National Institute for Health and Clinical Excellence (NICE): 19Th & 20Th Wave Work Programmes

To: Medical Directors or LHBs and NHS Trusts
Nursing Directors of LHBs and NHS Trusts
Eich cyf * Your ref
Ein cyf * Our ref
10 December 2008

Dear Colleague

National Institute for Health and Clinical Excellence (NICE): 19th & 20th wave work programmes

Purpose

1. I am writing to draw your attention to the 19th & 20th wave work programmes, which have recently been referred to NICE. You are asked to note the topics which are being referred and ensure that systems are in place to prepare for the guidance as and when issued by NICE.

Background

2. NICE appraises the clinical benefits and costs of health care interventions notified to it by Ministers at the Department of Health, following consultation with the Welsh Assembly Government. Topics are referred to NICE in batches known colloquially as a “wave”. Each “wave” could potentially be split into three areas under which the Institute will produce guidance:

Technology appraisals - guidance on the use of new and existing medicines and treatments within the NHS in England and Wales. This guidance is subject to the three month funding Direction issued by the Minister for Health and Social Services on 23 October 2003.

Clinical guidelines - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS in England and Wales.

Public Health Topics - 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. Please note: NICE public health guidance does not apply to Wales.

19th wave work programme

3. The programme comprises:

Eleven cancer technology appraisals;
Five technology appraisals;
One short clinical guideline;

One public health programme and five public health intervention guidance topics (not applicable in Wales).

20th wave work programme

4. The programme comprises:

Twelve cancer technology appraisals (nine awaiting full consultation);
Nine technology appraisals;
One additional topic has also been referred to NICE (Ablative therapy for the treatment of Barrett's oesophagus), but it has not yet been decided whether it should be carried out as a Short Clinical Guideline or Multiple Technology Appraisal;
No full clinical guidelines;
Two public health programme guidance and eight public health intervention guidance (not applicable in Wales).

5. Details of the topics are given at Annex A.

6.There will be several opportunities to comment on drafts of each individual piece of guidance produced by NICE, before the final guidance is issued. Information on the timescales involved in each of the topics will appear on NICE’s website:

7. For further information please contact Dominic Worsey, Healthcare Excellence Branch, Quality, Standards and Safety Improvement Directorate, Department for Health and Social Services, Welsh Assembly Government, Cathays Park, Cardiff CF10 3NQ. Tel: 029 2082 3083. E-mail:

Yours sincerely
Carl Eley
Head of Healthcare Excellence Branch

Annex A

Topics referred to NICE’s 19thth Wave

Non-Cancer Technology appraisals

Remit “To appraise the clinical and cost effectiveness of…”
To appraise the clinical and cost effectiveness of golimumab within its licensed indications for the treatment of ankylosing spondylitis.
To appraise the clinical and cost effectiveness of golimumab within its licensed indication for the treatment of psoriatic arthritis.
To appraise the clinical and cost effectiveness of golimumab within its licensed indication for the treatment of rheumatoid arthritis.
To appraise the clinical and cost-effectiveness of dronedarone within its licensed indication for the treatment of atrial fibrillation and atrial flutter.
To appraise the clinical and cost-effectiveness of tarenflurbil within its licensed indications for the treatment of Alzheimer’s disease

Cancer Technology Appraisals

Remit “To appraise the clinical and cost effectiveness of…” -
To appraise the clinical and cost effectiveness of temsirolimus within its licensed indication for the treatment of relapsed or refractory mantle cell lymphoma.
To appraise the clinical and cost effectiveness of bevacizumab within its licensed indication in combination with oxaliplatin and either 5FU or capecitabine for the treatment of metastatic colorectal cancer.
To appraise the clinical and cost effectiveness of bevacizumab in combination with non-taxane chemotherapy within its licensed indications for the first line treatment of metastatic breast cancer.
To appraise the clinical and cost effectiveness of erlotinib, within its licensed indications, in combination with bevacizumab for the treatment of advanced or metastatic non-small cell lung cancer.
To appraise the clinical and cost effectiveness of vandetanib within its marketing authorisation, for the second line treatment of non-small cell lung cancer.
To appraise the clinical and cost effectiveness of trabectedin within its licensed indication for the treatment of relapsed ovarian cancer.
To appraise the clinical and cost effectiveness of ipilimumab within its licensed indication for the treatment of unresectable stage III and IV malignant melanoma.
To appraise the clinical and cost effectiveness of pemetrexed, within its licensed indications, for the maintenance treatment of non-small cell lung cancer.
To appraise the clinical and cost effectiveness of aflibercept within its licensed indication for the third line or subsequent treatment of advanced ovarian cancer
To appraise the clinical and cost effectiveness of arsenic trioxide within its licensed indication for the first line treatment of acute promyelocytic leukaemia.
To appraise the clinical and cost effectiveness of vorinostat, within its licensed indication, for the second-line treatment of cutaneous T-cell lymphoma.

Short Clinical Guideline

To produce a short clinical guideline on the pharmacological management of neuropathic pain in adults, in non-specialist settings.

