25 years of helping to get the best care to people fast

1999 to 2009 – the first 10 years

Making independent, rigorous and difficult decisions

Within months of being set up, we started work on our first drug appraisal. The appraisal was noteworthy as it immediately challenged us to put our principles into practice.

Our guidance said that Relenza, an antiviral treatment for flu was not cost-effective and should not be provided on the NHS. This was because there was insufficient evidence to show Relenza reduced the severity of the illness for those most at risk: the elderly and people with asthma.

The decision set the tone for NICE as an organisation that issues rigorous, but fair challenges to the pharmaceutical industry.

Not long after, in 2000, we produced our first technology appraisal which recommended healthy wisdom teeth should not be removed as a precaution. The estimated cost savings to the NHS of this were £5 million.

First independent committees set up, clinical guidelines launched

In 2001, we started developing clinical guidelines, which remain a core part of our activity.

NICE guidelines are based on the best available evidence. They contain recommendations that are put together by experts, people using services, carers and the public.

Each guideline is developed according to a process that starts from the topic being chosen and extends to any future guideline updates.

In 2002, we published our first clinical guideline on the topic of schizophrenia. The guideline had a significant effect, as prior to this, there was little in the way of national guidelines for mental health. It has been used in Australia and the state of California and translated and adopted in Spain and Italy.

Since then, we have produced a raft of guidance on mental health conditions ranging from depression and anxiety, to eating disorders and maternal mental health. 

Integrating the voice of the public into our work

In 2002, we established the Citizens Council.

The Council was made up of members of the public and provided us with a public perspective on ethical issues such as fairness, which could then be taken into account when producing our guidance. The work of the Citizens Council was ground-breaking and widely respected across the health and care system.

We have since introduced NICE Listens, which expands and updates the important work of the Citizens Council. NICE Listens builds on the Citizens Council’s success and aims to address the challenges of the fast-changing health and care landscape in which we operate.

Now, instead of a standing group of council members, we invite a new sample of the public to take part. The group is given time to learn and become familiar with the topic area, before discussing it in detail.

The findings from NICE Listens help make sure our policies on complex and controversial issues reflect the values of informed members of the public. 

Expanding to provide advice on surgical procedures and public health

Our role expanded in October 2002 when the interventional procedures advisory committee held its first meeting, looking at what operations should be offered to patients. The first guidance we published as part of this programme was on uterine artery embolisation for fibroids.

In 2002, NICE took on an additional new role of producing public health guidelines. Our debut public health guideline was on the use of brief interventions to reduce smoking.

With this new responsibility, came a change of name. We became known the National Institute for Health and Clinical Excellence. Decisions on which drugs should be available on the NHS also became legally binding, meaning the NHS has to pay for them if NICE recommends them where conditions are met.

Our portfolio of products expanded further with 2 pioneering programmes to assess new medical technologies, devices and diagnostics.

The programmes have helped the NHS to make consistent decisions about which new technologies have the most potential to transform patient care while providing the best value for money for the health system. 

2009-2019: setting the foundations for the future

In 2010 the government established the Cancer Drugs Fund (CDF) as a source of funding for cancer drugs in England.

This meant that new cancer drugs can be made available to people much more quickly than before.

A new approach to the CDF began in 2016. The new approach provides:

• access to promising new treatments, via managed access arrangement, while further evidence is collected to address clinical uncertainty
• interim funding for all newly recommended cancer drugs, giving people access to these treatments many months earlier than before.

By April 2024, over 100,000 people had benefitted from early access to treatments through the CDF.

Health and Social Care Secretary Victoria Atkins said: “This is a huge milestone and demonstrates the success of the Cancer Drugs Fund in fast-tracking patient access to ground-breaking new cancer treatments while allowing us to gather further real-world evidence on their effectiveness.”

By March 2024, nearly 100,000 people had benefitted from early access to NICE-recommended treatments through the CDF.

A change in name, expanded remit for social care, first highly specialised technologies guidance published

In 2012, Professor David Haslam was appointed as NICE's chair, and in the following year, NICE was re-established in primary legislation by the Health and Social Care Act 2012. This wider remit was reflected in a further change to our name, and NICE became the National Institute for Health and Care Excellence.

