1. What does it mean if a drug is licensed?
2. How do new drugs get approved for routine use on the NHS?
3. How do I know which drug treatments I can have?
4. How can I access drug treatments that are not routinely available on the NHS?
5. What is an early access scheme?
6. What is a compassionate access scheme?
7. Why can’t I access a new drug treatment?

What does it mean if a drug is licensed?

New cancer drugs can only be widely used in the UK if they have been given a licence.

To get a licence a drug treatment must have been thoroughly tested to show it is effective and safe to use. The licence will confirm what the drug can be given for and the dose that should be used.

However, having a licence does not mean a drug will automatically be available on the NHS. It will need to be assessed for use on the NHS by the National Institute for Health and Care Excellence (NICE) or the Scottish Medicines Consortium (SMC).

How do new drugs get approved for routine use on the NHS?

Before new cancer drugs are made available on the NHS they need to be assessed and approved by the relevant organisation for England, Scotland, Wales and Northern Ireland.

England

In England, NICE produces guidance about which drugs should be 
available on the NHS.

NICE looks at how effective a drug is and whether it’s cost effective.

Based on its assessment, NICE can:

  • Recommend the drug for routine use on the NHS
  • Not recommend the drug for use on the NHS
  • Recommend the drug be made available through the Cancer Drugs Fund  

If NICE recommends a drug for use on the NHS, it should be made available within 2 months.

Wales

In Wales, all drugs recommended by NICE should be made available on the NHS within 2 months.

The All Wales Medicines Strategy Group (AWMSG) can make recommendations about drugs that have not been assessed by NICE.

Scotland

In Scotland, the SMC makes decisions on the use of drugs on the NHS. Like NICE, it looks at how effective a drug is and whether it’s cost effective.

SMC can make one of the following decisions about a drug:

  • Accept the new drug
  • Accept with a restriction – for example, the drug can only be recommended in a particular group of patients with a condition
  • Accept on a temporary basis – the drug will have ongoing reviews
  • Not recommend the drug

If SMC accepts a new drug, NHS boards are expected to make it available.

Northern Ireland
Northern Ireland usually follows NICE decisions.

 

How do I know which drug treatments I can have?

Your treatment team will discuss your treatment options with you. If they think a new treatment will benefit you but it’s not available on the NHS, there may be other ways to access it.

How can I access drug treatments that are not routinely available on the NHS?

The Cancer Drugs Fund (CDF)

The Cancer Drugs Fund (CDF) gives people in England early access to new cancer drugs not yet routinely available on the NHS. This may include drugs to treat primary and secondary breast cancer.

When a drug is available on the CDF more information is collected to see whether it can be made routinely available on the NHS.

After around two years on the CDF, NICE will review the drug and will make a final decision on its use.

While the CDF covers England, the drugs on the fund also benefit people in Wales and Northern Ireland.

Private treatment

If you have private health insurance, it may cover the cost of some drugs.

You may want to find out if you can pay for a treatment privately (self-fund). Private cancer treatment is usually very expensive. Speak to your treatment if you want to explore self-funding.

Find out more about private treatment on the Cancer Research UK website.  

Clinical trials

Find out more about clinical trials for breast cancer.

Individual funding

You may be able to access treatment through individual funding. Individual funding is different in England, Wales, Scotland and Northern Ireland.

Find out more about individual funding on the Cancer Research UK website.

What is an early access scheme?

In some cases drug companies provide treatments free of charge. This may be:

  • While the drug is waiting for a licence
  • After a drug has been given a licence, but a decision has not been made on its use on the NHS

This is called early access. You may also hear it referred to as an expanded access, managed access or pre-reimbursement scheme.

Speak to your treatment team if you think you may be eligible for a new drug treatment. They can contact the medical team at the drug company.

What is a compassionate access scheme?

Drug companies may sometimes provide a drug that is not yet licensed for a particular group of people. It may be provided if other treatments are not available or have already been tried. This is called compassionate access.

Speak to your treatment team if you think you’re eligible. They can contact the medical team at the drug company.

Why can’t I access a new drug treatment?

You may hear about new drug treatments and want to know why you’re not being given them.

It may be for one of the following reasons:

  • The drug can only be used for breast cancers with certain features
  • The drug can only be used in specific circumstances based on the available evidence – for example it can only be used at a certain time or following another type of treatment
  • There may be other routine drugs that can be used first
  • It’s not been approved for use on the NHS  

Everyone’s treatment plan is based on individual circumstances. Speak to your treatment team if you’re unsure about what drug treatments you can have or whether there are any clinical trials you can take part in.

Last reviewed: December 2022
Next planned review begins 2024