The UK National Institute for Clinical Excellence (NICE) has today published for consultation a proposed interim appraisal process that will assess technologies belonging to a class of drugs on which the Institute has already issued guidance. The interim process will appraise new products in a shorter space of time than the normal process, enabling the NHS to be confident in prescribing new drugs in line with existing NICE guidance.
NICE currently has a single technology appraisal process which takes around 14 months, but can take longer if additional data is needed or if there are appeals against guidance. New entrants in a class of technology on which NICE has produced recent guidance are not normally considered until the scheduled review date for the original guidance: this can be between 12 months and 5 years.
The interim appraisal process will be used when the review date for relevant guidance is more than 12 months after the anticipated launch of the 'next in class' product.
Andrew Dillon, Chief Executive at NICE, said: 'The NHS can be wary of prescribing treatments that have not been appraised by NICE, even if the drug belongs to the same class of drugs that have already been appraised. The objective of the interim appraisal will be to establish whether or not the clinical and cost effectiveness of the new product is broadly consistent with the recommendations in the original appraisal.'
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Where the Institute concludes that the recommendations made in the original appraisal can apply to a 'next in class' product, the direction on funding the acquisition of the technology in England and Wales will apply. NHS organisations are required to make the resources necessary to allow the technology to be used within 3 months of the Institute issuing its guidance.
The decision emerging from the interim appraisal will apply only until the scheduled review of the technology appraisal or clinical guideline has been completed and guidance issued.
The Institute's stakeholders have been invited to comment on the proposed interim appraisal process that has been posted on the NICE web site at [nice/page.aspx?o=interimappraisalconsultation] to enable all those with an interest to comment. The consultation period ends on 15 October 2004.
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Notes to Editors
About NICE
1. NICE is part of the NHS. It is the independent organisation responsible for providing national guidance on treatments and care for those using the NHS in England and Wales.
Its guidance is for healthcare professionals and patients and their carers to help them make decisions about treatment and healthcare. For further information about NICE you can visit nice.
2. NICE produces guidance in three areas of health:
-- the use of new and existing medicines and treatments within the NHS in England and Wales - technology appraisals
-- the appropriate treatment and care of patients with specific diseases and conditions within the NHS in England and Wales - clinical guidelines.
-- whether interventional procedures used for diagnosis or treatment are safe enough and work well enough for routine use - interventional procedures. NICE also funds three enquiries that undertake research into the way patients are treated to identify ways of improving the quality of care (the investigations are known as confidential enquiries).
3. NICE guidance and recommendations are prepared by independent groups that include professionals working in the NHS and people who are familiar with the issues affecting patients and carers.
About technology appraisals
4. Technology appraisals are recommendations on the use of new and existing medicines and treatments within the NHS in England and Wales, such as:
-- medicines (for example, drugs)
-- medical devices (for example, hearing aids or inhalers)
-- diagnostic techniques (tests used to identify diseases)
-- surgical procedures (for example, repairing hernias)
-- health promotion activities (for example, patient education models for diabetes).
5. Our technology appraisal recommendations are prepared by an independent Committee, who include healthcare professionals working in the NHS and people who are familiar with the issues affecting patients and carers. The Committee considers the evidence on the clinical and cost effectiveness of the technology - this includes hearing the views of, and evidence from, clinical health professionals, experts and patients.
6. NHS organisations in England and Wales have to make the resources and facilities available to enable NICE guidance to be implemented. In January 2002 the Government announced a legal obligation for the NHS to provide funding for treatments and drugs recommended by NICE as a part of its technology appraisals work programme.