Regulatory Availability of new drugs result in U.S. Task Force’s...

Availability of new drugs result in U.S. Task Force’s consideration of routine kidney disease screening

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According to reports, screening for CKD (Chronic Kidney Disease) is now a part of preventive services that are being considered actively by an influential U.S. panel. This may aid in the identification of potential patients that could be eligible for the new drugs that provide early treatment of the disease.

The issue was last addressed ten years ago, by the U.S. Preventive Services Task Force (USPSTF), which was inconclusive as not enough evidence was found to evaluate routine screening for CKD in asymptomatic adults. The chair of the aforementioned government-backed panel, Dr. Carol Mangione mentioned that the result found a decade ago does not hold true today because of advances in science. A representative of USPSTF confirmed that the news has not been revealed publicly.

One reason an update is being worked on is that the new drugs being used to slow down the progress of a disease without symptoms can lead to the failure of kidneys which may require dialysis filtering or kidney transplant in extreme cases.

SGLT2 inhibitors, new type 2 diabetes treatments have had a noticeable positive impact on the kidneys and heart. These inhibitors make the kidneys eject surplus blood sugar via urine.

In 2021, Farxiga, produced by AstraZeneca (AZN.L), won U.S. approval to slow down the advancement of kidney disease in the early stage. A few months ago, after establishing the benefits for kidney disease the trial for Jardiance (a drug made by Boehringer Ingelheim and Eli Lilly (LLY.N) concluded. 

By the estimation of the National Kidney Foundation, 37,000,000 people in the U.S suffer from kidney disease. The catch is that only 10% of the people are aware of the fact that they have it. Of the 37M people, 800,000 (a little over 2%) suffer from end-stage renal disease, which requires a transplant, or at least dialysis to stay alive.

Director of the University of California Los Angeles kidney health program, Dr. Ajay Rastogi said, “Most of kidney and cardiovascular disease is silent … until something happens and then it is catastrophic.”

Multiple medical societies suggest screening people with medical conditions like diabetes and hypertension because they are considered to be at higher risk of kidney disease. National Kidney Foundation estimates diabetes to be one of the main causes of kidney failure, attributing to 4 in 10 of the new cases.

Prior to the development of new ways to treat people with early CKD, they were treated using blood pressure medicines that were mostly over ten years old. In an email, Eli Lilly said that more education on the subject, as well as the availability of additional options for treatment, are critical. In addition, a kidney disease expert at the University of Washington in Seattle, Dr. Katherine Tuttle said older drug usage “is dismally low” ranging from 25%-40% patients of CKD and this is because a lot of cases are not even detected.

AstraZeneca highlighted the need for screening recommendations to be updated in order to combat this underdiagnosed disease. Screening for CKD is usually a blood test measuring levels of creatinine, a waste product, and a urine test for a type of protein called albumin.

Dr. Katherine Tuttle said that tests like the urine albumin tests, which cost only $10 are not something that will dent the healthcare budget. However, the drugs to be used are expensive, which results in low usage. The list price of Farxiga in the U.S. is $533 for a month’s supply, while AstraZeneca highlights assistance programs for patients to make it affordable.

Sarah Walters, head of cardiovascular, metabolism and renal for AstraZeneca, believes that a lot of these patients will end up on dialysis until and unless something is done about it.

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