To determine the level of awareness of health technology assessment (HTA) and its predictors among clinical year medical students in public universities in Klang Valley, Malaysia.

A cross-sectional study using the stratified random sampling method was conducted among clinical year medical students in four public universities in Klang Valley, Malaysia. Data on the level of awareness of HTA and its associated factors were collected using a self-administered online questionnaire. Descriptive, bivariate, and multivariate analyses were performed using IBM SPSS version 27 to determine the level of awareness of HTA and its predictors.

Majority (69 percent) of participants had a low level of awareness of HTA. The predictors of high-level awareness of HTA were attitude toward HTA (adjusted odds ratio (AOR) = 7.417, 95 percent confidence interval (CI): 3.491, 15.758), peer interaction on HTA (AOR = 0.320, 95 percent CI: 0.115, 0.888), and previous training on HTA (AOR = 4.849, 95 percent CI: 1.096, 21.444).

Most future doctors in public universities exhibit a low awareness of HTA. This study highlights the interplay between attitudes toward HTA, peer interaction, and previous training as influential predictors of HTA awareness. An integrated and comprehensive educational approach is recommended to cultivate a positive attitude and harness the positive aspects of peer interaction while mitigating the potential negative impact of misconceptions. Emphasizing early exposure to HTA concepts through structured programs is crucial for empowering the upcoming generation of healthcare professionals, enabling them to navigate HTA complexities and contribute to evidence-based healthcare practices in Malaysia and beyond.

To achieve universal health coverage (UHC), countries must make difficult choices to optimize the use of scarce resources. There is a growing interest in using evidence-based priority setting processes, such as Health Technology Assessment (HTA), to inform these decisions. In 2020, the Palestinian Institute of Public Health (PNIPH) and the Norwegian Institute of Public Health (NIPH) initiated a pilot to test the feasibility of coproducing an HTA on breast cancer screening in the West Bank, occupied Palestinian Territory. Additionally, a secondary aim was to test whether using an adaptive HTA (aHTA) approach that searched and transferred published evidence syntheses could increase the speed of HTA production.

The applied stepwise approach to the HTA is described in detail and can be summarized as defining a core team, topic selection, and prioritization; undertaking the HTA including adaptation using tools from the European Network for HTA (EUnetHTA) and stakeholder engagement; and concluding with dissemination.

The aHTA approach was faster but not as quick as anticipated, which is attributed to (i) the lack of availability of local evidence for contextualizing findings and (ii) the necessity to build trust between the team and stakeholders. Some delays followed from the COVID-19 pandemic, which showed the importance of good risk anticipation and mitigation. Lastly, other important lessons included the ability of virtual collaborations, the value of capacity strengthening initiatives within low- and middle-income countries (LMICs), and the need for early stakeholder engagement. Overall, the pilot was successfully completed.

This was the first HTA of its kind produced in Palestine, and despite the challenges, it shows that HTA analysis is feasible in this setting.

Health technology assessment (HTA) is an area that remains less implemented in low- and lower middle-income countries. The aim of the study is to understand the perceptions of stakeholders in Uganda toward HTA and its role in decision making, in order to inform its potential implementation in the country.

The study takes a cross-sectional mixed methods approach, utilizing an adapted version of the International Decision Support Initiative questionnaire with both semi-structured and open-ended questions. We interviewed thirty key informants from different stakeholder institutions in Uganda that support policy and decision making in the health sector.

All participants perceived HTA as an important tool for decision making. Allocative efficiency was regarded as the most important use of HTA receiving the highest average score (8.8 out of 10), followed by quality of healthcare (7.8/10), transparency (7.6/10), budget control (7.5/10), and equity (6.5/10). There was concern that some of the uses of HTA may not be achieved in reality if there was political interference during the HTA process. The study participants identified development partners as the most likely potential users of HTA (66.7 percent of participants), followed by Ministry of Health (43.3 percent).

