Oral Treatment for Renal Anemia Draws Attention From Congress

CMS’ decision to exclude a treatment for renal anemia from Medicare coverage has drawn the ire of 4 members of Congress, who last week introduced a bill that would require coverage for drugs they say would allow seniors with chronic kidney disease (CKD) to be treated at home, a high priority as coronavirus disease 2019 (COVID-19) hits hard among these patients.

Patients with CKD who have not progressed to dialysis are still at risk of developing iron deficiency anemia (IDA) which historically has been treated by non-dialysis infusions. FDA approved an oral therapy, ferric citrate coordination complex, sold as Auryxia by Keryx Biopharmaceuticals; it was first approved for patients on dialysis in 2014 and then for non-dialysis patients in 2017. Medicare Part D initially covered the therapy, but in 2018 excluded it for patients not on dialysis, according to a recent commentary in The Hill.

A 2019 study found the treatment is effective and well-tolerated; among the non-dialysis patients in the study, 10% stopped taking ferric citrate and 9% stopped taking placebo.

US Reps. Larry Bucshon, MD, R-Indiana, Markwayne Mullin, R-Oklahoma, G.K. Butterfield, D-North Carolina, and Tom O’Halleran, D-Arizona, introduced the Renal Anemia Innovation Support and Expansion (RAISE) Act, which they said would keep older patients with CKD healthy and put Medicare on par with health coverage enjoyed by federal employees and veterans.

“American seniors have paid into Medicare their entire lives; the program should serve them completely and holistically. As we continue to battle the coronavirus pandemic, Medicare beneficiaries with pre-existing conditions like CKD are at a higher risk of infection and complication,” O’Halleran said in a statement.

The lawmakers noted that patients with CKD are often older and immunocompromised, putting them at higher risk of severe illness or death from COVID-19. Many also suffer from comorbidities such as diabetes or heart disease, and public health officials including the CDC have recommended that these patients remain isolated during the pandemic.

“As a physician and a co-chair of the Congressional Kidney Caucus, I understand the importance of treating iron deficiency anemia in patients with chronic kidney disease and making sure patients have access to treatment,” Buschon said in the statement. “Given the heightened risk of severe complications associated with COVID-19 for patients with CKD, allowing for an at-home treatment option during this pandemic is important because it will allow CKD patients to get the treatment they need without increased risk of exposure to the virus.”