BACKGROUND AND OBJECTIVES:Aboriginal and Torres Strait Islander people can experience inequitable access to health services. This study assessed the effectiveness of a culturally responsive medication management service (referred to as IMeRSe). METHOD:This is a pre-post single-arm study involving Aboriginal and Torres Strait Islander health services and community pharmacies. Participants had a chronic condition, were pregnant or postpartum within 2 years. Pharmacists wrote a collaborative Medicines Plan and made recommendations to clinicians. The primary outcome was serious medication-related problems 6-months post-IMeRSe. Secondary outcomes included medication adherence. RESULTS:For 255 participants, mean serious medication-related problems reduced from 4.11 to 3.85 per 6 months at risk (incidence rate ratio, 0.93; 95% confidence interval, 0.86-1.01), although rates of potentially preventable medication-related hospitalisations remained similar. Significant improvements in medication adherence were observed. General practitioners accepted 709 of 762 pharmacist recommendations. DISCUSSION:A culturally responsive medication management service delivered by community pharmacists can contribute to reduced serious medication-related problems, improved medication adherence and consumer empowerment.

The current study aimed to examine the influence of distinct patterns of prenatal alcohol exposure (PAE) and postnatal threat and deprivation during infancy on sleep outcomes at three-years. Data were derived from a longitudinal cohort originating from predominately low-income hospital settings in Australia (n = 1952 children; 50.6% female; 80.1% maternal education of trade school or less; 87.4% born in Australia or UK; 2.1% identified as Aboriginal and/or Torres Strait Islander) across three developmental waves (prenatal, 12 months, and three years). Children with two distinct patterns of heavy PAE, heavy reducer and heavy throughout, showed statistically significantly reductions in sleep duration at age three in the context of early threat exposure, relative to children with no PAE (11 minute reduction per threat exposure & 30 minute reduction per threat exposure, respectively; small effects). Threat exposure during infancy also independently predicted more night waking (11% increase in frequency per threat exposure; moderate effects) at three years. Overall, Overall, addressing children's intersectional pre- and post-natal risks remains a critical way forward.

BACKGROUND:Human papillomavirus (HPV) vaccination is a global strategy for the prevention of cervical cancer (CC). Although Australia and the United States (US) have achieved high coverage, the cumulative HPV rate of the first vaccination for Japanese females born in 2008 was approximately 55%, despite policy efforts. This study compared the situation in Japan with that in Australia and the US, where vaccination rates are higher. METHODS:We conducted a unified benefit-risk assessment using disability-adjusted life year (DALY) rates to quantify the expected net value (ENV) of HPV vaccination programs per 100,000 eligible girls in Australia (2013-2020), the US (2013-2020), and Japan (2013-2024). Data on vaccination coverage, adverse events (AEs), and CC incidence were sourced from national health agencies and the Global Burden of Disease Study 2019. RESULTS:The vaccination coverage was 78.3% in Australia, 50.1% in the US, and 21.4% in Japan during the survey period. The ENV gained were 52.9 for Australia, 56.7 for the US, and 23.4 for Japan, reflecting differences in vaccination rates and CC burden. Across countries, the reporting rate of AEs was <0.05%, with most reports related to nervous system disorders and nonspecific symptoms. The benefit-to-risk ratio in Japan improved 7.9-fold after the resumption of active vaccination recommendations in 2021, largely owing to reduced reports of AEs. CONCLUSION:Japan's lower ENV gained compared to those of Australia and the US is primarily attributable to its low vaccination coverage and higher DALY rate for CC. HPV vaccination programs in Australia and the US have demonstrated strong benefit-risk profiles. Achieving vaccination rates comparable to those in Australia and the US can substantially improve outcomes. Japan's recent policy changes and educational initiatives have reduced AE concerns; however, further efforts are needed to raise the coverage of international benchmarks.

The purpose of this study was to estimate the consensus of Australian Health Professionals and/or Researchers (HP/Rs) and Consumers (patients/family/carers) (Cs) on international genetic testing recommendations. Modified Delphi Panel study with seven domains of interest. Fifty-five statements were devised for an online survey administered in REDCap. HP/Rs and Cs were recruited from professional networks and associations for participation in the study. Statements were rated using a Likert scale and analysed using descriptive statistics. Free text comments were allowed within each domain and analysed using thematic analysis. Thirty-six HP/Rs and 27 Cs participated. There was consensus on testing men with a family history of a high-risk hereditary gene; men with PCa and a family history of Hereditary Breast and Ovarian Cancer (HBOC) syndrome or Lynch syndrome; and men with metastatic PCa. There was consensus on testing BRCA2, BRCA1 and DNA MMR genes for men with metastatic PCa. Thematic analysis of HP/R comments revealed three main topics: the lack of information to make a decision, insufficient knowledge of genetic testing, and capacity to provide genetic testing and counselling. This is the first Australian study on genetic testing recommendations in PCa to inform who should be tested and how. Our study showed apparent deficits in knowledge and implementation, exacerbated by workforce issues around the provision of genetic counselling and testing. Future work should focus on evaluating these recommendations for implementation in Australian practice.

