Cost-effectiveness and benefits of perinatal health interventions in high-income settings: A protocol for a systematic review of economic evaluations.

BACKGROUND: Despite ongoing efforts, perinatal morbidity and mortality persist across all settings, imposing a dual burden of clinical and economic strain. Besides, the fragmented nature of economic evidence on perinatal health interventions hinders the formulation of effective health policies. Our review aims to comprehensively and critically assess the economic evidence for such interventions in high-income countries, where the balance of health outcomes and fiscal prudence is paramount. METHODS AND ANALYSIS: We will conduct a comprehensive search for studies using databases including EconLit (EBSCO), Cost Effectiveness Analysis (CEA) Registry, Medline (Ovid), Embase (Ovid), CINAHL Ultimate (EBSCO), Global Health (Ovid), and PubMed. Furthermore, we will broaden our search to include Google Scholar and conduct snowballing from the final articles included. The search terms will encompass economic evaluation, perinatal health interventions, morbidity and mortality, and high-income countries. We will include full economic evaluations focusing on cost-effectiveness, cost-benefit, cost-utility, and cost-minimisation analyses. We will exclude partial economic evaluations, reports, qualitative studies, conference papers, editorials, and systematic reviews. Date restrictions will limit the review to studies published after 2010 and those in English during the study selection process. We will use the modified Drummond checklist to evaluate the quality of each included study. Our findings will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) 2020 statement. A summary will include estimated costs, effectiveness, benefits, and the incremental cost-effectiveness ratio (ICER). We also plan to conduct a subgroup analysis. To aid comparability, we will standardise all costs to the United States Dollar, adjusting them to their 2022 value using country-specific consumer price index and purchasing power parity. ETHICS AND DISSEMINATION: This systematic review will not involve human participants and requires no ethical approval. We will publish the results in a peer-reviewed journal. TRIAL REGISTRATION: We registered our record on PROSPERO (registration #: CRD42023432232).

Cost-utility analysis of a palliative care program in Colombia.

BACKGROUND: The economic assessment of health care models in palliative care promotes their global development. The purpose of the study is to assess the cost-effectiveness of a palliative care program (named Contigo) with that of conventional care from the perspective of a health benefit plan administrator company, Sanitas, in Colombia. METHODS: The incremental cost-utility ratio (ICUR) and the incremental net monetary benefit (INMB) were estimated using micro-costing in a retrospective, analytical cross-sectional study on the care of terminally ill patients enrolled in a palliative care program. A 6-month time horizon prior to death was used. The EQ-5D-3 L questionnaire (EQ-5D-3 L) and the McGill Quality of Life Questionnaire (MQOL) were used to measure the quality of life. RESULTS: The study included 43 patients managed within the program and 16 patients who received conventional medical management. The program was less expensive than the conventional practice (difference of 1,924.35 US dollars (USD), P = 0.18). When compared to the last 15 days, there is a higher perception of quality of life, which yielded 0.25 in the EQ-5D-3 L (p < 0.01) and 1.55 in the MQOL (P < 0.01). The ICUR was negative and the INMB was positive. CONCLUSION: Because the Contigo program reduces costs while improving quality of life, it is considered to be net cost-saving and a model with value in health care. Greater availability of palliative care programs, such as Contigo, in Colombia can help reduce existing gaps in access to universal palliative care health coverage, resulting in more cost-effective care.

Differential Target Multiplexed Spinal Cord Stimulation: A UK Cost-Effectiveness Analysis.

