The chances of extending the Transitional Drug Add-on Payment Adjustment (TDAPA) to a 3-year period for drugs like Unicycive’s Oxylanthanum Carbonate (OLC) are high but currently depend on pending legislation rather than finalized CMS rules.
While CMS has maintained a minimum 2-year window, there is significant momentum toward a 3-year standard through legislative and regulatory pathways:
Active Legislation (S.2730 / H.R.6214): The Kidney Care Access Protection Act (S. 2730) specifically proposes extending the TDAPA period to at least 3 years for new renal dialysis drugs approved after January 1, 2020. This bill has strong backing from major advocacy groups like Kidney Care Partners.
CMS Regulatory Shifts: In the CY 2026 ESRD PPS Final Rule, CMS modified the eligibility timeframe to require FDA approval within 3 years of a TDAPA application submission. While this change primarily affects when a drug can apply, it signals a shift toward aligning with the 3-year window used for other Medicare innovative payment adjustments (like TPNIES).
Impact on Unicycive's OLC: PDUFA Target Date: June 29, 2026. Commercial Launch: Anticipated in Q3 2026. If OLC is approved and launches in late 2026, its standard TDAPA period would currently cover 2027 and 2028. A legislative extension to 3 years would push its add-on payment eligibility through 2029.
Industry Precedent: CMS has previously allowed extensions under specific circumstances; for example, certain oral-only phosphate binders are already receiving TDAPA payments into 2026 to ensure a stable transition into the bundle.
3 yrs in TDAPA would be major for UNCY as it would allow more time to prove patient preference for OLC , better compliance , reduced hospital costs associated with heart attacks etc
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