Astellas announces the assignment of a product-specific, permanent J-code for PADCEV.

Astellas has announced the assignment of a product-specific, permanent J-code for PADCEV. The Centers for Medicare & Medicaid Services (CMS) released the July 2020 Quarterly Healthcare Common Procedural Coding System (HCPCS) File, which includes the designation of J9177 for PADCEV with the effective date of July 1, 2020.1
* Note that the product’s NDC code has been “zero-filled” to ensure creation of an 11-digit code that meets HIPAA standards.3
The zero-fill location is indicated in bold. Dose descriptor is provided as the smallest amount that can be billed in multiple units in order to accommodate a variety of doses.1

PADCEV was approved by the U.S. Food and Drug Administration on December 18, 2019. PADCEV is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor‑1 (PD‑1) or programmed death‑ligand 1 (PD‑L1) inhibitor and a platinum‑containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.2 This indication is approved under accelerated approval based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.2

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