OBJECTIVES: The aim of this economic analysis was to evaluate the cost-effectiveness of differential target multiplexed spinal cord stimulation (DTM-SCS) for treating chronic intractable low back pain, compared with conventional spinal cord stimulation (C-SCS) and conservative medical management (CMM), by updating and expanding the inputs for a previously published cross-industry model. MATERIALS AND METHODS: This model comprised a 12-month decision-tree phase followed by a long-term Markov model. Costs and outcomes were calculated from a UK National Health Service perspective, over a base-case horizon of 15 years and up to a maximum of 40 years. All model inputs were derived from published literature or other deidentified sources and updated to reflect recent clinical trials and costs. Deterministic and one-way sensitivity analyses were performed to calculate costs and quality-adjusted life-years (QALYs) across the 15-year time horizon and to explore the impact of individual parameter variability on the cost-effectiveness results. Probabilistic sensitivity analysis was undertaken to explore the impact of joint parameter uncertainty on the results. RESULTS: DTM-SCS was the most cost-effective option from a payer perspective. Compared with CMM alone, DTM-SCS was associated with an incremental cost-effectiveness ratio (ICER) of £6101 per QALY gained (incremental net benefit [INB] = £21,281). The INB for C-SCS compared with CMM was lower than for DTM-SCS, at £8551. For the comparison of DTM-SCS and C-SCS, an ICER of £897 per QALY gained was calculated, with a 99.5% probability of cost-effectiveness at a £20,000 per QALY threshold. CONCLUSIONS: Among patients with low back pain treated over a 15-year follow-up period, DTM-SCS and C-SCS are cost-effective compared with CMM, from both payer and societal perspectives. DTM-SCS is associated with a lower ICER than that of C-SCS. Wider uptake of DTM-SCS in the UK health care system is warranted to manage chronic low back pain.

A Dutch cost-effectiveness analysis of fremanezumab versus best supportive care in patients with chronic migraine and inadequate response to prior preventive therapy.

BACKGROUND: Chronic migraine (CM) is the most severe and burdensome subtype of migraine. Fremanezumab is a monoclonal antibody that targets the calcitonin gene-related peptide pathway as a migraine preventive therapy. This study aimed to conduct a cost-effectiveness analysis of fremanezumab from a societal perspective in the Netherlands, using a Markov cohort simulation model. METHODS: The base-case cost-effectiveness analysis adhered to the Netherlands Authority guidelines. Fremanezumab was compared with best supportive care (BSC; acute migraine treatment only) in patients with CM and an inadequate response to topiramate or valproate and onabotulinumtoxinA (Dutch patient group [DPG]). A supportive analysis was conducted in the broader group of CM patients with prior inadequate response to 2-4 different classes of migraine preventive treatments. One-way sensitivity, probabilistic sensitivity, and scenario analyses were conducted. RESULTS: Over a lifetime horizon, fremanezumab is cost saving compared with BSC in the DPG (saving of €2514 per patient) and led to an increase of 1.45 quality-adjusted life-years (QALYs). In the broader supportive analysis, fremanezumab was cost effective compared with BSC, with an incremental cost-effectiveness ratio of €2547/QALY gained. Fremanezumab remained cost effective in all sensitivity and scenario analyses. CONCLUSION: In comparison to BSC, fremanezumab is cost saving in the DPG and cost effective in the broader population.

Strategies, processes, outcomes, and costs of implementing experience sampling-based monitoring in routine mental health care in four European countries: study protocol for the IMMERSE effectiveness-implementation study.

BACKGROUND: Recent years have seen a growing interest in the use of digital tools for delivering person-centred mental health care. Experience Sampling Methodology (ESM), a structured diary technique for capturing moment-to-moment variation in experience and behaviour in service users' daily life, reflects a particularly promising avenue for implementing a person-centred approach. While there is evidence on the effectiveness of ESM-based monitoring, uptake in routine mental health care remains limited. The overarching aim of this hybrid effectiveness-implementation study is to investigate, in detail, reach, effectiveness, adoption, implementation, and maintenance as well as contextual factors, processes, and costs of implementing ESM-based monitoring, reporting, and feedback into routine mental health care in four European countries (i.e., Belgium, Germany, Scotland, Slovakia). METHODS: In this hybrid effectiveness-implementation study, a parallel-group, assessor-blind, multi-centre cluster randomized controlled trial (cRCT) will be conducted, combined with a process and economic evaluation. In the cRCT, 24 clinical units (as the cluster and unit of randomization) at eight sites in four European countries will be randomly allocated using an unbalanced 2:1 ratio to one of two conditions: (a) the experimental condition, in which participants receive a Digital Mobile Mental Health intervention (DMMH) and other implementation strategies in addition to treatment as usual (TAU) or (b) the control condition, in which service users are provided with TAU. Outcome data in service users and clinicians will be collected at four time points: at baseline (t0), 2-month post-baseline (t1), 6-month post-baseline (t2), and 12-month post-baseline (t3). The primary outcome will be patient-reported service engagement assessed with the service attachment questionnaire at 2-month post-baseline. The process and economic evaluation will provide in-depth insights into in-vivo context-mechanism-outcome configurations and economic costs of the DMMH and other implementation strategies in routine care, respectively. DISCUSSION: If this trial provides evidence on reach, effectiveness, adoption, implementation and maintenance of implementing ESM-based monitoring, reporting, and feedback, it will form the basis for establishing its public health impact and has significant potential to bridge the research-to-practice gap and contribute to swifter ecological translation of digital innovations to real-world delivery in routine mental health care. TRIAL REGISTRATION: ISRCTN15109760 (ISRCTN registry, date: 03/08/2022).

