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NICE to offer early advice to payers about new medicines

Will provide evidence summaries ahead of publishing its formal health technology assessments

National Institute for Health and Clinical Excellence (NICE)
The National Institute for Health and Clinical Excellence (NICE) has launched a new service to give payers in the UK's NHS information about new medicines before it issues a formal health technology assessment (HTA).

These 'evidence summaries' are intended to help commissioners, budget holders and groups such as Area Prescribing Committees to “make informed decisions and aid local planning on the introduction of key new medicines”, the cost-effectiveness watchdog said.

They will be produced by NICE's Medicines and Prescribing Centre, and are only to be used as a support tool before they are superseded by formal NICE guidance in the form of an HTA.

Drugs will be considered for inclusion in an evidence summary either at the time of their launch, or up to a year in advance.

NICE said it expects to publish advice on 20 new medicines every year, with each evidence summary reviewing the best available evidence that is considered to be of significance to the NHS.

This includes information on the drug's clinical effectiveness and safety, as well as the strength and limitations of compiled evidence.

In addition, evidence summaries will also features details about the drug's action, licensed therapeutic indications and cost, as well alternative treatments and its estimated impact on the NHS.

Professor Mark Baker, director of NICE's Centre for Clinical Practice, said: “The NHS Constitution gives patients the right to expect that decisions about the funding of medicines and treatments will be made rationally following a proper consideration of the evidence.

“Where there is no technology appraisal from NICE, these summaries help to ensure consistent access to evidence for decision-makers.”

The first drug to receive an evidence summary is Astellas Pharma's Dificlir (fidaxomicin) for the treatment of Clostridium difficile infection (CDI).

Its concludes that based on evidence from two double-blind, randomised controlled trials, the drug is non-inferior to vancomycin in curing patients with mild to severe CDI.

NICE has also published an interim process statement for the development of the evidence summaries that provides an overview of the key aspects of how the summaries will be produced and what they will contain. This will be replaced by a final process statement, which will be made available later this year.

16th July 2012


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