Health Technology Assessment (HTA)
A Health Technology Assessment (HTA) consists of a systematic evaluation of the properties and effects of a health technology. The assessment evaluates the intended effects of the technology, and investigates the unintended consequences. HTAs are conducted by interdisciplinary groups that use explicit analytical frameworks drawing on a variety of methods such as clinical trials, observational studies, systematic reviews/meta-analyses, health economic evaluations and budget impact analyses. These groups compare the clinical effectiveness and cost effectiveness of the health technology or intervention with existing technologies, interventions or standards of care. The goal of an HTA is to inform policy decision makers on the technology’s safety, efficacy, potential for health innovation and return on investment. This information is used to facilitate reimbursement decisions.
An HTA is not required for sale of a medical device or health technology in Canada. However, senior management and health care decision makers often request an HTA to ensure that they make an informed decision about whether to fund a health technology and adopt it into practice. Any person or organization can request an HTA to be conducted, with the exact framework depending on the organization conducting the HTA and the relevant evidentiary standards. HTAs can be conducted at a provincial or hospital level, or through programs like MaRS EXCITE.
Health Technology Assessment Agencies
Health Technology Assessment International (HTAi)
HTAi is a global scientific not-for-profit agency representing professionals who produce or encounter HTA. This group contains over 1200 members from 65 different countries representing researchers, policy makers, industry, academia, health service providers and patients/consumers. HTAi holds regular meetings, interest groups and policy fora which serve as information sharing venues. Currently, HTAi has an interest group in patient and citizen involvement in health technology assessment.
Canadian Health Technology Assessment
The Canadian Agency for Drugs and Technology in Health (CADTH)
CADTH is a not-for-profit organization which provides evidence-based information about health technologies. All the reviews CADTH completes are freely available on their website.
Decision makers can request CADTH’s services through their website. CADTH can provide advice, recommendations or tools to inquiries that pertain to a health care decision or policy. CADTH can also be contacted through Liaison Officers located regionally in each province.
CADTH acts as the primary body for performing provincial HTAs in all provinces and territories that do not have their own provincial HTA agency: Saskatchewan, Manitoba, Nova Scotia, New Brunswick, Prince Edward Island, Newfoundland and Labrador, Yukon, Northwest Territories and Nunavut. In Alberta and British Columbia, CADTH works to perform HTAs in collaboration with provincial bodies that formulate the recommendations for use.
Types of HTA
CADTH provides different HTA services under their Health Technology Management Program:
- The Rapid Response Service provides decision-makers with the most relevant information in a time-sensitive manner.
- The HTA Program provides 2 services:
- A full HTA, involving a comprehensive review of both clinical and cost effectiveness and an examination of ethical, legal and social implications of the technology, or
- A Technology Review, consisting of an assessment of either clinical or cost effectiveness, but not both.
- The Optimal Use Service provides decision makers with a complete HTA and a set of recommendations developed by a panel of experts.
Eligibility
CADTH preforms HTAs on health technologies, which they define as drugs, diagnostic tests and medical, dental and surgical devices and procedures.
Data Requirements
In completing an HTA, CADTH evaluates clinical and cost effectiveness of the technology. This might include ethical, legal and social implications for patients and for the broader healthcare system
Provincial Health Technology Assessment
Provincial HTA processes do not involve an application process from the manufacturer. These provincial organizations identify technologies through regular environmental scanning and passive surveillance, or through communication with hospital administrators.
British Columbia
The Health Technology Review Office begins the Health Technology Review process by completing a business case for the technology. This business cases is the evaluated by the Health Technology Assessment Committee (HTAC).
Eligibility
Non-drug health technologies (tools, devices, diagnostics and procedures) being considered for public reimbursement are eligible for the review process. All new non-drug health technologies that are being considered for reimbursement at a cost threshold of $25,000 per patient or $1,000,000 province wide, undergo the review process in British Columbia. Technologies that have already been adopted are also reviewed if requested by leadership.
Data Requirements
The province of British Columbia examines the social and system demographics, clinical effectiveness and costs of technologies in their HTA process.