Costs in conservation: Common costly mistakes and how to avoid them.

There has been an increasingly prevalent message that data regarding costs must be included in conservation planning activities to make cost-efficient decisions. Despite the growing acceptance that socioeconomic context is critical to conservation success, the approaches to embedded economic and financial considerations into planning have not significantly evolved. Inappropriate cost data is frequently included in decisions, with the potential of compromising biodiversity and social outcomes. For each conservation planning step, this essay details common mistakes made when considering costs, proposing solutions to enable conservation managers to know when and how to include costs. Appropriate use of high-quality cost data obtained at the right scale will improve decision-making and ultimately avoid costly mistakes.

What Is the Potential Value of a Randomized Trial of Different Thresholds to Initiate Invasive Ventilation? A Health Economic Analysis.

OBJECTIVES: To estimate the expected value of undertaking a future randomized controlled trial of thresholds used to initiate invasive ventilation compared with usual care in hypoxemic respiratory failure. PERSPECTIVE: Publicly funded healthcare payer. SETTING: Critical care units capable of providing invasive ventilation and unconstrained by resource limitations during usual (nonpandemic) practice. METHODS: We performed a model-based cost-utility estimation with individual-level simulation and value-of-information analysis focused on adults, admitted to critical care, receiving noninvasive oxygen. In the primary scenario, we compared hypothetical threshold A to usual care, where threshold A resulted in increased use of invasive ventilation and improved survival compared with usual care. In the secondary scenario, we compared hypothetical threshold B to usual care, where threshold B resulted in decreased use of invasive ventilation and similar survival compared with usual care. We assumed a willingness-to-pay of 100,000 Canadian dollars (CADs) per quality-adjusted life year. RESULTS: In the primary scenario, threshold A was cost-effective compared with usual care due to improved hospital survival (78.1% vs. 75.1%), despite more use of invasive ventilation (62% vs. 30%) and higher lifetime costs (86,900 vs. 75,500 CAD). In the secondary scenario, threshold B was cost-effective compared with usual care due to similar survival (74.5% vs. 74.6%) with less use of invasive ventilation (20.2% vs. 27.6%) and lower lifetime costs (71,700 vs. 74,700 CAD). Value-of-information analysis showed that the expected value to Canadian society over 10 years of a 400-person randomized trial comparing a threshold for invasive ventilation to usual care in hypoxemic respiratory failure was 1.35 billion CAD or more in both scenarios. CONCLUSIONS: It would be highly valuable to society to identify thresholds that, in comparison to usual care, either increase survival or reduce invasive ventilation without reducing survival.

Partial-Cost Analysis and Economic Impact of Ambulatory Coronary Angioplasty in a Private Hospital in the Caribbean: Análisis Parcial de Costos e Impacto Económico de la Angioplastia Coronaria Ambulatoria en un Hospital Privado del Caribe.

