Despite recommendations from the European Society for Medical Oncology and the EU Beating Cancer Plan, uptake of next-generation sequencing (NGS) in lung cancer remains slow and inequitable across Europe.^[i]

In the first report of its kind, experts highlight action needed to correct disparity in access to a gold-standard diagnostic technology that could benefit tens of thousands of lung cancer patients across Europe every year.

Takeda and the Office of Health Economics (OHE) have announced the launch of a landmark report investigating the case for improving uptake of next-generation sequencing (NGS) for lung cancer in Europe.[ii] The report, developed by OHE and Takeda with input from an expert advisory panel, highlights the life-changing potential of NGS in lung cancer, alongside compelling evidence of the long-term value it could offer to health services and Governments.

At present, despite recommendations from leading professional organizations such as the European Society for Medical Oncology (ESMO) and inclusion as a flagship initiative within the EU Beating Cancer Plan, NGS uptake across Europe is highly varied.i In countries where it is accessible, its use is commonly limited to expert centers. Expanding its use through the endorsed recommendations in this report could potentially help tens of thousands more people across Europe access comprehensive genetic testing over the coming years. In doing so, it should be possible to significantly reduce health service inefficiencies and ensure patients receive the most effective care possible – that is uniquely tailored to their cancer type – whilst minimizing unnecessary exposure to treatments that may not work for them.

“Understanding the genetics of cancer has never been more important, and lung cancer is one of the clearest examples of just how powerful this knowledge can be,” said Stephanie Jagger, franchise head solid tumors, Takeda Europe and Canada. “Understanding the driver of the cancer through NGS is the bedrock of this principle; however, the slow and inequitable uptake of this technology across Europe is of real concern. In many cases this means that valuable resources are being wasted on providing care that may be ineffective or inappropriate. For health systems struggling to find efficiencies, this is less than ideal. Moreover, patients living with lung cancer could be missing out on vital care, whilst also receiving treatments that are not as effective for their cancer type. The findings of this report reinforce the urgency with which we must act and provides a path forward. Working collectively, our belief is that if we act now, NGS can become a routine part of care, so that health systems, patients, and societies across Europe benefit.”

Lung cancer is commonly associated with a large number of gene mutations. Some can help healthcare professionals better predict the prognosis of a patient’s lung cancer, and present potential targets for precision treatment.[iii] NGS is a diagnostic tool used to identify these gene mutations, commonly referred to as ‘biomarkers’. It differs significantly from single-gene testing (SGT) as it simultaneously tests and characterizes the nucleic acid sequences of hundreds or thousands of genes using much smaller amounts of tissue sample.[iv] By using this one-stop approach, NGS can often be performed at a relatively lower cost than SGT. In part, this is because it reduces the need for patients to undergo multiple invasive surgical procedures to obtain tumor tissue.ii

“Next Generation Sequencing (NGS) is now an essential tool for identifying the genetic abnormalities that drive the growth of many cancers and lung cancer is a standout example of where it can radically improve the care a patient receives,” said John Gosney, Professor of Thoracic Pathology at the Royal Liverpool University Hospital, Liverpool, UK. “The problem is that, too often, the investment and infrastructure this technology requires to be effective is not being prioritized. The result is that we have seriously ill cancer patients potentially missing out on life-extending therapies or even receiving treatments that might be inappropriate for their individual tumor. It is now several years since key guidelines recommended NGS for the detailed analysis required for the treatment of cancer but, in many parts of Europe, progress has been slow. For the benefit of all patients with cancer, it is crucial that we keep pace with the science.”

The report: ‘The case for expanding uptake of next-generation sequencing for lung cancer in Europe’, was developed by OHE with funding and support from Takeda. Content and recommendations were informed by an independent advisory panel with expertise in pathology, oncology, genomics, patient advocacy, and health economics.ii

Key findings included:

• The clinical value of NGS is widely recognized and has a robust evidence base, particularly in non-small cell lung cancer (NSCLC).
• The cost and efficiency of NGS constitutes a strong case for investment; evidence suggests that NGS testing can be cost-saving over sequential SGT and avoid inefficiency in health care delivery.
• NGS generates value beyond the usual parameters assessed by health authorities who assess medicines. These benefits may be realized both by patients as well as many functions across health systems.
   

The report includes recommendations to address the barriers identified under the following headings:

• Inclusion of NGS for lung cancer in national minimal care provision
• Reimbursement of NGS testing according to its value
• Adoption of national standards for sample analysis and reporting
• Development of local clinical guidelines
• The rollout of national initiatives to map referral pathways
• Introduction of national education and awareness programs
   

“Our research clearly shows the clinical efficacy and technical superiority of NGS over alternatives such as polymerase chain reaction (PCR) and single-gene testing,” said Professor Lotte Steuten, Deputy CEO at OHE and co-author of the report. “This is the cornerstone of the case for expanding its use in lung cancer. Coupled with potential efficiency savings and a chance to improve patient outcomes, the case for investing in NGS strengthens. For the first time, we have a clear, credible, and practical route forward. Our hope is that, across the lung cancer community, this will prompt greater scrutiny of the barriers to NGS use, so that steps are taken to break them down.”

