Radiopharmaceuticals Patient Advocacy Toolkit

Cancer care has advanced a lot over the years, but some people still do not have access to the most effective diagnosis and treatment options. Radiopharmaceuticals are cancer diagnostics and treatments that administer radioactive material internally. They are a type of theranostic, which means they can be used for both the diagnosis (i.e. imaging and staging) and treatment of cancer and other diseases.

The availability of radiopharmaceuticals varies depending on where you live. Low availability may be due to:

• limited numbers of healthcare professionals and a lack of trained specialists
• a lack of facilities (such as scanners or radiation-safe rooms) to administer radiopharmaceuticals
• an inconsistent supply of radioisotopes (a type of chemical element that releases radiation as it breaks down and becomes more stable).

Many people know very little about radiopharmaceuticals. Some people may have negative ideas about them because they contain radioactive materials, but radiopharmaceuticals have relatively low toxicity and are widely used. For example, about 40 million procedures are performed every year using technetium-99, a radioactive isotope commonly used in radiopharmaceuticals.

We have developed this toolkit for patient advocates, to help you better understand what radiopharmaceuticals are and how you can help advocate for more equitable access to these diagnostics and therapies where you live. We hope the toolkit can play a role in ensuring all people who could benefit from radiopharmaceuticals have access to them as part of their cancer care.

The toolkit is for patient advocates and patient organisations working in areas where radiopharmaceuticals are a cancer management option. It is for people who want to know more about radiopharmaceuticals and learn how to advocate for their appropriate use.

The toolkit is divided into three sections:

• Radiopharmaceuticals: the basics. This is an overview of what radiopharmaceuticals are, how they work and who can receive them. You may find that this section helps you explain radiopharmaceuticals to people with cancer and their families, as well as policymakers.
• How to advocate for more equitable access to radiopharmaceuticals. This section suggests how patient advocates can help overcome some of the barriers to optimal use of radiopharmaceuticals. It includes case studies of how various patient organisations around the world have done this.
• Radiopharmaceuticals frequently asked questions (FAQs). This section offers answers to some common questions that people ask about radiopharmaceuticals.

Radiopharmaceuticals work by using radioisotopes to image, diagnose and treat a variety of diseases. In all instances, the radioactive isotope gathers in certain cells in the body. Depending on the radiopharmaceutical, the radioisotope may naturally gather in those cells, or it may be directed to them by an accompanying targeting molecule. This gathering of isotopes is used for the following:

• Imaging and diagnosis: The concentration of radiation in one area aids the detection of cancer using imaging such as PET, SPECT and gamma scans.
• Treatment and symptom management: The gathering of radioisotopes in sites with cancer cells, whether it occurs naturally or with a targeted molecule, allows radiation to disrupt or destroy them. This is a targeted approach as the radiation mostly impacts cancer cells rather than affecting healthy tissue.

Radiopharmaceuticals are the latest development in a long history of radiation-based therapies. Radioiodine was first used to treat thyroid cancer in the 1940s, and later evolutions included radiotherapy. Imaging using radiopharmaceuticals was then developed in the 1950s, when it involved the administration of sodium iodine to image brain tumours. PET imaging, which allowed for full body internal imaging, followed in the 1970s.

A wide range of radiopharmaceuticals is available. Technetium-99m is the most commonly used radioisotope, often serving as a radiopharmaceutical in PET scans. Radium-223 chloride was one of the first radiopharmaceuticals to be approved for targeted cancer treatment. This video shows how radioligand therapy, another type of radiopharmaceutical, works.

Once they have gone through clinical trials, all new radiopharmaceuticals must be licensed (authorised) for use by an appropriate regulatory body (such as the FDA in the US, the EMA in Europe, and the MHRA in the UK) before they can be provided in routine clinical care. The relevant national health system or health insurance system also needs to agree to fund the radiopharmaceutical, and it should be included in clinical guidelines. The process for a radiopharmaceutical being approved, funded and recommended is different in every country, but it generally looks like this:

The possibility of radiopharmaceuticals being available to you depends on whether they have been approved where you live and whether their administration is funded.

To receive a radiopharmaceutical, a person needs to be seen by a physician who has been specially trained to administer nuclear medicine or radiation-based theranostics.