OBJECTIVES: This study aimed to assess direct costs of percutaneous coronary intervention (PCI) without hospital admission versus PCI with hospital admission longer than 24 hours in a private hospital-institutional perspective in the Dominican Republic in 2022. METHODS: This study has a comparative approach based on a prospective cross-sectional partial-cost analysis. We evaluated the direct costs of 10 patients from PCI without hospital admission approach and 10 patients from a hospital admission longer than 24 hours as a control group. We used a "first-come-first-served" approach from December 2021 to March 2022. The analysis used the electronic invoice generated for each patient. RESULTS: PCI without hospital admission approach represents $472.56 in patient savings, equivalent to a cost reduction of 12.5%. The subcosts analysis showed the pharmacy section as the main driver of the overall cost difference. CONCLUSIONS: PCI without hospital admission was economically cost-saving compared with the control approach in direct costs in the Dominican perspective. The economic benefit is substantial and compliments the ease of use. This analysis may lead to improvements in institutional management of resources and can potentially be adapted to other health systems in the region.

Cost-Effectiveness of Ibrutinib for Chronic Lymphocytic Leukemia Treatment in India: Is Evidence Really at Crossroads?

In recent years, newer drugs, such as ibrutinib, have shown promising improvements in the survival of patients with chronic lymphocytic leukemia (CLL). Despite their effectiveness, concerns about their cost have arisen, prompting the need for an evaluation of their cost-effectiveness. However, recent assessments of ibrutinib's cost-effectiveness for treating CLL in India reveal divergent conclusions. The discord centers on divergent cost-effectiveness thresholds, comparator regimens, cost calculations, and outcome valuation approaches. Such discrepancies affect public health decisions and patient care. The recommendation calls for adherence to methodological guidelines by future studies, fostering consistent findings to empower policy makers and clinicians in leveraging economic evidence for informed decision making in CLL treatment strategies.

New Anticancer Drugs: Reliably Assessing "Value" While Addressing High Prices.

Countries face challenges in paying for new drugs. High prices are driven in part by exploding drug development costs, which, in turn, are driven by essential but excessive regulation. Burdensome regulation also delays drug development, and this can translate into thousands of life-years lost. We need system-wide reform that will enable less expensive, faster drug development. The speed with which COVID-19 vaccines and AIDS therapies were developed indicates this is possible if governments prioritize it. Countries also differ in how they value drugs, and generally, those willing to pay more have better, faster access. Canada is used as an example to illustrate how "incremental cost-effectiveness ratios" (ICERs) based on measures such as gains in "quality-adjusted life-years" (QALYs) may be used to determine a drug's value but are often problematic, imprecise assessments. Generally, ICER/QALY estimates inadequately consider the impact of patient crossover or long post-progression survival, therapy benefits in distinct subpopulations, positive impacts of the therapy on other healthcare or societal costs, how much governments willingly might pay for other things, etc. Furthermore, a QALY value should be higher for a lethal or uncommon disease than for a common, nonlethal disease. Compared to international comparators, Canada is particularly ineffective in initiating public funding for essential new medications. Addressing these disparities demands urgent reform.

Cashing in: cost-benefit analysis framework for digital hospitals.

BACKGROUND: For many countries, especially those outside the USA without incentive payments, implementing and maintaining electronic medical records (EMR) is expensive and can be controversial given the large amounts of investment. Evaluating the value of EMR implementation is necessary to understand whether or not, such investment, especially when it comes from the public source, is an efficient allocation of healthcare resources. Nonetheless, most countries have struggled to measure the return on EMR investment due to the lack of appropriate evaluation frameworks. METHODS: This paper outlines the development of an evidence-based digital health cost-benefit analysis (eHealth-CBA) framework to calculate the total economic value of the EMR implementation over time. A net positive benefit indicates such investment represents improved efficiency, and a net negative is considered a wasteful use of public resources. RESULTS: We developed a three-stage process that takes into account the complexity of the healthcare system and its stakeholders, the investment appraisal and evaluation practice, and the existing knowledge of EMR implementation. The three stages include (1) literature review, (2) stakeholder consultation, and (3) CBA framework development. The framework maps the impacts of the EMR to the quadruple aim of healthcare and clearly creates a method for value assessment. CONCLUSIONS: The proposed framework is the first step toward developing a comprehensive evaluation framework for EMRs to inform health decision-makers about the economic value of digital investments rather than just the financial value.

