Last month, the National Institute for Clinical Excellence (NICE) ruled that crucial life-prolonging drugs for bowel cancer patients would not be made available on the NHS. The negative headlines that followed were the latest in a series of stinging criticism aimed at the drugs body.
On 20 August, NICE ruled there was insufficient evidence that two drugs - Avastin and Erbitux - had ‘meaningful benefit', despite alternative research and prolonged campaigning from groups including Bowel Cancer UK arguing they can lengthen life by up to five months. The controversial decision was the main news story on that day's BBC Breakfast, which featured consumer champion Lynn Faulds Wood (a former bowel cancer sufferer) branding NICE as ‘cruel'.
NICE has also been under fire for its decisions on Alzheimer's drugs (see below), and Herceptin, but the institute - led by CEO Andrew Dillon - insists that it provides impartial guidance and is not influenced by such campaigning.
Yet, with almost constant pressure from the media and campaigning groups, can NICE - which was created in 1999 - really be so immune? Can PROs really reach the inner sanctum and change its policies, especially when the pharma industry itself has an obvious interest in influencing reviews.
‘The way we set out from the beginning was to be inclusive, transparent and genuinely consultative,' responds NICE director of comms Louise Fish. ‘All recommendations by NICE are made by independent advisory groups made up of a representative mix of clinicians, nurses, people from the pharma industry and the public.' She insists that NICE operates completely outside emotive campaigns and bases its decisions purely on the facts.
However, debate around Alzheimer's treatment and Herceptin appears to put the organisation's commitment
to neutrality in a different light.‘Comments by ministers favouring Alzheimer's disease treatments in the run-up to the 2005 general election, and more recent dissatisfaction by Health Secretary [Patricia Hewitt] on the availability of Herceptin for early stage breast cancer, shows that pressure can be brought to bear,' says Jamie Holyer, MD of start-up healthcare public affairs agency Advocate.
For pharma firms, patient groups and the PROs representing them, this indicates that, whatever its claims to the contrary, NICE must surely be influenced by lobbying, media relations, medical education and patient power. Holyer argues it is simply a case of knowing who to contact.
What is certain is that the institute's very existence has changed how PR practitioners approach the launch of drugs. Previously there were two hurdles in introducing drugs: licensing approval from authorities and availability, as well as pricing negotiations. Pre-NICE, these two elements were fairly predictable and planning for launch was focused on building a strong efficacy and safety platform.
Now, with many new drugs also undergoing a NICE appraisal, there is a third hurdle to overcome. Jennie Talman, director of Just Health PR, says agency PROs must now prepare documentation that demonstrates they are fully aware of the cost-effectiveness arguments. This not only enables them to develop a response to NICE, but also to the Primary Care Trusts and individual prescribers.
In the spirit of transparency, NICE posts documentation around its deliberations on its website, giving the media an open door to stories about public access to drugs.
‘This means that the pharma industry needs to have a watertight NICE communications strategy, detailing what aspects of the appraisal they are prepared to comment on, and what they are prepared to say,' says Talman.
In practice, due to regulations that set clear parameters on the ethical promotion of drugs, pharma firms often can say very little.
Moreover, NICE guidance around evaluations rarely distinguishes between medicines in the same class.
According to manufacturer Lilly, this means it is not unusual for NICE to provide guidance that falls outside a medicine's licence: another no-go area in terms of drugs promotion in the UK.
For example, NICE recently issued guidelines on bipolar disorder and depression in which it advised on how to treat children and adolescents. ‘Two of our medicines [not licenced for it] are included,' says a Lilly spokesperson. ‘But we can't comment as to do so may be seen as promoting off-licence.'
So, are PR professionals approaching NICE in other ways? Roche says it tends to target NICE by issuing press releases at key points in a NICE appraisal.
Its feeling is that this softly-softly approach is the best it can do, with a company spokesman saying: ‘I don't think there is anything you can do to influence the appraisal process itself. As NICE makes clear, all decisions are based on the evidence it reviews.'