ABSTRACT Background Metabolic and bariatric surgery is the most effective long‐term treatment for patients with obesity; however, access to publicly funded surgery in Australia has been limited despite strong evidence of clinical benefit. The Bariatric Surgery Initiative (BSI) was established to improve equitable access for people with obesity and type 2 diabetes, but its long‐term economic value has not been evaluated. This study assessed the cost‐effectiveness of metabolic and bariatric surgery compared with usual medical care to inform health‐system decision‐making. Methods A Markov model was developed to simulate health outcomes and costs over the rest of life for patients with BSI. The model had five health states representing BMI classes. Costs obtained from the BSI for the surgical procedure were used and long‐term costs for BMI classes were drawn from the literature. Quality of life (utility) weights were obtained from the BSI as were outcomes at 12 months following surgery. A Usual Care comparison group was developed from the literature and long‐term costs were applied to both groups depending on the BMI class. Incremental cost‐effectiveness ratios were estimated and sensitivity analyses were undertaken from the perspective of the Australian public health system. Results The base‐case analysis demonstrated that MBS was the preferred strategy that is, better health outcomes (2.5 QALYs gained) and lower costs (cost‐savings of $67,000). Scenario analyses identified that younger age groups have greater health benefits and higher BMI classes have greater cost‐savings. Conclusions MBS is a cost‐effective intervention for patients with obesity class 2 and diabetes. The BSI was an efficient service that provided the necessary information to develop the local evidence.

Background and objectives Heart failure requires complex and daily self-care that many patients struggle with for a range of reasons including limited health literacy, cognitive impairment, comorbidities, and emotional distress. This study describes the user-centred design and development of a mobile app (SmartHeart) to support comprehensive self-monitoring and improve self-care engagement for people with heart failure. Methods Building on previous co-design research and expert panel feedback, we developed an initial Figma prototype following user-centred design principles. Two online sessions were conducted with adults living with heart failure (n=7), including a focus group session and a follow-up individual feedback session. The same participants took part in both sessions to provide feedback on the functionality, aesthetics, navigation, and content. Data were analysed deductively based on heuristic principles of user interface design, with findings informing the iterative development of the SmartHeart mobile app. The functional app was tested in-home by two participants over two weeks to evaluate real-world usability and gather contextual feedback to inform further refinement. Results The SmartHeart prototype was developed through expert workshops and user feedback. Participants emphasised simplicity, leading to a streamlined design with clear navigation, adaptable graphics, and larger fonts. The app’s health tracking features were iteratively improved. User-driven modifications included personalised threshold alerts, simplified symptom reporting, and integrated medication reminders. Participants reported high satisfaction with the prototype interface and health monitoring capabilities; however, formative testing identified reliability issues that are being addressed prior to pilot evaluation. Findings primarily inform design refinements before evaluating clinical effectiveness. Conclusion The SmartHeart app was refined through user-centred design process involving direct feedback from individuals with heart failure, resulting in a self-care tool with user-friendly features, to be further evaluated in future research. These user-driven enhancements support self-care engagement and highlight the app’s potential for real-world use and broader clinical integration.

OBJECTIVE:People with disability and carers often experience poorer social, physical and mental health than the general population. Capitalising on opportunities for physical activity to improve these outcomes, we co-designed a prototype digital health platform (ConnectUp) to help geographically proximal consumers connect with each other to engage in shared physical activities. This protocol describes the design of a multi-stage study that aims to (1) address consumer feedback from formative research by co-designing citizen science informed features to collect, curate and share physical activity opportunities, then (2) evaluate the expanded ConnectUp platform when implemented at scale in a single-arm geographically staged implementation study. METHODS:Our project incorporates co-design and citizen science principles and will include two sequential stages: (1) iterative intervention design and user testing and (2) implementation and evaluation. The reach, effectiveness, adoption, implementation and maintenance (RE-AIM) evaluation framework will guide project evaluation. Stakeholders (people with disability, carers, partner organisations) will co-design project stage two outcome measures to ensure meaningful impact for the target communities and promote pragmatic impact and knowledge translation. IMPACT:Using a consumer and community-driven digital health approach, the ConnectUp project aims to reduce social, physical and mental health inequities among people with disability and carers and empower these communities to create, curate and share knowledge to support advocacy for inclusive practices and policies.Study registration: Not applicable as this project will not include a controlled experimental trial.

