A robotically assisted surgical system, the da Vinci surgical system (DVSS), is a sophisticated surgical platform equipped with immersive 3D visualization and dexterous articulating endoscopic instruments. Surgeons can intuitively control the surgical system to perform delicate surgical tasks. Robotic surgery has gained popularity globally ever since its birth and was approved to market by the China Food and Drug Administration in 2006. This study aims to map the current use of DVSSs in mainland China and the trends from 2009 to 2019.

A full-sample survey of all hospitals equipped with DVSSs was conducted in mainland China, collecting data on hospitals and surgical departments using DVSSs, operation volume, and time of installation. Disease classification was standardized to obtain DVSS use in each department. EXCEL software was used for logging and cleaning the data. The analysis focused on descriptive analysis to map trends of DVSS use in China and present geographical and department distribution.

The DVSSs installed have grown from seven in 2009 to 135 in 2019. By the end of 2019, twenty-eight provinces in China have been equipped with the DVSSs, among which eighty-seven in the eastern regions, twenty-seven in the central regions, and twenty-one in the western regions. The annual volume of operations grew from 339 in 2009 to 38,991 in 2019, at an annual rate of 60.7 percent. The average workload conducted by a single robot is much higher than that of their counterparts in other countries. The largest share of the volume is in department of urology (48%), followed by general surgery (25%) and thoracic surgery (13%).

The use of DVSSs in China has been growing rapidly and extensively, with certain differences between geographical regions and surgical departments. We need to further explore the factors affecting its use and operation efficiency and to evaluate the effectiveness as well as cost-effectiveness in real-world clinical practice to inform public policies on application of DVSS, for example, license and insurance.

Turkey's health reforms, which started in 2003, have led to increased access to health care and pharmaceuticals as well as rising public pharmaceutical expenditures. The need to improve healthcare decision making by implementing health technology assessment (HTA) has become an important priority for Turkey. This study sought to provide a tailor-made HTA implementation roadmap, drawing on insights from national stakeholders.

Our study aimed to describe the current HTA environment in Turkey and to explore long-term perspectives and suggestions from a wide spectrum of Turkish stakeholders regarding the preferred status of HTA in ten years (by 2029).

We conducted an online survey using a questionnaire previously applied in other HTA research. We assessed the current evaluation of medical and economic decision-making processes and examined the need for HTA. We also ascertained stakeholder perspectives on potential developments that can be done together with policymakers, representatives of pharmaceutical companies, and patient organizations. We also included general information about the pharmaceutical market and decision making processes in Turkey.

The survey was sent to various stakeholders from different areas within the health system. Additional face-to-face interviews were conducted with a few respondents to clarify some of their answers. A total of twenty-seven Turkish stakeholders completed the survey. Of these, twenty-one (78%) participants were employed in the public sector and six (22%) were from the private sector. The majority of the participants would introduce HTA for all new health technologies being considered for public reimbursement and institute an additional review process for currently reimbursed technologies. Most of the respondents considered that only new technologies with significant budget impact should be evaluated in the next ten years.

It is clear that Turkey needs to implement an HTA process in the future. Our study shows stakeholder expectations, which will be helpful for creating an HTA implementation roadmap, and it is clear that different stakeholders have different views and expectations about HTA implementation in Turkey. The experiences of other countries will also be helpful during the implementation process.

This study aimed to compare assessments between Beneluxa Initiative member countries’ assessments and identify alignments and divergences.

A retrospective comparative analysis was performed that investigated (i) number and type of assessed indications (for Austria (AT), Belgium (BE), Ireland (IE), and the Netherlands (NL)); (ii) added benefit conclusions (for BE, IE, and NL); and (iii) the main arguments underlying differences in conclusions (for BE, IE, and NL). Data were retrieved directly from agency representatives and from public HTA reports. European Medicines Agency approved indications were included for drugs assessed between 2016 and 2020, excluding veterinary drugs, generics, and biosimilars.

Only 44 (10 percent) of the 444 included indications were assessed by all four member countries. Between any pair of two countries, the overlap was higher, from 63 (AT–NL) to 188 (BE–IE). Added benefit conclusions matched exactly in 62–74 percent of the indications, depending on the countries compared. In the remaining cases, most often a difference of one added benefit level was observed (e.g., higher vs. equal relative effect). Contradictory outcomes were very rare: only three cases were observed (lower vs. higher effect). When assessing the underlying arguments for seven cases with different outcomes, differences were attributable to slight differences in weighing of evidence and uncertainties rather than disagreement on aspects within the assessment itself.

