Approximately 70% of US dialysis patients are on phosphate binders for the treatment of elevated serum phosphorus levels or hyperphosphatemia.1 Our quarterly tracking studies2 from 2015 indicated that the three most important attributes that nephrologists consider when choosing a phosphate binder are long-term safety, efficacy in reducing serum phosphorus and tolerability. In addition, the high daily pill burden associated with phosphate binder prescriptions is a significant barrier to treatment adherence and thus another concern for these physicians. Iron-based phosphate binder Velphoro (sucroferric oxyhydroxide), with a starting dose of 3 chewable pills/day, received US Food and Drug Administration (FDA) approval in November 2013 to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. In 2014, Floege J. et al published results from a 52 week Phase III trial demonstrating that Velphoro was non-inferior to the current gold standard sevelamer-based phosphate binder Renvela in maintaining serum phosphorus levels with fewer mean pill number (3.3 vs. 8.7).3
At the National Kidney Foundation (NKF) April 2016 Spring Clinical Meetings in Boston, Ficociello L. et al shared results on the effectiveness of Velphoro among 269 adult in-center dialysis patients who were switched from Renvela to Velphoro as part of routine care.4 Patients were required to have at least one serum phosphorus measure at baseline (3 months prior to switching to Velphoro), after 1-2 months of Velphoro treatment and after 4-6 months of Velphoro treatment. Some of the clinical parameters of interest included pill burden, serum phosphorus, serum calcium, intact-parathyroid hormone (i-PTH) and calcium-phosphorus (Ca x P) product. At baseline, patients had a mean serum phosphorus level of 6.84 mg/dL and were prescribed 10.1 Renvela pills per day. Treatment measures after 1-2 months of Velphoro treatment and 4-6 months of Velphoro treatment were compared against the baseline.
Table 1. Comparison of Clinical Parameters Among Dialysis Patients Switched from Renvela to Velphoro
|Measure||Baseline (3 months prior to switching to Velphoro)||1-2 months of Velphoro treatment||4-6 months of Velphoro treatment|
|Pill Burden (pills/days)||10.1 ± 4.4||3.8 ± 1.3||3.9 ± 1.4|
|Serum Phosphorus (mg/dL)||6.84 ± 1.38||6.53 ± 1.45||6.37 ± 1.54|
|Serum Calcium (mg/dL)||9.24 ± 0.68||9.21 ± 0.65||9.11 ± 0.68|
|iPTH (pg/mL)||659.1 ± 577.9||653.9 ± 559.9||690.3 ± 612.8|
|Ca x P (mg2/dL2)||63.3 ± 13.2||60.1 ± 13.6||58.4 ± 14.9|
The results in Table 1 suggest that serum phosphorus levels were well maintained after patients were switched from Renvela to Velphoro. However, despite the comparable efficacy and significantly reduced pill count compared to Renvela, our biannual tracking study1 suggests that Velphoro uptake has been slow since its approval with physicians reporting less than 10% of their dialysis patients on Velphoro. Despite continued promotion of Velphoro at Fresenius Medical Care (FMC), physicians affiliated with FMC reported a meager 3% increase in Velphoro use over the last year. Renvela’s years of dominance in hyperphosphatemia treatment, physician comfort in prescribing effective and reliable Renvela, and nephrologists’ perception that their phosphate binder-treated patients would prefer pills to be swallowed over chewable tablets2 are significant hindrances to Velphoro uptake. The sluggish uptake of new phosphate binder Velphoro also indicates newer-to-market agents’ uphill battle in accessing larger dialysis chains due to costs associated with newer agents. Finally, due to its newness, there may be concerns over long-term safety with Velphoro, an attribute critical for nephrologists when choosing a phosphate binder. However, in light of this new data and more long-term safety data, physicians may be encouraged to start switching some of their hyperphosphatemic patients from Renvela to Velphoro.
1 Decision Resources Group’s CurrentTreatment® Bone and Mineral Metabolism Q1 2016 (US) provides a deep dive and longitudinal information on the bone and mineral metabolism (BMM) disorder market dynamics. It examines the management of dialysis and mid-to late-stage CKD patients from the perspective of 100 US nephrologists with emphasis on hyperphosphatemia, secondary hyperparathyroidism (SHPT), and hyperkalemia. Also included in this content are sales and messaging efforts of key market players and coverage of late-stage products for the treatment of BMM.
2 Decision Resources Group’s TreatmentTreatments® Nephrology Q4 2015 (US), a quarterly report series, examines the management of dialysis and mid-to late-stage CKD patients from the perspective of 200 nephrologists. Emphasis is on renal anemia management, calcium-phosphorus metabolism, SHPT, and hyerkalemia. The content 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.
3 Jürgen F., et al. Long-term effects of iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients. Nephrol. Dial. Transplant. 29, 2092-2099, 2014.
4 Ficociello L., et al. Hemodialysis patients switched from sevelamer to sucroferric oxyhydroxide as part of routine care: A 6 month follow-up. Poster at the NKF 2016 Spring Clinical Meetings in Boston, April 2016.