How medicines become available on the NHS and HSC

Once a medicine has a licence, organisations will decide if it should be available as part of free healthcare. In England, Wales and Scotland, free healthcare is with the National Health Service (NHS). In Northern Ireland, this is called Health and Social Care (HSC). 

The organisations that make these decisions are:

• England - National Institute for Health and Care Excellence (NICE)

• Scotland - Scottish Medicines Consortium (SMC)

• Wales - All Wales Medicines Strategy Group (AWMSG)

• Northern Ireland - Department of Health, Social Services and Public Safety (DHSSPS)

National Institute for Health and Care Excellence (NICE)

NICE was set up by the Government to decide which treatments are available on the NHS in England. It aims to make sure that people have the same access to treatment wherever they live.

Their main responsibilities are to:

• assess new drugs and treatments as they become available

• provide guidelines on the treatment of particular conditions

• provide guidelines on how public health and social care services can support people

• provide information for those managing and providing health and social care

NICE considers whether a treatment will benefit patients. Also if it helps the NHS meet its targets, for example, by improving cancer survival rates. It also considers if a treatment is value for money or cost effective.

NICE will make one of 5 decisions about a treatment. This could be:

• recommended - the medicine should be routinely available 

• optimised – the medicine is only available for certain people with a condition

• recommended for use within the cancer drugs fund (CDF) - the medicine can become available via the CDF so that we can be sure it is effective 

• only in research – you can only have the medicine as part of a clinical trial, so researchers can collect more evidence about how well it works

• not recommended - the medicine should not be available 

Your local NHS has up to 90 days to make the treatment available after NICE publishes their decision.

Read more about the Cancer Drugs Fund (CDF)

Scottish Medicines Consortium (SMC)

The SMC advises the NHS Health Boards about medicines in Scotland.

The SMC aims to make sure that people have the same access to treatment wherever they live in Scotland. It assesses how well each new medicine works and how cost effective it is. It looks at all medicines as they are licensed and decides:

• which patients would benefit from them

• whether they should be available on the NHS in Scotland

The SMC will make a recommendation on the medicine:

• accepted – the medicine should be routinely available

• accepted with restrictions - the medicine might only be available for some people with a condition

• accepted on an interim basis - the medicine is available for a limited time so there is more time to collect evidence about how well it works

• not recommended – the medicine should not be available 

Once the SMC makes a decision, the NHS boards in Scotland take this into account. The NHS boards are then expected to make this medicine, or an equivalent, available to patients.

Doctors can use their clinical judgement. Sometimes a medicine isn’t recommended by the SMC, but your doctor might think it is right for you. Your doctor can ask the NHS board to consider this.

All Wales Medicines Strategy Group (AWMSG)

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

They work with NICE. They don'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.

Department of Health, Social Services and Public Safety (DHSSPS)

The DHSSPS in Northern Ireland works with NICE. 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.

How they make decisions

Decisions on whether a medicine or treatment should be available on the NHS or HSC are based on:

• evidence – committees review the evidence for each treatment or new technique 

• value – your quality of life and how much longer you could live using the medicine. This is called Quality Adjusted Life Years (QALYs)

• 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, with or without the new treatment.

Quality of life includes:

• how well you are, including pain and mental wellbeing

• whether you can work or carry out your usual daily activities

• whether you can care for yourself

Who makes the decision?

When making decisions, organisations ask for expert advice from:

• medical, health and social care professionals

• patients, carers and members of the public

• NHS or HSC organisations and health boards

• pharmaceutical industry

• social care businesses

• local government

Appeals

Each organisation has an appeal process if the medicine isn’t made available on the NHS or HSC. They each have slightly different rules about how you can appeal.

Getting a medicine before a decision

Your doctor can't usually prescribe a drug for you:

• while it is still under review

• before they publish their decision

The Medicines and Healthcare Products Regulatory Agency (MHRA) licenses medicines. Very rarely, it is possible to access medicines that aren’t licensed yet through schemes, such as the early access to medicines scheme (EAMS).

Read more about the Early Access to Medicines Scheme (EAMS)

What to do if you can't get a medicine

All of the organisations publish versions of their 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.

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.

Things your specialist will 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

If your specialist thinks that a treatment could benefit you but it isn’t available on the NHS or HSC, there might be other ways to access it.

Read about ways to access treatment

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 Llais

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