Elsevier

The Lancet Oncology

Volume 19, Issue 12, December 2018, Pages e709-e719
The Lancet Oncology

Policy Review
Defining priority medical devices for cancer management: a WHO initiative

https://doi.org/10.1016/S1470-2045(18)30658-2Get rights and content

Summary

Medical devices are indispensable for cancer management across the entire cancer care continuum, yet many existing medical interventions are not equally accessible to the global population, contributing to disparate mortality rates between countries with different income levels. Improved access to priority medical technologies is required to implement universal health coverage and deliver high-quality cancer care. However, the selection of appropriate medical devices at all income and hospital levels has been difficult because of the extremely large number of devices needed for the full spectrum of cancer care; the wide variety of options within the medical device sector, ranging from small inexpensive disposable devices to sophisticated diagnostic imaging and treatment units; and insufficient in-country expertise, in many countries, to prioritise cancer interventions and to determine associated technologies. In this Policy Review, we describe the methods, process, and outcome of a WHO initiative to define a list of priority medical devices for cancer management. The methods, approved by the WHO Guidelines Review Committee, can be used as a model approach for future endeavours to define and select medical devices for disease management. The resulting list provides ready-to-use guidance for the selection of devices to establish, maintain, and operate necessary clinical units within the continuum of care for six cancer types, with the goal of promoting efficient resource allocation and increasing access to priority medical devices, particularly in low-income and middle-income countries.

Introduction

Cancer is a major cause of death worldwide resulting in more than double the number of deaths from AIDS, malaria, and tuberculosis combined.1 Over 70% of global deaths attributable to cancer occur in low-income and middle-income countries (LMICs), and data clearly show that LMICs still have a larger relative percentage of mortality for almost all cancers that can be detected early and effectively treated, compared with global incidence.2 An increasing body of evidence has shown that a substantial proportion of this cancer burden could be avoided with adequate prevention, early detection, treatment, monitoring, and palliative care through an integrated approach along the cancer care continuum.3 These strategies require having coordinated health-system elements, human resources, health technologies, medicines, information, infrastructure, and policies to provide appropriate cancer management. Health technologies, specifically medical devices (eg, capital medical equipment, surgical instruments, implantable devices, protective equipment, and single-use medical consumables) are indispensable for effective prevention, screening, diagnosis, treatment, palliation, and rehabilitation of disease;4 however, many of these existing medical interventions are not equally accessible to the global population, which contributes to disparate mortality rates between and within countries, with particularly worse outcomes in LMICs compared with high-income countries.5

Since 2010, WHO has done global surveys on medical devices that have revealed major gaps between countries in the availability of and access to specialised high-cost medical devices to diagnose and treat patients with cancer, and have revealed large discrepancies in regulatory capacities, national policies, priority or essential lists, or technical specifications for the procurement, reimbursement, and maintenance support of medical devices.6 The selection of a comprehensive list of appropriate medical devices has been difficult because of the extremely large number of devices needed for the full spectrum of cancer care; wide variety of options within the medical device sector, ranging from small inexpensive disposables to sophisticated diagnostic imaging and treatment units; and insufficient in-country expertise, in many countries, to comprehensively list and prioritise cancer interventions, and determine associated technologies. The improvement of access to priority medical technologies, linked to a package of core interventions, is important to implement universal health coverage (UHC). UHC has emerged as the reigning political commitment and public health principle of the 21st century under Sustainable Development Goal 3.7 Therefore, establishing which essential cancer services should be part of a benefits package in UHC, which medical devices are required to provide these services, and whether such devices fulfil the criteria of value for money is crucial to achieving UHC. Although the complexity of this task is compounded by the heterogeneity of health systems in cancer, delineating core medical devices linked to essential interventions will support national governments to implement UHC and improve efficiency in health expenditure.

In 2015, WHO convened global experts to define core medical devices for the screening, prevention, diagnosis, treatment, follow-up, and palliative care of patients with cancer, resulting in the WHO guidance book WHO list of priority medical devices for cancer management.8 The objective of this WHO initiative was to create ready-to-use guidance for the selection of devices to establish, maintain, and operate necessary clinical units within the continuum of care for a defined set of cancer types, with the goal of facilitating efficient resource allocation and increase access to these medical devices, especially in LMICs. The list was published in May, 2017, in the guidance book. The methods and output of this WHO initiative are instructive to global stakeholders given the complexities of establishing normative guidance for cancer globally. First, the present paper describes innovative methods using evidence-based guidelines and global expert input that considers multicriteria decision analysis (MCDA) for the selection of technologies, and a deliberative consultative process to reach consensus. Second, the recommendations generated are applicable to health systems at different resource and income levels, and are relevant to set cancer-specific priorities and to build general cancer infrastructures. Finally, this initiative has focused on providing guidance for guideline implementation, ensuring that the documentation created is used to inform country-level implementation.

Section snippets

Data collection

The development of a list of priority medical devices is a complex task for many reasons. An estimated 1·5 million different medical devices exist, in more than 10 000 types of generic device groups.8 Besides the management of the intrinsic complexity of medical devices, a model reference list requires the identification of the function needed for oncology care, the definition of associated devices to perform these functions, the classification of the requirements of each device and their

Findings

The main outcome of the project is the guidance book, WHO list of priority medical devices for cancer management.8 The publication is intended for Ministries of Health, public health planners, health technology managers, researchers, policy makers, funding and procurement agencies, and support and advocacy groups for patients with cancer. The book is structured around the following broad clinical units: vaccination, clinical assessment and endoscopy; medical imaging and nuclear medicine;

Discussion

A 70% increase in cancer incidence and a 45% increase in cancer mortality is expected over the next two decades globally.43 The rapid increase will require countries of all income levels to use their finite resources in effective and efficient ways through priority setting. Appropriate selection and prioritisation of medical devices is crucial to achieve UHC for cancer care, through progressive implementation and value for money. WHO priority medical devices for cancer management8 provides

Conclusion

In global health, substantial work has been done on vaccines, essential medicines, and specific high-cost equipment, such as radiotherapy devices for cancer. However, a global standard that articulates a comprehensive, coherent list of priority medical technologies required for every clinical intervention, from prevention, to diagnosis, treatment, and palliation, especially in cancer, has never been published for policy makers, health facility managers, procurement agencies, health technology

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