ICD-10 — urothelial carcinoma
| Code | For |
C67.0–C67.9 | Malignant neoplasm of bladder by site (trigone, dome, lateral wall, etc.) |
C67.9 | Bladder, unspecified (most common) |
C65.x | Renal pelvis (upper tract urothelial) |
C66.x | Ureter (upper tract urothelial) |
C68.0 | Urethra |
Z85.51 | Personal hx of bladder ca (surveillance only — not for active tx) |
Stage docs: "locally advanced" or "metastatic" urothelial carcinoma must appear in chart. Include prior platinum & PD-1/L1 exposure for monotherapy claims; absence for 1L combo.
Payer requirements (May 2026)
| Payer | PA | Notes |
| UnitedHealthcare | Yes | Combo — concurrent PA on Padcev + Keytruda; site-of-care steerage |
| Aetna | Yes | Stage docs + line-of-therapy for mono (post-platinum + post-PD-1) |
| Anthem / Carelon | Yes | NCCN-aligned; oncology pathway routing common |
| Medicare (MAC LCDs) | Evolving | Verify current LCD; coverage per FDA label + NCCN |
1L combo trap: If Padcev approved but Keytruda PA pending (or vice versa), do NOT start — partial regimen denials are hard to appeal. Confirm both PAs before infusion.
Medicare reimbursement (Q2 2026)
| Field | Value |
| ASP + 6% | $36.707 / 0.25 mg unit (4/1 – 6/30/2026) |
| Per mg equivalent | $146.83 / mg (4 × unit price) |
| 125 mg max dose (500 units) | $18,353.50 |
| Cycle (3 doses @ 125 mg) | ~$55,060 |
| Annualized (39 doses, 13 cycles) | ~$715,786 |
| Sequestration ~2% | Net ~ASP + 4.3% |
Underbilling risk: Reporting "125 units" instead of "500 units" for a 125 mg dose → payer pays 25% of allowed. Audit Padcev claims monthly until billers internalize the 0.25 mg unit.
Site of care
| Setting | POS | Notes |
| Physician office | 11 | 30-min infusion fits cleanly |
| Ambulatory infusion suite | 49 | Common; payer-preferred |
| Hospital outpatient | 19/22 | UHC/Aetna disfavor for non-complex pts |
| Patient home | 12 | Not typical — ADC requires monitoring |
Patient assistance — Astellas / Pfizer
- Pfizer Oncology Together: 1-877-744-5675 (benefits, PA, appeals, copay)
- Padcev Co-pay Program: commercial insurance only; excludes Medicare/Medicaid/federal
- Astellas Patient Assistance Foundation: free product for uninsured/underinsured (501(c)(3); income criteria)
- Astellas Pharma Support Solutions: hub support for prior auth & appeals
- Web: padcev.com/healthcare-professional/access-and-support
BOXED WARNING — Serious Skin Reactions (SJS/TEN): Stevens-Johnson syndrome and toxic epidermal necrolysis — some fatal — reported predominantly during cycle 1. Monitor closely; withhold for severe skin reactions; permanently discontinue if SJS/TEN suspected or confirmed. Other significant W&P: hyperglycemia (esp. diabetics), pneumonitis/ILD, peripheral neuropathy (most common AE), ocular disorders, infusion reactions, embryo-fetal toxicity.
Pending SME review. This sheet is a working reference. Verify ASP, NDC, modifiers, and current LCDs against CMS, the FDA label, and your MAC at billing time. Do not substitute for the package insert.