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 EU5, 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), and Amgen’s Mimpara (cinacalcet). 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 manufactures 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; causes of chronic kidney disease (CKD); predialysis care; blood transfusion rates; hemoglobin at time of blood transfusion; ESA hyporesponders; prevalence of calcification; vascular access procedures; hospitalization rates; and laboratory testing patterns (26 unique laboratory values are assessed). In this sample of dialysis patients, 88% receive hemodialysis (HD) and 12% are peritoneal dialysis (PD) patients. Across the EU5, what percentage of patients were dialysis-emergent and what percentage had less than a year of predialysis 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 have arterial calcification and is it suspected or confirmed? What percentage of patients had a blood transfusion in the past year?

  • 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, Mimpara, magnesium supplements, Kayexalate (sodium polystyrene sulfonate), insulin, and any other diabetic medication. For example, in 2015, across all dialysis patients, the use of oral iron is significantly higher in Italy than in Germany, and the use of phosphate binders is significantly higher in Germany than in France and the U.K. The report also includes an analysis of concomitant use across the eight key renal therapies. For example, what percentage of patients in the EU5 is on ESAs, according to patient charts and, more importantly, how does this percentage differ between 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?

  • Understand patient-share changes for renal anemia, bone and mineral, and other renal medications between HD and PD. For example, in Italy in 2015, 90% of HD patients undergoing IV iron maintenance therapy are treated with Ferlixit. Physicians’ estimated use of Ferrograd in the PD setting is higher in 2015 than it was three years ago. Across the EU5 and by country, 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), Amgen’s AMG-416, Keryx Biopharmaceuticals’ Auryxia (ferric citrate), Vifor Fresenius Medical Care Renal Pharma’s Velphoro, ZS Pharma’s ZS-9, and Relypsa’s patiromer. After review of a product profile, what percentage of their patients would be considered to start 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, phosphorous level) would be present in candidates for these new therapies?

Scope:

Markets covered: Europe (France, Germany, Italy, Spain, and the United Kingdom).

Primary research: 225 nephrologists via an online survey. Nephrologists completed a profile about their practice demographics and certain attitudes around treatment with renal medications and reviewed and provided data from an average of 4.1 (median: 5) dialysis patient charts.

Nephrologist screening criteria: Nephrologists must be in practice for 2-35 years and have a minimum of 50 dialysis (in-center hemodialysis, peritoneal dialysis, and/or home hemodialysis) and 100 CKD-ND (stage 3, 4, and/or 5 ND) patients under their care and seen at least once in the past year.

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 18 years old and less than 89 years to qualify.

Field dates: January 15 - February 25, 2015.

Report: PowerPoint format with 274 pages.

Author(s): Rob Dubman
Jihan Khan