
C53.8 | Malignant neoplasm of overlapping sites of cervix uteri | Tumor crossing endo/exo boundary |
C53.9 | Malignant neoplasm of cervix uteri, unspecified | Default when site not further specified in documentation |
Secondary malignancies (e.g., C78.x, C79.x) | Metastatic sites | Add as secondary dx for metastatic involvement (lung, liver, bone, etc.) |
Z85.41 | Personal hx of malignant neoplasm of cervix uteri | Use only for surveillance after disease control; not for active treatment |
Documentation must establish "recurrent or metastatic" status AND prior chemotherapy.
ICD-10 alone is insufficient for prior auth. PA submissions need: pathology confirming recurrent or
metastatic cervical cancer, documentation of prior chemotherapy regimen(s) and disease progression on
or after that therapy, and ophthalmology baseline exam. ENGOT-cx12/innovaTV 301 confirmatory data
supports full approval — cite this in PA appeals if denied as "investigational."
Site of care & place of service Verified May 2026
Tivdak is generally administered in physician oncology offices, ambulatory infusion suites, oncology ASCs, or hospital outpatient infusion centers. The boxed ocular toxicity protocol does not require a specific site, but it does require an ophthalmology partnership (referral pathway) and the supply chain for cooling pads, vasoconstrictor, corticosteroid, and lubricant drops.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician oncology office | 11 | CMS-1500 / 837P | Preferred by commercial UM |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM |
| Oncology ASC | 24 | CMS-1500 / 837P | Acceptable |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored after first 3 months by some commercial plans |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored after first 3 months |
| Patient home | 12 | CMS-1500 (with home infusion) | Not recommended — ocular protocol + ADC handling not suitable for home administration |
Operational note: Sites that already infuse Adcetris / Polivy / Padcev have most of
the operational infrastructure for Tivdak (chemo admin, MMAE handling, neuropathy monitoring). The
net-new requirement is the ophthalmology partnership and ocular kit supply chain. Plan for this 2–4
weeks before the first patient.
Claim form field mapping Pfizer/Seagen 2025
From Pfizer Oncology Together coding & coverage materials.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 51144-0040-01 + ML + total reconstituted volume (8 mL per vial × vial count) |
| HCPCS J9273 (administered) | 24D (drug line 1) | JZ if no waste; otherwise no waste modifier on this line |
| HCPCS J9273 (waste) | 24D (drug line 2) | JW modifier; units = mg discarded |
| Drug units | 24G | Actual mg administered (line 1) and mg discarded (line 2) |
| CPT 96413 (admin line) | 24D | 30-min chemo IV; fits within 1-hour window |
| ICD-10 | 21 | C53.0 / C53.1 / C53.8 / C53.9 (use most specific) |
| PA number | 23 | Required by all major payers |
Phase 3
Get paid
PA universal; ophthalmology pre-treatment exam is increasingly a hard documentation requirement.
Payer policy snapshot Reviewed May 2026
Universal PA. Documentation of recurrent/metastatic cervical cancer, prior chemo failure, and ophthalmology baseline exam are the three checkpoints.
| Payer | PA? | Documentation requirements | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes | Recurrent/metastatic cervical cancer dx; documented progression on or after platinum-based chemotherapy; ophthalmology pre-treatment evaluation; per-cycle ophthalmology exam | Yes (Optum-managed program); ICI/ADC steering away from HOPD |
| Aetna CPB / Medical Drug policy |
Yes | Same as UHC; PA criteria align with FDA label and NCCN Cervical Cancer guidelines | Yes (separate Site-of-Care policy) |
| BCBS plans Vary by plan |
Yes | Generally aligned with FDA label + NCCN guidelines; ophthalmology baseline exam typically required | Plan-specific |
| Medicare (MAC LCDs) | No prior auth (FFS) | Coverage for FDA-labeled indication with appropriate ICD-10 (C53.x) and supporting documentation; some MA plans add PA | FFS no UM; MA plans variable |
Step therapy
By definition, Tivdak's indication requires prior platinum-based chemotherapy (typically platinum + paclitaxel ± bevacizumab in 1L recurrent/metastatic). PA criteria thus build step therapy into the indication. After Tivdak, NCCN options include Keytruda (J9271, +chemo with bevacizumab in 1L recurrent/metastatic if PD-L1 CPS ≥1; mono in 2L+) and Jemperli (J9272, dMMR/MSI-H endometrial; off-label cervical).
