This report leverages physician insights, as well as patient chart data, to provide the most up-to-date information about chronic kidney disease non-dialysis (CKD-ND) patient care in France, Germany, and Italy (EU3), including patient demographics and the use of medications. Our in-depth analysis of CKD-ND 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 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 CKD-ND patients who are under the care of a nephrologist. This feature includes topics such as referral patterns, CKD-ND stage at time of referral, common reasons for referral, blood transfusion rates, presence of comorbidities, hospitalization rates, office visits, physician co-management and length of treatment, and expected time to renal replacement therapy (e.g., dialysis). In this sample of CKD-ND patients, in France, Germany, and Italy, 32% have stage 3, 35% have stage 4, and 34% have stage 5 CKD-ND. What was the primary cause of kidney disease? How does the frequency of office visits vary by disease severity? What other physician types are also seeing these patients?

  • Understand the standard of care for CKD-ND patients and how it differs between stages. 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), and diabetic medications. For example, in 2015, among EU3 CKD-ND patients NVD, ESAs, oral iron, and phosphate binders are used most often. The report also includes an analysis of concomitant use across the eight key renal therapies. For example, what percentage of patients in the EU3 is 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 CKD-ND 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 stages of the disease. For example, in 2015, sevelamer continues to lead audited monotherapy and combination phosphate binder patient share, followed by total calcium and Shire’s Fosrenol. Across the EU3 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’ vadadustat, GlaxoSmithKline’s daprodustat, Keryx Biopharmaceuticals’ Fexeric (ferric citrate coordinate complex), OPKO Health’s Rayladee, ZS Pharma’s ZS-9, Relypsa’s patiromer, AbbVie’s atrasentan, and Bayer’s finerenone. After review of a product profile, what percentage of their 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 would be present in candidates for these new therapies?

Scope:

Markets covered: France, Germany, and Italy.

Primary research: 134 nephrologists via an online survey. Nephrologists completed a profile about their practice demographics and certain attitudes regarding treatment with renal medications, and they reviewed and provided data from 605 CKD-ND patient charts.

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

CKD-ND patient chart qualification criteria: Patients must CKD stage 3, stage 4, or stage 5 not on dialysis to qualify. Patients must be aged 18-89 years old to qualify. Charts selected based on last five patients seen.

Field dates: May 12, 2015 to June 12, 2015.

Report: PowerPoint format with 295 slides.

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