Ivabradine Front-Page UK News for Heart Failure

March 6, 2012 (London, United Kingdom) — The approval of ivabradine (Procoralan, Servier) in the European Union for the treatment of heart failure has hit the headlines in the UK today, more than a month after the official announcement [1,2]. Appearing as front-page stories in two tabloid newspapers that claim, "Wonder pill beats heart disease: £1.40-a-day tablet will save thousands of lives" and "10 000 patients a year could be saved by newly licensed drug," the news "seems to have caught people's imagination," heart-failure expert Dr Martin Cowie (Royal Brompton Hospital, London, UK) told heartwire . The mortality benefits are enormous. It's very impressive. That's what's caught the media's attention. Cowie--who is the current chair of the British Society for Heart Failure--notes that the EU approval for the additional indication of heart failure for ivabradine [the drug has been licensed for stable angina since 2006] is restricted to specific patients [3,4], constituting around 15% of the heart-failure population: those with a heart rate of 75 beats per minute (bpm) or greater who are in sinus rhythm and who are optimally treated on ACE inhibitors and maximal doses of beta blockers. The SHIFT study looking at use of ivabradine in heart failure was first reported in 2010, but rather than using the whole study population for the approval, the European regulators noticed the drug was more effective in those with a higher heart rate and asked for a subgroup analysis in those patients, he explains. "The regulator decided it wanted to concentrate on mortality benefit. Within that subsection, the benefits are enormous," he observes. "I know it's post hoc, but total mortality is reduced by 17%, heart-failure mortality is down by 39%, and that's on top of really good ACE-inhibitor and beta-blocker therapy. It's very impressive. That's what's caught the media's attention." Ivabradine cheap; will be used for HF despite absence of NICE ruling Ivabradine has yet to be ruled as cost-effective for heart failure by the UK National Institute for Health and Clinical Excellence (NICE): a decision on this is expected in December 2012 [5]. But Cowie does not believe this will radically limit use of the drug in those heart-failure patients in whom it is indicated. "I don't think NICE is going to say this is not affordable; it's really good value for money," he says, noting that he has worked on the economic analysis of the drug for this indication. "It's only £40 a month [in the UK] and although HF is a lot of people nationally, for any one GP it's not a huge number of patients, it's not going to be something they are going to push back on very much at all. Most GPs only have about eight patients with heart failure, and not all of them will be eligible," he notes. "Most cardiologists in Europe are using ivabradine already, and they will just use it even more now that it's licensed and they have been given permission to use it [for heart failure]. It's actually started to be used already since SHIFT was published; the uptake is pretty steady, and I think it will become much more steady now, because it's not like an oncology drug or device that costs a lot. I don't think many places will wait for the NICE statement. Compared with other big issues, like dabigatran instead of warfarin, this pales into insignificance in terms of cost." UK coverage "factually correct" on the whole Some of the UK reports erroneously stated ivabradine had been approved by EU regulators for heart failure "today" on the basis of "newly published data," neither of which are true. But Cowie says, for the most part, he believes the UK media reports of the subject are reasonable. "Some have reported it in less sensational terms than the others, but the coverage has been pretty much factually correct," he says. He adds that he has run a National Health Service HF clinic today, "and every patient who has seen the coverage has said, 'Is this drug for me?' " It wasn't suitable for any of them, he noted, because their heart rate wasn't above 75 and they weren't in sinus rhythm. "But they quickly accepted that and said, 'That's fine, I just wanted to know.' I just hope that process happens for everyone with heart failure going to their GP or specialist." Ivabradine not available in US or Canada As well as the EU approval for ivabradine for heart failure, the drug has also recently been approved for this indication in Russia and the Philippines (although the approval is not restricted to those with a heart rate of 75 bpm or more in those countries), and it is included in the Australian heart failure guidelines published in March 2011, Servier spokesperson Alison Phillips told heartwire . Ivabradine is not available in Canada or in the US, where "Servier has no commercial presence," she notes. In Japan, the company has an agreement to develop and market ivabradine with Ono Pharmaceutical, but the drug is not yet launched, she said. Cowie was the UK principal investigator for SHIFT and has consulted with Servier on an economic analysis of ivabradine.