November 26, 2018
All statement quotes for attribution to National Kidney Foundation (NKF)
“November 26, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.
The National Kidney Foundation is concerned that proposed changes to Medicare Part D protected classes will make it more difficult for some transplant recipients to access the drugs they need to prevent organ rejection.
Patients want lower costs but are not willing to trade their lives or put their kidney transplant at risk. The proposed rule would remove key protections for transplant patients that allow them to access the immunosuppressive drug regimen that best meets their individual needs and would leave the government in the position of deciding what is clinically appropriate when reviewing Part D plan formularies.
Immunosuppressive drugs are prescribed in combinations tailored to meet the unique needs of the individual transplant recipient in order to achieve sufficient immunosuppression while minimizing the toxicity associated with individual agents. Restrictive formularies limit physicians’ ability to prescribe the right combination of medications to protect the recipient from organ rejection and other serious side-effects. This delicate balance was recognized in the original decision to include these medications under protected status.
Not all patients respond the same to just one or two combinations of medications. Often, the first prescribed drug combination needs to be adjusted or replaced altogether, further underscoring the need to have all drugs available under Part D plans.
While we understand the need to control healthcare spending, this is not the way to achieve savings. As of October, this year there have been over 30,000 organ transplants in the U.S. and many were Medicare beneficiaries for whom Medicare Part B covers immunosuppressive drugs. While this proposal will impact a small number of organ recipients, it puts those who do get their immunosuppressive drugs under Part D, health and lives at risk.
It is also likely to result in higher spending under Medicare Parts A and B, particularly if more patients’ organs fail, fueling the need for more health care services and/or the need for a Medicare covered transplant.
Most immunosuppressive drugs are generic and in fact there has been little innovation in new drugs. A kidney transplant is not a cure, but for most patients is the superior treatment. New medications to prevent rejection and reduce side-effects are sorely needed and the CMS proposal will hinder innovation in this space.
While we appreciate the Trump Administration’s focus on reducing the cost of prescription drugs, we have significant concerns with this proposed policy. We are hopeful that CMS will hear our concerns and ensure that patient’s safety is the first and foremost priority.”
Kidney Disease Facts
In the United States 30 million adults are estimated to have chronic kidney disease—and most aren’t aware of it. 1 in 3 American adults are at risk for chronic kidney disease. Risk factors for kidney disease include diabetes, high blood pressure, heart disease, obesity and family history. People of African American, Hispanic, Native American, Asian or Pacific Islander descent are at increased risk for developing the disease. African Americans are 3 times more likely than Whites, and Hispanics are nearly 1.5 times more likely than non-Hispanics to develop end stage renal disease (kidney failure).
The National Kidney Foundation (NKF) is the largest, most comprehensive and longstanding organization dedicated to the awareness, prevention and treatment of kidney disease. For more information about NKF visit www.kidney.org.