The National Institute for Health and Clinical Excellence has put together its first evidence summary on a new medicine for commissioners and prescribing groups, to help support uptake throughout the National Health Service and thereby increase patient access to innovation.
Astellas’ Dificlir (fidaxomicin) for the treatment of Clostridium difficile infection (CDI) is the first topic covered by its new service, which is designed to “provide high quality information to the NHS and patients in England on the best available evidence for selected new medicines, or for existing medicines with new indications”.
Evidence summaries for new medicines do not constitute formal guidance, but aim to help commissioners, budget holders and groups such as Area Prescribing Committees best manage the introduction of certain new medicines or new indications for existing ones not covered by NICE’s Technology Appraisal programme.
“As well as considering the strengths and limitations of the available evidence of the drug’s safety and efficacy, they also consider the context of the new drug in terms of what other treatments are available for the condition and their cost, as well as the likely place of the new drug in local prescribing and its estimated cost impact for the NHS,” explained Professor Mark Baker, Director of the Centre for Clinical Practice at NICE.
“Where there is no technology appraisal from NICE, these summaries help to ensure consistent access to evidence for decision-makers,” he added.
Dificlir safe and effective, with advantages
Approved in Europe in December last year, Dificlir is a first-in-class macrocyclic antibiotic indicated for the treatment of the hospital superbug C. difficile, which can cause severe diarrhoea and even death.
The Evidence summary for Dificlir concludes that clinical trials of the drug, the first new weapon against the superbug in 50 years, have shown that it has a similar efficacy and safety profile to that of the current gold standard of treatment, vancomycin. However, it was able to significantly cut the rate of disease recurrence, a crucial factor in treatment outcomes for patients.
It is expected that around 20 new evidence summaries will be produced every year by NICE’s Medicines and Prescribing Centre, which formed after the Institute took the National Prescribing Centre under its wing in April last year.