Lung cancer is one of the most common cancers in Europe, with around 318,000 cases diagnosed in 2020.[v] In the same year, it was also the leading cause of cancer death, claiming around 257,000 lives in Europe.v Approximately 80-85% of lung cancer diagnoses (over 270,000 people) will be NSCLC.[vi] In NSCLC, research shows that almost 70% of patients will have specific genes and mutations that act as cancer drivers, and who may therefore benefit from genetic testing.vi In just NSCLC, in the EU this would equate to nearly 190,000 people.vi However, at present multi-biomarker testing uptake varies across countries in Europe, from around 0% to around 75%. If it was routinely accessible for a majority of patients, it is likely that many tens of thousands more would have biomarkers identified.[vii] The benefit of identifying such biomarkers includes the ability to consider the option of precision treatment that targets that specific gene (or gene mutation).

Over the past 20 years, innovative targeted treatments and diagnostics have ushered in a new era of precision oncology and several treatments are now licensed that target specific gene mutations in lung cancer. In NSCLC specifically, therapies that target specific biomarkers have been suggested to be two- to three-times more effective than standard chemotherapy.[viii] Across small cell and NSCLC, there are currently around 34 known biomarkers that may influence patient care and it is anticipated that more are likely to be discovered as knowledge and technical capabilities in genetic sequencing continue to improve.[ix],[x]

Access the full report via the Office of Health Economics website

About the report

The report was developed by the Office of Health Economics (OHE) in collaboration with Takeda and is supported by input from an expert advisory panel. Panel members included Alfonso Aguaron, Davide Croce, Javier de Castro, Marc Denis, John Gosney, Alastair Greystoke, Frederique Penault-Llorca, and Entela Xoxi who provided their independent experience and knowledge.

About OHE

With over 60 years of expertise, the Office of Health Economics (OHE) is the world’s oldest independent health economics research organisation. Every day we work to improve health care through pioneering and innovative research, analysis, and education.

As a global thought leader and publisher in the economics of health, health care, and life sciences, we partner with Universities, Government, health systems and the pharmaceutical industry to research and respond to global health challenges.

As a government–recognised Independent Research Organisation and not–for–profit, our international reputation for the quality and independence of our research is at the forefront of all we do. OHE provides independent and pioneering resources, research and analyses in health economics, health policy and health statistics. Our work informs decision–making about health care and pharmaceutical issues at a global level.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit https://www.takeda.com/.

Refererces

[i] Mosele, F. et al. (2020). Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: A report from the ESMO Precision Medicine Working Group, Annals of Oncology, 31(11), pp. 1491–1505. doi:10.1016/j.annonc.2020.07.014. Last accessed: July 2023. 

[ii] Sampson et al. (2023). The case of expanding uptake of next-generation sequencing in lung cancer in Europe. Last accessed: July 2023.

[iii] Saarenheimo, J., Andersen, H., Eigeliene, N. and Jekunen, A.P. (2021). Current challenges in applying gene-driven therapies in clinical lung cancer practice, World Journal of Clinical Oncology, 12(8), pp. 656–663. doi:10.5306/wjco.v12.i8.656. Last accessed: July 2023.

[iv] Pruneri, G. et al. (2021). Next-generation sequencing in clinical practice: Is it a cost-saving alternative to a single-gene testing approach? PharmacoEconomics - Open, 5(2), pp. 285–298. doi:10.1007/s41669-020-00249-0. Last accessed: July 2023.

[v] Lung cancer burden in EU-27. European Commission. Last accessed: July 2023.

[vi] Chevallier, M. et al. (2021). Oncogenic driver mutations in non-small cell lung cancer: Past, present and future, World Journal of Clinical Oncology, 12(4), pp. 217–237. Last accessed: July 2023

[vii] Unlocking the potential of precision medicine in Europe: improving cancer care through broader access to quality biomarker testing. IQNPath, ECPC, and EFPIA, 2021. Last accessed: July 2023

[viii] Gutierrez, M.E. et al. (2017). Genomic profiling of advanced non–small cell lung cancer in community settings: Gaps and opportunities, Clinical Lung Cancer, 18(6), pp. 651–659. doi:10.1016/j.cllc.2017.04.004. Last accessed: July 2023

[ix] Taniguchi, H., Sen, T. and Rudin, C.M. (2020). Targeted therapies and biomarkers in small cell lung cancer, Frontiers in Oncology, 10. doi:10.3389/fonc.2020.00741. Last accessed: July 2023

[x] Biomarker testing, explained. ALK Positive. Last accessed: July 2023