NICE - Son of SERNIP - RAD Magazine

The New NICE Interventional Procedures Review Process

The National Institute for Clinical Excellence [NICE] was set up in 1999, to provide ‘guidance for healthcare professionals, patients and their carers in making decisions about treatment and healthcare’ in England and Wales. SHTAC carries out a similar responsibility for assessment in Scotland. The Department of Health decides on the programme of work. Anyone can recommend topics for review

NICE Technology Appraisals

The first review process, ‘Technology Appraisals’, looks at the cost effectiveness for any medical intervention that is likely to have a significant impact on NHS resources.

One of the first Technology Appraisals was of the Glaxo 'flu drug - Relenza. This looked at clinical and economic implications to the NHS, but did not include the costs to the public, industry or NHS staffing.

The appraisal process starts with very full [systematic] review of all the clinical data. All the stakeholders who have registered on the NICE web site and experts in the field are invited to give evidence. The review committee, having assessed all the evidence will then publish their initial findings for consultation on the NICE web site. There is an appeal process. The final recommendations are published a few months after consultation or any appeal.  

Dr Jane Adam, Consultant Radiologist to St George's Hospital, London is the radiologists on the Technology Appraisal committee.

In the past a positive NICE Technology Appraisal has not necessarily adopted as there is no additional funding, but a negative appraisal will stop use of a procedure or the product.  However, the Government is now making it mandatory for the NHS to adopt all NICE recommendations.

NICE Clinical Guidelines

‘Clinical Guidelines ’were added to the NICE repertoire.  These ‘cover specific aspects of clinical care and clinical management of specific conditions’, some of which follow on from National Service Framework’ recommendations. They also include cost effectiveness as well as clinical efficacy and promote 'best practice'. The process is similar to Technology Appraisals.

There are 7 National Collaboration Centres [NCC] that manage the development of clinical guidelines for NICE. Only the NCC for Cancer has a radiologist on the review panel - Dr John Hyslop, Consultant Radiologist, Truro.

15 'Clinical Guidelines' have been completed to date. There are 48 current 'Clinical Guidelines' in progress. A number involve radiology. The complete list can be found on the NICE web site.

NICE New Interventional Procedures Review

In February this year NICE added the 'Interventional Procedures Review’ to its portfolio, when it took over the SERNIP [Safety & Efficacy Register for New Interventional Procedures] list. This appraises the clinical efficacy and safety of new interventional procedures.

There are currently 97 Interventional Procedures on the NICE web site - 87 in the process of being reviewed, 7 where guidance has been issued and 3 completed because guidance could not be issued for various reasons.

There are 5 reviews where radiology is cited as the main speciality - 2 have had guidance issued - uterine artery embolisation [UAE] and stent-graft placement in the thoracic aorta and 3 others are in progress:

  • Coil embolisation of intracranial aneurysms
  • MRI guided percutaneous laser ablation of uterine fibroids [myolysis] 
  • CT guided thermocoagulation of osteoid osteoma.

Many of the others involve radiology and it is important that radiologists and radiographers are aware of these.

Any new interventional procedures should, from now on, be submitted to NICE for inclusion in this programme.

The Interventional Procedures Review Process

The process NICE adopted for the Interventional Procedures differs greatly from the other NICE review and appraisal procedures.  The main emphasis is on speed rather than thoroughness.

There is an Interventional Procedures Advisory Committee [IPAC] comprising one leading clinician from each clinical speciality, with an industry and patient representative. The radiology representative on IPAC is Dr Anna-Maria Belli, Consultant and Senior Lecturer in Interventional and Diagnostic Vascular Radiology at St George's Hospital and Medical School and President of the BSIR. Each clinical speciality also has 'Specialist Advisors', who can be asked to give evidence to IPAC. There are a number for radiology covering interventional, neuroradiology, skeletal and paediatric subspecialities.

Clinical Evidence

NICE does not carry out a systematic review of up-to-date clinical data and evidence for IPAC to consider. IPAC uses whatever clinical evidence NICE has to hand to issue guidelines for a procedure. For the recent review of UAE this evidence was 3 years out of date and did not include any mortality or morbidity data on current treatments for fibroids, for comparison. This obviously compromises the validity of the guidelines significantly. Clinical evidence is also sought from the ‘Special Advisors’, but not from the leading and most experienced clinicians in the field. Indeed they may not even know the review is taking place, as was the case with UAE. 

Informing Stakeholders

NICE relies on the relevant Royal Colleges to cascade information to any clinician who may be involved and the ABHI [Association of British Healthcare Industries] to inform any manufacturers, even if they are not members. There is no mechanism to inform the private healthcare sector and that for patients groups is very sketchy. This process doesn’t work. Although the direct stakeholders for UAE number over 100 in England and Wales only 15 people took part in the consultation process.

Initial Review Outcome and Consultation

The Advisory Committee reviews whatever evidence NICE already has on the new interventional procedure for safety and clinical efficacy and issues a ‘consultation document’ on the NICE web site. This document may make four different recommendations:

  • That the procedure is safe and efficacious enough to be used without any restriction
  • That is it unsafe and/or non-efficacious and should be stopped immediately
  • That there is uncertainty about the procedure and further evidence is required
  • A full ‘systematic’ review to look at all the evidence properly should be started to lead to a full review.

Consultees, are given a month to respond to the consultation. The pre-set format is annoying, but NICE will send the document by e-mail on request and will allow e-mail responses. IPAC will not necessarily see the information submitted.

Criteria to Judge Safety and Efficacy

There are no specific criteria laid down to judge safety and efficacy. It might be presumed that if the new interventional procedure were safer than the existing treatment it would be adopted. This is not necessarily so. The burden of proof is much higher for these new interventional procedures than existing treatments, which have probably never been reviewed. There is no benchmark for the amount of evidence required.

Recommended Improvements to the Interventional Procedures Process

The current process should be scrapped and replaced with one similar to the Technology Appraisals and Clinical Guidelines. There should be a systematic review of all the up-to-date clinical data. Advertisements should appear in relevant clinical journals advising of imminent reviews. The most experienced clinicians in the field and stakeholders should be invited to give evidence. This process would ensure that IPAC would make recommendations on the best evidence and experience available.

In the meantime it is recommended that one person in each radiology department and company sign up for the NICE web alert service. This will automatically e-mail you with information. As it is now becoming compulsory for the NHS [and soon the private sector] to implement the guidance produced by NICE it is even more important that radiology becomes involved in these processes.

For more information please look at the NICE web site www.nice.org.uk

Ginette Camps-Walsh
Medical & Healthcare Marketing Consultant, Co-ordinator of FEmISA [Fibroid Embolisation Information, Support & Advice] Patient Group and Chairman of the Medical Marketing Group of the Chartered Institute of Marketing.