PP205 The Use Of Real-World Evidence To Support National Institute For Health And Care Excellence Medical Technology Submissions

IntroductionAlthough randomized controlled trials (RCTs) are recognized as providing the highest level of clinical evidence, few medical device RCTs are available due to underfunding or inherent challenges associated with trial design. This study examines the extent to which real-world evidence (RWE) supports the recommendations made by the National Institute for Health and Care Excellence Medical Technologies Evaluation Programme (MTEP).MethodsAll MTEP guidance documents published online prior to October 2020 were reviewed. The “case for adoption” recommendation, type of clinical data, and clinical critiques for each MTEP submission were extracted and categorized. RWE was defined as studies with neither blinding nor prospective selection or control of patient characteristics.ResultsOf the MTEP submissions reviewed, 34 of 45 (76%) received a positive recommendation. Independent of outcome, all submissions included RWE, but only 19 (42%) utilized RCT evidence (15 were recommended and four were not). Meta-analyses of RWE were used whenever possible. The most common clinical critiques in unsuccessful submissions were the following: (i) not generalizable to the United Kingdom National Health Service (NHS); (ii) low quality; (iii) likelihood of bias; (iv) trial design faults; (v) uncertain benefit; and (vi) evidence unrelated to scope.ConclusionsThis study suggests that while the use of RCTs has not always led to a positive recommendation, RWE can be valuable in decision-making. Evidence that is generalizable to the NHS, is related to the scope, and shows clear indication of benefit is more likely to positively influence MTEP decision-making.

PP89 The Investigation And Development Of A National Formulary Monitoring System Across Wales

IntroductionThe New Treatment Fund (NTF), launched in January 2017, aims to support the faster introduction of new medicines recommended by the National Institute for Health and Care Excellence (NICE) and the All Wales Medicines Strategy Group (AWMSG). The NTF requires seven health boards and one trust to make recommended medicines available within 60 days of any positive recommendation decision. The project goal was to develop a system for demonstrating how monitoring the NTF improves medicines access for the people of Wales.MethodsThe process was derived via a series of task and finish group meetings with relevant stakeholders. The monitoring criteria were agreed through a collaborative expert approach using a nominal group technique. This determined a minimal dataset of formulary status, which included time to formulary addition. Pre-NTF medicines data (n = 59) were available for a six-month period.ResultsBy the three-year milestone of the NTF, the average time taken for newly recommended medicines (n = 219) to become available to patients across Wales had decreased by eighty-five percent from 90 to 13 days (p < 0.01).ConclusionsAn innovative and robust system has been created for accurately monitoring the formulary addition of medicines within the NTF, supporting the rapid and comprehensive uptake of medicines deemed clinically and cost effective by NICE and the AWMSG.

The Effects of Service Quality and Positive Recommendation on Trust Building in Mobile Banking Adoption Among the Customers of Private Banks in Myanmar

This study attempts to follow the research direction and fill the research gaps of previous studies, most notably mobile financial service landscape, specifically mobile banking (MB) services of private banks in Myanmar. The proposed research model in this study emphasizes service quality, positive recommendation, and different perspectives of trust in namely: trust in bank and trust in MB, evaluated their extent of influence on customers of private banks to adopt MB. The data was collected from 310 customers of private banks in Myanmar. Structural equation modeling (SEM) and confirmatory factor analysis (CFA) were employed to analyze the data and investigate the hypotheses. The analysis results indicate that customer intention to adopt MB is significantly influenced by trust in MB however trust in the bank was found to be statistically insignificant. The positive recommendation plays a critical role in the improvements of trust in the bank and MB according to the research results. Although service quality is a key factor to obtaining positive recommendations and acquiring trust in the bank, it is an insignificant factor for building trust in MB. Further, trust in the bank has a significant effect on trust in MB. These findings are highly beneficial for future research studies in a similar context and bank managers to develop appropriate strategies regarding MB services in the private banking sector in Myanmar.

Maintaining AACSB international accreditation: from basics to best practices

Purpose A truly successful continuous improvement review (CIR) visit does more than merely check the boxes for a positive recommendation. It builds the story of the school and should be an opportunity for its culture to shine through. The purpose of this paper is to demonstrate how to facilitate a successful CIR visit by moving from the basics of accreditation to understanding, implementing and “living” best practices. Design/methodology/approach Short tenure and high turnover among business school deans, mean that the majority of those leading the CIR may have no previous experience with the process. Findings This study begins by providing an overview of the role of accreditation and the role of the dean in the accreditation process. With a combined experience of over 35 years in the dean role and having served on or chaired over 35 accreditation visits, the authors share their experiences and offer a seven-step process for understanding and implementing best practices in the Association to Advance Collegiate Schools of Business accreditation process. Originality/value The suggestions offered in this study should help schools enhance long-term positive outcomes and serve as a guide to those navigating the CIR process.

