Benzinga | Dec 20, 2021 07:08AM EST

Cara Therapeutics Announces The CMS Has Granted Transitional Drug Add-On Payment Adjustment To KORSUVA Injection

Cara Therapeutics, Inc. (NASDAQ:CARA) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted Transitional Drug Add-On Payment Adjustment (TDAPA) to KORSUVA(tm) (difelikefalin) injection in the anti-pruritic functional category. TDAPA will apply to KORSUVA injection beginning April 4, 2022, for two years. KORSUVA injection was approved by the U.S. Food and Drug Administration (FDA) in August 2021 for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.

TDAPA enables payment for new injectable end-stage renal disease (ESRD)-related therapies to be reimbursed outside of the ESRD Prospective Payment System (PPS) bundle.

As KORSUVA injection is just the second product to be approved for TDAPA, CMS expressed in its written communication to Cara and Vifor Pharma, Cara's U.S. commercial partner for KORSUVA injection, a continuing interest in engaging with the companies regarding potential post-TDAPA support to ensure all beneficiaries with ESRD have access to innovative products such as KORSUVA injection.

"Receiving TDAPA from CMS is a crucial step toward the commercial launch of KORSUVA injection, which we believe will benefit thousands of chronic kidney disease patients undergoing dialysis who suffer from pruritus," said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. "We are pleased to have secured TDAPA reimbursement for KORSUVA injection and are encouraged by the willingness of CMS leadership to engage with Cara and Vifor Pharma regarding potential post-TDAPA support."

"We are pleased to have secured TDAPA reimbursement in the United States for KORSUVA injection effective April 2022, and we look forward to bringing this important treatment option to the people who need it," said Molly Painter, President USA, Vifor Pharma.