Despite high variability in European HTA procedures, collaboration on HTA between the Beneluxa Initiative member countries is very feasible and would likely not result in added benefit conclusions that would be very different from added benefit conclusions in national procedures.

One of the main tools for Hospital-Based Health Technology Assessment (HB HTA) is the preparation of a mini-health technology assessment (HTA) report. Despite the high value of the results of mini-HTA reports for hospital decision-makers, the classical mini-HTA report does not allow a direct comparison of several health technologies among themselves.

Based on the analysis of international experience of using the principles of multiple-criteria decision analysis (MCDA) in the field of HB HTA, we created and approved our own managerial decision-making model which includes five standardized multiple criteria. The value (weight) of each criterion was defined as the arithmetic mean obtained as a result of interviewing hospital decision-makers and an HTA expert group.

Five standardized multiple criteria were included in the structure of our mini-HTA report. These criteria presented the main results of assessment of the viability of implementing new health technologies (HTs) in hospital practice and contain the following: i) Novelty/innovation; ii) Comparative clinical effectiveness and safety; iii) Relevance (demand); iv) Economic effectiveness; and, v) Payback period. We conducted the modeling of various options of HTA results by using multiple criteria, which allowed us to determine the threshold values of the evaluated HTs corresponding to their priority for implementation: i) High priority - HTs are recommended for implementation; ii) Medium priority - HTs can be recommended only if there are sufficient financial resources in hospital; and, iii) Low priority - HTs may be recommended only if there are strong reasons for their need.

Integration of the principles of MCDA in the structure of mini-HTA reports gives the opportunity to i) make comparative assessments of implementing new health technologies based on standardized criteria; ii) determine the priority for implementation of newly evaluated health technologies; iii) avoid the influence of subjective factors on the managerial decision-making in hospitals.

While involving patients in health technology assessment (HTA) has become increasingly common and important around the world, little is known about the optimal methods of evaluating patients’ involvement (PI) in HTA. This scoping review was undertaken to provide an overview of currently available methods for the evaluation of PI, specifically the impact of PI on HTA recommendations.

A literature search was conducted using nine databases as well as a grey literature search of the websites of 26 organizations related to the conduct, practice or research of HTA to identify articles, reports and abstracts related to the evaluation of PI impact in HTA.

We identified 1,248 unique citations, six of which met our eligibility criteria. These six records (five articles, and one report) were all published after 2012. Four assessed the impact of patient experience submissions on final HTA recommendations; one evaluated the impact of direct involvement on HTA committees, and one assessed impact of multiple forms of involvement. Methods of evaluation included quantitative analyses of reimbursement decisions, qualitative interviews with those directly involved in an assessment, surveys of patient groups and committee members, and the review of HTA reports.

Quantitative evaluation of PI based on associations with funding decisions may not be feasible or fully capture the relevant impact of PI in the assessment of health technologies. Rather, a combination of both qualitative and quantitative strategies may allow for the most comprehensive assessment of the impact of PI on HTA recommendations when possible.

The Health Technology Assessment (HTA) of medicines is performed separately at the country level with some differences, but Italy, France, and Germany have implemented price and reimbursement systems strongly focused on the Added Therapeutic Value (ATV). This study investigates the level of agreement on ATV assessments by Agenzia Italiana del Farmaco (AIFA), Haute Autorité de Santé (HAS), and Gemeinsamer Bundesausschuss (G-BA).

A database was created collecting all information about drugs with innovativeness status requests in Italy from July 2017 to December 2022 and populated with the corresponding HAS and G-BA ATV assessments. The primary comparative analysis was conducted by grouping the ATV ratings into “higher added value” and “lower or no added value”, while a secondary analysis considered the Italian innovativeness status as a criterion to include the quality of evidence assessment. The concordance between ATV assessments was investigated through percentage agreement and unweighted Cohen k-value.

189 medicines/indications were included. The greatest agreement was found when comparing G-BA versus HAS (82 percent; k = 0.61, substantial agreement). Lower levels of agreements were observed for AIFA versus HAS and AIFA versus G-BA (respectively 52 percent; k = 0.17 and 57 percent; k = 0.25). The secondary analysis led to a reconciliation to moderate agreement for AIFA versus HAS (72 percent; k = 0.45) and AIFA versus G-BA (74 percent; k = 0.47).

