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To estimate the budgetary impact of adopting selinexor (XPOVIO; Karyopharm Therapeutics, Inc.) for the treatment of adult patients with penta-refractory multiple myeloma (MM) from the perspective of a third-party payer in the United States (US). A budget impact analysis was conducted in one-year increments for the first 3 years after the introduction of selinexor for a private payer or Medicare Part D. Total annual treatment costs (2018 US dollars) were calculated as the sum of drug costs, costs of adverse events (AEs; grade ≥3), along with ongoing best supportive care costs. The number of eligible patients was derived from national epidemiology statistics, healthcare databases, and published literature. In the base-case analysis, selinexor was associated with a per member per month (PMPM) cost of $0.0103 in year 3, assuming a market uptake of 64%, for a hypothetical private payer plan with one million members and four eligible patients. In a scenario analysis with 16 eligible patients with triple-class refractory MM regardless of the line of therapy (this additional scenario analysis was performed with an eligible population that does not fit squarely within the approved label for selinexor but was performed strictly for the purpose of demonstrating the results of the budget impact model when based on a larger pool of eligible patients), the estimated PMPM cost in year 3 was $0.0388. The model showed comparable sensitivity to treatment duration, wholesale acquisition cost for selinexor, and year 1 uptake. The base-case analysis conducted from the perspective of Medicare Part D was associated with a PMPM cost of $0.0078 in year 3 with 159 eligible patients. The model estimates a small and manageable budget impact of adopting selinexor into a third-party US payer plan, given the low prevalence of penta-refractory MM.

Hypothermia is a well-known risk of the perioperative period and considered a preventable effect of anesthesia care. Nevertheless, it is not fully controlled, causing a number of adverse outcomes following surgical operations and thus increasing length of stay in hospital and treatment costs. The aim of this study was to assess the budget impact (BI) of the implementation of proactive strategies to prevent inadvertent perioperative hypothermia (IPH) in surgical patients in Italy, as recommended by international guidelines and by a good clinical practice (GCP) guideline of the Italian Society of Anesthesia, Analgesia, Reanimation, and Intensive Care. BI was calculated over a 3-year period from the perspective of the Italian National Health Service (NHS). Model inputs were extracted from national literature when available and otherwise from international sources. The reference analytic model was based on the cost-effectiveness analysis of the National Institute for Health and Care Excellence clinical guidance 65. Estimates were based on assessments made about current malpractice in Italy and on a hypothesis of how future practice might change by implementing the GCP. Model output included overall BI results, variations in the number of warmed patients, medical-device average costs and use of mix. The base-case estimate quantified a decrease of 35% in extra days of hospital stay due to IPH and a net BI of -€60.92 million. Increasing protocol adoption for preventing IPH would lead to both clinical advantages and significant savings for the NHS. Its large diffusion in Italian hospitals is thus desirable.