Other than measuring public opinion, policy makers have not pursued the involvement of the Australian public in decisions about the provision of medicinal cannabis (MC). This research measures public preferences for the provision of MC and the relationship of these preferences to current Australian policy. A total of 1166 Australian adults completed an online discrete choice experiment (DCE). The DCE consisted of 12 pairwise forced choice policy profiles per participant. Profile alternatives were described according to the attributes access, evidence, medical supervision, intoxicating ingredient, therapy format and cost, and were patient specific. Conditional logit (CL) and latent class analyses were conducted. Participants preferred MC to be prescribed at any time during a patient’s treatment plan and for costs to be subsidised. Oral formulations were preferred to raw flower forms. In general, the public preferred patients to be prescribed MC with low levels of tetrahydrocannabinol (THC). THC levels in MC were not important to the choices of males or when prescribing MC to patients with a terminal condition. Three response groups were found. Group 1 (34.9%) preferred patients to be prescribed oral formulations of low-intoxicating MC when all other medications have failed and there is good evidence for its use. Group 2 (40.3%) preferred MC to be available at any time of a patient’s treatment plan, and medical supervision or the level of intoxicating ingredient in the therapy was not important. Group 3 (24.8%) were the only group to have no preferences for the subsidisation of MC costs. All groups were disinclined toward the prescription of raw cannabis flower. In general, public preferences do not completely align with current Australian policy. The public would likely support the Australian government’s liberal policy on MC for terminal patients.

INTRODUCTION:Minimum important changes (MICs) represent thresholds for clinically meaningful change. Multi-attribute utility instruments (MAUIs) generate health state utilities (holistic measures of health-related quality of life). No systematic review of MICs specifically for MAUIs has been conducted. In addition, no guidelines for estimating MICs for MAUIs have been proposed. We aimed to correct these evidence gaps by producing guidelines contextualised by a systematic review. METHODS:We searched ten databases for relevant records using various search terms. Extracted data were analysed narratively and descriptively. The presence of key reporting items (relating to precision, sensitivity, and concurrent validity) was also evaluated. Guidelines for MIC estimation were informed by the broader MIC literature and contextualised using study results. RESULTS:The review identified 5035 non-duplicate records, with 68 entering the study. 282 unique, anchor-based MICs were extracted. Of these MICs, 119 (42.20%) pertained to the EQ-5D-3L, 82 (29.08%) to the EQ-5D-5L, and 50 (17.73%) to the SF-6D.v1. The most common anchor-based method used to estimate MICs (107, 37.94%) involved taking the mean change score for a group considered to have experienced a MIC. Distribution-based methods were also common, appearing in 31 (45.59%) of the included studies. The inclusion of key reporting items was generally deficient. CONCLUSIONS:Deficiencies in reporting and diverse estimation methods raise concerns regarding the extant MAUI MIC literature. Researchers should exercise caution when using existing MAUI MICs. Recommendations presented in our study may assist researchers in effectively estimating MICs for use in health economics.

OBJECTIVE:To determine the predictive accuracy of an early high risk of cerebral palsy (CP) classification for CP diagnosed by 2 years' corrected age within an implementation study of international clinical CP guidelines. DESIGN:Implementation cohort study. SETTING:Eleven Australian neonatal intensive care units. PATIENTS:453 infants born 2019-21 <28 weeks' gestation, or ≥28 weeks with other newborn-detectable risk factors for CP. INTERVENTIONS:Implementation included providing professional development for clinicians, technology (smartphone app) and health network peer support. Infants were classified as high risk of CP if they had abnormal findings on at least two of the following three assessments: neonatal neuroimaging, General Movements Assessment at 3-4 months or Hammersmith Infant Neurological Examination. MAIN OUTCOME MEASURES:Baseline perinatal data and 2-year outcome data were collected from medical record review. Any parent-report of CP at the 2-year interview was confirmed by medical records and/or a paediatrician's report. We calculated predictive values for high risk of CP classification for confirmed CP at 2 years. RESULTS:We obtained 2-year outcomes from 425 infants (95%). High risk of CP was classified in 105 (25%) of these infants at a mean age of 3.5 months (SD 2.5). This classification demonstrated 91% sensitivity (95% CI 82% to 96%), 90% specificity (95% CI 86% to 93%) and 90% accuracy (95% CI 87% to 93%) for predicting CP, with a mean age of diagnosis of 10.8 months (SD 6.3). CONCLUSION:Being classified as high risk of CP using a combination of neuroimaging, General Movements Assessment and/or Hammersmith Infant Neurological Examination can predict CP by 2 years of age with high accuracy.

