MARKET ACCESS PLANNING FOR EMERGING MEDICAL TECHNOLOGY: Health Technology Assessments

BY JACQUELINE CSONKA-PEEREN

MEDICAL DEVICE MANUFACTURERS LOOKING TO COMMERCIALIZE EMERGING MEDICAL TECHNOLOGY NEED TO CONSIDER NOT ONLY STRATEGIES FOR INTELLECTUAL PROPERTY PROTECTION AND REGULATORY APPROVAL, BUT ALSO FOR TECHNOLOGY DIFFUSION, OR MARKET ACCESS. PLANNING FOR MARKET ACCESS CAN HELP ACCELERATE SALES GROWTH, ECONOMIES OF SCALE AND BRAND RECOGNITION. THIS PLANNING SHOULD START EARLY, IDEALLY AT THE STAGE OF CLINICAL DATA COLLECTION, WHEN THIS COLLECTION CAN INCLUDE INFORMATION TO HELP HEALTH-CARE PROVIDERS EVALUATE AND ULTIMATELY ACCEPT ADOPTION OF A NEW TECHNOLOGY.

This article discusses new medical device technology diffusion in the public health-care system in Canada and how medical device manufacturers can prepare for this market access. The focus is on disruptive medical equipment and supplies. While market access planning for established or existing medical devices and assistive devices is also prudent and worthy of discussion, these have some special considerations and could best be considered in another article.
In general, the mainstream public system provides access to the largest Canadian market. While private clinics exist in Canada, public hospitals are the largest component of total health-care spending,1 and medical equipment, and medical and surgical supplies, are estimated to account for one tenth of total public hospital operating expenses, or roughly $1.2 billion in Ontario alone.2
Canada’s adoption of new medical technology is considered simultaneously a national and local issue. Issues such as universality and accessibility to public health-care services are federal requirements, as per the Canadian Health Act (CHA). While the federal government enforces the CHA and provides direction on health priorities, it also transfers funds for health services to the provinces and territories.
The provinces and territories have autonomy as long as their actions in delivering health-care services are not in contravention of the CHA. In turn, each provincial and territorial government transfers this funding for the delivery of services to local agencies within its jurisdiction, such as hospitals. Consequently, Canada’s health-care system remains decentralized. Decisions about introduction and diffusion are ultimately made at the local level, with consideration given to microeconomic and local social issues such as human resource impacts, societal consequences and ethical dilemmas.
Government can take the decision to limit the range of services provided by local agencies — for example, not to provide dental or optometric services — and can also influence hospitals to restrict their services by limiting their global budget. However, by and large, decisions pertaining to the introduction, adoption and diffusion of new devices are a provincial matter that may be delegated to a provincial agency.
Regulatory approval is not an indication of market acceptance in the public health-care system (or the private one, for that matter). However, it is a prerequisite to market approval, and market approval decisions rely on some of the same data used to make regulatory decisions.
As a federal matter, regulatory approval of new devices is carried out by the Therapeutic Products Directorate of Health Canada. The Food and Drugs Act and Food and Drug Regulations required a manufacturer to present substantive scientific evidence on a product’s safety, efficacy and quality prior to being given market authorization.
Health Technology Assessment (HTA) organizations have been established at some regional and provincial/territorial levels, and at the national level, to assist hospitals and other provincial health-care agencies with their adoption decisions.
HTA refers to the secondary research activity of collecting and analysing primary research data about a health technology. HTAs are meant to provide objective information to health policy-makers about the many dimensions of a technology’s impact, from clinical to economic.
The results of an HTA are typically made available to health system administrators and government policy-makers, and may also be made available to health-care workers and patients.
While the HTA organization may also make policy recommendations based on the HTA, decisions ultimately rest with the decision-makers at the provincial agency.
HTA units are an important part of the diffusion process and can have an influential reach beyond a local agency. Canada has made progress in the last few years to co-ordinate efforts, share best practices and avoid duplication within its various HTA organizations. HTAs help to create efficiencies in the uptake of new medical technology, and as such can provide a manufacturer with a portal through which to diffuse their technology.
