Budget impact analysis of continuous glucose monitoring in individuals with type 2 diabetes on insulin treatment in England.

INTRODUCTION: In 2022, updated guidance from NICE expanded the options for self-monitoring of blood glucose for patients with type 2 diabetes (T2DM), to include continuous glucose monitoring (CGM). In this budget impact analysis, the cost impact of CGM was compared with traditional self-monitoring of blood glucose (SMBG) in adults with T2DM over 1 year from the commissioner perspective in England. RESEARCH DESIGN AND METHODS: The NICE-eligible T2DM cohort was split into 4 subgroups to enable nuanced costing by insulin administration frequency: basal human insulin, premixed insulin, basal-bolus insulin and bolus insulin. The model's cost components comprised mild and severe hypoglycaemia (SH), diabetic ketoacidosis (DKA), consumables and healthcare resource utilisation in primary and secondary care. RESULTS: The introduction of CGM is estimated to be cost additive by approximately £4.6 million in the basecase, driven by increased spending on the CGM device. Overall, healthcare activity was reduced by approximately 20,000 attendances, due to fewer SH and DKA episodes in the CGM arm. General Practitioner (GP) practice-based activity is expected to drop after the first year as patients requiring CGM training is reduced. The budget impact could be neutralised if the CGM sensor was discounted by 13.2% (£29.76 to £25.83). CONCLUSIONS: CGM may result in increased spending in the NICE-eligible T2DM cohort but is expected to reduce demand on secondary care services and GP time. These findings may be of interest to local decision-makers who wish to resolve the COVID-19 backlog with transformational investment in primary care to reduce secondary care activity.

The Budget Impact Analysis of Adopting Direct Oral Anticoagulants for Stroke Prevention in Nonvalvular Atrial Fibrillation Patients in Malawi.

OBJECTIVES: This study aimed to estimate the budget impact of adopting direct oral anticoagulants (DOACs) for stroke prevention in patients with nonvalvular atrial fibrillation in Malawi after the inclusion of DOACs in the World Health Organization's essential medicine list. METHODS: A model was developed in Microsoft Excel. An eligible population of 201 491 was adjusted with 0.05 % incidence rate and mortality rates yearly according to the treatments. The model estimated the implication of supplementing rivaroxaban or apixaban to the standard treatment mix (also the comparator), thus warfarin and aspirin. The current market share of 43% aspirin and 57% warfarin was adjusted proportionally with 10% DOAC uptake in the first year and 5% annually over the subsequent 4 years. Clinical events of stroke and major bleeding from the ROCKET-AF and ARISTOTLE trials were used because health outcome indicators affect resource utilization. The analysis was conducted solely from the Malawi Ministry of Health perspective and it considered direct costs over 5 years. The sensitivity analysis involved varying drug costs, population, and care costs from both public and private sectors. RESULTS: The research suggests that despite potential savings of $6 644 141 to $6 930 812 in stroke care because of fewer stroke events, the total Ministry of Health healthcare budget (approximately $260 400 000) may increase by between $42 488 342 to $101 633 644 in 5 years because drug acquisition costs are greater than savings. CONCLUSIONS: With a fixed budget and current DOACs prices, Malawi can consider using DOACs in patients at the highest risk while waiting for cheaper generic versions.

Review and Assessment of Policy Options for Improving Access to Combination Therapies in Oncology in Europe.

OBJECTIVES: Combinations of on-patent therapies (CTs) are increasingly common in oncology. They cause challenges for funding and affordability, and hence patient access, especially when constituent therapies are owned by different manufacturers. The aim of our study was to develop policy proposals for the assessment, pricing, and funding of CTs and identify which might be relevant in different European countries. METHODS: Following a review of available literature, seven hypothetical policy proposals were developed and subsequently assessed through 19 semi-structured interviews with health policy, pricing, technology assessment and legal experts in seven European countries to identify those most likely to gain traction. RESULTS: Experts saw a need for agreed approaches within a country to manage affordability and funding challenges for CTs. Changes to health technology assessment (HTA) and funding models were considered unlikely, but other policy proposals were seen as mostly useful, with country-specific adaptations. Bilateral discussions between manufacturers and payers were deemed important, and less challenging and protracted than arbitrated dialogue between manufacturers. Usage-specific pricing, possibly using weighted average prices, was considered a prerequisite for the financial management of CTs. CONCLUSIONS: There is a growing need to ensure that CTs are affordable to health systems. It would appear that there is no one set of policies that is appropriate for all countries in Europe, so countries wishing to ensure that patients have (or continue to have) access to CTs of value to them must explore and implement the policies that are best suited to their general approach to funding health care and to the assessment and reimbursement of medicines.

The Use of Economic Evaluation Tools in Essential Health Benefits Package Selection for Universal Health Coverage.

