Systematic review for the development of a pharmaceutical and medical products prioritization framework

Objective To identify and analyze the criteria, approaches, and conceptual frameworks, used for national/international priority setting. Data sources We performed a search of the main biomedical databases (Medline/PubMed, Embase, Centre for Reviews and Dissemination, and Cochrane), and we reviewed assessment agency websites, among other sources. Study design An systematic review of the literature was carried out. Data collection Eligibility criteria for inclusion were based on set of predefined criteria. Systematic reviews and/or qualitative studies (interviews, surveys, expert consensus, etc) that aimed to identify prioritization criteria or develop general operational frameworks for the selection of health priorities were included. A critical analysis is made of all the aspects that may be useful for any public body that intends to establish priorities in health. Principal findings We found that there are no standardized criteria for priority setting, although common trends have been identified regarding key elements. Eight key domains were identified: 1) need for intervention; 2) health outcomes; 3) type of benefit of the intervention; 4) economic consequences; 5) existing knowledge on the intervention/quality and uncertainties of the regarding evidence; 6) implementation and complexity of the intervention/feasibility; 7) justice and ethics; and 8) overall context. Conclusions Our review provides a thorough analysis of the relevant issues and offers key recommendations regarding considerations for developing a national prioritization framework. Findings are envisioned to be useful for different public organizations that are aiming to establish healthcare priorities. Electronic supplementary material The online version of this article (10.1186/s40545-019-0181-2) contains supplementary material, which is available to authorized users.


Introduction
A health technology is defined as an intervention that may be used to promote health, to prevent, diagnose or treat acute or chronic disease, or for rehabilitation. Health technologies include pharmaceuticals, devices, procedures and organizational systems used in health care [1].
The World Health Organization (WHO) state that defines health technology assessment (HTA) refers to the systematic evaluation of properties, effects, and/or impacts of health technology [2]. It is a multidisciplinary process to evaluate the social, economic, organizational and ethical issues of a health intervention or health technology [3].
The main purpose of conducting our assessment is to develop an explicit priority setting methodology to support decision-making regarding Medicines and Medical Devices to be included in Hospital Pharmacy practice. The development of a comprehensive prioritization system is the outcome essential for an important benefit    to the healthcare system [4]. The aim of this research is to identify and analyze the processes and decision criteria used internationally for priority setting in order to establish a comprehensive set of strategic criteria for starting point for the development of a Medicines and Medical Devices prioritization framework.

Methods
A systematic search of the literature was carried out in December 2017, in the main biomedical electronic databases: Medline/PubMed, Embase, Centre for Reviews and Dissemination (CRD), and Cochrane. For this, a specific search strategy was designed combining the terms: "medicine", "technology assessment, biomedical", "technology", "intervention" with "priority", "prioriti*", "selection" with "criteria", "Setting", "approach*"and "procedure*". The detailed search terms for different electronic databases is listed in Additional file 1. Eligibility criteria for inclusion / exclusion were based on set of predefined criteria (Table 1). Systematic reviews and/or qualitative studies (interviews, surveys, expert consensus, etc) that aimed to identify prioritization criteria or develop general operational frameworks for the selection of health priorities were included. The web pages of the international agencies belonging to EUnetHTA and INAHTA were reviewed, and manually searched in the main scientific journal of the specialty (International Journal of Technology Assessment Health Care) [5][6][7][8]. In addition, a general search was carried out in the Google and Google Scholar search engine to locate gray literature, and bibliographic citations of included studies were reviewed. For perusal of the complete text, we selected records in which any type of pharmaceutical or medical product was assessed. It was not considered relevant to apply a methodological quality scale or gradation of evidence when not addressing a clinical research question. Data of the studies were analyzed and synthesized qualitatively.

Results
A total of 17 documents complied with eligibility criteria, out of which 15 were published in scientific journals [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] and two elsewere [24,25]. Fig. 1 details the selection process of the articles and the reasons for exclusion of potentially relevant articles. The studies showed great heterogeneity. A total of 56 potentially relevant priority setting criteria were identified, which could be grouped in eight categories: 1) Need for intervention; 2) Outcomes of intervention; 3) Type of benefit; 4) Economic consequences; 5) Existing knowledge/quality of evidence and uncertainties; 6) Implementation complexity/feasibility; 7) Justice and equity; and 8) Context. Table 2 describes these eight categories. Table 2 describes the domains and general criteria identified or proposed in these studies, detailing the conceptual terms used to classify them. The current work includes eight studies that address the identification, selection or classification of criteria used in the international arena for the establishment of health priorities. [10][11][12][13][14][15][16] Three of the studies retrieved refer to the EVIDEM (Evidence and Value: Impact on Decision Making) tool. In this multicriteria tool, developed from a thorough analysis of the literature, the opinion of experts and different international experiences, refers to 13 universal quantitative criteria (5 domains) and 7 contextual qualitative criteria (3 domains). [10][11][12]

Discussion
The results of our review show that, despite a general agreement regarding the need to establish rational and transparent procedures to prioritize medicinal products and medical devices, and a certain concordance with respect to critical domains exists, there is scarce information available on the explicit processes employed by the evaluation agencies for the establishment of priority issues [26][27][28][29]. This review can be used by different bodies interested in priorization framework. All domains and criteria have advantages and limitations, despite the fact all themes were devised rigorously. It should be noted that the present review is limited by the difficulties inherent in the bibliographic search. To improve efficiency, the search has been restricted to the title, so it is possible to have lost some relevant article despite using different combinations of keywords and related terms. In addition, in many cases this type of information is not published in scientific journals and is difficult to recover due to the serious shortcomings of the search engines of web pages, or because it is published in other languages. In any case, we believe that this would not detract from the current work, since we do not intend to describe all international experiences, but to identify those criteria and elements that may be key to the development of a national prioritization proposal. The implementation science principles for pharmacist and other healthcare providers, discovering and applying strategies designed to incorporate evidence-based interventions into routine practice is a must [30].

Conclusion
Our review provides a thorough analysis of the relevant issues and offers key recommendations regarding considerations for developing a national prioritization framework. Findings are envisioned to be useful for different public organizations that are aiming to establish healthcare priorities.