BackgroundHeart failure (HF) is a chronic, progressive condition where the heart cannot pump enough blood to meet the body’s needs. In addition to the daily challenges that HF poses, acute exacerbations can lead to costly hospitalizations and increased mortality. High health care costs and the burden of HF have led to the emerging application of new technologies to support people living with HF to stay well while living in the community. However, many digital solutions have not involved consumers and health care professionals in their design, leading to poor adoption. The SmartHeart project aimed to codevelop a smart health ecosystem to support the early detection of HF deterioration and encourage self-care, potentially preventing hospitalizations. ObjectiveThis study aims to provide an overview of the SmartHeart project by describing our approach to designing the SmartHeart system, outlining its features, and describing the planned pilot study to determine the feasibility of the system. MethodsWe used the Integrate, Design, Assess, and Share (IDEAS) framework to guide the development of the SmartHeart system, involving users (people with HF and their caregivers) and stakeholders (health care providers involved in the management of HF) in its design. SmartHeart is a complete remote heart health monitoring and automated feedback delivery system. It includes 2 user interfaces for patients: an Amazon Alexa conversational agent and a smartphone app. The system collects physiological, symptom, and behavioral data through wireless sensors and self-reports from users. These data are processed and analyzed to provide personalized health insights, self-care support, and alerts in case of health deterioration. The system also includes a web-based user interface for health care professionals, allowing them to access data, send messages to users, and receive notifications about potential health deterioration. A single-arm, multicenter pilot trial (N=20) is planned to determine the feasibility and acceptability of SmartHeart before evaluation through a randomized controlled trial. The primary outcome will be a description of the study's feasibility (recruitment, attrition, engagement, and changes in self-care). ResultsThe SmartHeart study started in January 2021 on procurement of funding. Recruitment for the pilot trial started in August 2024 and will be completed by March 2025. We have currently enrolled 12 participants. Follow-up of all participants will be completed by the end of May 2025. ConclusionsWe have co-designed and developed a complete remote heart health monitoring and automated feedback delivery system for the early detection of HF deterioration and prevention of HF-related hospitalizations. The next step is a pilot study, which will provide valuable information on feasibility and preliminary effects to inform a larger evaluation trial. SmartHeart has the potential to augment existing health services and help people with HF stay well while living in the community. International Registered Report Identifier (IRRID)DERR1-10.2196/62964

Aim To explore preferences, experience and trust in digital health in people living with chronic kidney disease (CKD), and tailor these findings towards solutions that may enhance uptake of digital health services. Methods Mixed methods study, with cross-sectional survey and individual interviews with adults living with CKD attending specialist appointments at an Australian metropolitan hospital. Descriptive statistics and Wilcoxon matched-pairs test were used for survey responses and thematic analysis of interview transcripts, both reported on a theme-by-theme basis provided an overall understanding of trust in digital healthcare. Results Digital health is changing the way health services are provided, and our results demonstrate that despite limited familiarity, participants are open to learn and adapt to existing digital models of care. Limited exposure to technology may undermine trust in digital health, and telehealth can promote improvements in health literacy. Having the choice in healthcare modalities can promote trust, which can arise from trustful relationships with clinicians who demonstrate genuine interest in patient care. Participants expressed more concerns about sharing identity data than health data online and worry about fragmented information among providers. They preferred public health services due to distrust generated by the perceived risk of private sector data commercialisation. Building trust requires increasing awareness of digital health benefits, promoting positive experiences, improving digital literacy and ensuring interoperability and transparency in digital healthcare systems. Conclusion People with CKD want to learn and benefit from digital health. Choice and open disclosure on data management and purpose are paramount to building trust.

