Renal anemia is one of the primary complications of chronic kidney disease (CKD) and is treated with erythropoiesis-stimulating agents (ESAs) and oral/IV iron. The market for renal anemia drugs is poised to expand owing to the growing size of the CKD non-dialysis (CKD-ND) and dialysis patient populations as well as the expected launches of novel therapies such as oral hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHis) to treat renal anemia (e.g., FibroGen/Astellas/AstraZeneca’s roxadustat, Akebia Therapeutics’ AKB-6548, GlaxoSmithKline’s daprodustat) and other new renal anemia treatments. Significant clinical and commercial opportunities remain for new renal anemia therapies that can provide improved effects on increasing hemoglobin, greater safety, and/or an improved delivery profile.
Questions Answered in This Report:
- Improved effect on increasing hemoglobin levels from baseline, improved effect on the reduction of major cardiovascular events, and improved effect on mortality are key goals in the treatment of renal anemia. 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 specific efficacy end points and other drug attributes in their prescribing decisions for renal anemia?
- Greater effect on decreasing mortality and greater effect on reducing major cardiovascular events are key areas of unmet need for renal anemia, according to the insights of surveyed U.S. and European nephrologists. Which therapies in development for renal anemia are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?
- Formulation and price are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new renal anemia therapies. What trade-offs across these and other clinical attributes are U.S. nephrologists willing to make when considering the use of emerging therapies for the treatment of renal anemia? Based on the trade-offs in price and performance across key drug attributes that U.S. nephrologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for renal anemia?
- Based on its clinical profile, darbepoetin alfa (Amgen’s Aranesp) is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies in development challenge darbepoetin alfa as the future gold standard in 2018 or 2023?
Attributes included in conjoint analysis-based assessment of target product profiles for renal anemia:
- Mean increase in hemoglobin levels from baseline
- Reduction in median ESA intake
- Reduction in median IV iron intake
- Reduction in major cardiovascular events (event rate)
- Frequency of dosing
- Price per year (average price per day)
Attributes included in assessment of U.S. payers’ receptivity to new therapies for renal anemia:
- Improved efficacy in increasing mean hemoglobin levels
- Ability to reduce the patient’s median IV iron intake
- Lower risk of major cardiovascular events (event rate)
- Oral administration at various dosing frequencies
Physicians surveyed: 60 U.S. and 31 European nephrologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Epoetin alfa (Procrit/Epogen) (Janssen/Amgen)
- Darbepoetin alfa (Aranesp) (Amgen)
- Roxadustat (FibroGen/Astellas/AstraZeneca)
- AKB-6548 (Akebia Therapeutics)
- Daprodustat (GlaxoSmithKline)
- Ferric citrate (Auryxia) (Keryx Biopharmaceuticals)