How Are Novel Therapies Differentiated from Current Treatment Options in This Highly Genericized Market?
Acute heart failure (AHF) is one of the leading causes of hospitalization in the developed world, representing a significant healthcare burden. Treatment of AHF relies on different lines of therapy to relieve symptoms and to encourage sufficient hemodynamic stabilization. Long-term patient prognosis remains bleak: both mortality and hospital readmission rates are very high. The high attrition rate of drugs in development for AHF has resulted in a very genericized market in which no new therapies have launched since 2002. However, the AHF therapies in development boast promising new mechanisms of action and have the potential to fill the gaps in efficacy and safety left by current agents.
Questions Answered in This Report:
- Reducing the rate of mortality, reducing rehospitalization, and reducing the incidence of worsening heart failure are key goals in the treatment of AHF. 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 AHF?
- Improving quality-of-life measures, reducing the rate of rehospitalization, and reducing the incidence of worsening renal function are key areas of unmet need in AHF, according to surveyed U.S. and European cardiologists. Which therapies in development for AHF 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. hospital pharmacy directors (PDs) seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?
- Drug price and effect on mortality are key drivers of physicians’ prescribing decisions for new AHF 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 AHF? 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 AHF?
- By 2018, serelaxin (Novartis’s Reasanz) will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile. On what clinical attributes is serelaxin most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by serelaxin?
Attributes included in conjoint analysis-based assessment of target product profiles for AHF:
- Rate of mortality.
- Rate of rehospitalization.
- Effect on symptoms of dyspnea.
- Incidence of hypotension.
- Incidence of worsening renal function.
- Length of hospital stay.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for AHF:
- Effect on reduction in rate of mortality at six months.
- Effect on reduction in rate of rehospitalization at 30 days.
- Effect on reduction in length of hospital stay.
- Effect on symptoms of dyspnea at 24 hours.
Physicians surveyed: 60 U.S. and 31 European cardiologists.
Payers surveyed: 20 U.S. hospital PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Furosemide (Sanofi’s Lasix/Lasilix, generics)
- Nitroglycerin (generics)
- Dobutamine (Eli Lilly’s Dobutrex, generics)
- Milrinone (Sanofi’s Primacor/Corotrope, generics)
- Nesiritide (Scios/Johnson & Johnson’s Natrecor)
- Serelaxin (Novartis’s Reasanz)
- Ularitide (Cardiorentis)
- Omecamtiv mecarbil (Amgen/Cytokinetics)
- TRV-027 (Trevena/Forest Laboratories)
- CXL-1427 (Cardioxyl)