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Webwatch
February 2008
Drug approvals
Patient to Doctor, "Can I have Eltrombopag for my ITP?"
Doctor, "Well, there are a number of factors, firstly……"
Apart from any drug specific detail, the Doctor's reply may well include
mention of an organisation that is frequently in the news in the UK, NICE,
the National Institute for Health and Clinical Excellence, website at
www.nice.org.uk
There seems to be quite a lot of misunderstanding about what NICE does.
Firstly, it does not licence drugs. In the UK, the Licensing Authority
for drugs is the Medicines and Healthcare Products Regulatory Agency the
MHRA, website www.mhra.gov.uk. This is assisted by the CSM or Committee
on the Safety of Medicines and the Medicines Commission, both now part
of the Commission for Human Medicines. If this was not complex enough
already, the European aspect makes it even more so. Drugs can be licensed
in the UK through the MHRA or through a centralised European body called
the European Medicines Agency or EMEA, website www.emea.europa.eu. Getting
worse, a drug can be licensed by "mutual recognition" where
one country recognises the licensing in another. This is well set out
in section 4 of a Parliamentary publication called "Health - Fourth
Report" available from www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/4202.htm.
Section 4 is headed as "From drug development to prescription".
The process is also described on a page headed "How are drugs licensed
in the UK?" available on www.cancerhelp.org.uk/help/default.asp?page=9858.
So where does NICE fit in? Since 2004, NICE has been responsible (after evolving from a previous incarnation also called NICE) for producing guidance in three areas of health. In "A guide to Nice" available from www.nice.org.uk/aboutnice/, there is a good summary of what it does, i.e. to produce guidance in public health, health technologies (including drugs) and clinical practice.
Since January 2002, NHS organisations in England and Wales have been required to provide funding for drugs recommended by NICE. On the other hand, if a drug is licensed it may not be approved by NICE so will not automatically be available on the NHS. Although it is usually seen as simply coming down to funding, the NICE approvals process takes into account cost, effectiveness and quality of life. If a drug is safe but too expensive or does not contribute sufficiently to quality of life, it will not get NICE approval. All that means is that it is not automatically available on the NHS, you could still have it if you paid for it yourself. The trouble is, the NHS rules say that should you go down that route, you have to pay for the whole of your treatment, you cannot get NHS treatment with a self funded drug in the middle.
There have been many complaints that the NICE approval process is too slow. For example, the BBC webPage at news.bbc.co.uk/1/hi/health/4263222.stm gives the example of Anastrozole for early breast cancer. It was licensed in October 2002, but the NICE recommendation would not due until November the following year (2006 as the page is dated September 2005). Other examples can be found at www.medicalnewstoday.com/articles/93607.php, news.bbc.co.uk/1/hi/programmes/file_on_4/4439038.stm or in Section 9 of the Parliamentary publication "Health - Fourth Report" as above.
NICE do not seem too coy about their speed. In what they call the "Guide To The Short Clinical Guideline Process" available on www.nice.org.uk/media/EBD/23/SCGProcess.pdf, it says "Short clinical guidelines are clinical guidelines that address only part of a care pathway. They are intended to allow the rapid (9-11 month timescale) development of guidance for which the NHS requires urgent advice." Urgent? The OED at www.askoxford.com says "urgent" means "requiring immediate action or attention." In their own publication "A guide to Nice", it says "It is in the interests of patients that the NICE recommendations are acted on as quickly as possible". They seem to be saying that once their guidance is published, the NHS must act quickly, they do not seem fazed by their own sluggish performance.
When it comes to speed, one can perhaps gauge NICE by the wordiness of their publications, many of which are available online at www.nice.org.uk. Should you decide to delve deeper into these, you may like to issue a warning to your family. To paraphrase Captain Lawrence Oates, "I am just going online...I may be sometime".
Happy surfing
Howard