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UK's Office of Health Economics, Takeda Make Case for Improving NGS Test Access in Europe


NEW YORK – Providing routine, comprehensive next-generation sequencing (NGS) tests to European lung cancer patients can be cost-effective and yield clinical benefits, according to a report by drugmaker Takeda and independent UK research organization the Office of Health Economics, but policy changes including appropriate reimbursement, standardized clinical guidelines, and more robust infrastructure are needed to facilitate broader access.

In 2020, the European Society for Medical Oncology recommended NGS testing for patients with advanced cancers including lung cancer. Subsequently, the European Commission made a political commitment in 2021 to improving cancer prevention, early detection, diagnosis, and treatment in the Beating Cancer Plan, which included an initiative to improve patients' access to personalized cancer care through greater use of NGS testing. 

Still, uptake of NGS testing has remained low in European countries. A 2021 report published by the trade group European Federation of Pharmaceutical Industries and Association (EFPIA) found that access to high-quality oncology biomarker testing including NGS testing is inconsistent across Europe and contributes to health inequalities both within and between countries. When it came to NGS testing, the EFPIA found that, on average, only 10 percent of patients had access, ranging from as low as 2 percent of patients in Italy to up to 75 percent in Denmark.

Tanja Podkonjak, director of oncology access and reimbursement policy for Takeda's Europe and Canada business unit, said that internal market research by the company lined up with EFPIA's findings, prompting further study into the reasons NGS testing has not been widely adopted despite authoritative recommendations. "We wanted to understand more about what the barriers were and how they could be overcome," Podkonjak said.

The report authors reviewed the literature on the clinical and economic value of NGS testing in lung cancer, seeking to include cost-effectiveness and economic analyses, clinical guidelines, and policy-relevant reports. They also assembled an advisory group of experts in pathology, oncology, genomics, and health economics, as well as patient and payor representatives. The advisory group identified gaps in research, evaluated interpretation of evidence, and designed case studies. The experts also confirmed that NGS test access is indeed low across Europe, identified barriers to test adoption, and reinforced existing evidence that NGS testing is beneficial from both a clinical and economic perspective.

Podkonjak expressed surprise over the amount of data supporting the economic value of NGS testing. "I expected that there would be compelling clinical evidence, but what surprised me was the amount of published economic evidence supporting the uptake of NGS testing," Podkonjak said, adding that while evidence on cost-effectiveness is still evolving, "what the research did show is that for lung cancer, NGS is cost-efficient and could actually be cost-saving." Pathologists in the advisory group strongly recognized the value in this regard, she noted.

In lung cancer, where there are multiple targetable cancer-driver mutations, conducting many single-gene tests quickly becomes untenable in terms of cost and sample needs. "The economic evidence showed that if you are testing for more than five genetic alterations, which is done regularly, the cost of an NGS test that's able to sequence these immediately is actually cheaper," Podkonjak said, adding that beyond that, "you're gaining health efficiencies because you're not taking time to test gene by gene."

In an Italian study cited in the report, NGS testing reduced hospital costs by up to €879 ($978) for each advanced non-small cell lung cancer patient compared to targeted single-gene testing. And a 2022 analysis of advanced NSCLC at a Spanish hospital found that while the diagnostic costs were "slightly higher" for NGS compared to sequential single-gene testing, the former testing strategy yielded better outcomes by getting more patients on targeted therapies and clinical trials. Factoring in the total cost of NGS testing and more pricey targeted therapies that patients tend to receive based on the results, spending was €47,432 more per patient over a lifetime compared to getting treatment based on sequential single-gene testing. However, NGS-guided treatment was also associated with gains of 7.9 life years, 5.22 quality-adjusted life years, and an incremental cost-utility ratio of €9,084 per QALY gained.

Another efficiency offered by NGS testing highlighted in the report is that it conserves tumor samples, which is often in short supply in advanced NSCLC cases. Repeated single-gene tests can quickly use up the small amount of lung tissue retrieved in a biopsy.

Given these advantages with NGS, the report's authors outline several categories of recommendations that they said may improve access to such tests for lung cancer patients in Europe. First, the authors urged reimbursement bodies to cover NGS testing initially according to its clinical value by, for example, the extent to which testing improves patients' survival or staves off disease progression. They further recommended that all European countries advance a "national minimum requirement," where policymakers stipulate specific biomarkers and indications for which NGS testing is covered.

Another area where policy can guide improved uptake of NGS testing, according to the report, is standardization of testing pathways and biomarker analysis. Issuing national standards for sample analysis and reporting and developing local clinical guidelines informed by international recommendations can help achieve this, the report authors wrote.

Lastly, the authors called for improvements in testing infrastructure. In many countries, capacity and expertise for NGS testing is lacking and could be improved with national initiatives related to test referral pathways and physician education.

Podkonjak emphasized that if Europe is going to meet the goals set forth in Europe's Beating Cancer Plan, policymakers should start making a concerted effort now to implement the changes outlined in this report, or European countries will continue to fall behind international standards for NGS testing.

"I would like to see this topic be a prominent feature of the next mandate of the EU parliament," Podkonjak said. "There's a lot of compelling support and evidence. This is a real opportunity to not only improve patient outcomes but also healthcare efficiency."