Congress is considering a bipartisan bill that would allow chronic kidney disease (CKD) patients with renal anemia to avoid lengthy, expensive treatments by covering oral iron supplements under Medicare.
Iron-deficiency anemia (IDA) is a life-threatening condition that afflicts more than 15 percent of kidney patients, including more than half with liver failure (stage 5 CKD), according to the National Institutes of Health (NIH). Renal iron-deficiency anemia (IDA) is “a condition in which your blood has a lower-than-normal amount of red blood cells or hemoglobin,” states the NIH.
Patients suffering from IDA face serious complications, wrote Wayne Winegarden, Ph.D., director of the Center for Medical Economics and Innovation at the Pacific Research Institute, in the American Journal of Managed Care on March 12.
“Some 37 million Americans live with chronic kidney disease (CKD), a serious condition that occurs when the kidneys fail to effectively filter out toxic waste and extraneous fluid from the body,” wrote Winegarden. “Without timely, regular treatment, kidney patients face a significantly elevated risk of stroke, heart disease, and premature death.”
Pills to treat IDA are not covered by Medicare prescription drug plans (Part D), forcing millions of Americans to seek frequent and lengthy intravenous (IV) infusions with erythropoiesis-stimulating agents (ESA) that cause bone marrow tissues to produce more red blood cells.
Infusion Center Alternative
The oral treatment for IDA isn’t the same as the iron in multi-vitamins and mineral supplements, says Winegarden.
“Due to the unique nature of the condition, over-the-counter iron supplements don’t work,” wrote Winegarden. “Traditionally, this condition has required patients not yet dependent on dialysis to make the trek to infusion centers, where they undergo an hours-long intravenous (IV) infusion process.”
Long visits to IV infusion centers are no longer necessary, says Winegarden.
“Continued medical innovation has led to a safe and effective oral treatment for renal anemia that can be taken at home rather than IV infusion in a clinical setting,” wrote Winegarden.
Scientific Backing
A form of ferric citrate taken orally outperformed traditional infusion treatment, a peer-reviewed study published by the National Library of Medicine in 2019, found.
“Compared with usual care, ferric citrate coordination complex treatment resulted in significantly fewer annualized hospital visits, fewer days in hospital, and a lower incidence of the composite endpoint of death, provision of dialysis, or transplantation,” wrote the study’s authors.
End-stage renal disease patients who received the oral medication did not need infusion treatment as frequently, a study published in the Journal of the American Society of Nephrology in 2015, found.
“In conclusion, treatment with ferric citrate (FC) as a phosphate binder results in increased iron parameters apparent after 12 weeks and reduces IV iron and ESA (e.g., Procrit) use while maintaining hemoglobin over 52 weeks, with a safety profile similar to that of available binders,” write the study’s authors.
Pill Approved, Not Covered
As effective as at-home ferric citrate treatments appear to be, however, they will remain beyond the reach of Medicare patients unless the Centers for Medicare and Medicaid Services (CMS) revises its regulations.
Currently, Medicare only covers the therapy when a patient reaches end-stage renal disease, or kidney failure, and receives preauthorization from CMS.
The Food and Drug Administration (FDA) approved Auryxia for IDA in 2017 but CMS removed the treatment from Medicare Part D in 2018.
The action resulted in a lawsuit by Auryxia maker, Akebia.
“Although CMS provided almost no explanation for its decision, CMS appears to have concluded that Auryxia falls within the exclusion for ‘mineral products,’” states the complaint, Healio Health website reported.
“That conclusion is contrary to the plain meaning of the statute,” says Akebia’s complaint. “Auryxia is a patented drug product consisting of a complex synthetic compound, not a naturally occurring mineral product.”
The lawsuit is still active, Akebia stated in a press release on October 25.
Alternative Less Costly
At-home treatment of renal anemia with oral medications is less expensive and more convenient than infusion with drugs, says health economist Devon Herrick, Ph.D., a policy advisor to The Heartland Institute, which co-publishes Health Care News.
“The list price for Auryxia (ferric citrate) is about $8 per pill,” said Herrick. “CKD patients take anywhere from one to 12 pills a day. By contrast, injections of ESAs, such as Procrit, to treat anemia, cost $70 per vial to $1,100 per vial depending on the dosage.
“Infusions of ESA drugs will always exceed the cost of an $8 tablet,” said Herrick.
Congress: End Exclusion
Reps. Tom O’Halleran (D-AZ), Larry Bucshon (R-IN), Markwayne Mullin (R-OK), and G.K. Butterfield (D-NC) introduced the Renal Anemia Innovation Support and Expansion (RAISE) Act in 2021.
The one-page bill (H.R. 2934) would “amend Title XVIII of the Social Security Act to remove from the list of drugs excluded from coverage under the Medicare prescription drug program prescription oral vitamins and mineral products indicated for the treatment of iron deficiency anemia in individuals with chronic kidney disease.”
The RAISE Act was referred to the Committee on Energy and Commerce and could be included in another measure, say the amendment’s sponsors.
Bonner R. Cohen, Ph.D.(bcohen@nationalcenter.org) is a senior fellow at the National Center for Public Policy Research.