- Social and System Demographics: disease burden, impact on the population, implementation plan, and training and credentialing required for adoption of the technology
- Clinical Effectiveness: health effects, non-health effects, and the quantity and quality of life improvements caused by the adoption of the technology
- Incremental Cost: budget impact, and cost of implementation.
Alberta
Alberta Health Technologies Decision Process uses all appropriate evidence and information to consider which health services will be publicly funded. Alberta Health uses the HTA to develop policy options. Through consultations with stakeholders and considerations of broader health systems impacts, recommendations are developed and presented to the Minister or Deputy Minister for final decisions.
Eligibility
Health technology assessments are conducted by partner organizations and referred to Alberta Health Technologies Decision Process. As such the eligibility of a technology is dependent upon the referring agency.
Data Requirements
For the Health Technologies Decision Process, four categories of data are examined:
- Social and System Demographics: incidence and prevalence of the health issue addressed by the technology, and the capacity of the system to deliver the new service
- Clinical Effectiveness: health effects and the non-health effects of the technology
- Costs
- Political and Public Policy Considerations
Ontario
In Ontario, HTAs are performed by the Ontario Health Technology Assessment Committee (OHTAC), a subcommittee of Health Quality Ontario (HQO). OHTAC identifies, appraises and interprets existing evidence surrounding new health technologies to provide recommendations about the uptake, diffusion, distribution or removal of the technology from the health system. These recommendations are provided to decision makers at the Ontario Ministry of Health and Long-Term Care, as well as to identified stakeholders and the general public.
Eligibility
OHTAC indicates that technologies and treatment strategies eligible for the HTA process can include “new and existing diagnostic- and treatment-related medical devices, equipment and supplies, and clinical procedures used in any health care service delivery setting”. Reviews of technologies and treatment strategies that have not yet been diffused into the health care system are completed before those that have been diffused. The exception to this preference occurs when OHTAC considers the technology to warrant assessment because it is being considered as an alternative to a new technology or treatment, there are safety concerns, or it has a new application.
Data Requirements
OHTAC examines:
- Social and System Demographics: burden of the illness being addressed by the technology and the need for the technology
- Feasibility of Adoption into the Health System: economic feasibility, and organizational feasibility
- Clinical Effectiveness: effectiveness of the technology and the safety of the technology
- Value for Money: value of the technology is considered in comparison to the cost of the technology
- Political and Public Policy Considerations: consistency of the technology with expected societal and ethical values
Quebec
The Institut national d’excellence en santé et en services sociaux (INESSS) works to promote clinical excellence and the efficient use of resources in health and social services by assessing the clinical and cost effectiveness of health innovations. The assessments are completed by a multi-disciplinary team of professionals, managers, patients and beneficiaries. These assessments result in a set of recommendations concerning their adoption, use and coverage. In addition, guides for best clinical practice are developed to ensure optimal use of the innovation.
Eligibility
Health technologies, medications and interventions are assessed by Universities and other external organizations, who collaborate with INESSS to produce recommendations. These partnering bodies have differing criteria for eligibility.
Data Requirements
The data requirements for review by organizations partnered with INESSS varies according to the type of technology. However, clinical effectiveness and social and system demographics are always evaluated.
Local Health Technology Assessment (Payer Level)
HTA bodies exist at a local level within most provinces, most often within hospitals. Typically, reimbursement decisions are made at this level, as such HTAs are often conducted at this level. However, hospital administrators can request advice from formal assessment organizations at a provincial level.
Local HTA Bodies by Province
Hospital-Based HTA
Approaches taken by hospitals vary greatly with organizational complexity. Most teaching hospitals have HTA bodies to facilitate their reimbursement decision making, given their greater funding allocations. In Quebec, all teaching hospitals are required to have HTA bodies. These bodies may support hospital-wide decisions or may be contained within certain departments. As such, they may have varying levels of support from senior administration and varying impacts on decision-making.
Alternative HTA Options
A medical device company can conduct their own assessment of their technology’s clinical and cost effectiveness to inform decision-makers, as long as the quality of the evidence presented remains high and valid in the eyes of the decision makers.
Provincial policy may create programs based on their strategic directions or changes in federal funding. These resulting programs may provide opportunities for HTA for health innovations. Similarly, decisions to fund or investigate health technologies may be impacted by political decisions.