Assessment of karst geomorphosites on Kučaj and Beljanica mountains as a resource for the development of karst-based geopark

Protection and promotion of geoheritage has been changing and improving in recent decades, in line with the growing research in this field. Some research papers specifically study geomorphological geoheritage and introduce a special term − geomorphosite. Karst geomorphosites present specific objects of geomorphological heritage. On Kučaj and Beljanica mountains there is the largest karst area in Serbia. The purpose of this paper is to select and evaluate the scientific value of karst geomorphosites of Kučaj and Beljanica. More than one hundred karst geomorphosites were analyzed. In order to achieve more adequate coverage and representation, they were grouped into 25 geomorphotypes in three major geomorphological components of the investigated area. The results of this analysis highlighted the most important natural potentials of this area for establishing a karst-based geopark. More than 20 geomorphotypes have a positive recommendation index, which provides a good basis for further geotourism analysis.

Reimbursement recommendations for cancer drugs supported by phase II evidence in Canada

Background Phase ii data are increasingly being used as primary evidence for public reimbursement for oncologic drugs. We compared the frequency of reimbursement recommendations for phase ii and phase iii submissions and assessed for variables associated with a positive or conditional recommendation. Methods We identified submissions made to the pan-Canadian Oncology Drug Review’s Expert Review Commit­tee (perc), of the Canadian Agency for Drugs and Technologies in Health, July 2011 to July 2019, that were supported only by phase ii data. We identified variables within the perc’s deliberative framework, including clinical and eco­nomic factors, associated with the final reimbursement recommendation. We conducted a multivariable analysis with logistic regression for these variables: feasibility of phase iii study, hematologic indication, and unmet need. Results We identified 139 submissions with a perc final recommendation. In 27 instances (19%), the submission had only phase ii evidence, and a positive recommendation was issued for 63% of them (the positive recommendation rate was 82% for submissions with phase iii evidence). Clinical benefit (p < 0.001), unmet need (p = 0.047), and patient alignment (p = 0.015) were associated with a positive recommendation. If a future phase iii study was deemed feasible for submissions with only phase ii evidence, then in univariable (p = 0.040) and multivariable analysis (p = 0.024), the perc was less likely to recommend reimbursement (odds ratio: 0.132). Conclusions Although more than half the oncologic submissions with phase ii data were recommended for pub­lic reimbursement, compared with submissions having phase iii data, they were less likely to be recommended. A positive or conditional recommendation was more likely if clinical benefit and alignment with patient values was demonstrated. The perc was less likely to recommend reimbursement for submissions with phase ii evidence if a phase iii trial was deemed possible.

Reimbursement recommendations for cancer drugs supported by phase II evidence in Canada.

e14133 Background: Historically, pharmaceutical companies submitted phase III evidence for consideration of public reimbursement; however, phase II data is being more commonly used as primary evidence. Whether submissions with phase II data lead to similar rates of positive reimbursement recommendations as phase III data has not been comprehensively investigated. We compared frequency of reimbursement recommendations between phase II and phase III submissions for oncologic drugs and assessed for factors associated with a positive or conditional recommendation. Methods: We identified all submissions with phase II data from the CADTH pCODR’s expert review committee (pERC) recommendations from July 2011 to July 2019. We identified fourteen binary variables relating to clinical benefit, patient-based values, economic impact, and adoption feasibility. We used Fisher’s exact test to characterize associations between all variables and the final recommendation. We conducted multivariable analysis with logistic regression for three variables: feasibility of phase III study, hematologic indication, and unmet need. Results: We identified 139 submissions with a pERC final recommendation. Twenty-seven (19%) submissions were supported by phase II evidence, with 63% having a positive recommendation in comparison to 82% among submissions with phase III evidence. Clinical benefit (p < 0.001), gap in current treatment standards (p = 0.047), and patient alignment (p = 0.015) were associated with a positive recommendation, whereas the future feasibility of conducting a phase III study was associated with a negative recommendation (p = 0.040). No significant association was found between the recommendation and factors related to cost effectiveness or adoption feasibility. In multivariable analysis, only feasibility of a phase III study was significantly associated with a negative recommendation (p = 0.024, OR = 0.132). Conclusions: Oncologic submissions with phase II data were less likely to be recommended for public reimbursement than phase III studies. Positive or conditional recommendation was more likely if they demonstrated clinical benefit and aligned with patient values. pERC was less likely to recommend a submission with phase II if a phase III trial was either possible or already initiated.