Luc Boileau, president and CEO of INESSS, the Quebecois National Institute of Excellence in Health and Social Services, the region’s healthcare technology assessment (HTA) body, describes how his organization is adapting to the evolutions taking place in global healthcare and the synergies that exist between the separate Quebecois and Canadian healthcare systems.

Could you please introduce the mandate of the Institute national d’excellence en santé et en services sociaux (INESSS) to our international audience?

The genesis of INESSS came in 2011 from the current Secretary General and Clerk of the Conseil exécutif of the Quebec province, Juan Roberto Iglesias, who was subsequently appointed the first president and CEO of INESSS and I succeeded him in 2014.

The mission of INESSS is officially to promote clinical excellence and the efficient use of resources in the health and social services sector. Quebec is unique within Canada for having a fully integrated health and social  services (HSS) sector under the Ministry of Health and Social Services, so INESSS’ activities cover the monitoring and evaluation of both health and social services provision. More concretely, this means developing performance evaluation criteria, preparing recommendations and guides, and promoting a general culture of clinical excellence within the province. There is still space to improve our HSS system as others. We consider that probably around 10 to 15 percent of current health and social service interventions may not be beneficial to target groups.

My career has been dedicated to public health from a global perspective. After a few years of practice as an emergency physician medic, I have worked extensively with various healthcare bodies, hospitals and regional authorities, including the National Institute of Public Health of Quebec, and of course INESSS. I moved from the public health and the organisation of the management of health services environments, and had the privilege of acting in similar areas at the national institutes’ level. I accepted this position because I wanted to contribute my expertise to the promotion of healthcare excellence through the modernization of existing practices and the mobilization of all healthcare and clinical stakeholders in a perspective of change management, particularly in the context of major transformations in the HSS system of Quebec.

Looking at the broader context, the global pharma market is worth USD 1.1 trillion. The US represents around 45 percent of that while Canada is less than 2 percent, which means that Quebec as a province may be less than 0.5 percent of the global market. On the other hand, healthcare stands at 50 percent of the provincial budget this year. It shows how critical it is to support decision makers with reliable knowledge.

The healthcare industry is really evolving extremely rapidly. For a regulator or assessor entity, it must be very difficult to keep on top of new developments. How is INESSS adapting to this?

Minister Barrette has instituted a significant transformation of the healthcare system in the past two years with a major push to improve efficiency, efficacy and appropriateness. This is the mandate of INESSS and our responsibility to oversee the HTA component gives us a contextualized perspective of the health and social services systems in place in Quebec, including not just the use of products and technologies but medical practice and procedures.

I am pleased that in the past few two years, essentially all of our recommendations surrounding pharmaceutical products and biomedical tests regarding the inclusion onto the public registry have been accepted by the Ministry. This reflects positively on our work, considering of course that the Minister will not negotiate the price for any medication that have not been recognized as offering therapeutic value by INESSS.

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Nevertheless, as an organization, it is imperative that we remain attuned to industry developments and proactively adapt to changes in healthcare and social services. One particularly pressing debate surrounds the concept of ‘added value’. This is embedded in our mandate as we were expressly set up to determine the cost-effectiveness of new technologies and products, and we have a specific process dictated by legislation to advance this, setting us apart from other Canadian provinces and territories. The current evaluation criteria are based on therapeutic added value, price-competitiveness, pharmacology assessment, societal impact and finally, the recommendations of our scientific committee, but we are also piloting POETIS (Processus optimisé d’évaluation des technologies innovantes en santé), an iterative evaluation based on the lifecycle of innovative technologies, where we try to assess the product’s efficacy across the entire lifecycle of the disease to get a sense of the overall value it can bring to the healthcare system and patient.

We recognize that we do need to widen this concept of ‘added value’. For instance, the distinction between medicines and medical device is blurring with the advent of innovations like cell therapies, gene therapies and nanotechnology. We need to review our processes to be able to take these ground-breaking developments. I cannot claim that we have all the answers but we are engaging thoroughly with these questions.