Electronic Decision-Making Tool for Smoking Cessation (Pare de Fumar Conosco) Versus Standard of Care: A Cost-Effectiveness Analysis.

OBJECTIVES: The study aimed to evaluate the cost-effectiveness of the Pare de Fumar Conosco software compared with the standard of care adopted in Brazil for the treatment of smoking cessation. METHODS: In the cohort of smokers with multiple chronic conditions, we developed an decision tree model for the benefit measures of smoking cessation. We adopted the perspectives of the Brazilian Unified Health System and the service provider. Resources and costs were measured by primary and secondary sources and effectiveness by a randomized clinical trial. The incremental cost-effectiveness ratio (ICER) was calculated, followed by deterministic and probabilistic sensitivity analyses and deterministic and probabilistic sensitivity analyses. No willingness to pay threshold was adopted. RESULTS: The software had a lower cost and greater effectiveness than its comparator. The ICER was dominant in all of the benefits examined (-R$2 585 178.29 to -R$325 001.20). The cost of the standard of care followed by that of the electronic tool affected the ICER of the benefit measures. In all probabilistic analyses, the software was superior to the standard of care (53.6%-82.5%). CONCLUSION: The Pare de Fumar Conosco software is a technology that results in cost savings in treating smoking cessation.

Cost-Effectiveness Analysis of Pharmacological Treatment for Adult Kidney Transplant Recipients in Colombia.

OBJECTIVES: To evaluate cost-effective pharmacological treatment in adult kidney transplant recipients from the perspective of the Colombian health system. METHODS: A decision tree model for the induction phase and a Markov model for the maintenance phase were built. A review of the clinical literature was conducted to extract probabilities, and the life-years were used as the outcome. Costs were calculated using the administrative databases. The evaluating treatment schemes are organized by groups of evidence with direct comparisons. RESULTS: In the induction phase, anti-thymocyte immunoglobulin+ methylprednisolone is dominant, more effective, and less expensive, compared with basiliximab+methylprednisolone. In the maintenance phase, azathioprine (AZA) is dominant in contrast to mycophenolate mofetil (MFM) both with cyclosporine (CIC)+ corticosteroids (CE); CIC is dominant relative to sirolimus (SIR) and tacrolimus (TAC) (both with MFM+CE or AZA+CE), and TAC is dominant compared with SIR (in addition with MFM+CE or mycophenolate sodium [MFS]+CE); MFM is dominant in relation to MFS and everolimus, and SIR is more effective MFM but it does not exceed the threshold (in sum with TAC+CE); MFS and MFM are dominant relative to everolimus, and SIR is more effective than MFM, but it does not exceed the threshold (in addiction with CIC+CE); MFM is dominant in relation to TAC (in sum with SIR+CE), and CIC+AZA+CE is dominant in relation to TAC+MFM+CE. CONCLUSIONS: The base-case results for all evidence groups are consistent with the different sensitivity analyses.

Cost-Effectiveness Analysis of Triptorelin, Goserelin, and Leuprolide in the Treatment of Patients With Metastatic Prostate Cancer: A Societal Perspective.

OBJECTIVES: Metastatic prostate cancer is the most common malignant cancer and the second leading cause of death due to various types of cancer among men after lung cancer. This study aimed to analyze the cost-effectiveness of triptorelin, goserelin, and leuprolide in the treatment of the patients with metastatic prostate cancer from the societal perspective in Iran in 2020. METHODS: This is a cost-effectiveness study in which a 20-year Markov transition modeling was applied. In this study, local cost and quality-of-life data of each health state were gathered from cohort of patients. The TreeAge pro 2020 and Microsoft Excel 2016 software were used to simulate cost-effectiveness of each treatment in the long term. The one-way and probabilistic sensitivity analyses were also performed to measure robustness of the model outputs. RESULTS: The findings indicated that the mean costs and utility gained over a 20-year horizon for goserelin, triptorelin, and leuprolide treatments were $ 13 539.13 and 6.365 quality-adjusted life-years (QALY), $ 18 124.75 and 6.658 QALY, and $ 26 006.92 and 6.856 QALY, respectively. Goserelin was considered as a superior treatment option, given the estimated incremental cost-effectiveness ratio. The one-way and probabilistic sensitivity analyses confirmed the robustness of the study outcomes. CONCLUSIONS: According to the results of the present study, goserelin was the most effective and cost-effective strategy versus 2 other options. It could be recommended to policy makers of the Iran healthcare system to prioritize it in clinical guidelines and reimbursement policies.

