FOCUS: HEALTHCARE PR - A new pill to swallow. A further layer of healthcare regulation will necessitate greater levels of pre-launch PR for new drugs. Nick Purdom reports

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.

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

company.’



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

shows.





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

approach.’



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

stronger.



’We need to make patient groups aware of the processes of NICE. Our goal

is to ensure that the broadest church is considered,’ says

Pinkerton.



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

network.



’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

stake’.



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

Morgan.



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

messages.



’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

authorities.



’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

committees.



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

Relenza.



’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

prescription’.



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

year.



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

Pinkerton.



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

minister.’



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.’



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