Until now, there has been no standardized method of performing and presenting budget impact analyses (BIAs) in Canada. Nevertheless, most drug plan managers have been requiring this economic data to inform drug reimbursement decisions. This paper describes the process used to develop the Canadian BIA Guidelines; describes the Guidelines themselves, including the model template; and compares this guidance with other guidance on BIAs. The intended audience includes those who develop, submit or use BIA models, and drug plan managers who evaluate BIA submissions. The Patented Medicine Prices Review Board (PMPRB) initiated the development of the Canadian BIA Guidelines on behalf of the National Prescription Drug Utilisation Information System (NPDUIS). The findings and recommendations from a needs assessment with respect to BIA submissions were reviewed to inform guideline development. In addition, a literature review was performed to identify existing BIA guidance. The detailed guidance was developed on this basis, and with the input of the NPDUIS Advisory Committee, including drug plan managers from multiple provinces in Canada and a representative from the Canadian Agency for Drugs and Technologies in Health. A Microsoft® Excel-based interactive model template was designed to support BIA model development. Input regarding the guidelines and model template was sought from each NPDUIS Advisory Committee member to ensure compatibility with existing drug plan needs. Decisions were made by consensus through multiple rounds of review and discussion. Finally, BIA guidance in Canadian provinces and other countries were compared on the basis of multiple criteria. The BIA guidelines consist of three major sections: Analytic Framework, Inputs and Data Sources, and Reporting Format. The Analytic Framework section contains a discussion of nine general issues surrounding BIAs (model design, analytic perspective, time horizon, target population, costing, scenarios to be compared, the characterisation of uncertainty, discounting, and validation methods). The Inputs and Data Sources section addresses methods for market size estimation, comparator selection, scenario forecasting and drug price estimation. The Reporting Format section describes methods for BIA reporting. The new Canadian BIA Guidelines represent a significant departure from the limited guidance that was previously available from some of the provinces, because they include specific details of the methods of performing BIAs. The Canadian BIA Guidelines differ from the Principles of Good Research Practice for BIAs developed by the International Society for Pharmacoeconomic and Outcomes Research (ISPOR), which provide more general guidance. The Canadian BIA Guidelines and template build upon existing guidance to address the specific requirements of each of the participating drug plans in Canada. Both have been endorsed by the NPDUIS Steering Committee and the PMPRB for the standardization of BIA submissions.

Monosymptomatic nocturnal enuresis (MNE) imposes a notable clinical and psychosocial burden, yet no economic evaluations have been conducted in Thailand. This study conducted the cost-utility analysis (CUA) and budget impact analysis (BIA) of desmopressin acetate compared with imipramine and no treatment in children aged ≥ 7 years with MNE who have not responded to behavioural management and not responded, or expected not to respond, to alarm therapy. A CUA was conducted from a partial societal perspective, and a BIA was undertaken from a payer perspective. Model parameters were source from published evidence and expert opinion. Desmopressin yielded the highest quality-adjusted life years (QALYs) (9.77) and costs ($740.54). The incremental cost-effectiveness ratios were $2,385/QALY versus no treatment and $2,226/QALY versus imipramine, both below Thailand’s willingness-to-pay threshold ($4,733.73/QALY). Probabilistic sensitivity analysis indicated a 73.5–74.0% probability of cost-effectiveness. The five-year budget impact of introducing desmopressin was estimated at $26.998 million. These findings suggest that desmopressin may represent a cost-effective option for managing MNE, although its adoption would careful consideration of budgetary implications. The results provide context-specific evidence to inform policy deliberations in Thailand and may offer insights for other low- and middle-income countries.

BACKGROUNDRecently, the Massachusetts Group Insurance Commission (GIC) prioritized research on the implications of a clause expressly prohibiting the denial of health insurance coverage for transgender-related services. These medically necessary services include primary and preventive care as well as transitional therapy.OBJECTIVETo analyze the cost-effectiveness of insurance coverage for medically necessary transgender-related services.DESIGNMarkov model with 5- and 10-year time horizons from a U.S. societal perspective, discounted at 3 % (USD 2013). Data on outcomes were abstracted from the 2011 National Transgender Discrimination Survey (NTDS).PATIENTSU.S. transgender population starting before transitional therapy.INTERVENTIONSNo health benefits compared to health insurance coverage for medically necessary services. This coverage can lead to hormone replacement therapy, sex reassignment surgery, or both.MAIN MEASURESCost per quality-adjusted life year (QALY) for successful transition or negative outcomes (e.g. HIV, depression, suicidality, drug abuse, mortality) dependent on insurance coverage or no health benefit at a willingness-to-pay threshold of $100,000/QALY. Budget impact interpreted as the U.S. per-member-per-month cost.KEY RESULTSCompared to no health benefits for transgender patients ($23,619; 6.49 QALYs), insurance coverage for medically necessary services came at a greater cost and effectiveness ($31,816; 7.37 QALYs), with an incremental cost-effectiveness ratio (ICER) of $9314/QALY. The budget impact of this coverage is approximately $0.016 per member per month. Although the cost for transitions is $10,000–22,000 and the cost of provider coverage is $2175/year, these additional expenses hold good value for reducing the risk of negative endpoints —HIV, depression, suicidality, and drug abuse. Results were robust to uncertainty. The probabilistic sensitivity analysis showed that provider coverage was cost-effective in 85 % of simulations.CONCLUSIONSHealth insurance coverage for the U.S. transgender population is affordable and cost-effective, and has a low budget impact on U.S. society. Organizations such as the GIC should consider these results when examining policies regarding coverage exclusions.