Manufacturers may always approach provincial agencies individually to try to get their technologies introduced without an HTA. Indeed, whether a formal HTA is performed or not, hospitals make the final determination regarding the uptake of new technologies. However, manufacturers may find that HTAs provide them with a more transparent, organized and cohesive process for the update and diffusion of their new technologies in Canada.
The technologies chosen for HTA review are those where difficult questions need to be answered, usually in regards to uncertain overall benefits to health-care delivery or high utilization costs. Requests for an HTA generally require a hospital sponsor. At the national Canadian Coordinating Office for Health Technology Assessment (Ottawa, ON), topics are chosen by the Devices and Systems Advisory Committee, which is made up of representatives from provincial and territorial ministries of health and Health Canada. At the regional Health Technology Assessment Unit of the McGill University Health Centre (Montreal, QC), representatives from various disciplines and hospital sites form an executive committee, which screens and sets HTA priorities.
Medical device manufacturers need to have Health Canada approval for their product before HTAs will be performed. A manufacturer can, however, help speed up the HTA process by making as much primary research available as possible in advance of an HTA’s approved beginning.
Considerations for manufacturers at the early stages of market access planning:
     Manufacturers should partner early with a clinical site, preferably one that has experience with clinical outcome measurements that are relevant to the technology in question and has a reputation of providing measurements that are considered credible and of high quality by the HTA review panels.
     Manufacturers should dialogue with decision-makers within health-care organizations that influence procurement decisions, such as the directors of regional health organizations and chief operating officers of hospitals. By doing so, they may obtain insights on issues affecting market access — such as opportunity costs, legal or ethical issues — and the general opinion of the hospital community with regards to the technology in question. Manufacturers should also seek to understand the operational implications of utilizing their technology to the health-care system, such as training and recruitment, and systems efficiencies.
     In designing primary research studies, prepared data should cover as many topics as practically possible that are relevant to adoption of the new technology. In addition to the clinical efficacy data required for regulatory approval, manufacturers should seek to describe: direct health-care costs, such as hospitalization days, physician and emergency room visits, and costs of drugs and tests associated with the technology; direct health benefits, preferably in units that are familiar to decision-makers; and comparisons to available alternatives. Also critical to include are descriptions of how sensitive the costs and benefits of the technology are to variations in outcomes and other assumptions made during this analysis.
     Manufacturers must consider that there may be economic consequences beyond the immediate effects of technology. They should consider market access challenges around long-term costs and operational impact on a facility or a region, and the effect on patients, their satisfaction and perceptions regarding quality of life.
     A medical device manufacturer with emerging medical technology that considers the issues discussed in this article will gain more insight into its product’s positioning prior to market launch and be better prepared for the eventuality of an HTA. As such, this can improve the chances of successful market access.

References:
(1)     Rachlis, C. “Reimbursement and the Capacity for Innovation.” RAPS International, Toronto, Ont. June 2004.

(2)     McKinley, J. “Health Care Financing.” MEDEC Health Policy Seminar, Toronto, Ont. May 2004.

Jackie Csonka-Peeren is a consultant with BioAlliance Consulting Inc. (Kingston, ON), a strategy consulting firm for innovative medical technology manufacturers. She has nine years of product and program development experience with IBM Canada Ltd. (Markham, ON) and Celestica Inc. (Toronto, ON), and five years of intellectual property co-ordination, technology transfer, and commercialization experience through BioAlliance, Millenium Biologix Corp. (Kingston, ON) and the Ontario Rehabilitation Technology Consortium.

Csonka-Peeren holds an MBA for science and technology from Queen’s University (Kingston, ON), and an MASc in biomedical engineering and BASc in aerospace engineering from the University of Toronto (Toronto, ON).

She is a member of the Regulatory Affairs Professionals Society (Rockville, MD), the Licensing Executives Society (Alexandria, VA), Professional Engineers Ontario (Toronto, ON), and the Canadian Association of Healthcare Reimbursement Professionals.