NCCN positioning
NCCN Cervical Cancer Guidelines list Tivdak as a Category 2A preferred regimen for second-line treatment of recurrent or metastatic cervical cancer after platinum chemotherapy, regardless of PD-L1 status. This is the strongest non-biomarker-restricted second-line option in the guideline.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9273
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$196.121
per mg / per unit
140 mg dose (70 kg pt)
$27,456.94
140 units × ASP+6%
200 mg dose (max cap)
$39,224.20
200 units × ASP+6%
Annualized cost (Medicare ASP+6%): 70 kg patient on 2 mg/kg q3w × ~17 doses/year
= ~$466,768/year (drug administered) plus reimbursable JW waste of ~$66,681/year if
partial-vial waste of 20 mg per dose. Max-cap 200 mg patient: ~$666,811/year drug
only (no waste). After ~2% sequestration, actual Medicare paid drops to roughly ASP + 4.3%.
Coverage
No NCD specific to Tivdak. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9273 for FDA-labeled recurrent or metastatic cervical cancer with appropriate ICD-10 (C53.x) and clinical documentation of prior chemotherapy progression.
Code history
- J9273 — "Inj tisotu vedotin-tftv, 1 mg" — permanent HCPCS code; pre-permanent-code period used unclassified
J9999with NDC documentation
Patient assistance — Pfizer Oncology Together Pfizer verified May 2026
- Pfizer Oncology Together: 1-877-744-5675 — benefits investigation, prior authorization assistance, appeal support, ongoing case management
- Tivdak Co-Pay Card: commercial copay support for eligible commercially-insured patients (excludes Medicare, Medicaid, federal program patients); first dose may be $0 for commercial patients meeting eligibility
- Pfizer Patient Assistance Foundation: free product for uninsured / underinsured patients meeting income requirements (501(c)(3))
- Independent foundations (for Medicare patients): Patient Access Network (PAN), HealthWell Foundation, CancerCare Co-Payment Assistance Foundation — verify open cervical cancer / oncology funds quarterly (open and close based on funding cycles)
- Web: pfizeroncologytogether.com
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J9273 pre-loaded.
Phase 4
Fix problems
Missing JW waste line, missing ophthalmology pre-treatment exam, and wrong admin code are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Ophthalmology baseline exam not documented | PA submitted without ophthalmology pre-treatment evaluation | Schedule ophthalmology exam BEFORE first PA submission. Include the exam note + visual acuity in PA packet. |
| JW waste missing | Wasted Tivdak (partial vial) not reported on a separate claim line | Add JW line for discarded units. Given $196.121/mg, missing waste = $3,000–$6,000 unbilled per dose. |
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413. Tivdak (MMAE-bearing ADC) is chemo admin per CPT classification. |
| Prior chemo failure not documented | PA submitted without evidence of disease progression on/after platinum-based chemotherapy | Include prior chemotherapy regimen(s), dates, and documentation of progression (imaging, labs, clinical) in PA packet. |
| "Investigational" denial | Payer treating as accelerated approval (pre-April 2024) | Cite ENGOT-cx12 / innovaTV 301 phase 3 confirmatory data and FDA full approval (April 2024). Submit appeal with FDA approval letter. |
| Wrong NDC format | Vial-level NDC submitted without zero-pad | Use 11-digit padded NDC: 51144-0040-01 with N4 qualifier in 24A shaded area. |
| Site of care (HOPD) | HOPD administration after first 3 months on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required for ophthalmology coordination. |
| Dose exceeds 200 mg cap | Patient >100 kg billed at full 2 mg/kg without applying max cap | Cap dose at 200 mg per FDA label. Resubmit with 200 units (no JW since 5 vials = 200 mg exactly). |
Frequently asked questions
What is the HCPCS code for Tivdak?