Public Health Guidance – for Information only (not applicable in Wales)

Remit “To appraise the clinical and cost effectiveness of…” -
To produce public health programme guidance for PCTs and those working in primary care on the primary prevention of Type 2 diabetes mellitus in high risk BME groups.
To produce public health intervention guidance to reduce accidental injuries to persons under the age of fifteen in the external environment.
To produce public health intervention guidance on effective approaches for promoting the social and emotional wellbeing of children in early years (0-4 years of age) in pre-school settings.
To produce public health intervention guidance on effective approaches for promoting the social and emotional wellbeing of children in early years (0-4 years of age) in the home.
To produce public health intervention guidance for sexual health services (commissioners and practitioners) on effective approaches to prevent and reduce transmission of HIV among high risk groups.
To produce public health intervention guidance for sexual health services (commissioners and practitioners) on effective approaches to prevent and reduce transmission of HIV in individuals with high risk behaviours.

Topics included on NICE’s 20th Wave

Non-Cancer Technology appraisals

Remit “To appraise the clinical and cost effectiveness of…” -
Denosumab within its licensed indication for the primary prevention of osteoporotic fractures in post-menopausal women.
Denosumab within its licensed indication for the secondary prevention of osteoporotic fractures in post-menopausal women.
Fingolimod within its licensed indication for the treatment of relapsing-remitting multiple sclerosis
Fingolimod within its licensed indication for the treatment of primary progressive multiple sclerosis
Cladribine within its licensed indication for the treatment of relapsing-remitting multiple sclerosis
ABT-874 within its licensed indication for the treatment of moderate-to-severe chronic plaque psoriasis
Etanercept within its licensed indication for the treatment of moderate-to-severe chronic plaque psoriasis in children and adolescents
Ticagrelor within its licensed indication for the treatment of acute coronary syndromes
Liraglutide within its licensed indications for the treatment of type 2 Diabetes mellitus

Cancer Technology Appraisals

Remit “To appraise the clinical and cost effectiveness of…” -
Everolimus, within its licensed indication, for the treatment of metastatic renal cell carcinoma.
Pazopanib within its licensed indication for the first line treatment of advanced and/or metastatic renal cell carcinoma
Pazopanib within its licensed indication for the second line treatment of advanced and/or metastatic renal cell carcinoma

Cancer appraisals which NICE is currently consulting on:

Remit “To appraise the clinical and cost effectiveness of…” -

Panitumumab within its licensed indications for the first line treatment of metastatic colorectal cancer.

Nilotinib within its licensed indications for the first line treatment of chronic myeloid leukaemia.

Ipilimumab within its licensed indications for the treatment of stage III or IV metastatic melanoma.

Pemetrexed disodium within its licensed indications for the maintenance treatment of non small cell lung cancer.
Contusugene ladenovec within its licensed indications for the treatment of recurrent unresectable head and neck cancer
Trovax (MVA 5T4) within its licensed indications for the treatment of advanced and metastatic renal cell carcinoma

Everolimus within its licensed indications for the treatment of pancreatic entero-neuroendocrine tumours

Dutasteride within its licensed indications for the prevention of prostate cancer
Larotaxel within its licensed indications for the treatment of advanced, recurrent and/or second line pancreatic cancer

Referral ongoing: Short Clinical Guideline/ Multiple Technology Appraisal

Remit “To appraise the clinical and cost effectiveness of…” -
To produce a short clinical guideline on ablative therapy for the treatment of Barrett’s oesophagus

Public Health Guidance – for Information only (not applicable in Wales)

Remit “To appraise the clinical and cost effectiveness of…” -
Guidance for a programme on the prevention of obesity for PCTs, local authorities, primary care, sports recreational services, food retailers and the voluntary sector on effective community based approaches to maintaining a healthy weight and prevention of obesity, based on a whole systems perspective, and considering research of a natural experimental/ policies, including international work.
• For policy makers, food retailers and media/advertising industry on use of the media (including social marketing techniques) to promote healthy eating activity and limit advertising of unhealthy foods
• For policy makers and local authorities on transport policies that prioritise walking and cycling.
• For local authorities and food retailers on increasing provision of fruit and vegetables in deprived communities
• For those working in primary care (GPs, health visitors, schools nurses) and educational settings on the identification and management of overweight or obese children, (including advice to parents or carers).
• For PCTs, local authorities, primary care, sports recreational services, food retailers and the voluntary sector on targeted community based interventions for management of overweight and obesity among children, (such as MEND, Traffic Lights, and camps).
To produce public health intervention guidance for the police social services and health services on interventions for the prevention and reduction of domestic violence – joint referral, NICE and SCIE to develop joint guidance
To produce public health programme guidance for policy makers, planners, local authorities, primary care trusts on how to improve health and reduce health inequalities through the process of spatial planning, including those tools such as Strategic Environmental Assessment, Health Impact Assessment and Sustainability Appraisal.
To produce public health intervention guidance on smoking cessation in pregnancy and following childbirth
To produce public health intervention guidance on the prevention of unintentional injury in 15 to 24 year olds through road use