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Object lessons in implementing next-generation sequencing in cancer diagnosis in Europe.
Next-generation sequencing has become a key technology in cancer diagnosis, prognosis and prediction, but it is widely acknowledged that wide variations in implementing and using it can lower the quality of patient care. Belgium has developed an NGS playbook to overcome some of these challenges, and the approach was formally announced in mid-December as part of the EU-funded Innovative Partnership for Action Against Cancer, which has just come to an end.
The Belgian approach is comprehensive, with centralized governance, integrated technical and logistic actions with allocated budgets, and standardization across multiple program elements, such as data interpretation, reporting storage, reimbursement, ethics/legal requirements, and societal issues. Partners in the program include the ministry of health, the reimbursement authorities, the professional colleges of oncology and of genetics, government bodies on clinical biology, pathology, the national cancer registry, and the federal agency for medicines and health products.
The approach is possible because reimbursement of NGS tests is covered by the national sickness insurance funds, and Belgium has a health data platform which hosts and links over 50 datasets and registries in the country. In addition, a 2003 law obliges all hospitals and laboratories to send exam results to the cancer registry. But the program did not come into being automatically. A health service evaluation study was conducted in 2015, with the involvement of the national cancer center, Sciensano, and the national health technology assessment agency KCE. Based on the study's recommendations a plan covering 2016-2020 was prepared in concert with the stakeholders, and won approval from the health minister in 2016.
Under this plan the outcomes have included the creation of a national commission for personalized medicine, guidelines on NGS, along with an external quality assessment structure that laboratory are obliged to comply with, and a reimbursement system nomenclature to cover NGS testing. Networks of hospitals and laboratories were authorized to use, analyze and be reimbursed for NGS testing. Centralized data registration was established by 2019, and the link to the national cancer registry opens up the possibility of patient-matching applications to optimize diagnosis or match with clinical trials, for example. And broad consultation was undertaken with patients and citizens on ethical, legal, social implications of the use of genomics information.
The main outcomes to date, according to the launch announcement, have been effective coordination among the many stakeholders, the engagement of relevant experts in sharing experience with NGS, which has resulted in compliance with testing guidelines in routine practice, and consensus on the scope and content of NGS testing, which has increased standardization and made possible common–and cost-effective–purchasing of testing equipment.
In addition, the participatory approach with stakeholders–as diverse as clinicians, pathology, clinical biology, genetics, oncology, bioinformatics and patients/citizen–increases the likelihood of commitment and acceptance of the plan.
The creation of the Belgian approach has, admit its founders, demonstrated that sufficient time needs to be planned for discussion among stakeholders to achieve consensus on practical implementation. It has also shown that centralized data registration requires major information technology investments–and continuous helpdesk support. The standardized technical and clinical approach has proved essential for retrospective evaluation of the effectiveness of the diagnostic testing. And because adaptation of nomenclature for the reimbursement system is a complex and tedious exercise, payers need to be involved from the beginning.
The Belgian example stands in sharp contrast to the wider experience of introducing NGS in Europe. One of the foremost professional bodies in Europe only got round to making some first tentative recommendations during the course of 2021. The European Society for Medical Oncology has recently come out with an explicit recognition that NGS allows sequencing of a high number of nucleotides in a short time frame at an affordable cost, and at the same time acknowledged that although the technology is widely used, there are no recommendations from scientific societies about its use in oncology practice. 2022 may see some more coherent action at EU level–but here is an area where regulation and clinical practice are still far from any significant European consensus.