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NICE launches service to provide advice on new medicines

Fidaxomicin (Dificlir) for the treatment of Clostridium difficile infection (CDI) is the first topic to be covered by NICE as part of its new service to provide high quality information to the NHS and patients in England about the best available evidence for selected new medicines, or for existing medicines with new indications.

Produced by NICE's Medicines and Prescribing Centre (which was formed following the transfer into NICE of the National Prescribing Centre in April 2011 and is part of the Centre for Clinical Practice), the Evidence summaries: new medicines are aimed at commissioners, budget holders and groups such as Area Prescribing Committees. They do not constitute formal NICE guidance but are designed to support the managed introduction of selected new medicines or new indications for existing medicines not covered by NICE's Technology Appraisal programme by providing quality-assured summaries of the best available evidence about their use. Topics for Evidence summaries: new medicines will be considered either at the point of product launch, or up to 12 months in advance of launch. NICE expects to publish advice on 20 new medicines every year.

Fidaxomicin is the first in a new class of macrocylic antibiotics and has recently been licensed by the European Medicines Agency for the treatment of Clostridium difficile infection. The Evidence summary for fidaxomicin concludes that based on evidence from two double-blind, randomised controlled trials, it is non-inferior to vancomycin in curing patients with mild to severe CDI. Its side-effect profile appears similar to that of oral vancomycin and it may have advantages in reducing the rate of recurrence.

Professor Mark Baker, Director of the Centre for Clinical Practice at NICE said: "Our Evidence summaries for new medicines take the process a step beyond the regulatory requirements needed for a new drug to be able to be prescribed. So 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. 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."

NICE has today also published an interim process statement for the development of Evidence summaries: new medicines. It provides an overview of the key process principles and describes all stages of the development of the Evidence summaries. These procedures are designed to ensure that a robust, quality-assured commentary is developed for the NHS in an open, transparent and timely way, with appropriate input from key groups.

The interim process statement for Evidence summaries: new medicines will be superseded when the final process guide is issued later in 2012, following engagement and discussions with key groups.

The Evidence summaries: new medicines are part of a comprehensive suite of information and support for delivering quality, safety and efficiency in the use of medicines. Further information about the work of the Medicines and Prescribing Centre at NICE, including details about the Evidence summaries: currently being developed, as well as the interim process statement, is available on the newly launched Medicines and Prescribing Centre section of the NICE website.

ENDS

Notes to Editors

About the Evidence summary for fidaxomicin

1. The Evidence summary for fidaxomicin is available on the NICE website (from midday, 13 July) at: http://www.nice.org.uk/mpc/evidencesummariesnewmedicines/ESNM1.jsp

2. Fidaxomicin is the first in a new class of macrocylic antibiotics and has recently been licensed by the European Medicines Agency[1] (EMA). It has a narrow spectrum of antibacterial activity mainly directed

against C difficile and exerts moderate activity against some other Gram-positive species. It is very poorly absorbed systemically and exerts its activity in the gastrointestinal tract.

3. The recommended dose for fidaxomicin is one 200 mg tablet twice daily for 10 days, with or without food. The product has been launched at a cost of £1350 (excluding VAT) for a 10-day course[2].

About CDI

1. Clostridium difficile infection[3] (CDI) is the most important cause of hospital-acquired diarrhoea. CDI ranges

from mild to severe diarrhoea to, more unusually, severe inflammation of the bowel (known as pseudomembranous colitis).

2. People who have been treated with broad spectrum antibiotics, people with serious underlying illnesses, and older people are at greatest risk - more than 80% of CDIs reported are in people aged over 65 years.

3. In the quarter up to December 2011 there were 4345 reports of CDI[4], equivalent to 34 per 100,000

population in England. A recent systematic review found that in Europe the incremental cost of CDI ranged from £4577 to £8843 driven primarily by increased length of hospital stay[5]. According to a Department of

Health impact assessment report in 2010, the best estimate of costs to the NHS associated with a CDI is around £10,000[6].

4. Mild cases of CDI associated with treatment with broad spectrum antibiotics may recover after stopping the causative antibiotic therapy, although this approach is not straightforward in clinical practice given the concern that symptoms may worsen.

5. Conservative treatment often is not sufficient for moderate to more severe cases and targeted antibiotic therapy is required, most commonly with oral metronidazole or vancomycin. Both drugs are, in most cases, effective in treating CDI, but about a quarter of patients who initially respond to these agents have a clinical recurrence.

About fidaxomicin

1. The recommended dose for fidaxomicin is one 200 mg tablet twice daily for 10 days, with or without food. The product has been launched at a cost of £1350 (excluding VAT) for a 10-day course[7].

About NICE

1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

2. NICE produces guidance and advice in several areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • medicines and prescribing advice - advice on the use of selected unlicensed and off label medicines where there are no clinically appropriate licensed alternatives, and advice on the use of selected new medicines or new indications for existing medicines that are not being considered by NICE as part of its technology appraisals programme
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

About the Medicines and Prescribing Centre at NICE

1. Further information about the Medicines and Prescribing Centre at NICE, including the Evidence summaries: new medicines and Evidence Summaries: unlicensed and off-label medicines, is available on the NICE website.



[1] European Medicines Agency (2011) Assessment report: Dificlir (fidaxomicin)

[3] Health Protection Agency (2012) Clostridium difficile. [accessed 24 April 2012]

[6] Department of Health (2012) Quality and Outcomes Framework 2011/2012. Impact assessment No. 5014, [accessed 25 April 2012]

This page was last updated: 13 July 2012

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Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.