Time Trends in NICE HTA Decision Making: Setting the Record Straight

The Daily Mail front page article of 16 May 2012, ‘New cancer drugs held up by the NHS for nine years’ purports to draw, as its source, from a report by the Office of Health Economics. The Daily Mail article is misleading and inaccurate in several key respects, and misrepresents the purpose and results of our study. Our report, Time Trends in NICE HTA Decisions, was published in January 2012.

The Daily Mail front page article of 16 May 2012, ‘New cancer drugs held up by the NHS for nine years’ purports to draw, as its source, from a report by the Office of Health Economics. The Daily Mail article is misleading and inaccurate in several key respects, and misrepresents the purpose and results of our study.

Our report, Time Trends in NICE HTA Decisions, was published in January 2012. The study is not about cancer medicines; nor is it specifically about new medicines (since NICE’s work is not restricted to that). Nowhere in our report do we suggest that new medicines are being delayed by up to nine years as a result of NICE’s decision making process.

We looked at completed appraisals between March 2000 and December 2010. The key findings from our report, with respect to the speed with which NICE makes its recommendations, were that:

• The average time taken from the start of the HTA process to publication of guidance to the NHS is 1.73 years.
• For Multiple Technology Appraisals (MTAs) the average time is 1.97 years and for Single Technology Appraisals (STAs) it is 0.96 years.
• For MTAs, 19% are assessed within the target time of 1.15 years set out in NICE’s 2009 Guide to the MTA; for STAs, 23% are assessed within the target time of 0.83 years set out in NICE’s 2009 Guide to the STA.
• Neither the MTA nor STA process showed marked changes in time taken over the period observed.
• Certain factors appeared to be associated with longer decision processes: for example, if the decision is to restrict or not recommend a medicine (rather than recommending it); whether there is an appeal; and, for STAs, whether the sponsor company had applied for a patient access scheme to be considered.

We also analysed the time elapsed between the launch of a medicine and the publication of NICE guidance.  Our finding was that, of those medicines considered since NICE was established, the median time from launch to publication is 5.0 years (5.5 years for MTAs and 2.6 for STAs).  These figures are of interest to patients and to companies as positive NICE guidance means funding must be made available. They cannot be interpreted as a failure by NICE because:

• NICE does not have a remit to appraise all medicines when they are launched (in comparison to the Scottish Medicines Consortium, for example). Instead, the medicines that  NICE considers are chosen by the Department of Health via a ‘topic selection process’ – not by NICE.
• Further, as we emphasised in our report, the figures include the fact that NICE is often asked to assess medicines that were launched prior to 1999, when it was established.  Consequently, the descriptive statistics for time from launch date for all medicines appraised need to be interpreted with care.

There are differences, however, between our findings with respect the time taken in HTA processes, and NICE’s own assessment of this.  NICE has a number of process indicators, that provide an insight into NICE’s own benchmarking of its HTA process.  These focus on the aspects of the process over which NICE has most control.

Differences between OHE’s assessment of the timeliness of NICE processes and NICE’s own benchmarking of its performance arise from the fact that we each are measuring different things in different ways.  The key differences are most easily understood in the context of two questions.

Which medicines are included in the analysis?

• OHE’s report included all medicines that NICE has assessed between March 2000 and December 2010.
• NICE’s indicators focus specifically on new medicines.

How is the start and finish of NICE’s process measured?

• OHE’s report measures the time taken in NICE’s decision process as the time between the publication by NICE of the scoping document for the appraisal and the publication of NICE guidance.
• NICE’s own benchmarking of its decision process measures the time taken between NICE inviting a manufacturer’s submission after the publication of the scoping document and the first decision output of the committee (either an ACD or FAD). This is a subset of the time considered by the OHE report, focussing on those parts of the process that NICE can most directly control.

Each represents a different, but legitimate and useful way, of measuring the time taken in HTA. For further comment on time trends in NICE HTA decision making, see NICE’s comments from Andrew Dillon.