August 2006 - Issue E046

Welcome to the August edition of NICE's monthly E-newsletter.

  
   

NICE issues guidance on trastuzumab (Herceptin) more>>

  
 
 

A round-up of clinical guidance documents that NICE has issued and consulted on during August more>>
 
  Public health evidence documents that NICE has issued during August more>>  
 
  An update on new support for implementation more>>  
 
 

Thousands more people with hepatitis C to benefit from latest NICE guidance on drug treatments more>>

NICE invites applications for topic consideration panels more>>

NICE issues updated guidance on keyhole surgery for the treatment of colorectal cancer more>>

  
 
  Upcoming events more>>  
 
  Guidance and consultation papers expected to be issued next month more>>  
 
  NICE is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health. more>>  
     
 

About the E-Newsletter

The E-newsletter is intended to give everyone working in clinical and public health a regular update on the work of NICE. This includes those working in the NHS, local government, and the voluntary sector covering healthcare professionals, patients, the general public and other stakeholders. Each month it will include a round-up of guidance, consultation papers and public health evidence that has been published, together with information about forthcoming events and a list of guidance the Institute expects to launch next month. The E-newsletter is emailed on the fourth Wednesday of each month to users who have subscribed free of charge on the NICE website and is also available directly on the website.

NICE would welcome your views and comments on the E-newsletter and its content. If you would like to share your thoughts, contact us:

Telephone: 020 7067 5800
Fax: 020 7067 5801
E-mail: nice@nice.org.uk
Letter: NICE, MidCity Place, 71 High Holborn, London, WC1V 6NA

General queries to NICE should be directed to nice@nice.org.uk

 
 
 

NICE issues guidance on trastuzumab (Herceptin)

NICE has today issued final guidance on Herceptin to the NHS, just three months after the drug was licensed by the regulatory authorities for use in early breast cancer. NICE recommends Herceptin for women with early stage HER2-positive breast cancer, except where there are concerns about the woman’s cardiac function. 

NICE Chief Executive Andrew Dillon said: “Our assessment of Herceptin shows that it is clinically and cost effective for women with HER2 positive early breast cancer. The guidance has been issued rapidly, to ensure consistent use across the NHS and was produced in draft form just 2 weeks after the licence extension for Herceptin was granted. We plan to continue appraising certain technologies rapidly and close to when they are licensed for the benefit of both the NHS, patients and their carers.”

NICE recommends:

  • Trastuzumab, given at 3-week intervals for 1 year or until disease recurrence (whichever is the shorter period), is recommended as a treatment option for women with early-stage HER2-positive breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).
  • Cardiac function should be assessed prior to the commencement of therapy and trastuzumab treatment should not be offered to women who have a left ventricular ejection fraction (LVEF) of 55% or less, or who have any of the following:
    • a history of documented congestive heart failure
    • high-risk uncontrolled arrhythmias
    • angina pectoris requiring medication
    • clinically significant valvular disease
    • evidence of transmural infarction on electrocardiograph (ECG)
    • poorly controlled hypertension.
  • Cardiac functional assessments should be repeated every 3 months during trastuzumab treatment. If the LVEF drops by 10% from baseline and to below 50% then trastuzumab treatment should be suspended. A decision to resume trastuzumab therapy should be based on a further cardiac assessment and a fully informed discussion of the risks and benefits between the individual patient and their clinician.

More information is available on the NICE website.
 

 

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A round-up of clinical guidance documents that NICE has issued and consulted on during August

NICE issued the following guidance this month:

Guidelines

  • None

Technology appraisals

Interventional procedures

Public health

  • None

The following consultation documents were issued:

Guidelines

Calls for stakeholder registration:

  • None

Scope consultations:

  • None

Draft consultations:

Technology appraisals

ACD consultations:

FAD consultations:

Appeals heard:

  • None

Interventional procedures

NICE consulted on the following procedures (consultation period 25 July to 22 August

Public health

Calls for stakeholder registration:

  • None

Stakeholder meeting:

  • None

Scope consultations:

  • None

Final scope:

  • None

Consultation on draft recommendations:

  • None

Consultation on synopsis of evidence:

 

  
 

 

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Public health evidence documents that NICE has issued during August

No publications have been issued this month.

