New wave of radioligand therapy triggers Belgium to launch action plan [Advocacy Lab Content]

A new wave of radioligand therapies is approaching. With healthcare systems and policymakers ill-equipped to handle the change, Belgium is launching an action plan.

International stakeholders and countries have already expressed interest in expanding this initiative to other European member states.

Radioligand therapy (RLT) is an emerging cancer treatment targeting cancer cells throughout the body while sparing healthy ones. Europe faces challenges integrating RLT into its healthcare systems, with accessibility not keeping pace with innovation and risking unrealised potential without the necessary infrastructure, resources, and policies.

The radioligand therapy action plan collaboratively developed by multiple stakeholders in Belgium, offers a solution-oriented framework. Its primary goal is to overcome current barriers and improve patient access to these innovative therapies. The plan, presented during a press conference this week, outlines 24 specific actions, each addressing RLT challenges head-on.

During its presidency of the Council of the European Union, Belgium championed radiopharmaceuticals’ future.

Ingrid Maes, Managing Director of consultancy firm Inovigate, told Euractiv that the action plan’s timing aligns with the recent presidency’s focus on RLT. Belgium serves as a pilot, providing a blueprint for other European countries to follow.

Jan Bertels, Chief of Staff to outgoing Minister of Social Affairs and Public Health Frank Vandenbroucke, stated the importance of exploring and supporting innovative techniques and called for collaboration among stakeholders.

Navigating RLT challenges

RLT presents unique hurdles for healthcare systems to navigate as the therapies themselves are new to cancer and have special requirements that differ from those of the currently available treatments.

Patients require specialised treatment environments, necessitating careful planning and capacity allocation. Additionally, patient access and reimbursement remain complex issues.

In advocating for value-based pricing, Maes considers the societal impact of RLT – patients regaining quality of life. She underscores that Belgium’s healthcare system faces uncharted territory.

Policymakers often lack in-depth knowledge of healthcare systems, especially when assessing the importance of complex innovations. “These multifaceted advancements demand expertise not only in the specific innovation but also in navigating the intricacies of the healthcare system,” Maes told Euractiv.

“To expedite progress, we have actively engaged with political parties, ensuring that these critical topics find their place in policy agreements.”

A 2020 report in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) already highlighted barriers, including low awareness and understanding of RLT among decision-makers.

Novartis is ahead in RLT development

Novartis has been leading the way in RLT for advanced cancers, with the European Commission approving its first targeted RLT for gastroenteropancreatic neuroendocrine tumours (GEP-NETs) and the first treatment for prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).

Belgium stands as the first European country where these treatments are reimbursed.

Jasminka Taleska, Director of RLT HCS Readiness and Policy at Novartis, underscored to Euractiv the importance of overcoming hurdles to unlock the benefits of groundbreaking innovations like RLT.

“The application of RLT in cancer is endless, and Novartis is actively investigating its potential with two RLTs approved for use, ten assets in clinical development and over 15 clinical studies. Currently, RLT is poorly recognised in policy frameworks so there is work to be done to create common understanding and commitment around how to use this innovation in appropriate settings,” she said.

Christophe Deroose, Professor of Nuclear Medicine at the Belgian university hospital, UZ Leuven, and co-author of the Belgian action plan, highlights the plan’s significant impact on disease progression, symptom management and patient longevity.

“Our mission with the action plan is to make radiopharmaceuticals available to all cancer patients within the next 5 to 15 years, backed by evidence and reimbursement,” said Professor Deroose.

Balancing benefits and challenges

Eric Briers, a patient and Vice-Chair of Europa Uomo, emphasises the urgency of addressing advanced prostate cancer. Since 2014, diagnoses have surged by 50%, often leading to painful deaths due to bone metastases. RLT offers hope, potentially extending life by four months and alleviating pain for approximately 1,600 patients in advanced stages.

Briers explained that “The potential benefits of RLT often outweigh the initial fear associated with nuclear medicine.”

These therapies involve attaching radioactive atoms to cells with specific markers, allowing for targeted action. Despite potential side effects, they are generally less severe than those of other therapies, complementing rather than replacing existing treatments such as hormone therapy and chemotherapy.

A last resort

Currently, RLT is permitted only for patients with advanced cancers and is not authorised for early-stage metastasis or localised disease due to a lack of clinical evidence.

Nevertheless, ongoing research aims to expand its applicability into earlier lines of treatment and disease stages, with the hope that it can eventually be administered earlier with better results.

RLT, costing approximately €80,000, is not offered by the UK’s National Institute for Health and Care Excellence (NICE) due to cost and limited survival benefits. However, it is available privately in England for those who can afford it. Briers voices his concern and disagrees with creating a situation where only a privileged few can afford this treatment.

“This development is significant because it offers patients in the final stages of their lives a chance to have a few extra months with decent quality of life,” Briers adds. “Additionally, it encourages further research into other cancers.”

[By Nicole Verbeeck, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

Read more with Euractiv