In Québec, Canada, decisions about implementing innovations are taken both centrally for province-wide access and locally by healthcare institutions. There is no systematic evaluation process and various stakeholders are involved, notably within a new nationwide governance structure. There was a wish to increase consistency and clarity with the principles and methods used by various bodies across the innovation lifecycle.

The starting point was the Institut national d’excellence en santé et services sociaux (INESSS) multidimensional framework, which focuses on the population-level, clinical, economic, organizational, and sociocultural value of drugs, technologies, and interventions. The framework, already under evolution drawing on Responsible Innovation in Health (RIH), evolved through collaborative work between INESSS’ methodological and scientific teams, but also and foremost with diverse groups and institutions within the provincial innovation ecosystem (e.g., university-based incubators, regional hospitals). The first steps were to capture current concepts and practices from different stakeholders, as well as their operational needs in terms of assessment tools.

This multistakeholder taskforce resulted in the development of an operational toolbox meant to guide the value appraisal of innovations through a lifecycle approach. First aimed at stakeholders involved locally in healthcare institutions, the work conducted was equally beneficial to INESSS by enabling its evaluation teams to contribute to the operational tools needed to enhance clarity and legibility of the agency’s processes and methods. The level of collaboration with stakeholders across the province was also unique and has strengthened the understandability and actionability of the toolbox developed. Some challenges were faced, and related actions will be discussed.

Both the taskforce process and its output contributed to improving consistency in the assessment of innovations across the province. They made more explicit what may sometimes be perceived as the HTA “black box.” The INESSS value appraisal framework also evolved considering key elements of responsibility from RIH and through this collaboration with stakeholders, and its applicability in different contexts was reinforced.

Real-world evidence (RWE) can be of value to support comparative effectiveness of drugs and technologies by providing additional information about their use for a variety of patients in real contexts of care. However, the integration of RWE in appraisals can be challenging, and INESSS felt the need to reinforce and explicit the underlying methodological and theoretical foundations.

A comprehensive literature review was carried out, followed by collaborative development work by members of the methodological and assessment teams.

The literature review led to a common understanding of RWE underlying principles and fed the subsequent phases of the project. Three factors were identified as driving the integration of RWE in reimbursement appraisals at INESSS. Specifically, (i) the design and conduct of the real-world studies are done in accordance with best practices, (ii) the results are presented transparently and include all relevant information to assess the quality of the study and the data, and (iii) the RWE submitted is appropriate and relevant for decision-making. This third component is further ascertained by considering the decisional context (what are the circumstances motivating the submission of RWE and how does it correlate or not with existing evidence?), the data (is the dataset fit for decision needs?) and the study methods (are study design and analytical methods robust enough?). Globally, INESSS considers the integration of RWE in appraisals and its weighting, in relation with the (more traditional) available evidence, to be a case-by-case exercise.

The characterization of the main factors driving the integration of RWE in reimbursement appraisals at INESSS serves as a basis for communicating the requirements for evaluation submissions by sponsors. It further reinforces INESSS capabilities in assessing innovations, which can imply an appraisal of value at various moments along the lifecycle and with a diversity of evidence types. Considering the rapidly evolving literature and international experience, this work is expected to evolve too, and will be updated as needed.

Stakeholders from the innovation field in Québec (Canada) have collectively stressed the need to formalize the process for evaluating innovative technologies in the province. In the context of innovation, and more so for non-pharmaceutical technologies where the pace of development is rapid and the lifecycle short, evidence supporting the added value can be limited and uncertainties are common. Therefore, pragmatic approaches are needed to guide recommendations and to assure that the process is rigorous, transparent and fair.

Inspired by international experiences, the Institut national d'excellence en santé et services sociaux (INESSS) has developed a novel framework, where four types of recommendations are possible (introduction, refusal, limited or conditional introduction). The starting point is an evaluation of the technology's added value, for the patient, the population and the healthcare system, and the identification of uncertainties. The value of addressing uncertainty with further research is assessed, based on the value-of-information theory, and the distinct characteristics of medical devices are taken into account (e.g. learning curve effect, irrecoverable costs and incremental innovation). Those elements interact to support the formulation of recommendations by INESSS’ advisory committee.

The development of the framework was an iterative process supported by the use of the preliminary framework for the assessment of several innovative technologies. Challenges with its use were identified, and led to methodological and operational improvements. So far, the experience with the framework is positive and stakeholders confirm its relevance to support fair and reasonable recommendations for innovations.

In the rapidly changing landscape of innovation, HTA has to adapt to the challenges of assessing technologies in a context of promise and uncertainties. The framework developed by INESSS is a tool for supporting timely and fair value-based decision-making, which will benefit the healthcare system, and the patients and population it serves.

Decision makers worldwide face the challenge of offering the best health care within a context of scarce resources. Technological developments have multiplied in the past decades, with the lifecycle of technologies becoming shorter. As a result, the traditional Health Technology Assessment (HTA) model is often caught in a too early, too late syndrome. In the province of Québec (Canada), there is no standardized process for assessing non-pharmaceutical technologies for reimbursement purposes, and technologies are therefore introduced via multiple sources. There are concerns that the introduction of some of the most promising technologies is delayed, and on the contrary, that others are introduced without providing a real added value to patients and the health system.

INESSS (Institut national d'excellence en santé et services sociaux), collectively with stakeholders of the Québec innovation field, has developed a dynamic process for assessing the added value of innovative technologies. POETIS (Processus optimisé d'évaluation des technologies innovantes en santé) aims to identify the technologies with the highest potential for positive impact on patients and the health system, in order to accelerate their implementation and promote their optimal use.

POETIS comprises four phases aligned with the lifecycle of technologies: research and development, pre-implementation, limited implementation, and diffusion. It allows a continuum of assessment, from the promise of a technology to its real-world benefit. It differs from other approaches because of the sustained involvement of key stakeholders, including patients, and because it assesses technologies iteratively, therefore fostering their adaptation to better suit patients needs. It is hoped for the first technologies to be assessed in 2017.

HTA has to adapt to the challenges of innovation, and this could be done with a lifecycle approach and an enhanced collaboration with end-users. Developed in Canada, the goals behind POETIS are common to many countries and the process could be adapted by other HTA agencies.