BURLINGTON, Mass., April 22, 2014 /PRNewswire/ -- Decision Resources Group finds that reduction in mortality, reduction in serum phosphorus levels, followed by improvement in renal anemia parameters were selected by surveyed nephrologists as the top three most persuasive efficacy clinical trial end points when prescribing a new drug for the treatment of hyperphosphatemia. Additionally, in terms of relative importance among a list of delivery attributes, surveyed nephrologists in the United States and Europe scored improved pill burden the highest. This finding is likely due to the fact that hyperphosphatemia is a chronic condition that requires prolonged treatment.
Other key findings from the DecisionBase report entitled Hyperphosphatemia: Payer and Physician Receptivity to Novel Treatments—Which Emerging Drugs Excite Them?:
- Attribute importance and unmet needs: Surveyed nephrologists in the U.S. believe that efficacy is the most important attribute, compared with safety and tolerability, and delivery. However, European nephrologists believe that efficacy is equally important to safety and tolerability. The report also notes that there is high unmet need for drug manufactures to develop hyperphosphatemia therapies without the risk for vascular calcification.
- U.S. payer perspectives: Seventy percent of surveyed U.S. payers indicate that a therapy offering the ability to reduce the incidence of individual non-serious GI side effects 30 percent greater than that of the benchmark therapy, sevelamer carbonate, would be placed on their organization's formulary even if priced at least 4 times higher than expected generic sevelamer pricing. Similar analysis is also provided in the report regarding payer receptivity to hyperphosphatemia therapies with: improved efficacy in reducing serum phosphorous levels; ability to reduce median erythropoiesis-stimulating agent (ESA) intake; and improved pill burden. Surveyed U.S. payers are particularly receptive to new hyperphosphatemia therapies in dialysis that offer ability to reduce median ESA intake.
Comments from Decision Resources Group Director Rob Dubman, MBA:
- "We thought that a reduction in median ESA intake would score higher in terms of an unmet need and attribute weight among surveyed nephrologists in the U.S. and Europe. However, the lower importance could stem from the fact that the concept of a phosphate binder reducing the need of an ESA intake is new to physicians, and many products are on the market today that treat renal anemia."
- "Traditionally, Sanofi's Renagel/Renvela has dominated the U.S. dialysis market in terms of physician preference. However, this report indicates that physician preference of two emerging therapies, Vifor Fresenius Medical Care Renal Pharma's Velphoro (approved by the FDA in November 2013) and Keryx Biopharmaceutical's Zerenex (NDA submitted), respectively may actually receive higher physician preference compared with Renvela in a target product profile scenario analysis. However, these therapies will have a difficult time competing with generic sevelamer (Impax Laboratories launched an authorized generic of Renvela on April 16, 2014), as price was highly important to surveyed nephrologists."
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