The National Institute for Health and Care Excellence or NICE was set up in 1999 and is perhaps best known to the public for two areas – clinical guidelines on the most appropriate treatment and care for specific conditions, and guidance on whether treatments/procedures/diagnostics can be used by the NHS based on clinical and cost-effectiveness. The latter area covers what are known as Technology Appraisal Guidance, Highly Specialised Technologies Guidance, Diagnostics Guidance, and Medical Technologies Guidance.
The organisation tends to receive media attention when a new and very expensive drug or treatment has received approval in the UK, but there is doubt over whether it will be made available on the NHS.
From the outset its aim was to create guidelines on the use of treatments by the NHS across the UK and so reduce the rationing of treatment by postcode that had become commonplace.
In the ensuing decades, NICE’s responsibilities expanded considerably and it now has a much larger remit covering the NHS, public health and social care (see box). NICE produces a vast range of publications, including guidance, which includes clinical guidelines, quality standards, advice ( a critical assessment and summary of latest evidence), evidence summaries, and medical technology briefings.
Areas of work
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The development of clinical guidelines
NICE clinical guidelines advise the most appropriate treatment and care for people with a particular condition. They cover many topics, with most being about a specific illness or condition, such as dementia or breast cancer. Other guidelines focus on broad types of care, such as maternity services, or cover more general topics or symptoms.
There is a set process for the development of clinical guidelines (see box).
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Included in the development of a clinical guideline is an assessment of the cost-effectiveness of an intervention, service or programme. Cost-effectiveness is the balance between the estimated costs of the interventions or services and their expected benefits compared with an alternative.
Clinical guidelines normally take months to develop and publish, but in the case of Covid-19, NICE began work as soon as the pandemic was identified and by June 2021 had already published 18 guidances covering Covid-19 treatment in a range of patients, and related issues, and published 11 lots of NICE advice, on a range of subjects.
Technology Appraisals
The other area most often in the media is NICE’s technology appraisals, covering drugs, diagnostics, procedures and medical technologies (e.g., drug delivery technology, stents, etc.)
One of the reasons NICE was set up was to enable patients across the UK to receive costly drugs and technologies. Prior to NICE, drugs were approved and whether they got prescribed was based on whether the NHS in your area could afford them – a postcode lottery of prescribing. If the NHS refused to prescribe due to cost, this often led to lobbying by charities and the pharmaceutical industry including via emotive media stories.
The advent of NICE took all these issues away from individual NHS organisations. In addition, for very expensive drugs it has opened up a way for the NHS to prescribe these by triggering negotiations on price and usage between NHS England and companies based on data rather than emotive media stories.
NICE’s decisions are based on clinical data and a figure known as a Quality of Adjusted Life Year (QALY) which together are used to compare new drugs to ones already on the market and assess whether a new drug gives value for money.
This calculation can be made for a wide variety of treatments and procedures – ones that improve quality of life, like a treatment for eye disease, and for those that extend someone’s life, such as a cancer treatment.
For each drug/treatment a cost is calculated per QALY. Generally, the more it costs to achieve one QALY, the less likely NICE will recommend use by the NHS. If the cost to achieve one QALY is high, companies need to have a much better argument for approval. The threshold is not set in stone, but in practice if a treatment costs less than £20,000 per QALY it is likely to be considered cost-effective.
If a treatment costs between £20,000 and £30,000 then more questions will be asked – how the quality of life issues have been measured, does it offer other benefits, etc. For example, a treatment that means fewer clinic visits would lead to a benefit of increased clinic capacity. There are also social value judgments that are important considerations, for example there is always strong public support for treatments that save a child’s life.
The calculation of QALY is fed into the technology appraisals. NICE carries out a cost comparison case, using a QALY figure, to determine if the new drug shows that it is likely to provide similar or greater health benefits at a similar or lower cost than drugs already recommended in the guidance for the same condition.
There are three types of technology appraisal: the single technology appraisal, which assesses a single drug or treatment, usually one that is new or seeking an extension to its use; the multiple technology appraisal that assesses several drugs or treatments used for one condition; and the fast track appraisal.
For new drugs, the process of appraisal starts before approval of the drug, which enables NICE to produce guidance soon after the technology is introduced in the UK.
The fast-track appraisal (introduced in 2017) is used for drugs that offer exceptional value for money. The process aims to make the drug available to patients 30 days after the drug has been approved by NICE. This applies to drugs costing up to £10,000 per QALY.
For very expensive drugs – those that have a net budget impact of £20m or more per year in any of the first three years of its use in the NHS – NICE’s calculations trigger a commercial discussion between NHS England and the company.
The discussion will try to come to some arrangement to make the drug available to NHS patients, and may involve different models for how the NHS might pay for the product.
There are special arrangements for treatments for very rare conditions. They are evaluated against a sliding scale, so that the more additional QALYs a treatment offers, the more generous the cost per QALY level it will need to meet, starting at £100,000 per QALY, rising to a maximum of £300,000 per QALY.
NICE’s work allows patients access to extremely expensive life-saving products as soon as it is feasible. This was the case for Novartis Gene Therapies Zolgensma approved in March 2021, which costs £1.79 million for a single dose. It is used to treat babies and young children with the rare and often fatal degenerative disorder of progressive spinal muscular atrophy (SMA). The approval was based on draft guidance from NICE, which includes a managed access arrangement, while further data is collected.
NICE notes that despite the high cost of the treatment, it can be recommended for use on the NHS because of the evidence of exceptional benefit to young babies, potentially allowing them to reach normal childhood developmental milestones.
Although the headline figure is £1.79 million per dose, this is not the price the NHS will be paying. The developers of Zolgensma and NHS England negotiated a discounted price after confidential negotiations.
For anyone working in the NHS, public health and social care, the work of NICE is now ever present – from guidance on antibiotic prescribing to guidance for supporting adult carers.
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