Contrary to its friendly-sounding acronym, NICE - the National
Institute of Clinical Excellence - could be anything but good news for
pharmaceutical companies and their PR agencies. If a drug fails to win
approval from NICE for NHS prescription by GPs its earnings potential
could be severely diminished.
NICE was set up on 1 April this year as a special health authority. Its
official aim is to speed up the adoption of new drugs and medical
technologies by the NHS, but the pharmaceutical industry is viewing it
more sceptically as a ’fourth hurdle’ to bringing drugs to market, a
feeling strengthened by the Relenza judgment (see panel).
As well as looking at the health benefits, NICE will also judge
treatments on their cost-effectiveness. Pharmaceutical companies are now
being asked to provide figures looking at the total cost of a treatment
taking into account factors such as consulting times and potential
savings on hospitalisation.
In its first full work programme announced in Nov-ember, NICE is now
looking at outpatient referral protocols in a number of areas,
developing guidelines on general treatment areas including heart disease
and cancer, and - most controversially - appraising particular
treatments and technologies.
Among the latter which are set to attract most attention are multiple
sclerosis treatment Beta Interferon, and a number of new treatments for
Alzheimer’s disease. Relenza will also receive a full appraisal,
alongside a rival product from Roche called Tamiflu.
When the appraisal process is established NICE expects to give
manufacturers at least a two-year warning that their technologies are
likely to be referred, but it has said that less notice is inevitable in
the early days. For new technologies formal notice of referral will
usually occur one year before anticipated use by the NHS, while for
established technologies manufacturers would normally be expected to
provide information for appraisal within three months.
How does it affect healthcare PR?
The impact of NICE on PR work is bound to be considerable. NICE
communications director Anne-Toni Rodgers says: ’Clearly the drive to
improving quality in the NHS will mean that PR professionals should
understand fully the institute, its processes and work plans.’
Grayling MD of healthcare, Peter Holden says:’PR is going to have to
start earlier than before and at a much higher level in the
Director of healthcare at Countrywide Porter Novelli, Caroline Ashe,
adds: ’The companies that will do best are the ones that plan well ahead
for appraisals coming up and have a real focus on NICE that is
disseminated throughout the departments of the company.’
Getting the right data is going to be crucial, as the Relenza case
How can PR influence a NICE recommendation?
It will be down to medical companies to make their own submissions to
NICE, but PR agencies may have a role in presenting data. ’We will work
with companies to help them to develop the best way to present their
papers,’ says Janet Morgan, senior account director at EMC EuroPR.
But this is only likely to be a small part of the PR agency’s role. As
the chairman of Burson-Marsteller’s European healthcare practice, Dr
Stuart Pinkerton says: ’Our point of view is that the voice of patient
groups needs to be heard and is as relevant as a purely evidence-based
Pinkerton believes the way to influence NICE is through its Partners
Council, made up of key stakeholder groups, including patient groups,
NHS managers, the medical professions and colleges, and industry. ’What
you are trying to influence through your PR strategy is the patient
viewpoint which is represented by the Partners Council,’ he says.
The Partners Council was seen as having little influence in the Relenza
judgment, but Pinkerton and others believe its voice will become
’We need to make patient groups aware of the processes of NICE. Our goal
is to ensure that the broadest church is considered,’ says
Shire Hall Communications chief executive Margot James agrees the
Partners Council ’has real influence’. She feels the key to effective PR
in the new environment created by NICE is to have a good intelligence
’The influence pyramid in every disease area is different, and you need
to know who the authorities are that NICE listens to in that area.’
What other audiences should be targeted?
A lot of the communications work will be presenting information to key
audiences in one-to-one or small group settings, says James. ’Most of
our clients will do that themselves, but we can advise on how they
present.’ The objective, adds James, is to ’make sure the various
interest and pressure groups and the media are well versed in what is at
Trying to ensure that NICE hears the various points of view of the
stakeholder community will be part of the task of PR agencies. ’We will
be recommending that all sources of information are presented to NICE
proactively,’ says Pinkerton.