The pathway by which the person will reach this expert and receive treatment will depend on the set-up of services available locally, and many people will be given tests or treatments before radiopharmaceuticals are used. However, when radiopharmaceuticals are considered, most people will follow a broadly standard pathway:

All medical treatments carry risks. With radiopharmaceuticals, a specific consideration is that they contain radioactive material. International guidelines exist to guide the administration of nuclear medicine to ensure safety and minimise the risk of exposure to radioactivity for healthcare professionals, patients and the general public.

Your doctor will discuss with you the risks associated with radiation before you start your treatment. There will also be ongoing monitoring to ensure that you are not exposed to dangerous levels of radiation.

You can learn more about the risks of exposure to radiopharmaceuticals in the FAQs.

The decision about whether a radiopharmaceutical is appropriate for cancer diagnosis and treatment will depend on each individual patient. It should ideally be discussed by a multidisciplinary team that includes a healthcare professional with appropriate training in nuclear or radiation-based treatments and diagnostics.

Radiopharmaceuticals are an important part of cancer care, but certain barriers stand in the way of patient access. Patient advocacy organisations have a huge role in helping overcome these barriers.

We have put together some suggested advocacy activities for organisations to help improve access to radiopharmaceuticals for people who could benefit from them. Every health system works in a different way, so these activities will need to be tailored to your local healthcare environment. Setting clear, realistic goals and timelines for what you want to achieve can help ensure the success of advocacy activities.

The size and capacity of your organisation will influence which activities you can undertake. In general, we recommend that:

• smaller patient organisations focus on supporting patients directly, offering information and guidance on radiopharmaceuticals; share information where possible; and build relationships with other organisations
• larger patient organisations create broader advocacy campaigns and engage with decision-makers, with the aim of improving both legislation around radiopharmaceuticals and access to them for people with cancer.

Increasing the understanding and awareness of radiopharmaceuticals will help ensure that people who may benefit from them understand how they work and how they differ from other types of cancer care. It will also help people make informed decisions about whether radiopharmaceuticals are the best approach for them, based on their evaluation of the potential risks and benefits.

When developing information materials, look at clinical practice guidelines to see how radiopharmaceuticals are described. Guidelines you may wish to look at include those written by: National Comprehensive Cancer Network, European Society for Medical Oncology, European Association of Urology, European Neuroendocrine Tumor Society, North American Neuroendocrine Tumor Society, British Nuclear Medicine Society, European Association of Nuclear Medicine and Society of Nuclear Medicine & Molecular Imaging.

A patient is usually referred for disease management with radiopharmaceuticals by their primary clinician, such as an oncologist, endocrinologist, urologist or gastroenterologist. This means that these clinicians need to be aware of radiopharmaceuticals.

The administration of radiopharmaceuticals requires a multidisciplinary team featuring a range of specifically trained staff. However, there is a shortage of specialists trained in the provision of radiopharmaceuticals, and existing care teams are often working using outdated care plans. This puts a limit on the extent to which radiopharmaceuticals and nuclear medicine can be integrated into cancer care.

For large-scale change to happen, politicians, healthcare leaders and decision-makers need to be aware of radiopharmaceuticals and their potential benefits.

When engaging with policymakers, it’s important to know your topic in detail, prepare answers to the key questions that you are likely to be asked and establish relationships with your locally elected leaders.

When campaigning for legislative change, finding a ‘champion’ for your cause can make a huge difference in raising awareness, building public interest and putting your issue in front of policymakers. This champion could be an expert clinician, a doctor who is in the public eye, a politician, a celebrity with a personal connection to the issue, or a patient (or patient representative) who can eloquently present the issues and lived experience.

Limited data are available on the use of radiopharmaceuticals, from both a clinical and an economic perspective. This makes it difficult to plan the ‘best’ way to deliver care and has led to variations in how radiopharmaceuticals are delivered in different countries.

Making sure we have representative data about how many people are eligible to be treated with radiopharmaceuticals, how many are actually receiving them and how many healthcare professionals are available to administer them can help health system leaders understand the evolving demand for the approach and identify any gaps in workforce and technical capacity. They can then use these data to find sustainable ways to invest in radiopharmaceuticals and make informed plans about how to appropriately allocate resources across different locations to ensure equitable access.

Investing in real-world data will largely be a job for the research community and the life sciences industry, but there is still a role for patient advocates.