End of postcode lottery could put PCTs in a spin

There are few charges more damaging to the NHS than that of operating a "postcode lottery". This concern that patients in some areas were being denied drugs and treatments available in others was one of the motivations behind the establishment of the National Institute for Health and Clinical Excellence.

That attempt to create a level playing field has gone some way to solving the problem but in recent years the issue of medicines licensed by regulators but not yet assessed by NICE has come to the fore - most dramatically in the case of breast cancer drug Herceptin.

The decision on whether to fund drugs not yet assessed by NICE - effectively deciding whether or not they are a priority - lies with PCTs. And they need help.

"Individual PCTs are struggling with the capacity and also the consistency of decisions," says Shailen Rao, an independent consultant pharmacist and chair of the Primary Care Pharmacists Association.

He welcomes the creation of the Public Health Commissioning Network, where PCTs will share the burden of assessing drugs. PCTs have been asked to put forward areas of expertise where they would be happy to assess any new drugs; their conclusions, which may include recommendations on whether or not a drug is worth funding, would then be disseminated across all PCTs. In some cases, the expert opinion is likely to come from one person.

Tim Crayford, president of the Association of Directors of Public Health and a member of the network steering group, says the proposals are about avoiding duplication. He says public health doctors - expected to be among the experts who will be asked to do the evaluation - are likely to reach similar conclusions about drugs.

While PCTs will get the same recommendation, they will still have to decide whether to accept it. The government says that not having a NICE assessment does not mean that a drug should not be prescribed.

In many areas, co-operation on drug assessment already exists. Across NHS South Central, nine PCTs share four "priorities" committees, which assess drugs and other treatments to decide whether they should be funded in the absence of NICE guidance.

Ljuba Stirzaker, consultant in public health medicine at Oxfordshire PCT, says they can draw on the expertise of a central unit at the strategic health authority to evaluate treatments and pass the evaluations to the committees. Although decision making lies with each PCT, this does tend to mean they make similar decisions.

In other parts of the country there are similar arrangements: Greater Manchester PCTs have worked together on criteria for using some new drugs, involving stakeholders and allowing evaluations to be challenged and changed in the process. The area was one of the first to have a consistent approach to new drugs for macular degeneration.

Other areas also have local mechanisms for PCTs to work together on evaluation.

So the planned networks will build on what has gone before, rather than being a completely new approach. In addition, NICE has launched a "fasttrack" assessment process which means that significant new drugs will be assessed as soon as possible. While this will help, "given the breadth of medical technology compared against NICE's capacity to appraise, PCTs will still be required to evaluate and make many of these decisions themselves", warns Dr Crayford.

Breaking away

Will the network lead to more uniformity in decisions on new drugs? The answer seems to be probably - but that "postcode lotteries" are unlikely to be eliminated entirely. Faced with an expensive - but effective - new drug, PCTs in a healthy financial situation may break away from their hard-pressed neighbours. "It will be up to PCTs to evaluate that cost, along with all their other financial issues," says Dr Crayford.

"Cost is always important. We may look at a treatment which is clinically and cost-effective but also whether we [can] afford it," says Dr Stirzaker.

Even with good assessment processes, PCTs often struggle to fund new drugs immediately as they won't have been included in their financial plans - so a drug that launches in the spring of one year may not be funded until the following financial year.

This puts new drugs - especially if they are costly or used for a large number of patients - at a disadvantage. When they are potentially life-saving or lifeprolonging, or need to be used immediately, any delay can be a problem, as it was with macular degeneration drugs last year when some PCTs decided to fund new ones in-year.

But when a PCT does make a different decision from the rest of the country, they may be subject to even more press interest. It will be known what the advice from the commissioning network is and that a PCT has chosen not to follow it.

PCTs won't be able to hide behind internal evaluations of effectiveness. Press interest in the evaluations may become uncomfortable for those involved. Who would want to be the expert who writes the evaluation of the drug hailed as the next Herceptin, suggesting it is likely to fall outside normal costbenefit parameters? While NICE guidance often gets roasted in the press, that guidance is at least made by a large organisation with many people and stakeholders involved in it.

Some PCT leaders would like to see a more ambitious system for evaluating new drugs. Tim Riley, chief executive of Tameside and Glossop PCT, suggests something with a similar approach to NICE is needed, ensuring some consistency across the assessment process. "I would worry if there was something which was apart from the NICE process," he says.

NICE could "kitemark" processes or mechanisms used to reach interim decisions on drugs, he says. "Is there an opportunity for extending the NICE brand quality mark to something that is 'nearly good' for now instead of waiting for the gold standard?" he says.

Another option would be for the NHS in England to adopt the advice of the Scottish Medicines Consortium, which has a tried process for assessing new drugs, and new uses of old drugs, shortly after launch. That could then be superseded by NICE's decision. The Department of Health has suggested the SMC advice could help English organisations.

High expectations

Shared evaluations or national guidance may cut the burden on PCTs of making decisions about new drugs. However, Mr Rao warns that PCTs will still need to operate panels that make decisions on cases where exceptional circumstances - which may be clinical or social - may justify overturning a general rule on funding a drug or treatment.

Some PCTs are seeing more exception cases and increased media interest in these. Norfolk PCT says: "Over the years the number of cases referred to the panel has increased significantly. Many of the cases attract political and media attention." In just over a year its exceptions panel handled 156 drug cases and 274 non-drug cases; these cases are effectively pre-screened as they are already supported by hospital trusts' drugs and therapeutic committees. Oxfordshire sees about 60 cases a month, although this has remained stable over the last 18 months. It has two staff to manage applications.

Dr Crayford points to lobbying by patient groups, changing patient expectations and a greater awareness of how the NHS rations care as factors that could influence application numbers. In some cases, PCTs have been introducing "checklists" to ensure that only truly exceptional cases come before panels. But the burden on PCTs of hearing all these cases can be considerable and may remain.

In the longer term there may be a need to promote public understanding of medicines' limitations. Media talk of "wonder drugs" and "cancer cures" raises expectations - but often without informing people about side-effects and restrictions on use. Dr Riley says PCTs could address this by giving patients the information needed to make decisions. Pointing patients to NICE guidance could be a start.

There also seems to be a need for greater openness about the process of deciding which treatments should be funded. PCTs can seem reluctant to talk about why they make the decisions they do - probably because they fear a fierce reaction in the media.

There are exceptions: the Oxfordshire priorities forum includes lay people as well as clinicians and managers. It is chaired by a non-executive director, with two members from patient organisations and an observer from the council's overview and scrutiny committee. Decisions on drugs or treatments and reasons behind them are available on the PCT's website.

"It is invaluable having lay people there," says Dr Stirzaker. "They bring the patient's perspective. They often ask questions I think a clinician would not. It brings us down to earth." Martin Johnson, one of the trustees of the Patients Association, wants greater transparency and patient involvement in decision making - and more information put in the public domain. That might give the process more legitimacy and aid public understanding of why some treatments are not funded; but there will always be marginal cases where desperate people don't get drugs they argue would benefit them. PCTs will continue to face tough decisions whatever system is adopted.