Tivdak (tisotumab vedotin-tftv) is billed under HCPCS J9273 — "Inj tisotu
vedotin-tftv, 1 mg." Each milligram equals one billable unit. The drug ships in 40 mg lyophilized
single-dose vials (NDC 51144-040-01).
How many units do I bill for a Tivdak dose?
Bill the actual mg administered. Calculate 2 mg/kg of actual body weight, capped at 200 mg per dose for patients >100 kg. Example: a 70 kg patient receives 140 mg = 140 units of J9273; uses four 40 mg vials with 20 mg discarded — bill JW for 20 units of waste plus 140 units administered on a separate claim line.
What administration CPT do I use for Tivdak?
CPT 96413 — "Chemotherapy administration, IV infusion technique; up to 1 hour,
single or initial substance/drug." Tivdak's standard infusion is 30 minutes, fitting within the
1-hour window. As a complex monoclonal antibody-drug conjugate, it is billed under chemo admin codes
per AMA classification. Do NOT bill 96365.
Do I bill JZ or JW for Tivdak?
Bill JW on virtually every Tivdak claim. Because the only available vial is 40 mg and dosing is weight-based (2 mg/kg), partial-vial waste is the rule. Use JZ only when the calculated dose lands exactly on a 40 mg multiple (60, 80, 120, 160, 200 mg). One of JZ or JW must be on every J9273 claim per CMS's July 2023 single-dose container policy.
What is the boxed warning for Tivdak?
Tivdak carries a BOXED WARNING for ocular toxicity — severe vision changes, ulcerative keratitis, and conjunctival/corneal events. Baseline ophthalmology exam required before the first dose, then before every cycle. A mandatory eye care protocol must be followed: cooling eye pads during and 30 min after infusion, ophthalmic vasoconstrictor + corticosteroid drops per protocol, ophthalmic lubricants 4–6×/day, and NO contact lens use during therapy. See eye care protocol.
What is the Medicare reimbursement for J9273?
For Q2 2026, the Medicare Part B payment limit for J9273 is $196.121 per mg (ASP + 6%). A 140 mg dose (typical 70 kg patient) reimburses at approximately $27,456.94 per infusion; a max-cap 200 mg dose at $39,224.20. Annualized Medicare cost (q3w cycles, ~17 doses/year): approximately $466,000 for a 70 kg patient, plus reimbursable JW waste.
What is Tivdak approved for?
Tivdak is approved for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Initial accelerated approval was granted September 2021 (innovaTV 204 single-arm trial). Full traditional approval was granted April 2024 based on the ENGOT-cx12/innovaTV 301 confirmatory phase 3 trial showing OS benefit. It is the first FDA-approved drug specifically for this indication and the first tissue factor-targeted ADC.
How does Tivdak compare to other ADCs?
Tivdak is one of six FDA-approved oncology antibody-drug conjugates. It uses MMAE (monomethyl auristatin E) as its cytotoxic payload — the same payload as Adcetris (J9042, anti-CD30, Hodgkin), Polivy (J9309, anti-CD79b, DLBCL), and Padcev (J9177, anti-Nectin-4, urothelial). Enhertu (J9358) and Trodelvy (J9317) use different payloads (deruxtecan, govitecan). All MMAE-payload ADCs share peripheral neuropathy as a class effect. Only Tivdak carries a boxed ocular toxicity warning. See ADC class comparison.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- Tivdak HCP site — Pfizer/Seagen + Genmab
- DailyMed — TIVDAK (tisotumab vedotin-tftv) Prescribing Information
- FDA Tivdak label PDF (full approval revision, 2024)
- FDA — Full traditional approval announcement (April 2024)
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J9273 reference
- Pfizer Oncology Together — Patient Access & Reimbursement Support
- NCCN Clinical Practice Guidelines in Oncology — Cervical Cancer
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- 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, ocular protocol | 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,
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: Pfizer Oncology Together / Tivdak HCP site (2025). FDA label: April 2024 full traditional approval revision. Boxed ocular toxicity warning + mandatory eye care protocol included. ADC class comparison vs Adcetris, Polivy, Padcev, Enhertu, Trodelvy.
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 and ocular protocol are verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.