He says Burson-Marsteller has developed a number of proprietary
methodologies to facilitate this which he is unable to disclose.
’Galvanising and harnessing the influence of patient groups’ will be a
key factor. However, Pinkerton says there will be subtle differences
between the specific approaches of different clients. ’Some will want a
political campaign focused on getting change driven through a political
agenda, some will focus more on mobilising patient groups, and others
will focus specifically on the media.’
The variety of possible approaches highlights the number of potential
audiences PR agencies will have to communicate with. Opinion leaders, as
always, will be one target. ’One of the strategies in medical PR has
been developing key spokespeople for a product and in many ways that
will continue because you need advocates for therapies,’ says
Charities for different disease areas are another potentially
influential group. Many are watching with interest to see what viewpoint
the Multiple Sclerosis Society takes and what its influence is when Beta
Interferon comes to be appraised by NICE. And others wonder whether
Glaxo Wellcome could have done more to get the support of groups like
Age Concern for Relenza.
The audiences for healthcare communication may be similar in the new era
heralded by NICE, but what will change is the emphasis of the
’The focus and key messages will be different. Traditionally marketing
has probably focused on efficacy but not the cost benefits. With NICE
you will be looking at both,’ says Ashe.
What messages need to be communicated?
Communicating messages about cost-effectiveness is going to be one of
the major challenges for PR. ’This is an area that is quite difficult to
communicate cleanly and with clear outcomes,’ says Ashe.
One of the difficulties is that cost benefit studies have traditionally
been carried out over a period of five or six years and many feel that
such studies can only be done when a drug is in use. Another is that
some drugs can have a big impact on quality of life, but their cost
benefit is difficult to prove.
The key in communicating messages about cost-effectiveness is to look at
the cost of a disease when it is poorly treated, believes James. ’You
need to assess the financial burden of a disease by showing the cost of
operations and hospitalisation and then show how effective the new drug
is in preventing some of that cost. It’s important also to communicate
the impact on quality of life and state of disability.’
In light of the new emphasis on cost-effectiveness another important
target group is primary care purchasing groups, says Morgan. These are
groups of surgeries that buy services from hospitals and health
’They are setting up committees to look at therapies and medical devices
to see if they represent the best use of their resources. The emphasis
from the PR point of view is to show them how a product is more
cost-effective or can add to the quality of life,’ says Morgan.
What is the role of lobbyists?
Public affairs could also have an lead role to play in the new era of
NICE. ’What I could see happening is having a campaign around a
particular area aimed at awareness and education, dovetailing with
government affairs work by our sister agency Westminster Strategy,’ says
Holden at Grayling.
Westminster Strategy associate director Jane Cooper sees a role for the
consultancy ’advising on the political environment and the debate on
rationing and cost control’ and communicating with all-party disease
At Shire Hall, James also regards politicians as a significant potential
target. ’We would select MPs to target, based on their interests in
specific areas and work with them to build links to other MPs and set up
meetings in the Commons.’
The media will continue to be an important way to reach the medical
community and general public, says Ashe. ’The communications strategy
will be reflected in the type of features and stories you give the media
and these will have a NICE focus,’ she says.
What if NICE doesn’t recommend a drug?
PR may be difficult enough while a drug is undergoing appraisal, but it
could become even more difficult, and critical, if NICE decides not to
recommend the product. In such circumstances there are really two
options, says James.
One is to work to get more data, as Glaxo Wellcome is doing with
’You’ve got to keep the product promise in people’s minds in the time it
takes to provide that data, and work closely with patient groups that
represent at-risk groups to press home the seriousness of that
condition,’ she says.
The other option is to abandon all hope of NICE approval and to try to
develop the private market for the drug. One of the impacts of NICE is
that there is likely to be a greater polarisation between NHS
prescription drugs and so called ’lifestyle’ drugs.