Background: Current economic evaluations (EEs) of precision medicine (PM) often adhere to generic reference cases (RCs) which overlook the unique healthcare paradigms of PM. This study aimed to develop an RC to standardize the conduct and reporting of EEs of PM. Methods: A working group comprising 5 core health economists, 22 PM experts, and research staff from Singapore, Thailand, the Netherlands, UK, and Australia who were actively engaged in EE and clinical PM implementation. The RC development comprised four stages: (1) Expert consultation shaping the RC's scope and structure across nine domains: Population, Intervention, Comparator, Cost, Outcome, Time, Equity and ethics, Adaptability, and Modelling (ie, "PICCOTEAM" framework); (2) A comprehensive literature review on current PM EE approaches and challenges; (3) Obtaining expert consensus and drafting recommendations; (4) A workshop for RC refinement based on stakeholder feedback on relevance and feasibility. Following an experts' workshop, consensus was reached to tailor PM recommendations for screening, diagnosis, and pharmacogenomics, market-access, and early EEs. Results: The PICCOTEAM RC offers 46 recommendations for conventional EEs to guide PM reimbursement, emphasizing expert engagement, iterative study processes, disease-specific outcomes, decision uncertainty analyses, and equity considerations. Additionally, 30 recommendations are provided for early-stage evaluation to enhance PM's positioning and value proposition, mitigating uncertainty, equity, and ethical issues. Conclusion: The PICCOTEAM RC offers a standardized process to conduct and report diverse PM EEs. This will serve as guidance for health departments, researchers, clinicians, editors, and reviewers. Pilot testing and continuous updates are recommended for ongoing relevance and applicability of this RC.

ABSTRACT Background The TROG 99.03 trial demonstrated improved progression‐free survival for patients with early‐stage follicular lymphoma (FL) treated with systemic therapy using rituximab‐cyclophosphamide, vincristine, prednisolone (R‐CVP) after involved‐field radiotherapy (RT) versus RT. As systemic therapy was associated with more acute toxicity, the possibility of long‐term toxicity, and no survival benefit yet, the cost‐effectiveness of RT+R‐CVP is important. Aim We performed a cost‐effectiveness analysis of RT (reference), RT+CVP, and RT+R‐CVP from the TROG 99.03 trial. Methods We constructed a Markov model (15‐year horizon) to compare treatments: RT (reference), RT+CVP and RT+R‐CVP from the 150 patients in the TROG 99.03 trial. Median follow‐up was 11.3 years (range: 4.4–17.8). Lifetime direct health care costs, quality‐adjusted life‐years (QALYs) and incremental cost‐effectiveness ratios (ICERs) were calculated. Australian dollars AUD$50,000 was defined as the proposed willingness‐to‐pay threshold (WTP). Results RT+R‐CVP was associated with an improvement of 0.711 QALYs compared to RT, 0.532 QALYs compared to RT+CVP, and was the dominant strategy. The costs of adverse events or retreatment for relapses or transformation had a minimal influence on the ICERs. Sensitivity analyses resulted in ICER values below the WTP with RT+R‐CVP remaining the dominant strategy. Conclusion RT+R‐CVP is clearly cost‐effective and was the dominant strategy in early‐stage FL compared to RT or RT+CVP as it delivers superior outcomes at a lower cost from the Australian tax‐payer's perspective. Trial Registration The authors have confirmed clinical trial registration is not needed for this submission

PURPOSE:Genetic testing is recommended in localized prostate cancer (PCa) with elevated risk and in metastatic PCa. The economics of genetic testing in metastatic PCa has been evaluated but not assessed in localized PCa. We examined the cost utility of germline BRCA testing in localized PCa with high risk of pathogenic variants. METHODS:Cost-utility analysis of germline BRCA testing in localized PCa with (1) high/very high-risk classification, (2) family history of PCa, and (3) Ashkenazi-Jewish ancestry. Analyses were performed from an Australian payer perspective using semi-Markov models over lifetime; quality-adjusted life years (QALYs) were the health outcomes. Decision uncertainty was characterized using 1-way and probabilistic sensitivity analyses. RESULTS:The incremental cost-effectiveness ratio of BRCA testing compared with no testing was AU$591,408/QALY in patients with high/very high risk, AU$3.9 million/QALY with family history of PCa, and AU$650,098/QALY in Ashkenazi-Jews. Adding cascade testing of first-degree relatives (FDRs) resulted in incremental cost-effectiveness ratios of AU$18,872/QALY, AU$47,294/QALY, and AU$14,637/QALY in the aforementioned groups. At a willingness-to-pay of AU$75,000/QALY, BRCA testing was not likely to be cost-effective in PCa patients; however, it was cost-effective after cascade testing FDRs. CONCLUSION:Germline BRCA testing may not be cost-effective when limited to patients with localized PCa but demonstrates value for money when extended to FDRs.