Other initiatives have also been launched. For instance, we plan to introduce for medications a system of rolling submission of dossiers, where previously the Minister had set three deadlines through the year. This will help companies have more rapid access in Quebec. We are also looking to expand our pre-NOC review processes to include more drugs, as the other Canadian agencies such as CADTH do. We are also looking to start charging a nominal fee for our services to become more financially sustainable, as CADTH has been doing for a few years.

How advanced is the Quebec public’s understanding of the role of INESSS and the concept of HTA?

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As part of a broader definition of the concept of ‘added value’, we believe the patient’s voice is extremely crucial. HTA processes need to be based on solid scientific and economic knowledge but we need to consider just as well the role of the patient in their own healthcare decision-making. This is why we are now including the patient within our assessment framework at INESSS to participate in the deliberative process, namely, regarding patients’ expectations of the evaluated technologies. In all directorates, it is mandatory for teams to do a literature review from the patient’s perspective or ask partners to prepare patients’ reported outcomes.

For instance, in our ongoing review regarding the criteria that should guide the selection of an appropriate replacement defibrillator a group of patients was involved throughout the process. They were recruited as experts of their health condition, they validated and enriched the litterature review from their perspective and participated in the round of deliberations leading to the formulation of recommandations together with the clinical experts. There certainly is an added complexity to reunite those experts from different perspective around the table but it is worthwhile and a necessary endeavour.

We believe the public should be more aware of INESSS’ role and value, so we are also in the process of organizing some public outreach events. We have also run some very successful initiatives that have raised our profile as well – like the publication of field evaluations, where the performance of the management of the initial phase of myocardial infarctions is carefully assessed throughout Quebec (annual reports tracking health interventions for those cases on metrics like emergency services and ER wait times, as well as pre-hospital intervention times, door-to-balloon times, coordination of services, etc.), with feedback to the clinicians to help improve the quality of care and assure the full value of the technologies with a strong emphasis on the assessment of appropriateness.

Quebec of course has a separate healthcare system from the rest of Canada. How much interaction / synergy exist between the two systems? CADTH consult on its processes, share expertise and know-how, and so on?

Nevertheless, each of the Canadian provinces benefits from a few renowned Canadian organizations in the field of HTA, most importantly the Health Canada team, which acts as the “regulator”. Moreover, considering the mandates of INESSS, we have valuable collaborations with CADTH as well as with other scientific groups in Canada, whether they are in Ontario, Alberta,British Columbia or even from other jurisdictions in OECD contries

While organizations such as INESSS or even the government and industry are often in opposition, the collaboration between the industry and our institute, as well as with the government, is generally respectful, healthy and constructive. INESSS operates on the basis of a good working relationship between the industrial community and the public so that it can fully understand their demands, their submissions and the follow-up required for the proper functioning of the health system and, ideally, for scientific and industrial development. The Government of Québec’s recent National Strategy on Life Sciences 2017-2027 reflects its strategic interest in developing, if not investing in, the high-tech health sector by mobilizing all the levers available to develop knowledge, skills and innovations and ensure that they are valued at their true value and that they benefit both the people and the economic development of the province.

A final message?

Over the last few decades, Quebec as a province has been able to improve the life expectancy at birth of its population by more than 5 hours every single day. This is a remarkable piece of information that demonstrates how our societies such as ourselves have succeeded in taking solid action on several determinants of health and not just on the system of care itself. INESSS contribution aims essentially to ensure that the impact of the health system, particularly through the regulation and integration of new medicinal and non-medicinal technologies, can be achieved by improving the health of its population without losing sight of the optimal use of its resources. Indeed, on an economical basis and without wanting to oversimplify, investing public funds in the health care system means not investing these funds in other systems or determinants of population health. Therefore, INESSS must be very rigorous in analyzing the anticipated benefits of technologies, modes of intervention, organizational models and program development for the benefit of patients, population and society in general.