NICE is clearly still at a very early stage of development, and many
health PR agencies and their clients are waiting for further
clarification of the appraisal process and hoping to learn lessons as
different drugs go through this process.
There are tricky times ahead, but a real opportunity for switched-on
agencies to show their worth. ’NICE will demand very strategic PR, but
agencies which are true consultants and experts in their field will come
to the fore,’ says Holden.
GLAXO BEEFS UP RELENZA PR IN SECOND BID FOR NHS ACCEPTANCE
If NICE’s first judgment on Relenza is anything to go by then there are
interesting times ahead for the UK pharmaceutical industry.
Sir Richard Sykes, chairman of Relenza producer Glaxo Wellcome, reacted
to NICE’s decision not to recommend the flu drug for NHS prescription by
writing to then Health Secretary Frank Dobson asking him to overturn the
decision and saying the company could be forced to move overseas if
Britain proved to be such a hostile market for new products.
Other drug companies supported this sentiment, including AstraZeneca
chief executive Tom McKillop, who told Tony Blair the Relenza judgment
had potentially devastating consequences for the future of the
British-based pharmaceutical industry.
These ’get tough’ tactics failed to sway Dobson, who stood by NICE’s
decision. But interestingly, strong lobbying by Glaxo Wellcome led in
July to the US Food and Drug Administration overturning a decision by
its advisory committee not to approve Relenza.
Glaxo is widely reported to have failed to provide enough clinical data
to persuade NICE of the benefits of Relenza to high risk patients.
In a press release Sykes responded by saying: ’Having proved to the
satisfaction of regulators worldwide that Relenza is effective and safe,
we are now being asked in the UK for additional data which it is
impossible to collect without the product being available by NHS
This appears to be a Catch 22 dilemma that needs to be clarified. But
Glaxo is now working with NICE to get more data and it will get a second
chance with Relenza when the drug receives a full appraisal next
The fact Glaxo is committed to getting more data shows how important
NICE recommendation is. Without NHS prescription Relenza costs pounds 24
for a course of treatment.
Opinions differ about how important Relenza is to Glaxo’s future - some
believe it is a blockbuster drug with potential worldwide sales of
dollars 1 billion a year, others that peak sales will account for only
about 1.5 per cent of Glaxo’s total. But the NICE decision could knock
millions off the bottom line, particularly as it is likely to affect
sales in markets outside the UK.
Neither Glaxo nor the agency working on the Relenza account, Hill and
Knowlton, was prepared to talk about the PR work being done now or while
the drug was undergoing rapid assessment by NICE.
The lesson must be that plenty of planning, watertight evidence and a
vigorous PR effort are necessary if drugs are to gain NICE approval.
’Glaxo Wellcome didn’t seem to overtly engage in getting interested
third party groups like Age Concern coming out with a point of view that
might have been represented by the Partners Council,’ observes the
chairman of Burson-Marsteller’s European healthcare practice, Dr Stuart
Now that Glaxo is working with NICE to try to get the extra clinical
evidence it requires, Shire Hall chief executive Margot James thinks a
real effort should be made to keep key messages about the product in
people’s minds. ’There is a real PR need to get the message across about
how serious a condition flu can be,’ she says.
Westminster Strategy associate director Jane Cooper says the way Relenza
hit the headlines was unexpected, and meant PR needed to be handled in a
different way. ’Relenza hit the public domain, so I would want to talk
to journalists and national government including the health
The NICE appraisal of Relenza may prove not to be typical. This was the
first drug to be assessed, the appraisal was a rapid one, and Glaxo had
not had the benefit of learning from experience how NICE works.
Countrywide Porter Novelli director of healthcare, Caroline Ashe says:
’I have been talking to colleagues in public affairs and they don’t
think this is a good example of the way NICE works. It is not clear
there is that much to learn from it.’