This quarterly report series examines the management of dialysis and mid- to late-stage chronic kidney disease (CKD) patients from the perspective of nephrologists. Emphasis is on renal anemia management (erythropoiesis-stimulating agents [ESAs], oral iron, and IV iron), calcium-phosphorus metabolism (phosphate binders), and secondary hyperparathyroidism (SHPT) (nutritional and active vitamin D and calcimimetic agents). The TreatmentTrends series provides longitudinal information on market dynamics. It provides insight into practice patterns, attitudes and perceptions, and current and projected use of various products. It evaluates perceived product advantages and disadvantages, as well as sales and messaging efforts, of key market players. The series continuously evolves and covers high-interest areas in the renal field, such as the impact of the dialysis bundle or coverage of late-stage products for the treatment of hyperkalemia.

Questions Answered in This Report:

  • Assess current and anticipated use of renal-related classes of medications (ESAs, oral iron, IV iron, phosphate binders, vitamin D analogues, and calcimimetics) among dialysis and later-stage CKD patients. Which renal drug classes have the highest and lowest percentage of patients on therapy, and how does it differ by late-stage and dialysis patient populations and by time periods?

  • Assess current and anticipated use of products within each class for dialysis and later-stage CKD patients. For example, what is the reported patient share of ESAs, IV iron, phosphate binders, and active vitamin D? How does this share differ between hemodialysis, peritoneal dialysis, and CKD nondialysis? Also, how does this quarter compare with previous quarters?

  • Assess how the importance and performance of various attributes (e.g., efficacy, safety, dosing) differ between products. For example, is risk of hemoglobin overshoot in the ESA class an important or unimportant attribute? How do currently available products, such as Amgen’s Epogen or Roche’s Mircera, perform on this attribute? What hidden opportunities are available for drug manufacturers?

  • Assess sales representatives’ contact frequency and performance and physicians’ message recall between products. How many times, on average, in the past six months has a sales representative visited physicians for the various current therapies? What percentage of physicians were visited in the past month, and what messages were recalled by brand?

  • Understand disease awareness issues such as changes in target hemoglobin levels, complications in SHPT, and the role of calcium in end-stage renal disease (ESRD) and CKD. For example, at what PTH level are vitamin D and Amgen’s Sensipar initiated? Is phosphorus, calcium, or PTH most important to keep within the normal range in these patients, and how does this consideration differ between CKD nondialysis and dialysis?

  • Uncover awareness of new clinical information or recent news of key products. For example, are surveyed nephrologists aware of the recent FDA approvals of Vifor Fresenius Medical Care Renal Pharma’s Velphoro, Shire Pharmaceuticals’ oral powder formulation of Fosrenol, and Keryx Biopharmaceuticals’ Auryxia?

  • Understand nephrologists’ perception of late-stage renal therapies, including their awareness of them, familiarity with them, and the percentage of their patients who are likely candidates for them. For example, assuming an agent gains FDA approval for use in CKD-ND and dialysis patients and is available at dialysis centers, what percentage of patients would be considered likely candidates for treatment? The report covers approximately six products in late-stage development.

Scope:

Markets covered: United States.

Primary research: 300 nephrologists via an online survey.

Screening criteria: A nephrologist in practice for 2-30 years. A minimum of 50 dialysis and 100 CKD-ND (stage 3 and 4) patients under management. Must not practice in Vermont.

Field Dates: October 26-November 13, 2015.

Report: PowerPoint format with 214 pages.

Author(s): Jihan Khan, Ph.D.
Caitlin Koris, MSPH