What is NICE and how does it work?

This page explains the work of the National Institute for Health and Care Excellence (NICE). There is information about

What NICE is
What NICE does
How NICE works
How NICE makes a decision
Wales

Scotland and Northern Ireland
Appeals
Getting drugs before a NICE decision
What to do if you can't get a drug
The cancer drugs fund

NICE stands for The National Institute for Health and Care Excellence. It is an independent organisation, and was set up by the Government in 1999. NICE decides which drugs and treatments are available on the NHS in England and Wales. The All Wales Medicines Strategy Group also makes some decisions for the NHS in Wales. Generally they follow NICE decisions. Scotland and Northern Ireland have separate organisations to make decisions.

The government developed NICE to get rid of the post code lottery, in which some drugs and treatments were available in some parts of the country, but not in others. NICE aims to give independent advice about which treatments should be available on the NHS in England and Wales. And to make sure that people have the same access to treatment and care wherever they live.

NICE’s main functions are

To assess new drugs and treatments as they become available
To provide evidence based guidelines on how particular conditions should be treated
To provide information services for those managing and providing health and social care

NICE considers whether a treatment

Benefits patients
Will help the NHS meet its targets, for example by improving cancer survival rates
Is value for money, or cost effective

Once NICE issues its guidance, NHS trusts must find the money to make those drugs or treatments available. NICE doesn’t give any extra money, or advise on how to find the money.

When making decisions, NICE asks for expert advice from

Medical and other health professionals
Patients and patient organisations
Drug companies

The Department of Health (DH) for England and the National Assembly for Wales (NAW) decide which topics NICE will look at. Anyone can suggest a topic for NICE. You just need to fill out a form on the NICE website in the suggest a topic section. You can complete the form online, or print and post it.

Making a suggestion doesn’t mean that NICE will look at it. The DH has guidelines to help them decide which topics to choose.

NICE divides its guidance into 4 main areas

Health technology – specific medicines, treatments and procedures
Clinical practice – how doctors and nurses should treat diseases and conditions
Public health – preventing illness and health promotion
Quality standards – statements designed to drive quality improvements within a particular area of care

NICE make decisions on whether a drug or treatment should be available based on

Evidence – NICE reviews each treatment or new technique
Cost effectiveness – including the quality-of-life-adjusted-year (QALY)
Contributions from patient organisations, health professionals, experts, and other interested parties

A QALY is a tool that takes into account how a treatment affects

Quantity of life
Quality of life

Quantity of life means how long someone lives for. Quality of life is more about how the treatment affects you. It includes

How well you are
Whether you can work
Whether you can care for yourself

Unfortunately, NICE decisions only tend to make the news if they turn a drug down. It's worth knowing that they approve the majority of drugs they assess. Since they started, NICE has approved 7 out of 10 (70%) of the cancer drugs it has assessed.

NICE now has a fast track procedure, which aims to make reviews of new treatments and medical techniques available more quickly. All drugs need a licence before doctors can prescribe them on the NHS. With the fast track procedure, NICE can look at some drugs while they are still in the licensing stage, rather than waiting until after they are licensed. This means that NICE can make a decision very quickly after the drug has been licensed. You can find out more about how drugs are licensed in our cancer treatment questions.

The NHS should use NICE guidance as soon as it is published. Your doctors will still use their knowledge and skills to decide the best treatment for you.

Your local area NHS should find the money to fund technology guidance usually within 3 months of NICE issuing guidance.

When NICE issues clinical practice guidance, the NHS and health professionals will need to decide if they are already meeting the requirements in the guidance, or need to change the treatment and care that they provide.

In Wales the All Wales Medicines Strategy Group (AWMSG) also make decisions about which medicines should be available within the NHS in Wales. Like NICE, the AWMSG is a group of specialist doctors, pharmacists, patient representatives, pharmaceutical company representatives and other health care professionals. The AWMSG work with NICE and don’t usually review a medicine if NICE are planning to look at the medicine in the next 12 months. The guidance the AWMSG issues is interim to NICE guidance. This means that if the AWMSG say that a medicine should not be available and NICE decides it should then the NICE decision is the one that is followed.