Interviewed stakeholders in Uganda viewed the role of HTA positively, suggesting that there exists a promising environment for the establishment and operationalization of HTA as a tool for decision making within the health sector. However, sustainable development and application of HTA in Uganda will require adequate capacity both to undertake HTAs and to support their use and uptake.

In low- and middle-income countries (LMICs) striving to achieve universal health coverage, the involvement of different stakeholders in formal or informal ways in health technology assessment (HTA) must be culturally and socially relevant and acceptable. Challenges may be different from those seen in high-income countries. In this article, we aimed to pilot a questionnaire for uncovering the context-related aspects of patient and citizen involvement (PCI) in LMICs, collecting experiences encountered with PCI, and identifying opportunities for patients and citizens toward contributing to local decision- and policy-making processes related to health technologies.

Through a collaborative, international multi-stakeholder initiative, a questionnaire was developed for describing each LMIC's healthcare system context and the emergence of opportunities for PCI relating to HTA. The questionnaire was piloted in the first set of countries (Brazil, Indonesia, Nigeria, and South Africa).

The questionnaire was successfully applied across four diverse LMICs, which are at different stages of using HTA to inform decision making. Only in Brazil, formal ways of PCI have been defined. In the other countries, there is informal influence that is contingent upon the engagement level of patient and citizen advocacy groups (PCAGs), usually strongest in areas such as HIV/AIDS, TB, oncology, or rare diseases.

The questionnaire can be used to analyze the options for patients and citizens to participate in HTA or healthcare decision making. It will be rolled out to more LMICs to describe the requirements and opportunities for PCI in the context of LMICs and to identify possible routes and methodologies for devising a more systematic and formalized PCI in LMICs.

Depending on the health system context and the demands of relevant stakeholders in countries, the need, organizational structure, and prerequisites for enabling capacity building and development in health technology assessment (HTA) will vary. Core competencies are instrumental in this and include essential knowledge, skills, and attitudes (KSAs). They provide building blocks for delivering high-quality and effective practices of HTA. We aimed to systematically explore and develop an overview of the core competencies necessary for HTA.

This study was conducted during 2016–19 using different methods in a structured manner. We drew concepts of KSAs from various literature sources, surveyed universities and HTA professionals, and conducted expert workshops to arrive at a common understanding of the required competencies.

The terminology for KSAs defining competencies in HTA programs has been clarified. In addition, a list of competencies offered through different educational and training programs has been created. The surveys provided clarity on a common understanding of KSAs among HTA stakeholders. Thereafter, a set of competencies was described and classified according to the HTA domains.

Our study shows that there is diversity in HTA programs offered by educational institutions. The content of the programs varies due to differences between countries regarding the level of HTA development and the need for HTA, including the understanding of what HTA is. The preparation of a competency checklist or a “menu” of options mirroring the diversity of HTA will ensure that the specific needs of the HTA community will be covered.

This paper aims to describe the development of a flowchart to guide the decisions of researchers in the Spanish Network for Health Technology Assessment of the National Health System (RedETS) regarding patient involvement (PI) in Health Technology Assessment (HTA). By doing so, it reflects on current methodological challenges in PI in the HTA field: how best to combine PI methods and what is the role of patient-based evidence.

A decisional flowchart for PI in HTA was developed between March and April 2019 following an iterative process, reviewed by the members of the PI Interest Group and other RedETS members and validated during an online deliberative meeting. The development of the flowchart was based on a previous methodological framework assessed in a pilot study.

The guidelines on how to involve patients in HTA in the RedETS were graphically represented in a flowchart. PI must be included in all HTA reports, except those that assess technologies with no relevant impact on patients’ experiences, values, and preferences. Patient organizations or expert patients related to the topic of the HTA report must be identified and invited. These patients can participate in protocol development, outcomes' identification, assessment process, and report review. When the technology assessed affects in a relevant way patient experiences, values, and preferences, patient-based evidence should be included through a systematic literature review or a primary study.

The decisional flowchart for PI in HTA contributes to the current methodological challenges by proposing a combination of direct involvement and patient-based evidence.

