Sanofi-Aventis/Bristol-Myers Squibb’s blockbuster blood thinner Plavix could be in for some competition in the UK, after the National Institute for Health and Clinical Excellence said it will likely recommend Eli Lilly and Daiichi Sankyo’s rival Efient for use on the National Health Service under certain conditions.

The Institute has published an appraisal consultation document recommending a combination of Efient (prasugrel) and aspirin as an option for preventing atherothrombotic events in patients with acute coronary syndromes (ACS) having percutaneous coronary intervention (PCI), but only when immediate PCI for ST-segment-elevation myocardial infarction (MI) is necessary or stent thrombosis has occurred during treatment with Plavix.

The Institute’s Appraisal Committee has concluded that, compared to Plavix, the relative efficacy and therefore the relative cost effectiveness of Efient - an oral inhibitor of platelet activation and aggregation - would only be greater in this subgroup of patients.

Efient 5mg and 10mg packs containing 28 tablets cost £47.56, and the equivalent price of treatment with Plavix is £36.35. Lilly and Daiichi Sankyo claim that, while Efient is more expensive, clinical trials indicate it is actually more effective than Plavix.

According to findings from a head-to-head study of the two rivals, patients treated with Efient had a 19% reduction in relative risk for cardiovascular death, non-fatal heart attack or non-fatal stroke when compared with Plavix. On the flip side, the data also revealed that patients given Efient experienced a 32% increase in minor and major bleeding.

But the Institute’s Expert Review Group has questioned whether these results could be generalised to clinical practice in England and Wales. It says differences in the efficacy of Efient and Plavix in the TRITON-TIMI 38 trial were largely down to statistically-significant differences in non-fatal MI, which included both clinical MI (which is symptom driven) and non-clinical MI (based on biomarkers and ECG readings), and that if only clinical MIs were compared between treatment arms the differences between the drugs may not remain.

'Equivalent' efficacy
The ERG says following its review of all the data it actually considers Efient and Plavix to be “broadly equivalent in terms of clinical effectiveness at 15 months for patients with ACS having PCI”.

NICE currently recommends a combination of aspirin and Plavix for the treatment of ACS, but Lilly and Daiichi Sankyo have previously noted that research shows up to 25% of patients do not respond adequately to treatment with Plavix, again highlighting the need for an alternative, effective option.

And despite the availability of current blood thinners, the companies note that every six minutes someone dies from a heart attack, 90% of which are caused by blood clots.

Cardiovascular disease certainly represents a huge drain on NHS resources and the British economy, costing more than £14 billion a year, or as much £30 billion taking informal care and production losses into account, further illustrating the urgent need for better treatment outcomes in this area.

NICE says it expect to publish its final recommendations for Efient in October this year.