How to make a compelling submission to NICE: tips for sponsoring organisations
BMJ 2003; 327 doi: https://doi.org/10.1136/bmj.327.7429.1446 (Published 18 December 2003) Cite this as: BMJ 2003;327:1446
- Amanda Burls, senior clinical lecturer1,
- Josie Sandercock, research fellow in medical statistics1
- 1Department of Public Health and Epidemiology, University of Birmingham, Birmingham B15 2TT
- Correspondence to: A Burls
Evidence in support of products being assessed by the National Institute for Clinical Excellence can be presented in various ways to make products seem more attractive than they really are
During health technology appraisals the National Institute for Clinical Excellence (NICE) invites sponsors of the technology to make a submission in support of their product. These submissions can be of variable quality. We examine some of the more dubious techniques that can be used by sponsoring organisations to make their products seem attractive to those making reimbursement decisions.
Although the following “advice” is based on real examples of submissions to NICE, it should be remembered that similar biases can be found in academic, peer reviewed publications and that such practices are not the preserve of industry.
Make your technology look effective
Generating the evidence
Compare your intervention with an inactive control; placebo controlled trials are ideal for circumventing clinically relevant head-to-head comparisons.
If forced to use an active control make sure that the comparator is:
Inadequately dosed;
Toxic; or
Ineffective in the patient group studied (for example,select only those whohave failed to respond to standard treatment and then use standard treatment as the comparator).
Do not look at long term outcomes; for modelling purposes, extrapolating from short term data is far more flexible.
If the treatment effect may be short lived, switch all the controls to yourintervention at the end of the trial.This makes long term assessment impossible, and you can extrapolate the benefits from the early results. Justify this switch on ethical grounds.
To be taken seriously, you must describe at least one analysis as “intention to treat.” Do not over-interpret this requirement or stick slavishly to technical definitions. For example, by defining withdrawal criteria to include patients who find the intervention toxic or ineffective, you can avoid collecting follow up data for patients whose inclusion in …
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