Introduction: The present work aims to discuss the current scenario of procedures and regulations regarding budget impact analysis/models (BIA/BIM) at regional level in Italy and to provide a standardized approach and detailed recommendations for developing these analyses. Method: A systematic review of the literature was conducted in order to collect existing guidelines or specific regional procedures for budget impact analysis in Italy. All the records were analysed in qualitative terms according to a pre-specified analytical framework, based on the ISPOR BIA guidelines. At the end of the analysis, a consensus questionnaire was developed to establish agreed approaches and to provide possible solutions to any critical issues. A list of 39 statements was developed. The survey was distributed to 69 experts who rated their level of agreement with each statement on a 5-point Likert scale. Consensus was predefined as more than 66% of the panel agreeing/disagreeing with any given statement. Results: Sisty-nine experts answered the questionnaire; a total of 30/39 statements achieved consensus. There was agreement on most of the statements. Time horizon to consider and costs were the issues on which no agreement was found. The results allowed the working group to define a list of good practices. Conclusion: While the structure and development of BIM are now well-known and well-applied at national level, there remains a great diversity of management of BIM tools at regional level. Consensus was reached among participating experts, as to the main characteristics, determinants and features of regional BIA/BIM in the perspective of the Italian payer.

Introduction: Given the availability of a growing number of HIV treatment options, it becomes essential to have a clear understanding of the related economic-organizational evidence, to operate informed and conscious choices. The study aims to define the economic and organizational impact related to a consolidated use of Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), within the Italian National Healthcare Service (NHS), for the treatment of both naïve and experienced HIV individuals. Materials and methods: A budget impact analysis was developed assuming the NHS perspective and considering a 36-month time horizon. Scenario A, representative of the current situation of consumption of the different therapeutic alternatives (derived from the most update guidelines), was compared with Scenario B, assuming a greater adoption of BIC/FTC/TAF. An organizational impact analysis was conducted to define any advantages for hospitals, devoted to the management of any ART-related adverse events. Results: The BIA revealed an economic saving of 0.97% (26,040,271.36 €) given a higher penetration rate for BIC/FTC/TAF, for the treatment of HIV individuals assuming ART in Italy. From an organizational perspective, a greater BIC/FTC/TAF administration would generate a reduction in the overall hospital accesses devoted to the management of adverse events, generating an overall saving of 245,938 hours, considering the time spent by the healthcare professionals involved in the care and treatment of individuals with HIV. Conclusions: BIC/FTC/TAF represent an interesting possibility for the rapid initiation of ART, as well as for switches, being able to optimize the clinical pathway of a patient with HIV, from an economic and organizational perspective.

