Top of page

Lymphoma drug development, approval and funding

This information outlines how new drugs are developed and approved, and who decides whether they can be made available to patients on the NHS.

On this page

Drug development

Health technology assessments

Funding for NHS use

Drug development

There are always lots of new drugs being developed to treat lymphoma, but it is a long and expensive process. It can be frustrating hearing about these new drugs when they are not yet available, especially if they could improve outcomes for people with lymphoma.  However, it’s important that all new drugs are thoroughly tested to make sure they are effective and as safe as possible to use. 

Each drug development process starts at the discovery of the drug and ends with the drug’s approval to be provided by the NHS. This process takes on average 10 to 15 years, and according to the Association of the British Pharmaceutical Industry (ABPI) can cost more than £1 billion. Of the thousands of drugs which start this process, only a few will pass all the checks.

The drug development process image as a pyramid

The drug development process, showing the number of potential drugs tested at each stage for every one drug that eventually gets approved (based on figures from the Association of the British Pharmaceutical Industry)

1. Pre-discovery and drug discovery

The first stage in drug development for lymphoma involves research to understand why lymphoma develops and what makes lymphoma cells different from healthy cells. This research can help to identify possible targets for a drug to act on. This could be a particular protein found on the surface of lymphoma cells, or a protein that stops your immune system recognising and destroying lymphoma cells.

With this information scientists then design or search for drugs that act on the targets they’ve identified. Thousands of possible drugs are tested in this way but only a few are successful enough to get to the next stage of testing.

2. Pre-clinical tests

Before a drug can be tested in humans, it is tested thoroughly in laboratories. This is done using computer modelling, cells and testing on animals. However this year the government agreed to increase funding for, and to create plans to reduce the number of animals used. These tests help find out how the drug works, what the potential side effects are, and how the drug is broken down by the body, to see what dose is the safest to start testing in people. If serious problems are found in pre-clinical tests, a drug won’t be developed any further.

3. Clinical trials

If a drug passes all the pre-clinical tests, it can start being tested in people. Drug tests involving people are called clinical trials. Only a very small proportion of drugs make it as far as clinical trials.

As part of my treatment I joined a clinical trial, which worked for me, and I was pleased to learn that my involvement and comments might also help other patients and researchers in future.

Michael, treated as part of a clinical trial for CLL

Clinical trials are organised in phases. There are four different phases. Early phase trials (phase 1 or 2) involve small numbers of people. They make sure the drug has few side effects, and find out the best dose to use. Later phase trials (phase 3 and 4) involve larger numbers of people and test whether or not a drug is effective. More is learnt about a drug as it goes through each phase. If a drug is not successful in one phase, it can’t go on to the next.

We have more detailed information about clinical trials, including how they work, how you can get involved in one and where you can find more information about current trials. 

The clinical trial testing process usually takes several years, although this varies depending on the drug and the type of lymphoma it is being tested for. Some drugs may not need to complete all phases of testing before they can go forward for approval. Drugs may be approved based on phase 2 data if the condition they are being developed for is rare, or there is a high unmet need. 

4. Licensing approval

If clinical trials are successful, the pharmaceutical company that produced the drug applies for it to be licensed (approved) for use. To do this, they have to provide evidence of the drug’s safety and that it provides benefits for people with lymphoma. This could be that it improves outcomes, has less side effects than current treatments, or comes in a more convenient format, for example a tablet rather than an injection.

Your doctor can usually only give you treatments that have been officially licensed (unless you are in a clinical trial). The licensing process is designed to keep you safe and to make sure you only have treatments that are likely to benefit you.

Drug companies have to apply to different legal authorities in different parts of the world.

Being licensed (approved) is not the same as being available on the NHS. Approval means a drug can legally be prescribed. Once it has been approved, a drug is assessed separately to decide whether or not it will be available on the NHS.

Back to top


Health technology assessments

Once a drug has had its licence approved, it is assessed by funding bodies in the UK to decide how well it works in relation to how much it costs. This is called a ‘health technology assessment’ (HTA). It is used to decide whether or not the drug should be made available on the NHS.

A HTA is a process that assesses whether a new treatment is clinically and cost effective. Clinical evidence shows how well the medicine or treatment works. Cost effectiveness shows how well it works in relation to how much it will cost the NHS, and whether it is good value for money.

In the UK, HTAs are conducted by independent organisations which are different depending on which part of the UK you live in. This can mean that some treatments are available in one nation, but not in another.

How does the process work

The HTA process differs slightly depending on the nation and organisation involved but they all follow the same general framework.

  1. Scoping
    The independent organisation develops a detailed document of what the HTA is aiming to assess. This is sent to both the drug company, and relevant stakeholders such as Lymphoma Action to comment on. It provides information on the current available treatments and the potential uses for the new drug.
  2. Gathering evidence
    Evidence is taken from everyone involved. This can include healthcare professionals, people affected by the condition the drug is approved for, patient representative groups (such as Lymphoma Action), drug companies and independent health economic groups.
  3. Reviewing the evidence
    A committee meeting formed of independent panel members is held to review this evidence. These panel members have a range of expertise that enables them to evaluate the clinical evidence and cost-effectiveness.  Stakeholders are invited to attend this meeting, and members of the public can observe. 
  4. Final recommendations
    Based on their findings the committee develops a final appraisal document detailing whether the new treatment has been approved for use or not. Stakeholders can appeal this decision.