After taking on the remit of producing evidence-based guidance and standards for the social care sector in April 2013, our first piece of guidance was published in March 2014. The guidance outlined how medicines in care homes should be managed.

We've recommended 25 treatments for ultra-rare diseases since 2015.

A year later, we published our first highly specialised technologies (HST) appraisal. Our HST guidance looks at drugs for very rare conditions. Since 2015, we have recommended 25 treatments for ultra-rare diseases.

We published important guidance on combating antimicrobial resistance in 2017. This was accompanied by a series of guidelines covering the management of common infections, including cough, tonsillitis, sinusitis and sore throats.

A new milestone was reached at the start of 2018 with the publication of our 500th technology appraisal. We expect this number to double as we publish our 1000th technology appraisal in 2024.

2019-2024: a strategy for the future, new methods and processes, learning from the pandemic

In 2020, Professor Gillian Leng became NICE's chief executive and Sharmila Nebhrajani OBE took on the role of chairman.

The change of leadership arose at a time when the organisation had to react quickly to the new and exceptional pressures arising from the COVID-19 pandemic.

Overnight, we adapted processes so that staff could work remotely, and we could continue business during lockdowns.

It was clear that the health and care system required NICE to provide support during a particularly difficult and uncertain period.

We collaborated with researchers to identify potential new drugs for COVID-19 and produced rapid guidelines for clinicians on topics relevant to the pandemic.

In February 2022, we launched our new combined methods and process manual and our topic selection manual for health technology evaluation.

The manual outlines changed processes for new evaluations to give people earlier access to innovative new treatments, by allowing greater flexibility over decisions about value for money, and consideration of a broader evidence base.

They result from one of the largest and most comprehensive reviews of our health technology evaluations ever undertaken. 

Over the years, our approaches have meant the UK remains competitive when compared with other countries in Europe in terms of access decisions.

For example, England is 6^th out of 37 countries in the EU in terms of time in days from regulatory approval to reimbursed access (EFPIA WAIT report 2023). Furthermore, the timeliness of our appraisals increased by 17%.

However, there is more that we can do to improve and sustain these figures over the long term. And we know that people want and expect faster access to new treatments, even in cases where NICE needs more data to make a final decision.

So, we are carrying out a range of projects to help improve the timeliness of our guidance.

A streamlined approach for simpler, low-risk treatments

In 2022, we introduced a new proportionate approach to technology appraisals.

We simplified, removed, or reconfigured parts of the appraisals process. This means we applied light-touch, faster approaches to simpler, low-risk treatments allowing us to produce rapid guidance for some topics.

We’ve recommended 6 treatments in the first phase of this project, benefitting around 350,000 people.

This helped speed up our technology appraisals process by up to 20 weeks (45%) and increased our capacity for guidance on more complex treatments. 

Our streamlined approach to appraisals sped the process by up to 20 weeks (45%), benefitting 350,000 people.

We’re now applying lessons learned from this approach more widely, to simplify and speed up processes in other areas of our work.

Guidance coinciding with MHRA approval

In 2023, we achieved a significant milestone in providing guidance on a new treatment at the same time as it received its licence from the Medicines and Healthcare products Regulatory Agency (MHRA).

We recommended glofitimab for people with advanced lymphoma. The treatment works by encouraging the healthy cells in the body that are responsible for the immune system to destroy the cancer cells. 

Shortly after, we published guidance on a new 1-a-day pill as an option for treating sever ulcerative colitis. The guidance published on the same day that the treatment was granted a licence by the MHRA, in what was a first for NICE.

Increasing speed even further

In 2024, the Medicines and Healthcare products Regulatory Agency launched a new international recognition procedure.

We are using the opportunity to examine ways we can speed up our appraisals processes even further.

We are developing ways of enhancing horizon scanning, and issuing guidance on evidence requirements.

We will also work with our regulatory and industry partners to identify opportunities and methods for making our processes even speedier and more efficient.

As a health technology assessment body, with 25 years of experience, we’ve produced guidance and advice on a number of conditions and diseases ranging across diverse health and care settings.

But it is important that our advice continues to be relevant to the evolving pressures of the health and care system.

So, we are making sure that we’re focusing on what matters most. We’ve carried out activity that tackles the most urgent issues in health and care – from addressing system pressures, to a new resource to help tackle health inequalities, to developing a new subscription model for the evaluation and purchase of antimicrobials.