AIMS:This study aimed to explore the long-term cost-effectiveness of a nationally implemented, digitally enabled cardiac rehabilitation (DeCR) programme for patients admitted for coronary heart disease (CHD). METHODS AND RESULTS:We conducted a cost-effectiveness analysis, using a Markov model to compare DeCR with usual care. Coronary heart disease patients were recruited nationally post-hospitalization into an 8-week DeCR programme comprising telehealth consultations and a mobile app. Index hospitalization and rehospitalization costs were sourced from private hospital administrative insurance claims, and intervention delivery was micro-costed. Quality-adjusted life years (QALYs) were derived from EQ-5D-5L utility scores collected in the DeCR group and literature-based estimates for usual care. Costs and QALYS were modelled over a 5-year time horizon and discounted at 3% annually. Costs and QALYs were based on average values per patient, rather than being driven by sample sizes. Uncertainty was assessed using one-way and probabilistic sensitivity analyses, with a willingness-to-pay (WTP) threshold of AUD$50 000 per QALY. Of the 337 patients (DeCR: 88; usual care: 249), most were male (73%), aged ≥65 years (70%) with multimorbidity (Charlson Comorbidity Index ≥ 1: 61%). Digitally enabled cardiac rehabilitation yielded 4.677 QALYs at a cost of AUD$121,235, compared with 3.244 QALYs at AUD$100 733 for usual care. The incremental cost of AUD$20 503 resulted in an incremental cost-effectiveness ratio (ICER) of AUD$14 302 (€9082) per QALY gained, well below the WTP threshold. Key ICER drivers included mortality risk, proportion of usual care attending cardiac rehabilitation, and DeCR utility gained. Digitally enabled cardiac rehabilitation was cost-effective in 87% of simulations. CONCLUSION:Digitally enabled cardiac rehabilitation is a cost-effective alternative to usual care, offering improved health outcomes at an acceptable cost.

Digitally delivered health care, such as telehealth, mobile apps and remote monitoring via apps or devices, can result in improved outcomes for chronic conditions. However, Australia is struggling to maximise the potential of digital health for chronic conditions, due in part to funding arrangements that lack incentives for providers and end users. The aim of this article is to examine the current landscape of digital health funding for chronic conditions and considers potential funding arrangements for the future. Current funding arrangements for digital health in Australia lack sufficient incentives for both providers and end users, limiting the reach and effectiveness of digital health for managing chronic conditions. Alternative funding approaches, such as value-based models, are used internationally which include funding avenues for mobile apps and remote patient monitoring via apps or devices as well as for those operating digital health services. The development of sustainable value-based funding mechanisms that support stakeholder involvement and national adoption are recommended. For Australia to fully leverage the benefits of digital health in managing chronic conditions, funding reforms are one critical area to assist with the implementation of patient-centred and outcome-driven funding models. Effective and sustainable funding structures are essential to ensure long-term benefits of digital health for chronic disease management. Further research will be essential to identify effective funding avenues for digital health services, including mobile apps and remote patient monitoring.

Objectives: Economic evaluation has increased due to the emergence of national health technology assessment (HTA) agencies. This study aims to develop a country-specific guideline for conducting economic evaluation in the Kingdom of Saudi Arabia (KSA) as an HTA component to determine the value for money of new health interventions. Methods: The study conducted a real-time Delphi survey using 17 items from the method component of the Consolidated Health Economic Evaluation Reporting Standards checklist as foundation for guidelines. Consensus was reached for the relevance of guideline recommendations for the KSA healthcare system. We set a threshold of 80 % for agreement and an interquartile range less than three on a nine-point Likert scale. Interim analysis provided feedback for recommendations of items if no consensus exists. A natural language processing (NLP) approach was employed to examine the relationship between experts' comments and consensus decisions. Results: The study recruited 78 % experts with an average response progress rate of 97.2 %. Interim analysis provided a 63 % adjustment rate for recommendations with the majority requiring further clarification (65 %). The guidelines concluded with a consensus on 76 % of recommendations, while four remained undetermined, namely, choice of discount rate, use of same rates for health benefits and costs, outcome selection, and gross costing. The NLP results supported the consensus decision. Conclusions: Expert consensus contributed to the development of informative guidelines relevant to KSA. The guidelines serve as a reference case, thus providing a foundation for HTA practices, reimbursement decisions, and future research for the KSA and its neighboring countries.