How does Lymphoma Action get involved

Patient organisations such as Lymphoma Action play a vital part in HTAs. They are there to provide the patient voice. We can explain how the type of lymphoma impacts people and their family and friends, what it is like to receive the current treatment options and what impact the new treatment option could have. 

Once we have received notification of a new HTA we will reach out to our community, for example through social media, and ask them to answer a few simple questions. We will then use this information to write a document called a submission which we will send to the relevant independent organisation. This will be used as the evidence in support of a new treatment.

We sometimes also nominate a patient representative. This is someone with a lived experience of the condition. They will be asked to write a statement about their experience and will have an opportunity to speak at the committee meeting. Patients are involved in the HTA process because the patient voice is a crucial.

I agreed to take part in a technology appraisal because I wanted to see firsthand how the process worked. I knew of NICE and just how important their role is in making new treatments available on the NHS. Being involved in the NICE meeting was a fantastic opportunity. I feel that being at these meetings is one way in which I can make a difference. 

Frank, who took part in an HTA for mantle cell lymphoma

Listen to our podcast, Health Technology Assessment: NICE providing support to the NHS in the best way for the benefit of patients. In the podcast, Helen Knight, Director of Medicines and Evaluation at NICE talks about Health Technology Assessments and their role in making new treatments available through the NHS. 

Back to top


Funding for NHS use

Once a treatment has been licensed and approved for use the NHS is legally obliged to fund it, and must make sure it is available to patients living in the relevant UK nation within 3 months.

How can I find out if a drug is available for me?

Each nation in the UK has a different way of funding cancer drugs. The websites for each of the health and technology assessment bodies have up-to-date information on which drugs are recommended and which are currently being assessed.

  • If you live in England or Northern Ireland, visit the NICE website and search for the name of the drug you’d like to find out about. This will show you a list of assessments that are in progress as well as guidance that is already available.
  • If you live in Scotland, visit the SMC website and search for the name of the drug you’d like to find out about. This will show you a list of guidance that is already available.
  • If you live in Wales, visit the AWSMG website and search for the name of the drug you’d like to find out about. This will show you a list of assessments that are covered by NICE guidance and any separate assessments carried out by the AWSMG.
  • If you live in Northern Ireland, visit the technology appraisal section of the NI Department of Health website. This lists all the NICE guidance that has been approved in Northern Ireland.
  • You can also check our news section, where we report regularly on drug approvals and funding decisions for lymphoma treatments.

What if a drug I need isn’t available on the NHS?

First of all, talk to your consultant about what treatments are suitable for you. Even if a treatment has been approved for use in your type of lymphoma, it might not be right for you. Your consultant can give you advice based on your individual circumstances.

Occasionally, you might be able to access a treatment before it is available for routine use on the NHS. The main ways to do this are through the Cancer Drugs Fund or Early Access to Medicines Scheme. In exceptional circumstances, your consultant might be able to apply for individual funding on your behalf. However the criteria for this are very strict and it is only rarely successful. 

The Cancer Drugs Fund

For new cancer drugs, NICE sometimes decides that although clinical trial results are promising, there is not yet enough evidence to recommend it for routine use. In this case, they might decide to make it available for a limited time – usually 2 years – while more evidence is being collected. They can do this through an NHS England scheme called the Cancer Drugs Fund (CDF). At the end of the time limit, the drug is assessed by NICE again to decide if it should be funded routinely on the NHS.

There is a central list of drugs available on the CDF. It gives details of the criteria that must be met to access each drug. The list is regularly updated and drugs can be added or removed. If your consultant feels a drug on the CDF list is appropriate for you, they can apply for you to have it.

The CDF is not available in Scotland, Wales or Northern Ireland.

The Early Access to Medicines Scheme

The Early Access to Medicines Scheme (EAMS) is a UK-wide scheme run by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). It aims to give people with serious or life-threatening illnesses access to promising new drugs before they are licensed.

To be considered for the EAMS, a drug must have been tested in late phase clinical trials to find out if it is safe and effective and should be likely to offer a major advantage over the drugs that are currently available in the UK. The MHRA assesses the clinical trial results to decide whether the benefits of the drug are likely to outweigh the risks. If so, they can recommend a treatment for the EAMS.

There are only a few drugs on the EAMS list at any time, but drugs for people with lymphoma are sometimes available through the scheme. They may only be available for a short period of time (usually up to a year) prior to approval. If you are eligible for a drug that is on the EAMS list, talk to your consultant to help you decide if it is the right option for you.

If a drug on the EAMS list becomes licensed, it goes through the usual appraisal process to decide whether or not it should be routinely available on the NHS. It is then taken off the EAMS list.

Other ways to access drugs that aren’t available on the NHS

In exceptional circumstances, if your medical team think you need a treatment that is licensed but is not routinely available on the NHS, they might be able to make an individual funding request for you. Applications for individual funding are reviewed by an independent panel including medical experts and members of the public. The panel decides on an individual basis if the treatment should be funded. Individual funding requests can only be made if your medical team can show that your clinical situation is so different to other people with the same type of lymphoma that you should have your treatment paid for.

If a drug is approved for your type of lymphoma but you are not able to get it on the NHS, you may be able to organise funding from alternative sources. Macmillan Cancer Support and Cancer Research UK have information on these options.

Back to top

Further reading