The Health Service Executive, responsible for operating the Irish health service, has introduced health technology management (HTM) initiatives to manage expenditure on medicines. One such approach is managed access protocols (MAPs) to support access to high-cost medicines, while providing oversight, governance and budgetary certainty to the payer. Herein we describe the development and operation of MAPs, using case studies of liraglutide (Saxenda), dupilumab (Dupixent) and calcitonin gene-related peptide monoclonal antibodies. A MAP imposes the eligibility criteria attached to reimbursement support of a medicine. Criteria applied include controls on prescribing authority, clinical diagnostic and severity criteria, previous lines of treatment, concomitant treatments, outcome data collection, and validations within the reimbursement claims system. The choice of criteria are specific to each medicine, dictated by the areas of uncertainty highlighted in the health technology assessment report, such as the place in treatment, population, duration of treatment, etc., the commercial arrangements reached with the marketing authorisation holder, and specific recommendations made by the decision maker. By December 2023, there were 28 medicines reimbursed subject to a MAP in Ireland. Across the three case studies outlined, over 3000 patients were accessing novel treatments for chronic illnesses in September 2023. Managed access protocols can provide some cost certainty for the payer by aligning utilisation and expenditure with committed funds, while enabling access where unmet need is highest. Managed access protocols are now established in the drug reimbursement process in Ireland, meeting the needs of both payers, patients and industry, and are likely to remain a feature of the reimbursement landscape.

Genomic risk stratification methods for myeloid malignancies have moved beyond conventional karyotyping and single gene approaches to better define disease behaviour. Next-generation sequencing has been established as the new standard-of-care tool to accurately define prognosis at diagnosis and guide therapy decisions. We aimed to determine the economic value of a 37-gene panel test for informing subsequent care for patients with intermediate-risk myeloid malignancies.

Mutations in KRAS and NRAS are predictive of poor response to cetuximab and panitumumab, two anti-epidermal growth factor receptor (EGFR) monoclonal antibodies used in metastatic colorectal cancer (mCRC). Our objective was to explore the value of using KRAS and NRAS mutation status to inform third-line anti-EGFR therapy for mCRC using the value of heterogeneity (VOH) framework.

Clinical healthcare is not the only way to improve an individual's health. Community-based interventions can have health and wellbeing impacts as well; however, the nature of these interventions, which have public good characteristics, poses challenges for the typical ways in which we value outcomes for use in (health) economic evaluations. The approaches to valuation of these type of interventions should allow for the incorporation of all types of values including option value, externalities and individual use-value.

With its clear focus on financial protection, government-funded health insurance (GFHI) stands out among the strategies for universal health coverage (UHC) implemented by low-to-middle income countries globally. Since 2018, India has implemented a GFHI programme called the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY), which covers 500 million individuals. The current study aims to evaluate the performance of GFHI in meeting its key objectives of improving access, quality and financial protection for hospital-based care in two large central Indian states: Madhya Pradesh and Maharashtra.

The aim of this study was to examine the association between characteristics of novel drugs and incremental health gains relative to standard of care, in terms of quality-adjusted life-years (QALYs).

Patients may get more treatment options with off-label use of drugs while exposed to unknown risks of adverse events. Little is known about the public or demand-side perspective on off-label drug use, which is important to understand how to use off-label treatment and devise financial assistance. This study aimed to quantify public preference for off-label cancer treatment outcomes, process, and costs, and perceived importance of associated adverse events.

This study leveraged data from 11 independent international diabetes models to evaluate the impact of unrelated future medical costs on the outcomes of health economic evaluations in diabetes mellitus.

Tanzania recently changed its antenatal care (ANC) guidelines to reduce perinatal mortality and improve the experience of pregnancy care. The new guideline recommends increasing the number of ANC visits from four to eight and introducing one routine ultrasound scan, among other recommendations. We estimated the budget impact of implementing the new guideline compared to the previous focused ANC guideline at public dispensaries and health centers.

This paper considers the development and evolution of the short-form 6 dimensions (SF-6D), a generic preference-weighted measure consisting of a health classification with accompanying value set that was developed from one of the widest used health related quality of life measures, the SF-36 health survey. This enabled health state utility values to be directly generated from SF-36 and SF-12 data for a range of purposes, including to produce quality adjusted life years for use in economic evaluation of healthcare interventions across a range of different conditions and treatments. This paper considers the rationale for the development of the measure, the development process, performance and how the SF-6D has evolved since its conception. This includes the development of an updated version, SF-6D version 2 (SF-6Dv2), which was generated to deal with some criticisms of the first version, and now includes a standalone version for inclusion in studies without relying on use of SF-36 or SF-12. Valuation methods have also evolved, from standard gamble in-person interviews to online discrete choice experiment surveys. International work related to the SF-6Dv1 and SF-6Dv2 is considered. We also consider recommendations for use, highlighting key psychometric evidence and reimbursement agency recommendations.

Perinatal depression (PND) has emerged as a significant public health concern. There is no consensus among countries or organizations on whether to screen for PND. Despite the growing body of evidence regarding the economic value of PND screening, its cost-effectiveness remains inadequately understood due to the heterogeneity of existing studies. This study aims to synthesize the available global evidence on the cost-effectiveness of PND screening compared to routine or usual care to provide a clearer understanding of its economic value.

Predictive biomarkers are intended to predict an individual's expected response to specific treatments. These are an important component of precision medicine. We explore measures of biomarker performance that are based on the expected probability of response to individual treatment conditional on biomarker status. We show how these measures can be used to establish thresholds at which testing strategies will be clinically superior.

We assess whether the preferences regarding dependency-related health states as stated by informal caregivers are aligned with those expressed by the general population.

Caring for individuals with spinal muscular atrophy (SMA), a rare genetic disorder, poses tremendous challenges for the economy and healthcare system. This study evaluated the cost-utility of onasemnogene abeparvovec-xioi gene therapy and risdiplam for SMA in Thailand.

The use of robotic-assisted surgery (RAS) is growing rapidly. However, economic evaluation of this technology is challenging. This study aims to identify and discuss the different economic evaluation methods which have been used to evaluate RAS.

Smoking is an important risk factor leading to many diseases, which brings substantial healthcare costs as well as indirect costs due to decreased productivity. This article aims to quantify the social costs of smoking in the Czech Republic in 2019.

The National Health Service (NHS) in England has set a target to be net zero for carbon emissions by 2045. The aim of this study was to investigate how changes in key aspects of clinical practice over the last 8 years have contributed towards reducing the per-patient carbon footprint of elective total hip arthroplasty (THA).

The method used to model general population mortality estimates in cohort models can make a meaningful difference in appraisals; particularly in scenarios involving potentially curative treatments where a prior National Institute for Health and Care Excellence (NICE) appraisal demonstrated that this assumption alone could make a difference of ~£10,000 to the incremental cost-effectiveness ratio.

Recent studies suggest that medical cannabis laws may contribute to a relative reduction in health insurance costs within the individual health insurance markets at the state level. We investigated the effects of adopting a medical cannabis law on the cost of employer-sponsored health insurance in the United States.