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.
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)