April 21, 2014 — Decision Resources Group announced in a report that Servier's ivabradine (procoralan) is set to become the clinical gold standard in the treatment of chronic heart failure (CHF). Already available in Europe, where it has enjoyed moderate use in CHF and stable angina patients, ivabradine's clinical profile could prime this agent for a potentially successful launch in the United States, where Amgen own the marketing rights to procoralan.
Ivabradine has the potential to fulfill unmet needs relating to the treatment of CHF in that it was shown to reduce mortality and re-hospitalization in its Phase III trial in CHF patients. Although backed by comprehensive clinical data and enthusiasm from cardiologists, ivabradine will not be in an advantageous position in the treatment paradigm. As it is in Europe, this therapy will likely be restricted to patients in sinus rhythm unable to tolerate beta-blockers or those who have been unable to achieve sufficient rate control on beta-blockers alone.
Other key findings from the DecisionBase report, entitled “Chronic Heart Failure: In the Era of Generic Cardiovascular Agents, Can Emerging Therapies Achieve Substantial Clinical Differentiation to Gain Widespread Use?”, include:
- Prescribing decisions: Surveyed U.S. and European cardiologists agree that a therapy's effect on the rate of mortality and effect on hospitalization for worsening heart failure are the attributes that most influence their decisions regarding prescribing in CHF. Improvements in these attributes will be a crucial factor influencing the clinical differentiation and reimbursement of emerging therapies.
- Key unmet need: The prevention of worsening renal function was highlighted by cardiologists as one of the most pertinent unmet needs relating to the treatment of CHF and is an issue associated with the use of aldosterone antagonists. Bayer's novel mineralocorticoid antagonist, finerenone has the potential to capitalize on this unmet need as it is predicted to have renal sparing effects compared to spironolactone (Pfizer's Aldactone, generics) and eplerenone (Pfizer's Inspra, generics).
- Factors in treatment decisions: Surveyed cardiologists indicate that price is an overriding factor in their treatment decisions when considering certain efficacy, safety and delivery attributes. Issues relating to cost could substantially constrain the uptake of more innovative yet expensive emerging therapies like Celladon's gene therapy, Mydicar and Teva/Mesoblast's stem cell therapy, Revascor.
“CHF represents a particularly tough segment for novel therapies to emerge as first-line options. The standard of care, comprised of generic ACE inhibitors, beta-blockers and oral diuretics, is accompanied by a wealth of outcomes data and a relatively small price tag. More expensive novel agents will therefore likely find use as add-on therapies," said Joseph Dwyer, Decision Resources Group analyst. "R&D efforts in CHF have resulted in an eclectic yet healthy pipeline, with numerous therapies in various states of development. A variety of therapeutic strategies are being explored that range from novel nonsteroidal mineralocorticoid antagonists to allogeneic stem cell therapies."
For more information: www.decisionresourcesgroup.com