Introduction Low- and Middle-Income Countries (LMICs), burdened with a high incidence of cervical cancer, often face challenges in implementing National Immunization Programs (NIP) or Provincial Immunization Programs (PIP) of Human Papillomavirus (HPV) vaccines. In the context of limited resources, the economic evidence provided by Budget Impact Analysis (BIA) becomes crucial for the inclusion of vaccines in the NIP and PIP. Methods This study adopted the perspective of the Basic Medical Insurance System (BMIS) payer, took the imported and domestic bivalent HPV vaccines as the target vaccines. We estimated the effect of HPV vaccines on burden of cervical cancer in China from 2019 to 2110, assuming that there were different reimbursement rates and market substitution rates for the vaccines. This study aimed to establish a comprehensive and standardized BIA framework that can be referenced to promote HPV vaccination in LMICs. Input parameters included vaccine efficacy vs. HPV 16/18, target age group, cancer treatment cost (per episode, over lifetime), discount rate, cohort size at 9 years old and etc., which were mainly derived from public sources, published literature, and a database of field surveys on treatment costs for patients of cervical cancer in China. Main outcomes encompassed incidence and treatment costs of cervical cancer, vaccination costs. Results The proposed BIA framework included the target population, BIA, and uncertainty analysis across three scenarios based on origin. In the case of China, without immunization program, the average yearly spent on cervical cancer treatment throughout the country amounts to $6,736,507.32. Upon the execution of the immunization program (2019–2025), this expenditure reduced to $6,645,564.95 each year. Under Scenario 1–3, the vaccine reimbursement costs were $62,513,268.73, $44,927,307.37, and $58,916,163.27, respectively. During the period of immunization program, annual vaccination costs constituted a range of 0.05 to 1.08 parts per million relative to the current expenditure of BMIS fund and 2.68 and 14.12 parts per million relative to current balance of BMIS fund. Conclusion The BIA framework provided a valuable reference for policy formulation in other LMICs with a high burden of cervical cancer that have not yet included the vaccine in their NIPs.

Background An increasing number of orphan medicinal products (OMPs) are being included in social health insurance schemes, significantly improving access to medicines for patients with rare diseases. However, high-priced OMPs are still not covered, primarily due to health equity controversies and inadequate data systems required for economic evaluation. The aim of this study was to estimate the burden of drug expenditures and the size of the reimbursement budget required for high-priced OMPs from the perspectives of society and healthcare payers. Methods The study performed a budget impact analysis using data from multiple sources to estimate the reimbursement budget for high-priced OMPs in Chengdu, a densely populated metropolis in China. The budget analysis consisted of three main elements: the number of patients, the price of drugs, and the simulated policy scenario. By adjusting the combinations of these elements, the budget fluctuations for payers were estimated. Furthermore, the study predicted the budget trend for the next three years to validate its sustainability. Results The analysis indicated that 98 rare disease patients in Chengdu required high-priced OMPs in 2019. This suggested a projected budget of CNY 179 million for these patients without reimbursement policies, from a societal perspective. Under six assumed policy scenarios, this budget ranged from CNY 32 million to CNY 156 million. Over the next three years, the annual budget was estimated to range from CNY 200 million to CNY 1.303 billion. Conclusion Integration of multi-source data helps to obtain more scientifically reliable results on budget impacts. The study found that the budgetary impacts of high-priced OMPs on society and payers are relatively limited. Health policymakers can choose appropriate reimbursement strategies based on financial affordability among a diverse mix of elements. The results of related studies provided insights for optimizing the allocation of health resources and improving patient access to medications.

This study aimed to conduct a comprehensive analysis of the national glaucoma screening program in Kazakhstan from 2000 to 2022. A thorough search was conducted to identify policy documents regulating the provision of glaucoma screening from its inception to the present day. Official data on reimbursement for tonometry, glaucoma incidence, and the population aged ≥ 50 years were retrieved. Forecast modeling was utilized to project disease incidences up to 2030. The current program largely inherits the framework of the Soviet glaucoma screening, with tonometry serving as the primary screening tool. The budget allocated for glaucoma screening is not specified in official documents, as glaucoma screening is integrated into the routine activities of healthcare facilities. The highest costs are incurred when Maklakov tonometry is applied alone, reaching 7,557,679,411 Kazakhstani Tenge in 2023. The incidence of glaucoma increased from 59.1 per 100,000 in 2000 to 135.5 in 2022, reflecting the aging population. Disparities in incidence rates were observed between residents of urban and rural areas, as well as among residents of different provinces. It is anticipated that the incidence of glaucoma will continue to rise, reaching 154.5 per 100,000 in 2030. There is a need to initiate a discussion on potential amendments to the existing screening program.