There are slightly different processes in Scotland and Northern Ireland.

Scotland
Northern Ireland

Scotland

In Scotland the following organisations perform a similar function to NICE

The NHS Quality Improvement for Scotland carries out technology appraisals
The Scottish Intercollegiate Guidelines Network (SIGN) provides clinical guidelines
The Scottish Medicines Consortium (SMC) gives immediate advice on new medicines when they become available

NHS Quality Improvement for Scotland

This organisation provides Health Technology Appraisals for Scotland. Like NICE, they gather evidence and contributions from patient organisations and experts to make a decision about a particular topic.

Scottish Intercollegiate Guidelines Network (SIGN)

The members of this network include patients and their carers, health professionals and other professionals involved in caring for people, such as social workers and managers. SIGN aims to improve the quality of health care for people in Scotland by making sure everyone gets the same, good standard of care.

Northern Ireland

The Department of Health, Social Services and Public Safety (HPSS) in Northern Ireland agreed in July 2006 to link to NICE. This means that they will look at any guidance issued by NICE and decide if it is relevant for Northern Ireland.

If NICE’s guidance isn’t relevant, or if the HPSS decide it’s only partly relevant, they will advise on any changes that need to be made. The HPSS are likely to approve most NICE guidance. The Department usually makes a decision shortly after NICE has made their decision.

Patient organisations can comment on a piece of guidance while NICE are still developing it. There is also an appeals process and those with an interest can appeal against a decision. NICE call these interested parties stakeholders.

Stakeholders include

Patient organisations
Health professionals
Companies that make any of the treatments for that particular condition
Health service providers
Statutory organisations, such as the Department of Health and National Assembly for Wales

You have to be a registered stakeholder to be able to appeal to NICE.

Your doctor can prescribe a drug for you while NICE are looking at it if your local NHS clinical commissioning group agrees that they can. Once NICE makes a decision, it replaces any decision made locally.

NICE don’t licence drugs or new devices. The Medicines and Healthcare products Regulatory Agency (MHRA) does this. Your local NHS decides whether a drug or device should be prescribed. NICE looks at them

If there is uncertainty about whether they should be prescribed
To ensure you have access to treatment and care wherever you live

You may be able to get funding for a drug that NICE hasn't yet assessed through the cancer drugs fund. There is more about the cancer drugs fund below.

First, it's always best to talk to your specialist about your treatment. There may be good reasons why you aren’t having a particular treatment.

If it's a drug that NICE have approved, read the guidance to check exactly who it says should have the drug or treatment. It may be that the guidance says that you should have the drug only after another treatment has not worked, or is no longer working. NICE writes versions of their decisions for the public, which can be easier to read. You can find them on the NICE website.

Points to consider include

Is this the best treatment for your cancer at this particular time?
Are there any reasons why you shouldn’t have the treatment, for example side effects?

If it is a drug that NICE have not approved, you need to talk to your specialist about it. If your doctor agrees that the treatment would help to control your cancer, they can make an individual funding request application to your local clinical commissioning group (CCG). The CCGs have some money set aside for these claims. It will probably take some time and effort, but people do sometimes succeed in getting treatments funded this way. Or your doctor can apply to the cancer drugs fund. You may also find it helpful to contact a patient organisation, as they can often offer help and support. They may know of other people who have gone down this route.

You may be able to get funding from the Government's cancer drugs fund. The aim of the fund is to cover treatment costs for patients for drugs that have not yet been approved by NICE. You will have to go through your own specialist, who will make an application for you.

After doing all this, if you still believe you aren’t getting the right treatment, contact the Patient Advice and Liaison Service (PALS). There will be one within your local hospital. They may be able to help you resolve the problem. If it still isn’t sorted out, you can contact your local authority. From April 2013, they should either provide or commission locally an independent advocacy service which covers the NHS as well as social care and mental health services.