100,000 USD Spent on Lobbying This Year
Tricida Inc. is a well known pharmaceutical company that specializes in the development and marketing of veverimer. Veverimer is an investigational drug candidate designed to slow chronic kidney disease (CKD) progression in individuals with metabolic acidosis (MA) and CKD. CKD is a longstanding disease that ultimately leads to renal failure as the kidneys lose function over time and waste can no longer be removed efficiently from the body. Tricida Inc. is presently conducting a clinical trial called VALOR-CKD to determine if veverimer effectively slows the progression of CKD in patients with MA. MA is often caused by CKD and believed to accelerate the rate of kidney malfunction the overall progression of CKD. The clinical trial results are anticipated to be published some time in October with the average subject participating for 26.5 months. Currently, 4.3 million Americans are impacted by CKD, yet there are no Food and Drug Administration approved therapies to slow the profession of the disease.
Research and Development expenses were 16.9 million USD in 2022 and 19.8 million USD in 2021 for the three month periods ending in June. As of June 2022 the total cash, cash equivalents, and investment sum 98.7 million USD.
November 2021 saw the release of three Medicare payment final rules that deal with nephrology. They are: the Centers for Medicare and Medicaid Services (CMS) ruling on the 2022 End Stage Renal Disease (ESRD) Prospective Payment System (PPS), the release of the 2022 Medicare fee schedule that included updates to the Quality Payment Program, and the final ruling on the Hospital Perspective Payment System/ Ambulatory Surgical Center (HOPPS/ ASC). Not specifically mentioned by either Tricida Inc. or their lobbyists, H.R. 4065 is likely being endorsed. The bill, known as the Chronic Kidney Disease Improvement in Research and Treatment Act of 2021, primarily modifies provisions within Medica re coverage for the treatment of chronic kidney disease. It expands the annual wellness visit to include screening for chronic kidney disease and allows certain beneficiaries who have ESRD to enroll in Medicare supplemental policies. Additionally, it revises payment measures, establishes an incentive payment methodology, increases access to kidney disease education services, and provides alternative payment methodologies for for certain new drugs, biologics, and devices. Finally H.R. 4065 extends the coordination period in which private health insures may serve as the primary payer for Medicare beneficiaries with ESRD.
CKD and ESRD
Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD) are typically caused by other health problems that have damaged ones kidneys either via their presentation or treatment. Some common problems include diabetes, high blood pressure, nephrotic syndrome, chronic alcoholism, and various autoimmune disease. While these may not lead to CKD, there is also Acute Kidney Injury (AKI) which can lead to total kidney failure in as little as two days. Some of the more recognizable symptoms of AKD are itchy skin and rashes, loss of appetite, swelling of the feet and ankles, changes in urination, and frothy urine. There are three main test medical profession use to determine if one is undergoing kidney failure: a urine test, eGFR blood test, or a kidney biopsy. Once CKD has bee diagnosed there are traditional two routes one can take. The first being dialysis and the second being a kidney transplant. Of the 106,000 people in America of an organ transplant wait list nearly 90 percent of them (92,000) are waiting for a kidney.
