After showing steady growth beginning in 2012, the number of new starts on peritoneal dialysis in the U.S. took a major plunge this past year, likely due in part to a shortage of dialysate for performing the treatment.
Based on data from an annual survey conducted by Nephrology News & Issues of the 10 largest dialysis providers, the number of new starts from May 2014-May 2015 on peritoneal dialysis was 1,393. During the prior year, the same providers started 4,357 patients on PD.
The drop in new starts is likely connected to the dialysate shortage announced by Baxter Healthcare Corporation in August 2014. Baxter has the majority of the PD market in the U.S., and manufacturers its Dianeal PD4 glucose solutions for use during peritoneal dialysis.
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"Several factors, including limited manufacturing capacity along with increased overall demand for sterile solutions and changing PD prescribing patterns, have resulted in the current supply constraints," Baxter told NN&I at the time.
The company said they would institute a process to temporarily limit the number of new peritoneal dialysis patient referrals across their entire base of customers.
Baxter had already begun talking with some of its customers three months earlier about the impeding shortage. By speeding up construction of a new supply plant line for the solution, brokering an agreement with Fresenius Medical Care to help with bolstering the supply, and importing some of the glucose solution from Ireland, PD programs got some relief. But new starts on the therapy have still been limited.
NN&I’s annual survey collects data on growth among all modalities (conventional, in-center hemodialysis, peritoneal dialysis, and home hemodialysis), as well as for nocturnal in-center hemodialysis programs as of May of each year. NN&I has been issuing the survey since 1994.
While the NN&I survey doesn’t capture data among all providers, the 10 largest companies provided care for 415,794 dialysis patients as of May 2015.
Some dialysis providers have told NN&I that they are still being restricted on how many new patients they can start on PD, particularly continuous cycling PD, which uses more dialysate solution.
Home hemodialysis loses ground
The number of new patients starting on home hemodialysis has also seen significant decreases over the last three years. After hitting a high of 1,166 new patients during 2011-2012—the same period of time when PD dropped close to 900 new starts—the number of new home hemodilayis patients among the 10 largest providers took a steep drop in 2013 and 2014. There was a slight rebound in 2015 with 460 new starts.
Influence of in-center nocturnal programs on PD?
NN&I began to ask dialysis providers about the number of patients enrolled in in-center nocturnal hemodialysis programs in 2011, and in that first year, 3,012 patients were identified. The census went up each year by 200-300 patients until taking a dip by close to 200 patients enrolled in nocturnal programs between 2013-2014. In the next year, however, new starts in in-center nocturnal hemodialysis programs jumped by 561 patients—during the same year that the PD fluid crisis occurred. It’s possible that clinics started more patients on in-center nocturnal hemodialysis programs in response to the limitations posed by the PD fluid shortage.
Turning the tide
The U.S. Renal Data System data shows that overall growth in ESRD patient population has slowed in recent years, so there is a smaller pool of new patients starting on dialysis each year. Growth in the number of new patients collectively among the ten largest providers has been steady at around 5-6% each year, according to the NN&I surveys, but some of that growth can be attributed to acquiring other dialysis companies.
Likewise, starting patients on a home modality can be challenging. But if the PD fluid shortage continues through 2015 and into 2016, it will be harder for dialysis providers to introduce new patients to the therapy.
History of the dialysate shortage
Aug. 8, 2014: Baxter Healthcare Corporation tells the U.S. Food and Drug Administration that it is experiencing supply constraints for peritoneal dialysis solutions.
Aug. 18: Baxter tells its customers about the shortage in a letter and says it is exploring alternative options to increase supply, but it had already begun discussion with customers in May about the shortage. "Several factors, including limited manufacturing capacity along with increased overall demand for sterile solutions and changing PD prescribing patterns, have resulted in the current supply constraints," Baxter told NN&I. The company said they are instituting a process to temporarily limit the number of new peritoneal dialysis patient referrals across their entire base of customers. "This process will be aimed at ensuring access to PD therapy on an equitable basis," the letter said.
Aug. 29: In a letter sent to the U.S. Food and Drug Administration, the North American Chapter of the International Society for Peritoneal Dialysis (ISPD-NAC), expressed their “strong concerns” that the ongoing shortage of PD fluid was limiting patients’ option to choose PD.
“To our great dismay, PD growth will effectively stop as a result of the PD solution shortage. As of today, Baxter (who provides dialysis supplies for about 90% of U.S. PD patients) instituted a process to temporarily limit the number of new peritoneal dialysis patient referrals across their entire base of customers, effectively stopping the gains we have made in providing home dialysis to more patients in this country,” wrote North American Chapter president Peter Blake, vice president Rajnish Mehrotra, MD, and three others on behalf of the chapter.
Sept. 3: In a letter to health care professionals, Baxter says it has signed an agreement with Fresenius Medical Care to help bolster its PD fluid supply to customers, and indicates that resolving its problems with under capacity could take four to six months.
Oct. 16: Baxter, in conjunction with the U.S. Food and Drug Administration, has initiated temporary importation of its Dianeal PD4 glucose solutions for peritoneal dialysis into the U.S. market to address the fluid shortage; Baxter will import PD solutions manufactured at the company's Castlebar, Ireland facility. The FDA said it estimates the additional solution will be available beginning in November. -by Mark Neumann