Technology appraisals

A large proportion of the technology appraisals so far performed by NICE on pharmaceuticals have been on products recently introduced into the marketplace. This has created difficulties for manufacturers trying to answer the questions posed by the appraisal. For most compounds, at the time of launch it is very unlikely that outcome studies will have been completed that allow accurate cost effectiveness calculations to be performed. The emphasis in Phase III is on clinical efficacy and safety to satisfy the requirements of the regulatory authorities. In most cases, it is impossible (and probably imethical) to perform pragmatic studies on the general population imtil safety and efficacy have been satisfactorily demonstrated in a tightly defined trial population. 

The only alternative open to manufactures faced with a technology appraisal soon after laimch is to base their cost effectiveness argument on computer modelling. This is far from satisfactory but it is the best that can be done in the circumstances. 

For the purposes of this chapter the focus will be on the technology appraisals. However, for details of other aspects of the institute s work and their procedures, the NICE website is a useful source of material (http //www.nice.org.uk/). 

The scope for the technology appraisals was set out in the Department of Health discussion paper Faster Access to Modern Treatment How NICE Appraisal will Work. This document clearly... 

Details of the technology appraisal process itself can be found on the website but briefly, when a technology appraisal is referred from the Department of Health and the National Assembly of Wales all possible stakeholders are identified (stakeholders can be manufacturers, professional bodies and patient groups). They are then consulted on the scope of the appraisal. An independent review of the published literature is commissioned and submissions (both... 

Birch, S., and A. Gafni. 2002. On Being NICE in the UK Guidelines for Technology Appraisal for the NHS in England and Wales. Health Economics 11 185-191. 

National Institute for Clinical Excellence (NICE). 2000. Guidance on the Use of Zanamivir (Relenza) in the Treatment of Influenza. Technology Appraisal Guidance No. 15. London NICE. 

National Institute for Health and Clinical Excellence. The clinical effectiveness and cost-effectiveness of infliximab in Crohn s disease. Technology appraisal TA040. Available from URL www.nice.org.uk... 

National Institute for Health and Clinical Excellence. Hepatitis B (chronic) - adefovir dipivoxil and peginter-feron alpha-2a. Technology appraisal TA096. [2006], Available from URL www.nice.org.uk National Institute for Health and Clinical Excellence. Hepatitis C peginterferon and ribavirin. Technology appraisal TA106. [2006]. Available from URL WWW. nice. org. uk... 

Technological appraisal and implementation of environmental and human health standards for aquatic and terrestrial environments... 

NICE (2002a) Guidance on the use of trastuzumab for the treatment of advanced breast cancer. Technology Appraisal 34. Available at http //www.nice.org.uk/guidance/ index.jsp action=article o=32314 [Accessed 4 July 2008]. 

First-line treatment of her metastatic breast cancer should therefore incorporate the monoclonal antibody trastuzumab (Herceptin). NICE (2002b) have issued a technology appraisal on the use of trastuzumab in metastatic breast cancer which states that trastuzumab be used in combination with paclitaxel for women with tumours with excessive human epidermal growth factor receptor 2 (HER2) at levels of 3+ who have not had chemotherapy for metastatic breast cancer and for whom anthracycline treatment is inappropriate. ... 

National Institute for Health and Clinical Excellence (2008) NICE Technology appraisal 161, Osteoporosis - secondary prevention, including strontium ranelate. Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for secondary prevention of osteoporotic fractures in post menopausal women. Available at http //www.nice.org.uk/Guidance/TA161 [Accessed 18 November 2008],... 

Zanamivir was one of the first medicines to be the subject of a technology appraisal by the National Institute for Clinical Excellence (NICE) in the UK. NICE recommends that it be reserved for at-risk patients (those with chronic respiratory or cardiovascular disease, immunosuppression or diabetes mellitus, or over the age of 65) when virological... 

NICE has transformed the UK marketing landscape and companies need to build the capability to respond to an appraisal of one of its compounds. The NICE website (www.nice.org.uk) gives guidance on the elements and the timing of technology appraisals. There are four main elements of a technology appraisal and I have summarised the components of these subsections. 

National Institute for Clinical Excellence Technology Appraisal No. 43. Guidance on the use of newer (atypical) antipsychotic drugs for the treatment of schizophrenia, 2002. http //WWW. nice, org. uk/... 

Forette F, Seux M-L, Staessen JA et al. Prevention of dementia in randomised double-blind placebo-controlled systolic hypertension in Europe (Syst-Eur) trial. Lancet 1998 351 1347-51 Morris MC, Beckett LA, Scherr PA et al. Vitamin E and vitamin C supplement use and risk of incident Alzheimer disease. Alzheimer Dis Assoc Disord 1998 12 121-6 National Institute for Clinical Excellence Technology Appraisal Guidance No. 19. Guidance on the use of donepezil, rivastigmine and galantamine for the treatment of Alzheimer s disease, 2001. http //www. nice, org. uk/... 

Steedman, D. (1993) ASNI The Tutorial and Reference. Technology Appraisals, Twickenham, UK. 

National Institute for Clinical Excellence. Technology Appraisal Guidance No 57. Guidance on the use of continuous subcutaneous insulin infusion for diabetes. February 2003 (www.NICE.org.HK). 

National Institute for Clinical Excellence. Inhaled insulin for the treatment of diabetes (types 1 and 2). NICE technology appraisal guidance 113 (2006). Available from www.nice.org.uk/TAl 13... 

National Institute for Health and Clinical Excellence (2005a). Technology Appraisal Guidance no. 10, on inhaler systems (devices) in children under the age of 5 years with chronic asthma. http //www.nice.org.uk/page.aspx o=TA10 (accessed 19 October 2006). 

The purpose of this book is to concentrate exclusively on one topic within this broad issue, namely the use of renewable resources as precursors or aids to novel macromolecular materials. It reflects the concerted effort of a number of specialists to propose a hopefuUy cotiprehensive scientific and technological appraisal of the state of the art and the perspectives related to the numerous facets of this realm. In the 15 years that have elapsed since the first, much more modest review on this topic was published by one of us progress has been astounding, both qualitatively and quantitatively. Hence, the initiative to prepare this collective volume, which we hope will constitute a useful working or consulting tool for all those involved, associated or simply interested in these important issues. 

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