Servier's Procoralan has won the backing of cost regulators for the National Health Service in England and Wales as an option for patients with chronic heart failure (CHF).
The National Institute for Health and Clinical Excellence has published draft guidelines this morning (Tuesday) recommending the use of Procoralan (ivabradine) as an option for people with CHF, when used in combination with standard therapy such as a beta blocker.
Heart failure is a complex clinical syndrome that affects about 900,000 people in the UK, though this number is on the rise because of the improving prognosis of coronary artery disease, a key cause of the condition, as well as the ageing population and the availability of better therapies.
Still, currently around 30% to 40% of patients diagnosed with heart failure die within a year, although after this point mortality dips to less than 10% per year.
Heart failure accounts for a total of one million inpatient bed days - 2% of all NHS inpatient bed-days - and 5% of all emergency medical admissions to hospital, and hospital admissions as a direct result of the condition are forecast to rocket by 50% over the next 25 years.
Consequently, the aim of treatment for heart failure is not only to improve life expectancy and quality of life for patients but also to avoid these costly hospitalisations, which is particularly pertinent during the current NHS efficiency savings drive.
Cost effective for NHS
Clinical trials of Procoralan have demonstrated the drug's ability to reduce mortality and improving quality of life in patients with some types of chronic heart failure.
This, coupled with its relatively low cost of £40.17 per 56-tablet pack, led the NICE's Appraisal Committee to agree that the incremental cost for the drug is likely to be around £8,500 per QALY (quality adjusted life year), and that it is therefore likely to represent value for money as an option to treat CHF.
Even so, the Committee "was mindful that there is robust evidence for the effectiveness of ACE inhibitors, beta-blockers and aldosterone antagonists that are used routinely in managing heart failure", and so has stipulated that Procoralan should be initiated "only after optimal treatment with these drugs has been achieved when patients are still symptomatic after receiving optimised initial therapies, or when beta-blockers are contraindicated as specified in the marketing authorisation or not tolerated by the patients".