Close to home: the UK’s regional NHS influencers

pharmafile | June 3, 2008 | Feature | Sales and Marketing |  NICE, UK, healthcare, influencers, regional 

With so much attention directed at NICE since the parliamentary health select committee reported on the organisation in January, it would be easy to forget that the health technology assessment organisation is far from alone.

In fact, a thicket of national and local bodies exist to tell prescribing committees and the NHS at large what should be prescribed and what should not, and it seems fair to ask what they do, and what influence they really have.

National Horizon Scanning Centre

The NHSC isn't so much an influence on prescribing as an early warning system. It looks two to three years ahead into pharma's pipelines, identifies promising drugs expected to have an impact on patient care and outcomes, drug budgets and health service management, and alerts the DH and other bodies involved in policy making, including NICE and the National Prescribing Centre.

It's a job that requires effective communications with drug makers. "It would be very difficult without good links with pharma, and increasingly the medical devices companies," says NHSC director Dr Claire Packer. "We regularly meet with companies to talk about new products and significant new indications.

"The bigger companies we meet every six months, but we only call on the smaller companies when we find a new product through scanning the pharma media sources."

A new initiative for early summer this year is a mailing to invite companies to let the organisation know about their upcoming products. "We know that the SMC has done this for a couple of years, and we're basing our approach very much on theirs" says Packer.

Packer says that relations with drug manufacturers are generally good. "The NHSC is useful to pharma because it's probably the best route to getting a new drug onto NICE's work schedule, and companies also gain from the NHSC's knowledge of NICE's processes, when key committees will be looking at individual products."

Yet issues inevitable arise. Packer adds that new indications are frequently not reported to her organisation, perhaps because of some oversight – or possibly, as she mischievously suggests, because there may at times be advantages in avoiding the scrutiny of a NICE review.

"What we like is to have two and a half to three years notice before going to market – and that would be a year to 18 months or so before companies make the application for an extension.

"Pharma complains when NICE don't produce guidance close to launch, which means the PCTs won't fund treatments because they're waiting for guidance. But our argument is that telling us early enough can remove or reduce the wait", she adds.

National Prescribing Centre

The NPC has a much wider remit, only one part of which is supporting the NHS in managing new medicines – though chief executive Clive Jackson is quick to acknowledge that it's a very important part.

The NPC also contributes to horizon scanning, but instead of looking two to three years forward into drug company pipelines, its focus is closer to a year to 18 months prior to launch – and at that point it has a lot more information to work with than the NHSC is likely to see.

"We get information about a lot of chemical entities and indications, and the question then is how to prioritise them – how do you decide which new drugs the NHS needs to know about?

"Our people make their assessments and decide which are likely to be the most important chemical entities by looking at their financial impact, their clinical impact or their service delivery impact. We then go back to the pharmaceutical companies to get much more detailed information, and do a critical appraisal leading to an On the Horizon bulletin, which we aim to get out about six months pre-launch to aid local advance planning.

"If there is sufficient additional information at launch, we then provide an On the Horizon launch review, which updates the information we've published six months before.

"Post-launch, of course, all the other elements of the NPC's work kick in, so we might cover a particular drug in MeReC, or offer education and training on a particular treatment".

In general Jackson believes the NPC has pretty good relations with pharma. "We have direct communication with most of the companies. They provide most of the information early on, and we go back to them and ask for more as required."

UK Medicines Information

UKMi is another organisation with a wide remit that includes horizon scanning. It publishes the New Drugs Online searchable database which contains information on drugs in late phase II clinical trials through to product launch, focussing on those likely to reach market in the UK, or expected major licence extensions.

It also publishes pre-launch reviews, influential post-launch reviews including the therapeutic class summaries, and the excellent NELM news bulletins written by its network of contributing pharmacists.

More than these, it also produces a range of materials for healthcare planning including information on clinical guidance and GP contract developments expected to impact budgets, and even an Excel spreadsheet designed to calculate the potential costs of prescribing changes for a local population.

Scottish Medicines Consortium

However, after NICE, it's pretty clear that the Scottish Medicines Consortium is the most influential organisation influencing prescribing in the UK.

Instead of a single organisation that publishes both technology assessments of individual drugs and treatment guidelines for many important conditions, in Scotland the SMC decides whether to accept treatments on behalf of the health boards, and leaves the management side of things to other bodies, notably the Scottish Intercollegiate Guidelines Network (SIGN).

While this simplifies the SMC's role, it doesn't make it any less significant. In fact, its influence extends beyond Scotland's borders, and the point is not lost on the SMC's vice-chairman Dr Ken Patterson. "A third of our website visitors come from Scotland, a third from the rest of the UK and a third from the rest of the world, and we know that PCTs look at what we're doing.

"People are interested in our opinions because they're very often the first to become available because we have strict 12-week time limit. People doing their own assessments also look at our opinions as part of their overall assessment of a new drug."

Patterson also celebrates the way the SMC works with the companies. "We have an excellent relationship with pharma. We could not have forced the ABPI and the wider pharma community to cooperate with us. However, senior industry people saw that technology assessment was coming, and that they would rather be part of it."

And so they are. "We've got three members from the industry on the SMC, and two industry health economists on our new drugs committee – and they're each full voting members," says Patterson.