However, this is not the view of all pharma firms. Some have decided to vent their spleens to the media during the appraisals process, in a bid to change NICE opinion. In April this year, Pfizer mouthed off to The Times about NICE's initial decision to reject inhaled insulin treatment Exubera for NHS use, saying it was ‘perverse and short-sighted'. The firm's UK medical director Kate Lloyd then went on to say: ‘This is a terrible decision', and expressed her worries about costs and benefits to patients, concluding: ‘They [NICE] accept that inhaled insulin might be effective for some patients, but say it is difficult to identify them. We find that desperately concerning.'
Guidance under fire
Similarly, Eisai, manufacturer of anti-dementia treatment Aricept, has not been shy in voicing criticism of NICE's yet-to-be-finalised guidance on Alzheimer's treatments.
Eisai managing director Dr Paul Hooper has described NICE's ‘lack of transparency' in its disclosure of methodology as ‘disgraceful'. Moreover, the firm has drummed up support from a health economist, Dr Richard Phillips, and from Greg Hands, MP for Hammersmith and Fulham, in whose constituency the firm has offices.
In response, NICE's Fish points to the ongoing Alzheimer's saga as an example of where the institute has been thorough in going back to a group of drugs and revising its guidance in light of new evidence. ‘A couple of years on from our initial review, these drugs don't appear to be as effective as was first thought,' she says. Fish also asserts that NICE's processes and systems are the envy of the world: ‘The World Health Organisation looked at our methodologies and said they reached the gold standard.'
Of course some of NICE's more unpopular decisions are not as cut and dried as they first appear. For example, amid the media hype around the launch of Exubera, even Pfizer and Diabetes UK have tried to keep a lid on exaggerated claims, many of which hail the treatment as a wonder drug.
‘One of the difficulties has been highlighting that while a huge medical breakthrough, inhaled insulin is not suitable for everyone. It also does not replace all injections - people will still need to inject longer-acting insulin,' says Diabetes UK press officer Sarah Dickinson.
But the charity has also tried to keep its advocacy messages on a firm but fair footing. In April, the group stated clear dissatisfaction at NICE's initial draft guidance rejecting the use of inhaled insulin on the NHS, except in clinical trials. This June, however, following publication of the second draft guidelines on the drug, the charity made plain that it was pleased that NICE had reconsidered the evidence and decided to consider its use for people with injection phobias.
Some experts say that one campaigning technique to grow in popularity will be explaining how drugs under review can positively influence quality of life. Cancer information charity CancerBACUP is now questioning how NICE puts a value on giving patients another few weeks or months of life.
‘This is really crucial to patients, as treatments appear to be turned down on the basis of cost rather than effectiveness,' says PR and campaigns manager Michelle Rowley. ‘We are calling for the Department of Health, NICE and the pharmaceutical companies to find smarter ways to negotiate prices.'
Bowel Cancer UK has vowed to challenge NICE's decision. It has issued a release calling the ruling a ‘scandal', emphasising that the UK is the only EU country not offering Avastin and Erbitux.
The ongoing challenge for PR professionals will be to condition the environment around drug and clinical reviews to address the wider debate of what we expect from our NHS.
NICE has always said it is immune to lobbying.
Communications director Louise Fish says the body does consult and can change its mind, but maintains any changes would ‘not be as a result of lobbying'.
Fish says: ‘The only thing we listen to is the people who come to us and say "you've misinterpreted our evidence, look at it again" or "we have new evidence to present". And we're quite happy to stick to our guns.'
Fish says NICE's structure ensures anyone from ‘a big pharma company or a small patient group with just a few members' has an equal voice.
HOW NICE WORKS
NICE takes up to 18 months to undertake an appraisal. The Department of Health produces a list of provisional areas to examine. Then consultees are identified, usually including patient groups, health professionals and research groups.
NICE and the DoH identify the scope of the appraisal to establish what it will cover and then a number of reports are prepared. A committee then considers the evidence and an appraisal consultation document is drawn up. There are then four weeks for people, including the general public, to respond.
A final appraisal document can then be written, which is submitted to NICE for approval. Consultees can appeal against the final recommendations. If there are no appeals, or appeals are not upheld, the final recommendations are issued as NICE guidance.
NICE has also introduced a rapid process for assessing treatments. The Single Technology Appraisal process produces guidance more quickly on life-saving drugs that have already been licensed, and on new medicines close to when they first become available.