A high degree of concordance between HTA organizations is reached when considering jointly ATV and quality of evidence, suggesting that the system is extensively mature to make a Joint Clinical Assessment, avoiding duplications and reducing access inequalities.

The latest international guideline recommended the add-on therapy of ezetimibe and PCSK9 inhibitors in selected people for the secondary prevention of cardiovascular diseases (CVDs). However, it remains unclear whether these regimens fit the Chinese healthcare system economically.

Based on the Chinese context, this simulation study evaluated four therapeutic strategies including the high-dose statin-only group, ezetimibe plus statin group, PCSK9 inhibitors plus statin group, and PCSK9 inhibitors plus ezetimibe plus statin group. The team developed a Markov model to estimate the incremental cost-effectiveness ratio (ICER). With each 1-yr cycle, the simulation subjects could have nonfatal cardiovascular events (stroke and/or myocardial infarction) or death (vascular or nonvascular death event) with a follow-up duration of 20 yr. Cardiovascular risk reduction was gathered from a network meta-analysis, and cost and utility data were gathered from hospital databases and published research.

For Chinese adults receiving high-dose statins for secondary prevention of CVDs, the ICER was US$68,910 per quality-adjusted life year (QALY) for adding PCSK9 inhibitors, US$20,242 per QALY for adding ezetimibe, US$51,552 per QALY for adding both drugs. Given a threshold of US$37,655 (three times of Chinese GDP), the probability of cost-effectiveness is 2.9 percent for adding PCSK9 inhibitors, 53.1 percent for adding ezetimibe, and 16.8 percent for adding both drugs. To meet the cost-effectiveness, an acquisition price reduction of PCSK9 inhibitors of 33.6 percent is necessary.

In Chinese adults receiving high-dose statins for the secondary prevention of CVDs, adding ezetimibe is cost-effective compared to adding PCSK9 inhibitors and adding both drugs.

To assess the adherence of economic evaluations to the recommendations on principles of economic evaluation as stated in the country-specific guidelines for three countries across different income groups, namely, Canada, South Africa, and Egypt.

Searches were undertaken in three databases to identify economic evaluations meeting predefined inclusion criteria. Methodological and reporting standards listed in the country-specific guidelines were converted into discrete binary variables to calculate mean adherence scores. Quality appraisal was done using Drummond's checklist. Stratified analysis was undertaken to identify independent variables affecting adherence.

We identified forty-four, seventy-nine, and sixteen economic evaluations for Canada, South Africa, and Egypt, respectively. The mean adherence score was the highest for Canada (71%), followed by South Africa (65%) and Egypt (60%). Adherence to guidelines was positively correlated with quality of studies, r = .72. Furthermore, the mean adherence score was significantly (p < .05) higher for studies using a cost-utility analysis design (72%), having local/national funding aid (72%), undertaken by a health economist (71%) and for pharmacoeconomic evaluations (70%).

The quality of economic evaluations improves with adherence to country-specific guidelines. Locally funded and health-economist led health technology assessments (HTAs) should be encouraged for greater adherence to the guidelines. The HTA researchers and the HTA bodies should lay emphasis on adherence to the country-specific guidelines for improving the quality of HTA evidence.

Health Canada is committed to the modernization of the use of real-world data (RWD) and evidence (RWE) to support regulatory decisions. As such, telephone interviews with stakeholders, including government decision makers, health technology assessment (HTA) producers, industry, and patients, to understand their experiences with and perspectives on how to enhance RWE use for medical devices were performed.

Thirty-four semi-structured telephone interviews with forty key informants were conducted. Transcripts were reviewed independently by one individual to identify, define, and categorize key concepts and were verified by a second reviewer.

There are expectations for Health Canada to provide a framework and guidance on RWE use, identify relevant outcomes for data collection and criteria for data quality, conduct post-market surveillance more systematically, and partner with HTA organizations to develop methods for RWE generation. Stakeholders interviewed support the RWE use for regulatory decisions and HTA recommendations. Moreover, robust scientific methods for RWE generation will be critical to ensure that relevant questions are asked and rigorous statistical analyses are done to answer them. Patients are likely to consent to share their anonymized or de-identified medical information for nonprofit purposes.

Key concepts from the interviews centered on the current and future RWE use for medical devices, considerations for the organizational, medical, scientific, and legal aspects and privacy issues of RWD collection or RWE generation, and options to implement the use of RWD and RWE. Our study findings will help inform the development of an RWE framework for regulatory decisions and HTA recommendations.