Hyperphosphatemia, or treatment of elevated serum phosphorous levels, typically found as a complication of chronic kidney disease (CKD), is a commercially compelling indication, a fact that is evident in an active pipeline. Today patients are treated with oral phosphate binders; one phosphate binder candidate was recently approved and another is in preregistration. Some of the phosphate binders in the pipeline may prove to also impact renal anemia parameters, which may result in less use of erythropoietin-stimulating agents (ESAs) and IV iron, in addition to the potential to reduce serum phosphorous. Some phosphate binders in development may also prove to have a compelling advantage in terms of pill burden, which is an extensive compliance problem in this difficult-to-treat patient population.
Questions Answered in This Report:
- A drug’s performance on at least six efficacy end points, including reduction in mortality, reduction in serum phosphorous, and improvement in anemia parameters, are important for drug approval and physician use. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European nephrologists weight efficacy measures and other drug attributes in their prescribing decisions for hyperphosphatemia?
- Sevelamer carbonate (Sanofi’s Renvela) is the 2012 major-market sales leader for hyperphosphatemia in dialysis patients. What weaknesses exist in its profile that would allow emerging therapies to gain a traction in the market? Have emerging therapies demonstrated potential strengths on the attributes that surveyed nephrologists indicate are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed MCO PDs seek from new therapies?
- Despite the potential launch of several emerging therapies in the hyperphosphatemia market over the next ten years, sevelamer carbonate will remain the gold-standard therapy in our Drug Comparator Model. On what clinical attributes is sevelamer carbonate most differentiated from its competitors? What are the weaknesses of this therapy on which emerging therapies can capitalize? Which emerging therapies, if any, pose the greatest threat to sevelamer carbonate as well as the other key current therapies?
Attributes included in conjoint analysis based assessment of target product profiles for hyperphosphatemia:
- Reduction in serum phosphorous levels.
- Reduction in median IV iron intake.
- Reduction in median ESA intake.
- Reduction in incidence of non-serious GI side effects.
- Composition of phosphate binder.
- Pill burden.
- Price per day.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for hyperphosphatemia in dialysis patients:
- Efficacy in reducing serum phosphorous.
- Ability to reduce the patient’s median ESA intake.
- Ability to reduce the incidence of individual non-serious gastrointestinal (GI) side effects.
- Improved pill burden.
Physicians surveyed: 60 U.S. and 30 European nephrologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Sevelamer carbonate (Renvela)
- Sevelamer hydrochloride (Renagel)
- Lanthanum carbonate (Fosrenol)
- Calcium acetate (PhosLo/Phoslyra, generics)
- Ferric citrate (Zerenex)
- Sucroferric oxyhydroxide (Velphoro)
- Fermagate (Alpharen)
- SPI-014 (Renazorb