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How NICE makes decisions

NICE makes decisions on whether a drug or treatment should be available on the NHS.

What decisions are based on

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

  • evidence - NICE reviews each treatment or new technique and bases their decision on the best available evidence
  • value for money - NICE looks at the Quality Adjusted Life Years (QALYs) to assess the benefit and quality of life a treatment will provide
  • input from experts - lay members and members from clinical practice, public health, social care and industry
  • public involvement - patients, carers, service users and the general public

Quality Adjusted Life Years (QALYs)

QALYs show the benefits that a treatment has. It measures it in the length of life, and quality of life you might have.

Quality of life includes:

  • how well you are
  • whether you can work
  • whether you can care for yourself

QALYs look at, for example, how well you can carry out your daily activities. That is with and without treatment. Also, how the treatment affects your pain and mental wellbeing.

Reviewing cancer treatments

NICE now aims to review new treatments and medical techniques more quickly. In the past, NICE didn't always review every new cancer treatment. Particularly those used for treating rare cancers. But from July 2016, NICE reviews all new treatments within 90 days of them getting a license.

All drugs need a licence before doctors can prescribe them on the NHS. With the new procedure, NICE can look at some drugs while they are still in the licensing stage. So, they don't have to wait until after they have received a license.

This means that NICE can publish a decision soon after a drug has received a license.

Using NICE guidance

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

Your local NHS has a maximum of 90 days to make the treatment available after NICE's publication.

With new guidance, the NHS and health professionals have to decide whether they:

  • already meet the requirements in the guidance
  • need to change the treatment and care they provide

Appeals

Patient organisations can comment on guidance during its development by NICE.

There is also an appeals process and those with an interest can appeal against a decision. NICE calls these interested parties stakeholders. You have to be a registered stakeholder to be able to appeal to NICE. There are rules about what can be appealed.

Wales, Scotland and Northern Ireland

There are different processes in the different countries of the United Kingdom.

The All Wales Medicines Strategy Group (AWMSG) is a group of:

  • specialist doctors
  • pharmacists
  • other health professionals
  • patients
  • drug company representatives

They decide on which medicines should be available within the NHS in Wales.

The AWMSG works with NICE. It doesn't usually review a medicine if NICE are planning to look at it within the next 12 months. Sometimes the AWMSG says that a medicine shouldn't be available. But later NICE decides it should be. In these situations, professionals will follow the NICE decision.

Healthcare Improvement Scotland (HIS) was set up in 2010. Its goal was to support the Scottish Government's Healthcare Strategy. It develops guidance for clinical practice and supports improvement in healthcare.

HIS has different groups. Each group has specific roles:

  • Scottish Intercollegiate Guidelines Network (SIGN) – develops guidelines on the treatment of conditions, such as cancer
  • Scottish Medicines Consortium (SMC) – advises the NHS Health Boards about medicines and makes sure people have the same access to treatment wherever they live

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

When NICE's guidance isn't relevant, or only partly relevant, the DHSSPS advises on any changes that needs to be made. The DHSSPS usually approves most NICE guidance.

Getting a drug before a NICE decision

Your doctor can't prescribe a drug for you:

  • while NICE is still looking at it
  • before they publish their decision

NICE doesn't licence drugs or new devices. The Medicines and Healthcare Products Regulatory Agency (MHRA) does this. The NHS then decides whether to prescribe a drug or device.

What to do if you can't get a drug

NICE decisions only tend to make the news when they turn a drug down. It's worth knowing that they approve most of the drugs they assess.

It's always best to talk to your specialist about your treatment first. There might be good reasons why you can't have a particular treatment.

NICE publishes versions of its decisions for the public. So you can read the guidance to check exactly who should have the drug or treatment. The guidance might say that you can have the drug only after another treatment hasn't worked. Or you can have it if another treatment is no longer working.

Things to consider include:

  • whether this is the best treatment for your cancer at this particular time
  • if there is any reason why you shouldn't have the treatment, for example, the side effects

Individual funding request (IFR)

Talk to your doctor if you think that a drug that NICE hasn't approved could help you. If your doctor agrees, they can make an individual funding request (IFR). They do the application to NHS England.

It will take some time and effort. People don't usually succeed in getting treatments funded this way.

You might also find it helpful to contact a patient organisation. They can often offer help and support. They may know of other people who have taken part in this process.

Cancer Drugs Fund

The Cancer Drugs Fund (CDF) has been part of the official NICE process since July 2016.

NICE can sometimes give new drugs a preliminary approval. This is when a drug shows promising results, but NICE needs more evidence about how well the drug works. The drug might be available from the CDF for a short period of time until NICE publishes the final approval.

You will need to go through your specialist, who makes the application to the CDF for you.

Patient Advice and Liaison Service (PALS)

You might have tried to access a treatment and had no success. Or you might believe you aren't getting the right treatment. In these situations, contact the patient support service in your local hospital. They may be able to help you.

  • In England contact the Patient Advice and Liaison Service (PALS)
  • In Scotland, contact the Patient Advice and Support Service (PASS)
  • In Northern Ireland, you can get in touch with the Patient and Client Council
  • In Wales, you can contact your local Community Health Council

You can also contact your local authority. They should provide (or commission locally) an independent advocacy service. This service covers the NHS, social care and mental health services.

Information and help