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Novartis has gained earlier than expected US approval for its new heart failure treatment Entresto, which is forecast to be the biggest new drug approval of 2015.
Much initial focus is on the pricing of Entresto, which at a cost of around $12 a day is significantly more expensive that current standard of care therapies. A months supply of generic enalapril - the comparator drug in Novartis approval-supporting PARADIGM-HF study - is available at a cost of around $4.
The Swiss company has earned the opportunity to price Entresto at a significant premium, argues Pfizers former head of R&D John LaMattina, given the mortality benefits it has demonstrated versus the most widely used current therapy option. Furthermore, Novartis has discussed the introduction of risk-sharing price agreements with select payers, which could see the price of the drug increase if Entresto reduces hospitalisation rates (Spotlight On: Can Novartis Entresto revive risk-share pricing deals in the post-Sovaldi US market).
This provides a tangible benchmark of the potential efficacy benefits that Entresto offers for the treatment of heart failure. Efficacy of the drug - and how it is viewed and utilised by physicians - will nevertheless come under scrutiny in light of its price.
Following FDA approval of Entresto (and in anticipation of EU approval), we are asking both US and EU5-based cardiologists and primary care practitioners the following questions
- Novartis Entresto (previously known as LCZ696) reduced cardiovascular death by 20 percent and overall mortality by 16 percent versus the ACE inhibitor enalapril in patients with heart failure and reduced ejection fraction in the PARADIGM-HF study. How do you characterise the clinical profile of Entresto?
- Versus approximately $4 for a months supply of enalapril, Novartis has confirmed that Entresto has a list price of $12.50 a day in the US. In relation to efficacy benefit is this price justified?
- What percentage of patients currently treated with ACE inhibitors or ARBs would you expect to switch to treatment with Entresto within 2 years of launch?
- How quickly do you expect Entresto to become the standard of care for the treatment of heart failure?
- What percentage of new start patients would you expect to be prescribing Entresto to two years after launch?
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