All-Wales Medicines Strategy Group

The AWMSG advises the Welsh Assembly minister for health & social services on medicines management and prescribing, builds consensuses on medicines management issues, and audits the uptake of approved medicines.

It doesn't normally consider a product if NICE intends to publish a final appraisal within 18 months from learning of an intention to submit. AWMSG guidance can also be replaced by later NICE guidance.

As with NICE, Trusts and Local Health Boards in Wales are required to implement AWMSG advice once it has been endorsed by the Minister – but should not take action until this has happened.

The sting in the tail for pharma is that where a manufacturer does not engage with an AWMSG appraisal, the Welsh Government may instruct AWMSG to either appraise the medicine based on information in the public domain, or to place a statement on the organisation website confirming that it does not support its use within NHS Wales.

Despite this apparent threat, relations with pharma don't seem to be too bad. ABPI Cymru Wales officials meet with the Welsh Medicines Partnership, which channels suggestions from industry to the AWMSG steering committee. What's more, as with other health technology assessment organisations, manufacturers preview key AWMSG reports before publication, are allowed to correct factual inaccuracies and submit relevant new data, and attend AWMSG public meetings at which they are able to say whether all the relevant issues have been addressed.

How do they all stack up?

Faced with such a range of organisations that share at least some similar functions, one can't help wondering what two kinds of organisations on the ground think of them – the pharma companies and the formulary committees.

To find out, I turned to a health outcomes manager with one of the large pharmaceutical companies, and to a hospital pharmacist who sits on the medicines management committee of an important group of hospitals.

I should explain that the health outcomes specialist was obliged by his pharma employer to keep his identity shrouded in secrecy because the relationships involved are so important to business success.

Talking with both him and our pharmacist, the horizon scanning functions of the NHSC, the NPC and the UKMi appear to cause few concerns.

However, what is of great interest to both pharma and the formulary committess is the SMC: "We're aware PCTs and hospitals outside of Scotland take notice of SMC decisions" said my health outcomes manager. "It helps that it covers so many new drugs and that its time-scale is short. Another reason it's important is that it produces a large number of negative decisions.

"An NPC monograph is also important to us, as it goes out to all pharmaceutical advisers before launch. However, the process with the NPC is more opaque – you may be asked to provide information or you may be asked to comment on a monograph.

"The NPC can be very important, however, particularly if you have a drug that could have a big budget impact because pharmaceutical advisers will give the issue a lot of consideration.

"After the SMC and the NPC, the other organisations have less influence on prescribing decisions, though we're conscious the UKMi is particularly influential post-launch. Regional groups can also have a lot of local influence, particularly the Midlands Therapeutics Review and Advisory Committee and the London New Drugs Group.

"After that it would be certain PCTs and area health boards that have more influence than others – not least because some don't have systems in place to influence their prescribers."

The effort that goes into providing organisations with information varies with their importance and the data they need, says our health outcomes manager. "The SMC is quite sophisticated in what it requires, while some of the local groups and prescribing committees don't have the resources to make use of that information, and need something simpler.

"Again, in the case of the NPC we only provide information if we're asked, but we do have a good relationship with them. We tell them about our pipelines and we get to see drafts of their monographs".

I turned to Anthony Grosso, formulary and medicines management pharmacist at the UCLH group of seven London hospitals to discover how this pharma view was reflected in his world.

"We do like to see what others have said. Our first ports of call would be the SMC and NICE, but we don't automatically follow them. We make our decisions independently. In the rare situations where we diverge from NICE we have to have a very good reason and it has to be clearly documented.

"A problem with NICE appraisals, is that they may be out of date almost as soon as they are released. The SMC is much quicker and very useful, and it's good at providing cost effectiveness information at an early stage", he adds.

"Another influence is the Drugs & Therapeutics Bulletin, because its reviews are so robust. If I have an application in for a drug and know the DTB have looked at it in the past year, I'll be sure to look at it".

He also reports that the limited range of material he's seen from the NPC is very good. He sometimes uses material from the UKMi, but acknowledges that he could potentially do so on a routine basis as the London New Drugs Group's assessment process evolves.

Change in the air

If my outcomes manager has a problem, it is the workload involved in providing so much information. "The organisations are asking for similar information, but in different forms. Technology assessment groups are asking for cost per quality of life-year or QUALY, while the NPC asks for a combination of clinical data compared with comparators in relation to budget impart. And local payers are looking for budget impact at a local level, the clinical argument, potential cost savings and the impact on healthcare priorities.

"It's really tough having so many groups asking for something different", he says, observing that the number of health economists employed by his company has increased several times in just a few years.

There is potential for the demand for information to become much worse as the regional groups such as the MTRAC and the London New Drugs Group become more influential. Thankfully it seems the problem has not gone unnoticed.

One of the declared aims of the Ministerial Industry Strategy Group's review of the medicinces industry is to develop a single database that pharma will be asked to populate with information about its pipelines, and which the various horizon scanning and assessment organisations will then be able to access.

If the initiative succeeds, there's no doubt pharma health economics and outcomes managers will breathe a huge sigh of relief, as spiralling inflation in demand for information about drugs is finally brought under control.

Gavin Atkin is a freelance writer specialising in medical and pharmaceutical topics. He can be contacted at gmatkin@gmail.com