The Pharmaceutical Journal Vol 267 No 7171 p591-592
27 October 2001

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A NICE job and somebody's got to do it

For those with an interest in the workings of NICE, the Department of Health's review of the institute, which was expected this summer, has been eagerly awaited. So far, no review has been forthcoming. Meanwhile, NICE continues to issue guidance with the expectation that National Health Service organisations will follow it. But what is happening in practice? Harriet Adcock finds out

The National Institute for Clinical Excellence was set up on 1 April 1999. It is a Special Health Authority within the National Health Service with a remit to provide guidance on health care standards and new technologies to the NHS and to patients.

One of its aims is to help health professionals working within the NHS give patients the best possible health care within the resources available. In addition, NICE says it will help to promote faster access to the best treatments, and to new treatments that offer real benefits to patients. It adds that it will help to end post-code prescribing.

Most would agree that these aims are laudable, but has NICE delivered what the NHS needs? At the launch of NICE in 1999, the then Secretary of State for Health, Frank Dobson, said: "NICE will command the respect of doctors, nurses and other clinical professionals and provide authoritative guidance on what treatments work best for patients."

Dr Brian Curwain, chief pharmacist, New Forest Primary Care Group, says that there is a lot of scepticism about how NICE operates. However, guidance from NICE has meant some treatments are used where they might otherwise not have been because of their high cost.

Dr Curwain also points out that many new drugs offer only marginal benefits over old drugs, so by endorsing their use, NICE is driving up costs. In terms of additional funding, there have been shifts of cash in drugs budgets in secondary care to fund some of the costs stemming from NICE guidance. "But there have been no additional funds for primary care to pick up any of these costs once the patient leaves hospital," he said.

Dr Curwain cited the example of new drugs used to treat Alzheimer's disease, which are prescribed initially for three months by specialists working within secondary care. Thereafter, treatment is reviewed with any subsequent prescribing costs being picked up by primary care. "This is now costing my health authority £25,000 per month in primary care prescribing costs for which there is no extra funding."

Dr Curwain went on to say that NICE should concentrate on technologies other than drugs. "There is pressure for the NHS to fund different types of therapies. Even for established interventions such as physiotherapy we do not altogether know what the evidence base is."

Asked whether the recommendations of NICE were as important as those contained in national service framework (NSFs) documents, Dr Curwain said that NSFs take priority. "NICE guidance is not seen as a must do."

There is a general feeling among pharmacists that one of the most useful things that NICE provides is support on using medicines properly. Dr Curwain said: "For some drugs, such as nicotine replacement therapy and amfebutamone for smoking cessation, and orlistat and sibutramine for the treatment of obesity, it is not just prescribe and forget, but prescribe and support. NICE guidance gives the context as well as the green or red light."

Omar Ali, formulary development pharmacist, Surrey and Sussex Healthcare NHS Trust, says one criticism that can be raised is that NICE guidance and the NSF recommendations do not always add up. "Practitioners need clarity." He went on to say that prescribers like to have a yes/no answer to the question of whether a particular drug should be prescribed for a particular patient. "There is a need to prioritise patients but guidance must be clear for it to be useful in practice."

Mr Ali also comments that NICE lost credibility after its decision to approve the use of zanamivir (Relenza) following its earlier recommendation that it should not be prescribed for NHS patients. "That was a turning point when people started to ask who is really turning the wheels of NICE."

Positive recommendations about a drug can also affect patients' perceptions about their right to receive a particular treatment. Mr Ali said that after NICE issued guidance on donepezil (Aricept), patients and patients' groups applied pressure on the health authority to fund the drug. "Initially we had limited funding for Aricept but have now opened our funding and are waiting to see what the demand is."

Although its guidance has been useful overall, NICE made a mistake with glitazones, says Mr Ali. "Locally we are working on our own guidelines for using glitazones. NICE does not seem to have got a hold of how these drugs can change disease."

How the industry views NICE

Dr Trevor Jones, director general, Association of the British Pharmaceutical Industry, says that the terms of reference for NICE, particularly supporting innovation, are acceptable. However, he adds that its guidance has not made much difference to prescribing practice: "The data so far shows that the NHS does not necessarily put the advice into practice." This is not the fault of NICE though, he says.

The Department of Health has said that resources are factored into the budgets of primary care trusts but this is not how it is perceived by people within these organisations.

A particular problem with the process as it currently stands is that as soon as NICE is given a task to review, virtually everybody stops prescribing the medicine until NICE has made its decision. Dr Jones cited the case of beta interferon, which is still under review after being referred for appraisal in August 1999. He said: "The health service should not be putting its pen away while deliberations take place."

Dr Jones also asks why NICE has concentrated so heavily on pharmaceuticals. "Over the six waves of treatments selected for appraisal, 69 per cent of the total have been medicines." This is despite the fact that medicines form only 13 per cent of NHS expenditure.

Therapeutics Advisory Group

To address the issue of how products are selected for review, NICE has set up a Therapeutics Advisory Group (TAG). Dr Jones comments that TAG is non-transparent: "We do not know its terms of reference, who it reports to or who sits on the group." Dr Jones says that too many medicines are being selected for appraisal at the time of their launch, and that this is only appropriate in a limited number of cases.