OBJECTIVES: The sustainable development goals launched in 2015 are a follow-up commitment to the successful Millennium Development Goals. Goal number 3 of ensuring "good health and well-being" is a target to ensure universal health coverage. Universal health coverage means the provision of quality services that meet the needs of populations without risking financial impoverishment in the process. The guaranteed minimum health services in every health system constitute the health benefits package (HBP), which should be explicit and be composed of services that represent the best value for money and guarantee the best return on investment. The objective of this study was to review the application of cost-effectiveness analysis (CEA) and budget impact analysis in the development of HBP in low-to-middle income countries across the world. METHODOLOGY: A literature review using a systematic approach was used. A search of PubMed, Google Scholar, World Health Organization, and World Bank databases was made for articles outlining the development of HBP in low- and middle-income countries, and a narrative synthesis was used for analysis. RESULTS: Results from processes in Armenia, Ethiopia, Kyrgyz Republic, Lebanon, and Malawi showed CEA and budget impact analysis as 2 criteria used in HBP development in a limited number of countries with either no reference to the two or no reporting from the others. Local CEA estimates and cost data limitations were the biggest challenges to efforts to use robust methods. CONCLUSION: Sustained efforts are needed to understand and address the challenges to the use of economic evaluation in the development of HBPs.

Estimating the budget impact of adopting tenofovir/emtricitabine for pre-exposure prophylaxis of HIV in the public health sector in Namibia (2021 - 2023).

BACKGROUND: Although Namibia started implementing pre-exposure prophylaxis (PrEP) of Human Immunodeficiency Virus (HIV) in 2016, no study to determine its budget impact has been conducted. This study, therefore, aimed to estimate the budget impact of adopting tenofovir/emtricitabine for PrEP of HIV for all eligible people in the public health sector in Namibia from 2021 to 2023. METHODS: A country-specific model was developed for this budget impact analysis (BIA). PrEP has targeted all eligible people in Namibia who receive health services from the public sector. It was assumed that the adherence rate was 75% and PrEP effectiveness 60% in this study. Costs used in this study were taken from a study that included Namibian costs. RESULTS: The BIA suggests that adopting PrEP may be cost saving as US$104 823, US$143 620, and US$182 452 of additional HIV care costs will potentially be saved in 2021, 2022, and 2023, respectively. Cost savings rely on high adherence rates, high PrEP effectiveness rates, low PrEP costs, and a small number of people living with HIV (PLHIV). CONCLUSION: Further economic analysis could aid decision-making in Namibia, both to stress test assumptions in the BIA and conduct cost-effectiveness analysis to estimate the value for money of PrEP.

Public and patient involvement at the UK National Institute for Health and Clinical Excellence.

The National Institute for Health and Clinical Excellence (NICE) is the arms-length National Health Service (NHS) agency that provides recommendations to the NHS in England and Wales on clinical practice and technologies that should or should not be used in the NHS. NICE aims to ensure that both the public and patients are included in their work and deliberations that lead to recommendations. This article provides an overview of the ways in which the public and patients can engage with NICE based upon a review of the NICE website and relevant literature. It finds that there are a range of both formal and informal mechanisms that provide an opportunity for the public and patients to be involved, but suggests that there are some improvements that could be made to improve transparency, and suggests further work to explore with the public and patients their views of how involvement should be undertaken. Lessons from the NICE experience are likely to be relevant to other countries that have or are adopting health technology assessment.

Patient-reported outcome measures: implications for nursing.

The Patient Reported Outcome Measures (PROMs) Programme, which was implemented by the NHS in 2009, gives prominence to patients' views about their health. Self-reported measures of health are now being sought from all patients before and after four elective procedures--hip and knee replacement surgery, hernia repair and varicose veins surgery. This information will be used to assess changes in health and provides routine information on NHS patients' health outcomes for the first time. The information will be used to identify and reward good performance by providers; help patients to make choices and clinicians to monitor and improve quality; and inform commissioners' decisions about which services to prioritise. The aim of this article is to inform nurses about PROMs and encourage them to engage with it.

Single technology appraisals by NICE: are they delivering faster guidance to the NHS?

BACKGROUND: In 2005, a new technology appraisal process (the Single Technology Appraisal [STA]) was implemented by the National Institute for Health and Clinical Excellence (NICE), an independent agency that provides guidance to the UK NHS on the use of technology. The objective of STAs was to provide faster guidance to the NHS in order to help overcome the problems of 'NICE blight'. METHODS: Publicly available data from the NICE website and date of first marketing authorization (MA) from the Electronic Medicines Compendium were used to determine if STAs for cancer technologies have in fact been able to provide faster guidance than multiple technology appraisals (MTAs) for cancer interventions. RESULTS: STAs in cancer have, on average, taken 12.8 months from the date that NICE lists in the project history to guidance date. This compares with 20.7 months for MTAs in cancer. However, the time between the date of first MA and guidance is longer for cancer-related STAs than MTAs (95.1 months vs 74.6 months). The reasons for this are not clear; however, the STA programme includes examples of using an older product to treat a new cancer site, which may account for some of the differential. It may also reflect the timing that products are referred to NICE. CONCLUSIONS: The overall results suggest that STAs may be faster once NICE looks at the specific product, but that there is a greater delay in the referral of STA products to NICE than for MTA products. However, the time taken for STAs is still short of the target of 9.75 months (or 39 weeks) [assuming no appeals].