Behind The Headlines: Does NICE take too long to approve drugs?
Patients are “waiting up to nine years” for cancer and Alzheimer's drugs to be made available on the NHS because approval by NICE takes so long, The Daily Mail has claimed.
The story, published last week, warns that the “delays mean that even new drugs given the all-clear in extensive trials remain stuck in the queue for years.”
The story states that on average it takes five years from a treatment's launch by a manufacturer to approval by NICE.
The Mail goes on to suggest that one of the problems that is slowing down NICE is that it has a wide-ranging remit which includes drawing up NHS guidance on tackling obesity, alcohol abuse and other public health issues.
Here we take a closer look at the Daily Mail story, and the report it is based on, and explain why it is inaccurate and misleading.
Where did the story come from?
The story is based on a report by the Office for Health Economics (OHE) which was commissioned by Pfizer and published in January this year.
The report examines two aspects of the impact of the health technology assessment (HTA) process on access.
- First, it looks at the elapsed time between launch of a medicine to publication of a technology appraisal. If availability is delayed until NICE has published its appraisal, then this interval is an important determinant of speed of acces
- Second, the report analyses elapsed time between the start and completion of the technology appraisal process itself.
A total of 284 NICE appraisals were included in the report from March 2000 to December 2010.
What did the report find?
The report found that the average time from launch to publication of guidance was 5 years. For multiple technology appraisals (MTA) the average is 5.5 years and for single technology appraisals (STA) it takes 2.6 years.
The average time from start of the HTA process to publication of guidance was found to be 1.73 years. For MTAs the average time taken is 1.97 years and just under a year for STAs.
The OHE says that there are differences between their assessment of the timeliness of NICE processes and NICE's own benchmarking of its performance which arise from the fact that different things are being measured in different ways.
Key differences include:
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 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 the Department of Health selecting a topic ,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).
What do the authors say?
The authors - Phil O'Neill, Nancy Devlin and Ruth Puig-Peiro from the OHE - acknowledge the limitations of the data in their report.
The OHE says: “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.
“The figures 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 which 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 descriptive statistics for medicines launched need to be interpreted with care.”
What does NICE say?
Sir Andrew Dillon, Chief Executive of NICE, says: “The report includes in its average figures some drugs that received their licences many years before NICE was established. NICE has since been asked to appraise such drugs, but their inclusion in this report has skewed the average length of time elapsed from marketing authorisation to published NICE guidance quite considerably.
“NICE works hard to ensure the NHS has access to robust guidance for medicines as quickly as possible.
“The speed of production targets we have agreed with the Department of Health relate to the part of the appraisal process that NICE can control - the period of time between a treatment being licensed and the publication of first draft guidance by us.
“We aim to achieve this within six months for the vast majority of our single technology appraisals. Over the years, this time has decreased dramatically, with an average timeframe currently standing at around four months (shown on graph).
“There are many elements to the appraisal process that we cannot control, all of which can lengthen the time it takes to publish guidance, particularly late notification of changes to regulatory approval timescales.
“Appeals and other legal challenges may be lodged; pharmaceutical companies might submit patient access schemes part-way through an appraisal; further research might be requested.
“We recognise that all these factors are a legitimate part of the appraisal process, but we don't think they are a fair reflection of the time that NICE takes to appraise a drug.”
21 May 2012