The pan-Canadian Oncology Drug Review (pCODR) evaluates new cancer drugs for public funding recommendations. While pCODR's deliberative framework evaluates overall clinical benefit and includes considerations for exceptional circumstances, rarity of indication is not explicitly addressed. Given the high unmet need that typically accompanies these indications, we explored the impact of rarity on oncology HTA recommendations and funding decisions.

We examined pCODR submissions with final recommendations from 2012 to 2017. Incidence rates were calculated using pCODR recommendation reports and statistics from the Canadian Cancer Society. Indications were classified as rare if the incidence rate was lower than 1/100,000 diagnoses, a definition referenced by the Canadian Agency for Drugs and Technologies in Health. Each pCODR final report was examined for the funding recommendation/justification, level of supporting evidence (presence of a randomized control trial [RCT]), and time to funding (if applicable).

Of the ninety-six pCODR reviews examined, 16.6 percent were classified as rare indications per above criteria. While the frequency of positive funding recommendations were similar between rare and nonrare indication (78.6 vs. 75 percent), rare indications were less likely to be presented with evidence from RCT (50 vs. 90 percent). The average time to funding did not differ significantly across provinces.

Rare indications appear to be associated with weaker clinical evidence. There appears to be no association between rarity, positive funding recommendations, and time to funding. Further work will evaluate factors associated with positive recommendations and the real-world utilization of funded treatments for rare indications.

Traditionally, health technology assessment (HTA) focuses on assessing the impact of pharmaceutical technologies on health and care. Resources are scarce and policy makers aim to achieve effective, accessible health care. eHealth innovations are increasingly more integrated in all healthcare domains. However, how eHealth is assessed prior to its implementation in care practices is unclear. To support evidence-informed policy making, this study aimed to identify frameworks and methods for assessing eHealth's impact on health care.

The scientific literature in five bibliographical databases was systematically reviewed. Articles were included if the study was conducted in a clinical setting, used an HTA framework and assessed an eHealth service. A systematic qualitative narrative approach was applied for analysis and reporting.

Twenty-one HTA frameworks were identified in twenty-three articles. All frameworks addressed outcomes related to the technical performance and functionalities of eHealth service under assessment. The majority also addressed costs (n = 19), clinical outcomes (n = 14), organizational (n = 15) and system level aspects (n = 13). Most frameworks can be classified as dimensional (n = 13), followed by staged (n = 3), hybrid (n = 3), and business modeling frameworks (n = 2). Six frameworks specified assessment outcomes and methods.

HTA frameworks are available for a-priori impact assessment of eHealth services. The frameworks vary in assessment outcomes, methods, and specificity. Demonstrated applicability in practice is limited. Recommendations include standardization of: (i) reporting characteristics of eHealth services, and (ii) specifying assessment outcomes and methods following a stepped-approach tailored to the functional characteristics of eHealth services. Standardization might improve the quality and comparability of eHTA assessments.

This study aims to assess participants’ views on previous experiences, the current situation and future perspectives for early dialogue between the pharmaceutical industry, a regulatory agency and health technology assessment bodies (HTABs) in Europe.

Eleven semi-structured interviews were arranged purposively with experienced people from the pharmaceutical industry, the European Medicines Agency, and an expert in Health Economics. The interview questions focused on the value of early dialogue, the challenges faced during the process of early dialogue, the best time to start an early dialogue, the kind of products most suitable for early dialogue, the current situation, and future perspectives for the early dialogue process. The interviews were recorded and then transcribed for open and axial coding to summarize the findings.

All interviewees agreed that early dialogue is a valuable process that helps to inform the development program and accordingly provide patients with faster access to new medicines. However, at this stage, the pharmaceutical industry acknowledged certain challenges: (i) Finding resources within pharmaceutical companies and HTABs to support early dialogues (ii) Requirements between regulators and HTABs in different countries diverge.

This study revealed that people from the pharmaceutical industry perceive early dialogue as a valuable tool that can bring medicines to patients faster by streamlining development. However, the challenges mentioned above need to be mitigated to build a sustainable mechanism for early dialogue.