Cost-Effectiveness of Technologies for the Treatment of Spinal Muscular Atrophy: A Systematic Review of Economic Studies.

OBJECTIVES: This study aims to systematically collect data on cost-effectiveness analyses that assess technologies to treat type I and II spinal muscular atrophy and evaluate their recommendations. METHODS: A structured electronic search was conducted in 4 databases. Additionally, a complementary manual search was conducted. Complete economic studies that evaluated nusinersen, risdiplam, onasemnogene abeparvovec (OA), and the best support therapy (BST) from the health system's perspective were selected. The incremental cost-effectiveness ratios were compared with various thresholds for the analysis. The review was registered a priori in PROSPERO (CRD42022365391). RESULTS: Twenty studies were included in the analyses. They were all published between 2017 and 2022 and represent the recommendations in 8 countries. Most studies adopted 5, 6, or 10-state Markov models. Some authors took part in multiple studies. Four technologies were evaluated: BST (N = 14), nusinersen (N = 19), risdiplam (N = 5), and OA (N = 9). OA, risdiplam, and nusinersen were considered inefficient compared with the BST. Risdiplam and OA were generally regarded as cost-effective when compared with nusinersen. Because nusinersen is not a cost-effective drug, no recommendation can be derived from this result. Risdiplam and OA were compared in 2 studies that presented opposite results. CONCLUSIONS: Nusinersen, risdiplam, and OA are being adopted worldwide as a treatment for spinal muscular atrophy. Despite that, the pharmacoeconomic analyses show that the technologies are not cost-effective compared with the BST. The lack of controlled studies for risdiplam and OA hamper any conclusions about their face-to-face comparison.

The impact of willingness-to-pay threshold on price reduction recommendations for oncology drugs: a review of assessments conducted by the Canadian Agency for Drugs and Technologies in Health.

Since late 2020, the Canadian Agency of Drugs and Technologies in Health (CADTH) has been using a threshold of $50,000 (CAD) per quality-adjusted life-year (QALY) for both oncology and non-oncology drugs. When used for oncology products, this threshold is hypothesized to have a higher impact on the time to access these drugs in Canada. We studied the impact of price reductions on time to engagement and negotiation with the pan-Canadian Pharmaceutical Alliance for oncology drugs reviewed by CADTH between January 2020 and December 2022. Overall, 103 assessments reported data on price reductions recommended by CADTH to meet the cost-effectiveness threshold for reimbursement. Of these assessments, 57% (59/103) recommendations included a price reduction of greater than 70% off the list price. Eight percent (8/103) were not cost-effective even at a 100% price reduction. Of the 47 assessments that had a clear benefit, in 21 (45%) CADTH recommended a price reduction of at least 70%. The median time to price negotiation (not including time to engagement) for assessments that received at least 70% vs >70% price reduction was 2.6 vs 4.8 months. This study showed that there is a divergence between drug sponsor's incremental cost-effectiveness ratio (ICER) and CADTH revised ICER leading to a price reduction to meet the $50,000/QALY threshold. For the submissions with clear clinical benefit the median length of engagement (2.5 vs 3.3 months) and median length of negotiation (3.1 vs 3.6 months) were slightly shorter compared with the submissions where uncertainties were noted in the clinical benefit according to CADTH. This study shows that using a $50,000 per QALY threshold for oncology products potentially impacts timely access to life saving medications.

Challenges of Incorporating Life Cycle Drug Pricing in Cost-Effectiveness Models: A Review of Methods and Modeling Suggestions.