 

  
 

 

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Glossary of terms:
Technology appraisals are recommendations on the use of new and existing medicines and treatments within the NHS in England and Wales.
Clinical guidelines are recommendations on the appropriate treatment and care of patients with specific diseases and conditions within the NHS in England and Wales.
Appraisal Consultation Documents (ACDs) set out the independent advisory committee's initial recommendations to NICE based on the evidence for specific medicines and treatments. The consultation period usually lasts 4 weeks.
Final Appraisal Documents (FADs) set out the independent advisory committee’s final recommendations to NICE on specific medicines and treatments following consultation and are used as a basis for NICE guidance. A FAD is usually available for consultation for a period of 15 working days.
Appeals process is the final part of the NICE appraisal process to ensure that the final guidance is robust, where organisations representing patients and carers, healthcare professionals and manufacturers can appeal against final advice given by the independent advisory committee on a specific medicine or treatment.
Final scope - The final scope defines what aspects of care are covered by the guideline (and to whom it applies).
Public health intervention guidance makes recommendations on clear types of activity (‘interventions’) provided by local organisations with public health responsibilities.
Public health programme guidance deals with broader activities for the promotion of good health and the prevention of ill health.
Single Technology Appraisal (STA) is the new rapid process for enabling single new drugs, and existing drugs with new indications, and other treatments to be assessed.

  
 

 

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An update on new support for implementation

Welcome to the implementation section, featuring updates on current work, new resources to support implementation and products coming soon. Visit the "Using guidance" section of the NICE website for more information.

Support materials published this month

Technology appraisals:

Breast cancer (early) - trastuzumab

  • Cost template incorporating report
  • Audit criteria

Chronic hepatitis C: interferon alfa (pegylated and non-pegylated) and ribavirin

  • Cost template incorporating report

Colorectal cancer - laparoscopic surgery (review)

  • Cost template incorporating report

Coming soon

Technology appraisals

Breast cancer (early) – docetaxel

  • Cost template incorporating report
  • Audit criteria

Clinical guidelines

Anaemia management in chronic kidney disease

  • Slide set
  • Implementation
  • Cost template incorporating report
  • Audit criteria

Other implementation news

Additional resource

NICE has produced a new implementation leaflet Putting NICE guidance into practice’, available on the NICE website.

Local NICE representatives

NICE is establishing a new field-based team, consisting of five implementation consultants. Each consultant, based from a home office, will be responsible for a different part of England ensuring regular interaction with NICE stakeholders.

The implementation consultants will:

  • engage with organisations and networks at a strategic level, to encourage, inform and facilitate their own implementation activities;
  • create a feedback mechanism to underpin all aspects of the Institute’s work.

The new approach will be operational by September 2006 and the team will be organising meetings with those local organisations with a role to implement NICE guidance. These include: PCTs and Trusts (hospital and mental health), and Local Authorities. The team will also link with the Government Offices and Strategic Health Authorities to feedback on evidence of uptake of NICE guidance, and to promote awareness of the guidance in the development of local policy and practice. Regular NICE updates will be offered at other key networks, for example: relevant professional groupings; those for service development such as cancer and CHD networks; and others such as Patient Forums and Health Scrutiny Forums.

For further information please refer to the NICE implementation leaflet.

Audit criteria

NICE has commissioned CASPE Research to produce audit criteria for all NICE guidance as a separate implementation tool from April 2006 onwards. The audit criteria will no longer go through the consultation process with the guidance itself, so we are establishing a specialist audit panel as part of our external reference group to help validate the audit criteria produced.

For each guidance topic, three members of the audit panel will be invited to comment on average once every 3 months.  If you are interested in being part of the panel, terms of reference and an application form are available from Jim Coles, Director, CASPE Research, 15 Whitehall, London SW1A 2DD or by email: jcoles@chks.co.uk .

NICE to launch local commissioning guides

NICE is planning to introduce good practice commissioning guides from this autumn. These web-based guides set benchmarks to determine the level of service needed for a particular topic. They also offer advice on a range of issues, including local needs assessment and opportunities for disinvestment.

The first commissioning guide on Upper Gastrointestinal (GI) endoscopy will be published in September.

 

  
 

 

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Thousands more people with hepatitis C to benefit from latest NICE guidance on drug treatments

NICE has today issued guidance recommending the use of two drugs (peginterferon alfa and ribavirin) for the treatment of people with mild chronic hepatitis C within the NHS.

