In the Era of Generic Cardiovascular Agents, Can Emerging Therapies Achieve Substantial Clinical Differentiation to Gain Widespread Use?
Chronic heart failure (CHF) describes the long-term management of heart failure outside the hospital setting. CHF patients are subject to high rates of mortality and morbidity. Frequent readmissions to the hospital mean that CHF also represents a significant healthcare burden. First-line treatment of CHF usually involves use of an angiotensin-converting enzyme (ACE) inhibitor, oral beta blocker, and oral diuretic. The addition of second- or third-line agents is often dictated by patient symptoms and disease severity. The CHF segment boasts a healthy pipeline, with numerous therapies in various states of development. Furthermore, a variety of therapeutic strategies are being explored that range from novel nonsteroidal mineralocorticoid antagonists to allogeneic stem cell therapies.
Questions Answered in This Report:
- Reducing the rate of mortality and reducing the rate of hospitalization for worsening heart failure are key goals in the treatment of CHF. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European cardiologists weight specific efficacy end points and other drug attributes in their prescribing decisions for CHF?
- Reducing the rate of mortality, reducing the rate of hospitalization for worsening heart failure, and reducing the rate of worsening renal function are key areas of unmet need for CHF according to the insights of surveyed U.S. and European cardiologists. Which therapies in development for CHF are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. managed care organization pharmacy directors (MCO PDs) seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?
- A therapy’s price and effect on mortality are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new CHF therapies. What trade-offs across these and other clinical attributes are U.S. cardiologists willing to make when considering the use of emerging therapies for the treatment of CHF? Based on the trade-offs in price and performance across key drug attributes that U.S. cardiologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for CHF?
- In 2017, ivabradine (Servier/Amgen’s Procoralan) will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is ivabradine most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by ivabradine?
Attributes included in conjoint analysis based assessment of target product profiles for CHF:
- Effect on rate of mortality.
- Effect on rate of hospitalization for worsening heart failure.
- Effect on levels of biomarkers (i.e., B-type natriuretic peptide [BNP], NT-proBNP).
- Effect on New York Heart Association (NYHA) functional classification (% of patients improving).
- Dosing form.
- Dosing frequency.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for CHF:
- Effect on reduction of rate of mortality.
- Effect on improvement in NYHA functional classification.
- Effect on reduction of rate of hospitalization due to worsening heart failure.
- Effect on reduction of levels of NT-proBNP.
Physicians surveyed: 60 U.S. and 30 European cardiologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Valsartan (Novartis’s Diovan, generics)
- Digoxin (GlaxoSmithKline’s Lanoxin, generics)
- Eplerenone (Pfizer’s Inspra, generics)
- Spironolactone (Pfizer’s Aldactone, generics)
- LCZ-696 (Novartis)
- Finerenone (Bayer’s BAY-94-8862)
- Ivabradine (Servier/Amgen’s Procoralan)
- Mydicar (Celladon’s AAV1/SERCA2a)
- Revascor (Mesoblast/Teva’s CEP-41750)