OBJECTIVES: This study aimed to conduct a review of existing methods used to incorporate life cycle drug pricing (LCDP) in cost-effectiveness analyses (CEAs), identify common methodological challenges, and suggest modeling approaches for prospectively implementing LCDP in CEA. METHODS: Two complementary searches were conducted in PubMed, combined with hand searching and reference mining, to identify English language full-text articles that explored (1) how drug prices change over time and (2) methods used to apply dynamic pricing in cost-effectiveness models (CEMs). Relevant articles were reviewed, and authors discussed the common methodological practices used in the literature and their associated challenges on prospectively implementing LCDP in CEMs. For each key challenge identified, we provide modeling suggestions to address the issue. RESULTS: We screened 1200 studies based on title and abstract; 117 were reviewed for eligibility, and 47 individual studies were included across both searches. Variations in prices over a product's life cycle are complex and multifactorial, and models applying LCDP in CEA varied in their methodology. We identified 4 key challenges to modeling LCDP in CEA, including how to model price trends before and after loss of exclusivity, how to capture the effect of price changes on future patient cohorts, and how to report results. CONCLUSION: Accurately quantifying the impact of LCDP requires careful consideration of multiple aspects pertaining to both the evolution of drug prices and how to reflect these in CEA. Although uncertainties remain, our findings can aid implementation and evaluation of LCDP in economic evaluations.

Methods for Including Adverse Events in Economic Evaluations: Suggestions for Improvement.

OBJECTIVE: Inclusion of relevant effectiveness and safety outcomes in economic evaluation of health technologies is required to aid efficient healthcare decisions. Our objective was to identify the key issues related to the inclusion of adverse events (AEs) in economic evaluation and explore perspectives for good practice recommendations to handle these issues. METHODS: We focused on the frequently encountered methodological issues related to the integration of AEs in economic evaluations of health technologies. We distinguished the following elements: the incorporation of AEs in decision models, the terminology of AEs, the estimation of AEs consequences in terms of quality of life (QoL) and costs, and the exploration of the uncertainty related to the impact of AEs on the economic results. RESULTS: We illustrated and discussed each of the identified issues by giving health technology assessment examples. We focused on the extent to which the integration of AEs in decision models can be improved by dealing with the lack of relevant real-world safety data, estimating the consequences of AEs (eg, for costs and QoL loss), exploring the impacts of AEs that are not adequately captured in current measurement of health-related QoL, and identifying the need for development of a good terminology of relevant types of AEs to be incorporated in economic evaluation. CONCLUSION: Based on a reflection the key methodological issues related to the incorporation of adverse drug events in economic evaluations, we suggested several recommendations to serve a starting point for health technology assessment agencies and researchers to develop good research practices in this field.

Methods to Include Environmental Impacts in Health Economic Evaluations and Health Technology Assessments: A Scoping Review.

OBJECTIVES: The environmental impacts of healthcare are important factors that should be considered during health technology assessments. This study aims to summarize the evidence that exists about methods to include environmental impacts in health economic evaluations and health technology assessments. METHODS: We identified records for screening using an existing scoping review and a systematic search of academic databases and gray literature up to September 2023. We screened the identified records for eligibility and extracted data using a narrative synthesis approach. The review was conducted following the JBI Manual for Evidence Synthesis and reported according to the Preferred Reporting Items for Systematic Reviews and Meta Analyses Extension for Scoping Reviews checklist. RESULTS: We identified 2898 records and assessed the full text of 114, of which 54 were included in this review. Ten methods were identified to include environmental impacts in health economic evaluations and health technology assessments. Methods included converting environmental impacts to dollars or disability-adjusted life years and including them in a cost-effectiveness, cost-utility, or cost-benefit analysis, calculating an incremental carbon footprint effectiveness ratio or incremental carbon footprint cost ratio, incorporating impacts as one criteria of a multi-criteria decision analysis, and freely considering impacts during health technology assessment deliberation processes. CONCLUSIONS: Methods to include environmental impacts in health economic evaluations and health technology assessments exist but have not been tested for widespread use by health technology assessment agencies. Further research and implementation work is needed to determine which method can best aid decision makers to choose low environmental impact healthcare interventions.