The cost watchdog for the National Health Service in England and Wales has given the thumbs-up for doctors to prescribe Eli Lilly/Daiichi Sankyo’s bloodthinner Efient but has confirmed it will be only made available to a select group of patients.

The National Institute for Health and Clinical Excellence has published a Final Appraisal Determination endorsing the use of Efient (prasugrel) in combination with aspirin as an option for preventing atherothrombotic events in people with acute coronary syndromes having percutaneous coronary intervention. However the drug should only be used in limited cases, firstly “when immediate primary PCI for ST-segment-elevation myocardial infarction is necessary”.

NICE will also use on the NHS of Efient when stent thrombosis has occurred during treatment with Sanofi-Aventis and Bristol-Myers Squibb’s blockbuster Plavix (clopidogrel) or if the patient has diabetes mellitus. People currently receiving prasugrel for treatment of ACS, which was launched in the UK in April, whose circumstances do not meet the criteria “should have the option to continue therapy until they and their clinicians consider it appropriate to stop”, the agency says.

NICE noted that for patients with non-ST-segment-elevation MI, but without diabetes, it was “mindful of concerns about the clinical evidence, particularly that the effectiveness of prasugrel was highly
uncertain for these patients”. It therefore concluded that Efient“would not be a cost-effective use of NHS resources in these circumstances and could not be recommended”.

Lilly and Daiichi Sankyo have claimed that Efient is more effective than Plavix, citing data from the TRITON-TIMI 38 trial which showed that patients had a 19% reduction in relative risk for cardiovascular death, non-fatal heart attack or non-fatal stroke when compared with clopidogrel. However that data also revealed that patients given Efient experienced a 32% increase in minor and major bleeding.

The Institute’s Expert Review Group questioned whether these results could be generalised to clinical practice in England and Wales and considers prasugrel and clopidogrel “to be broadly equivalent in terms of clinical effectiveness at 15 months” for patients with ACS having PCI.

Furthermore, NICE acknowledged that formulations of generic Plavix had received a positive opinion from European regulators in May, which will bring down the price of clopidogrel. Efient 5mg and 10mg packs containing 28 tablets cost £47.56, and the equivalent price of treatment with Plavix is £36.35.

It adds that Efient should be considered for review in a year’s time, “when any substantial change to the nationally available price of clopidogrel could be considered”.