Recent estimates suggest that approximately 200,000 to 500,000 people are infected with hepatitis C in England and Wales although only around 47,000 people have been diagnosed and only around 7000 treated. Current practice in most centres is to treat only those patients with moderate or severe symptoms. Today’s guidance however states that:

  • People with mild chronic hepatitis should also be offered combination therapy with peginterferon alfa and ribavirin within the licensed indications of these drugs.
  • People with mild chronic hepatitis who are unable to tolerate ribavirin, or for whom ribavirin is contraindicated, should be offered peginterferon alfa monotherapy.
  • The decision as to whether a person with mild chronic hepatitis C should be treated immediately or should wait until the disease has reached a moderate stage (‘watchful waiting’) should be made by the patient after fully informed consultation with the responsible clinician
  • There is insufficient evidence to recommend combination therapy or monotherapy with peginterferon alfa for people with mild chronic hepatitis C who are under the age of 18 years, or those who have had a liver transplant.

More information is available on the NICE website.

NICE invites applications for topic consideration panels

NICE is inviting applications for membership of seven expert consideration panels to assess suggested topics for NICE’s clinical, health technology and public health guidance.

Panel subject areas are: cancer; children, adolescents and maternity; heart and stroke; long-term conditions; mental health; conditions not covered by the other panels; public health.

Members of the consideration panels will include health, social care and public health professionals, academics and researchers, and people who bring a patient, carer, and/or community perspective. Panel members will not be appointed to act as representatives of a particular organisation, but will be expected to apply experience and judgment from their individual backgrounds.

More information is available on the NICE website.

NICE issues updated guidance on keyhole surgery for the treatment of colorectal cancer

New guidance published today by NICE recommends laparoscopic (“keyhole”) surgery as an option for patients with colorectal cancer. The guidance, which replaces previous NICE guidance published in 2000, applies to patients in whom both laparoscopic and conventional open surgery would be considered as suitable options for treatment.

Colorectal cancer is the third most common cancer in the UK. Almost 30,000 new cases were registered in England and Wales in 2002, representing over 12% of all new cancer cases. In 70% to 80% of patients, complete excision of the tumour may be able to cure the condition. At present, the standard procedure for surgical resection of colorectal tumours uses the open approach to remove the tumour and the affected part of the large intestine via an abdominal incision.

Laparoscopic colorectal surgery involves inserting laparoscopic instruments through a number of holes in the abdominal wall to dissect tissues around the tumour. The tumour is then usually removed through an abdominal incision. The NICE guidance also applies to laparoscopically assisted surgery, in which the incision is enlarged to complete the dissection before the tumour is removed.

More information is available on the NICE website.

 
 

 

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Upcoming events

Board Meeting: Wednesday 20 August, Hull

The Institute's next public Board meeting will take place at the East Riding Medical Education Centre, Hull Royal Infirmary, Anlaby Road, Hull, HU3 2JZ on Wednesday 20 August 2006 at 2pm.

This is a public meeting and is open to all, however numbers are limited. If you are interested in attending please register by contacting our event organiser on 0121 248 3399 or book on line by e-mailing yhunter@health-links.co.uk.  Papers for this meeting will be available at least two days prior on the NICE web site.  More information is available on the website.

Date for your diary!
NICE 2006: Tackling health priorities

The 2006 annual NICE conference will take place from 6 to 7 December at the ICC in Birmingham.

‘NICE 2006: Tackling health priorities’ will explore issues raised by the increasing expectations of the public and politicians in the context of finite resources, and the challenges facing decision-makers at all levels of the health and social care sectors in using evidence to inform their decisions and in justifying the choices that they make. The conference programme is now available on the NICE website.

To take advantage of the early booking rate, places must be booked by 31 August 2006.  More information on registration is on the conference website.

 
 

 

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September 2006
Clinical and public health guidance to be issued to the NHS

NICE expects to issue the following guidance:

Clinical guidelines

Technology appraisals

Interventional procedures

Public health

  • None
Public health evidence

NICE expects to publish the following evidence documents:

  • Screening and rapid appraisal toolkits for HIA: context, processes and issues (summary)
  • Chronic illness management briefing
Clinical guidelines and cancer service guidance in progress

Calls for stakeholder registration:

  • None

NICE expects to issue consultation documents on:

Scope consultations:

Draft consultations:

  • None
Technology appraisals in progress

NICE expects to issue consultation documents on:

ACDs to be published:

  • None

FADs to be published:

  • None

Appeals to be heard:

Interventional procedures in progress

NICE will consult on the following procedures (consultation period 29 August to 26 September) :

Public Health

NICE expects to issue consultation documents on:

Call for stakeholder registration:

  • None

Scope consultations:

  • None

Stakeholder meetings:

  • None

Final scope :

  • None

Consultation on synopsis of evidence:

  • None

Consultation on draft recommendations :

  • None

 
 

 

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

NICE will produce guidance in three 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 and procedures within the NHS.
  • Clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

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