Helping a health and care system under strain

We recognise that the health and care system is under exceptional pressure.

We have been carrying out a range of activity that can support practitioners and commissioners with improving productivity and recovering core services.

In 2023, we published guidance that recommends doctors offer a home test to people with signs or symptoms of colorectal cancer, to spare the need and reduce the waiting times for a colonoscopy.

This guidance is helping GPs to better identify and refer the right people for further testing quickly, freeing up waiting lists for those more likely to have a positive diagnosis. Around 100,000 fewer colonoscopies are expected to take place each year as a result.

We also published guidance recommending that radiotherapy for some breast cancer patients could be reduced without compromising safety.

First introduced during COVID, this approach is now enshrined in our guidance, with 10,000 appointments freed up for every 1,000 patients undergoing shorter treatment.

Helping the NHS improve productivity

In 2023, we launched a new web resource that matches relevant NICE guidance and recommendations to areas of improving productivity and recovering core services for the NHS.

Each piece of guidance or recommendation is highlighted with the related productivity opportunity. For example, it might help reduce the length of a hospital stay, reduce A&E attendance, improve the speed of rehabilitation, or speed up discharges.

The resource is primarily aimed at commissioners and integrated care boards and will be continually updated with latest relevant guidance supporting NHS priorities.

We will continually update the resource with relevant guidance to support NHS priorities.

Virtual wards

Virtual wards (also known as hospital at home) provide hospital level care and monitoring outside of a hospital setting. 

The NHS has an ambition for virtual wards to expand the capacity of the acute care sector by managing people, who would otherwise be in hospital, remotely in their homes.

We recognise the potential benefits they have in releasing capacity. But we’re also aware of the challenges they may raise.

So in 2023, we launched a range of guidance and resources to help practitioners and commissioners implement this new model of care.

We've started by looking at the acute respiratory infection (ARI) pathway, aiming to help reduce pressure on the NHS over winter. We have since published a suite of guidance and resources to help manage ARI patients safely in their homes by implementing this new model of care.

Health inequalities 

Reducing health inequalities is part of NICE’s DNA. It’s one of our core principles.

The pandemic exposed the impact that health inequalities have on our society. They are caused by the conditions in which we are born, live, work and grow. These conditions influence how we think, feel and act and can affect both our physical and mental health and wellbeing.

Reducing health inequalities part of NICE’s DNA. It’s one of our core principles.

We have developed a programme of work on health inequalities, which embed the consideration of health inequalities in the production of our guidance. It also ensures NICE focuses its efforts on supporting the health and care system to reduce health inequalities, where it will have the highest impact.

Our health inequalities web resource, first launched in 2022, pulls together all our guidance and resources on the topic. The resource maps all our guidance onto existing health inequalities frameworks such as Core20PLUS5, and is regularly updated to include new guidelines.

Antimicrobial stewardship

Resistance to antimicrobials is complex and increasing. There is a growing risk that infections may not be treatable in the future, combined with a lack of new antimicrobial medicines.

Over the years, we have developed a suite of guidance that encourages the safe and effective use of antibiotics.

We published milestone guidance in 2022, that recommends 2 new antimicrobial drugs. The guidance followed a new subscription-style payment, model, developed with NHS England, that has been designed to try and address the lack of new antimicrobials being developed and the growing threat posed by antimicrobial resistance.

By using subscription contracts instead of paying for each dose used, this new NHS payment model aims to incentivise antimicrobial companies to develop new products, while also upholding the important principles of antimicrobial stewardship. It is an approach that seeks to limit the growth of resistant infections caused by an overuse of antimicrobials.

 For our users this will mean we are:

Focusing on what matters most

• We're developing more guidance that addresses major challenges to population health or the way the health and care system operates.
• We're aligning our methods between programmes to enable integrated guidance.
• We're building on our new NICE Advice service, which provides a single front door for early engagement with industry.

Providing useful and useable advice

• Faster guidance production across all NICE programmes.
• A new-look NICE website with easier navigation and clearer explanations of what we do.
• Guideline recommendations formatted in a way that makes it easier to read and easier to find what you’re looking for.

Constantly learning from data and implementation

• Developing a reproducible approach for automated monitoring of NICE guidance uptake, to enable implementation support and allow continuous evaluation.