This report leverages physician insights, as well as a year’s worth of patient chart data, to provide the most up-to-date information about dialysis patient care in the United States, including patient demographics and the use of laboratory assessments and medications. Our in-depth analysis of dialysis medications spans a wide range of variables, including product initiation, dosing, switching, and concomitant therapy; coverage includes erythropoiesis-stimulating agents (ESAs), IV iron, oral iron, phosphate binders, nutritional vitamin D (NVD), active vitamin D (AVD), Amgen’s Sensipar (cinacalcet), and Kayexalate (sodium polystyrene sulfonate). By comparing what nephrologists report about patient care with actual patient records, we uncover gaps in intended versus actual care and reveal opportunities for the expanded use of current and emerging therapies. In our new section on products in development, we cover nine emerging therapies. This section allows manufacturers to see profiles of those patients who would be considered to start on the emerging therapy, assuming that it receives regulatory approval.

Questions Answered in This Report:

  • Characterize dialysis patients who are under the care of a nephrologist. This feature includes topics such as dialysis modality; length, frequency, and location of dialysis treatment (e.g., dialysis chain vs. nonchain); causes of chronic kidney disease (CKD); pre-dialysis care; blood transfusion rates; hemoglobin at time of blood transfusion; ESA hyporesponders; prevalence of calcification; vascular access procedures; hospitalization rates; and laboratory testing patterns (22 unique laboratory values are assessed). For example, fluid overload, cardiovascular issues, and non-vascular access infection/complications are the most common reasons for hospitalization of dialysis patients. What percentage of patients were dialysis-emergent and what percentage had less than a year of pre-dialysis care? What percentage of patients had a vascular access procedure in the past year and what was the most recent intervention? What percentage of dialysis patients had arterial calcification and was it suspected or confirmed? What percentage of patients had a blood transfusion in the past year and what was the hemoglobin level at most recent blood transfusion?

  • Understand the standard of care for dialysis patients and how it differs between PD and HD. This feature includes such topics as the percentage of patients who are on ESAs, IV iron, oral iron, phosphate binders, calcium supplements, AVD, NVD, Sensipar, Kayexalate, insulin, and any other diabetic medication. The report also includes an analysis of concomitant use across the eight key renal therapies. For example, ESAs and phosphate binders are the more commonly used renal anemia and bone and mineral metabolism medications in dialysis patients. What percentage of patients are on ESAs, according to patient charts and, more importantly, how does this percentage differ from physician perceptions captured in the profile section of the study? Of the key therapies used to treat CKD, on average, how many therapies are dialysis patients taking? Of the patients initiated on an ESA in dialysis, what is the distribution of hemoglobin at time of initiation? How many hemoglobin, TSAT, ferritin, phosphorus, PTH, calcium, and potassium tests did patients undergo over approximately a one-year period?

  • Understand patient-share changes for renal anemia, bone and mineral, and other renal medications between HD and PD. For example, patient charts indicate few notable differences between HD and PD binder patient share. How has the use of individual brands changed in recent years? How common is brand switching within each drug class? Which medications are often used in combination? How do patient profiles differ for treated and untreated individuals and by other groups (e.g., patients on calcium- versus non-calcium-based phosphate binders, patients on an ESA versus not on an ESA)?

  • Profile the patients who would be considered for new products in development for renal anemia, hyperphosphatemia, secondary hyperparathyroidism, and hyperkalemia: FibroGen/AstraZeneca/Astellas’s roxadustat, Akebia Therapeutics’ AKB-6548, GlaxoSmithKline’s daprodustat (GSK-1278863A), Celgene/Acceleron’s sotatercept (ACE-011), Rockwell Medical’s Triferic, Relypsa’s patiromer, Amgen’s AMG-416, Keryx Biopharmaceuticals’ Auryxia (ferric citrate), and Ardelyx’s tenapanor. After review of a product profile, what percentage of patients would physicians consider starting on the emerging therapy now, if it received regulatory approval? What factors will promote and detract from their use? Which patient characteristics (e.g., hemoglobin level, potassium level, phosphorus level among many others) would be present in candidates for these new therapies?

Scope:

Markets covered: United States.

Primary research: 220 nephrologists via an online survey. Nephrologists first completed a profile about their practice demographics and attitudes about treatment with renal medications and then reviewed and provided data from an average of four dialysis patient charts.

Nephrologist screening criteria: Nephrologists must be in practice for 2-30 years and have a minimum of 50 dialysis (in-center hemodialysis or peritoneal dialysis) under their personal management.

Dialysis patient chart qualification criteria: Patients must be on dialysis for six months; the current modality is hemodialysis or peritoneal dialysis to qualify. Patients must be at least age 18 and younger than 89 to qualify.

Field dates: February 25 - March 23, 2015.

Report: PowerPoint format with 194 slides.

Author(s): Rob Dubman, M.B.A.