Advancing American Kidney Health, an executive order signed by President Donald J. Trump in July, has the goals of reducing the number of Americans developing ESRD by 25% by 2030; having 80% of new patients with ESRD in 2025 either receiving dialysis at home or having a transplant; and doubling the number of kidneys available for transplant by 2030. To accomplish these goals, suppliers of home dialysis equipment plan to ramp up production in the coming years.
For global renal care company Baxter International Inc., this production strategy comes in the form of up to a $500 million investment in its U.S. renal care market, including potential new U.S. facilities and additional jobs in its existing sites to produce more PD solutions, devices and cassettes. Meanwhile, U.K.-based Quanta Dialysis Technologies Ltd. announced in August a study to begin human factor testing in the United States on its SC+, a small, powerful, personal hemodialysis system designed to empower more patients to take control of their lives through self-care and home hemodialysis. Quanta intends to start the FDA submission process later this year and ultimately put the device in the U.S. market.
Global standard for patient-centered care
“The proposed model is a more patient-centric framework that provides a supportive reimbursement structure for increased patient education [and] higher rates of home dialysis adoption and transplantation, while still supporting patients better suited for [in-center hemodialysis],” Laura Angelini, general manager of Renal Care business for Baxter, told Healio/Nephrology.
“We think this is going to deliver better value for everybody,” agreed John Milad, CEO of Quanta. The company raised $48 million in July 2019 to help with the commercial launch of SC+, which received a CE mark in the European Union in 2015, into the U.K. later this year.
While the in-center dialysis clinic model is not likely to go away, Milad added, allowing at-home options for more patients gives them greater freedom and quality of life benefits.
Suppliers of home dialysis equipment plan to ramp up production in the coming years.
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Traditional clinic-based dialysis three times per week “puts a tremendous burden on patients, with many patients saying they feel they are just living to dialyze” Milad said, adding the traditional delivery model puts patients in a position of dependency and can leave them feeling disempowered. Dialysis at home allows patients to receive treatment more frequently, which he noted is linked to better outcomes. “We could liberate [patients] from the tyranny of the clinic,” he said.
While global trends point toward increased access to home dialysis, both Angelini and Milad said the United States has not kept pace.
Angelini cited, in particular, Hong Kong and Colombia as positive examples.
“In these countries, reimbursement policies encourage home dialysis as the front-line treatment, unless medically indicated for [in-center hemodialysis],” she said. “We also see consistent approaches to pre-dialysis care, including treatment education and catheter insertion programs.”
Milad said, “This policy shift is, in effect, validating our world view.” He added the Advancing American Kidney Health (AAKH) initiative creates “a stronger drive, a stronger incentive” to focus on the U.S. market.
Emphasis on innovation
In a press release, CMS Administrator Seema Verma said the AAKH initiative would focus on “eliminating regulatory barriers to unleash innovation that will improve health outcomes and quality of life for patients with chronic disease.”
Final parameters for the initiative are yet to be released, but early announcements focused on the need for innovation in the home hemodialysis market, with CMS considering five possible reimbursement structures. These structures attempt to disrupt the current payment system, encouraging in-center care as the default treatment for patients beginning dialysis.
“The proposed rule is a significant shift in supporting truly innovative new products that will have a positive impact on patient care and outcomes,” Angelini said. “We think that to realize these benefits, CMS should consider basing eligibility on whether a device receives [FDA] marketing authorization through the [premarket authorization] or de novo process. This will foster new technologies that fill gaps in care where limited options exist today.”
Baxter is conducting a U.S. clinical trial on its investigational on-demand PD solution system, which makes PD solutions in small batches in the patient’s home. Additionally, Angelini said Baxter recently completed a clinical trial on HDx therapy enabled by the Theranova dialyzer, which is an investigational HD therapy in the United States that targets the removal of large middle molecules; and, they are exploring approaches to preventative care that are less common in the United States.
Quanta, meanwhile, is looking at ways to ease the transition for in-clinic patients who are eligible for at-home care.
“It creates a unique opportunity to bridge from the clinic to the home,” Milad said of the AAKH initiative. He said Quanta will innovate improved delivery methods for at-home dialysis to help patients feel safe and confident using their device.
Angelini added, “Depending on the rule’s final form, [Baxter] plans to scale investments in the United States to align with proposed models from CMS, and patient and market dynamics across the adoption curve.”– by Amanda Alexander
Angelini reports she is the general manager of the global renal care business for Baxter. Milad reports he is founder and CEO of Quanta Dialysis Technologies.