Clinical studies conducted by pharmaceutical companies before the launch of a drug are designed to satisfy the Medicines Control Agency that a product is safe and efficacious, and that it can be granted a product licence. "These studies do not necessarily produce data relevant to local practice," says Dr Jones. "Such data will only emerge when a product is in routine use." He proposes that pharmaceutical companies should start a dialogue with TAG once phase II clinical trials have been completed so that the most appropriate time for the appraisal can be decided.

In the meantime, the Health Service should be advised on what a product is likely to be of benefit for and what its limitations are. "An extension to the role of the National Prescribing Centre would be a valuable way forward in this direction," he suggests.

Dr Jones also expresses concerns about the criteria used by NICE to make judgements on the cost-effectiveness of a particular treatment. "NICE seems to have relied heavily on QALYs [quality adjusted life years]. As a judgement marker, the QALY has a place but is a blunt instrument that does not necessarily take into account real patients' needs," he says.

Another significant gap in the NICE appraisal process is the appeals system, says Dr Jones. "The pharmaceutical industry must be able to appeal on scientific grounds where there is genuine disagreement on interpretation of data." Dr Jones points out that an appeal can only be invoked if the chairman of the appeals panel believes there to be a case. "The chairman of the appeals panel is also the chairman of NICE," he says.

Many believe that it is important that NICE is independent of the Department of Health if it is to take on the role of providing the NHS with best practice guidance. "Affordability has to be a political decision taken by ministers who are publicly accountable," comments Dr Jones.

The ABPI's concerns about the way NICE works are shared by some patients' groups. A spokeswoman for CancerBACUP said that the charity had welcomed the creation of NICE in the hope that it would end the unfairness of postcode prescribing. She said: "While CancerBACUP welcomes the positive guidance NICE has given the NHS on a number of cancer treatments, we have concerns about the appraisal process. In particular, we would like to see more transparency in how NICE arrives at its decisions."

She added that making sure that NICE guidance is fully implemented is vital: "At the moment there is very little information available on the extent to which NICE guidance is implemented throughout the NHS."

A spokesman for the Multiple Sclerosis Society voiced similar concerns. "Everyone would agree that the situation pre-NICE was hopeless. But the process that NICE has adopted has led to a situation that borders on the inhumane." He pointed out that in the case of beta-interferon, whatever the conclusion of NICE, many patients will have become too debilitated to be eligible for treatment. "This is inexcusable. People with multiple sclerosis have found the NICE process extremely tortuous and unsatisfactory."

Local practice

Dr Max Summerhayes, principal oncology pharmacist, Guy's and St Thomas' NHS Trust, says that local verdicts on oncology drugs are often at odds with NICE. "NICE appears to be having difficulty in producing guidance on drugs that have clear benefits and are already being used at local level." This might be because NICE appraises products in isolation, so their relative value cannot be assessed, he explained.

Dr Summerhayes is also concerned that there are no explicit guidelines on how to reject evidence. "NICE is in real danger of becoming discredited by its decisions, since it does not know how to turn a product down." Although he is supportive of the concept of NICE he points out that NICE has chosen to look at disease areas with few treatment options making it more difficult to reject drugs.

Commenting on the value of NICE guidance, Dr Bryony Dean, principal pharmacist, Hammersmith Hospitals NHS Trust, said: "Clinicians do not necessarily agree with NICE guidance but it is useful as supporting evidence for adding new drugs to the hospital's formulary. If the drug is something that clinicians want to use then it is really helpful."

In a recent education and debate article published in the BMJ (2001;323:743), health economists Dr Richard Cookson, Dr David McDaid and Professor Alan Maynard argue: "NICE has effectively become an advocacy mechanism by which lobbies of specialists and their supporters in the pharmaceutical industry extract more public money from the NHS. Instead of challenging the pharmaceutical industry to show value for money, NICE has become their golden goose." They comment that NICE needs to start saying no to costly and relatively cost-ineffective new drugs and devices. They suggest changes to the way in which NICE operates to ensure consistency in decisions on rationing. Their first proposal is a fixed growth budget for new technologies within which NICE must prioritise its guidance. A second change would be for NICE to be allowed to conclude that for some technologies, national guidance is inappropriate. "Leaving funding decisions to local discretion might be the best option," they say.

Another proposal suggested by the authors is to develop price-performance contracts. These would allow costly new technologies to be funded on condition that the future price is linked to the performance of the product: "If such binding price-performance agreements could be implemented, this would reduce the political pressure on NICE to give an unconditional acceptance at the launch of a product."

Commenting on the proposal, director general of the ABPI Dr Jones said: "Being predictive of the value of a drug at launch is difficult." He cited the example of ranitidine (Zantac), which at launch was seen by some as just a me-too product to cimetidine but went on to become the best-selling drug of its time. "Only after medicines have been used in practice in a variety of patients with different pathologies can we see what actually happens."

Since April 2000, NHS organisations have started to come under the scrutiny of the Commission for Health Improvement. One aspect of CHI's work is to ensure that health care providers are meeting targets and implementing national guidelines. A spokesman for CHI said that CHI is looking at how NICE guidance is being implemented at an organisational level in its reviews.

So, it seems that the jury is still out on NICE. In general it is welcomed, and the role of NICE is seen as a job that somebody has got to do. It appears though, that individual NHS organisations are using NICE guidance where is fits in with local requirements and policy, and ignoring it when it does not. It will be interesting to see if NHS organisations are brought to task by CHI if they fail to implement guidance put out by NICE.

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Harriet Adcock is on the staff of The Pharmaceutical Journal