Projected health-care resource needs for an effective response to COVID-19 in 73 low-income and middle-income countries: a modelling study.

BACKGROUND: Since WHO declared the COVID-19 pandemic a Public Health Emergency of International Concern, more than 20 million cases have been reported, as of Aug 24, 2020. This study aimed to identify what the additional health-care costs of a strategic preparedness and response plan (SPRP) would be if current transmission levels are maintained in a status quo scenario, or under scenarios where transmission is increased or decreased by 50%. METHODS: The number of COVID-19 cases was projected for 73 low-income and middle-income countries for each of the three scenarios for both 4-week and 12-week timeframes, starting from June 26, 2020. An input-based approach was used to estimate the additional health-care costs associated with human resources, commodities, and capital inputs that would be accrued in implementing the SPRP. FINDINGS: The total cost estimate for the COVID-19 response in the status quo scenario was US$52·45 billion over 4 weeks, at $8·60 per capita. For the decreased or increased transmission scenarios, the totals were $33·08 billion and $61·92 billion, respectively. Costs would triple under the status quo and increased transmission scenarios at 12 weeks. The costs of the decreased transmission scenario over 12 weeks was equivalent to the cost of the status quo scenario at 4 weeks. By percentage of the overall cost, case management (54%), maintaining essential services (21%), rapid response and case investigation (14%), and infection prevention and control (9%) were the main cost drivers. INTERPRETATION: The sizeable costs of a COVID-19 response in the health sector will escalate, particularly if transmission increases. Instituting early and comprehensive measures to limit the further spread of the virus will conserve resources and sustain the response. FUNDING: WHO, and UK Foreign Commonwealth and Development Office.

Developing a multisectoral National Action Plan for Health Security (NAPHS) to implement the International Health Regulations (IHR 2005) in Tanzania.

The Ebola outbreak in West Africa precipitated a renewed momentum to ensure global health security through the expedited and full implementation of the International Health Regulations (IHR) (2005) in all WHO member states. The updated IHR (2005) Monitoring and Evaluation Framework was shared with Member States in 2015 with one mandatory component, that is, States Parties annual reporting to the World Health Assembly (WHA) on compliance and three voluntary components: Joint External Evaluation (JEE), After Action Reviews and Simulation Exercises. In February 2016, Tanzania, was the first country globally to volunteer to do a JEE and the first to use the recommendations for priority actions from the JEE to develop a National Action Plan for Health Security (NAPHS) by February 2017. The JEE demonstrated that within the majority of the 47 indicators within the 19 technical areas, Tanzania had either 'limited capacity' or 'developed capacity'. None had 'sustainable capacity'. With JEE recommendations for priority actions, recommendations from other relevant assessments and complementary objectives, Tanzania developed the NAPHS through a nationwide consultative and participatory process. The 5-year cost estimate came out to approximately US$86.6 million (22 million for prevent, 50 million for detect, 4.8 million for respond and 9.2 million for other IHR hazards and points of entry). However, with the inclusion of vaccines for zoonotic diseases in animals increases the cost sevenfold. The importance of strong country ownership and committed leadership were identified as instrumental for the development of operationally focused NAPHS that are aligned with broader national plans across multiple sectors. Key lessons learnt by Tanzania can help guide and encourage other countries to translate their JEE priority actions into a realistic costed NAPHS for funding and implementation for IHR (2005).

Financing transformative health systems towards achievement of the health Sustainable Development Goals: a model for projected resource needs in 67 low-income and middle-income countries.

BACKGROUND: The ambitious development agenda of the Sustainable Development Goals (SDGs) requires substantial investments across several sectors, including for SDG 3 (healthy lives and wellbeing). No estimates of the additional resources needed to strengthen comprehensive health service delivery towards the attainment of SDG 3 and universal health coverage in low-income and middle-income countries have been published. METHODS: We developed a framework for health systems strengthening, within which population-level and individual-level health service coverage is gradually scaled up over time. We developed projections for 67 low-income and middle-income countries from 2016 to 2030, representing 95% of the total population in low-income and middle-income countries. We considered four service delivery platforms, and modelled two scenarios with differing levels of ambition: a progress scenario, in which countries' advancement towards global targets is constrained by their health system's assumed absorptive capacity, and an ambitious scenario, in which most countries attain the global targets. We estimated the associated costs and health effects, including reduced prevalence of illness, lives saved, and increases in life expectancy. We projected available funding by country and year, taking into account economic growth and anticipated allocation towards the health sector, to allow for an analysis of affordability and financial sustainability. FINDINGS: We estimate that an additional $274 billion spending on health is needed per year by 2030 to make progress towards the SDG 3 targets (progress scenario), whereas US$371 billion would be needed to reach health system targets in the ambitious scenario-the equivalent of an additional $41 (range 15-102) or $58 (22-167) per person, respectively, by the final years of scale-up. In the ambitious scenario, total health-care spending would increase to a population-weighted mean of $271 per person (range 74-984) across country contexts, and the share of gross domestic product spent on health would increase to a mean of 7·5% (2·1-20·5). Around 75% of costs are for health systems, with health workforce and infrastructure (including medical equipment) as the main cost drivers. Despite projected increases in health spending, a financing gap of $20-54 billion per year is projected. Should funds be made available and used as planned, the ambitious scenario would save 97 million lives and significantly increase life expectancy by 3·1-8·4 years, depending on the country profile. INTERPRETATION: All countries will need to strengthen investments in health systems to expand service provision in order to reach SDG 3 health targets, but even the poorest can reach some level of universality. In view of anticipated resource constraints, each country will need to prioritise equitably, plan strategically, and cost realistically its own path towards SDG 3 and universal health coverage. FUNDING: WHO.

The cost utility of solifenacin in the treatment of overactive bladder.

OBJECTIVES: Overactive bladder may cause significant discomfort to patients. The standard therapy for overactive bladder includes behavioural therapy and sometimes medication. Recently, a new medication (solifenacin 5 and 10 mg) was developed for treatment of overactive bladder. The objective of this study was to assess the cost utility of solifenacin 5 and 10 mg for overactive bladder. METHODS: We developed a Markov model to estimate the cost per quality adjusted life years (QALY) over a period of 12-months. Model parameters were based on randomized clinical trials for solifenacin 5 and 10 mg. Data on utility scores were taken from the literature. RESULTS: The incremental cost per QALY for solifenacin 5 mg and solifenacin 10 mg compared with placebo were 17,602 pounds and 24,464 pounds respectively. Sensitivity analyses showed that these results were robust to changes of relevant input data. CONCLUSION: Solifenacin 5 and 10 mg are cost-effective treatments in patients with overactive bladder.

Traditional versus up-front [18F] fluorodeoxyglucose-positron emission tomography staging of non-small-cell lung cancer: a Dutch cooperative randomized study.

PURPOSE: We investigated whether application of positron emission tomography (PET) immediately after first presentation might simplify staging while maintaining accuracy, as compared with traditional strategy in routine clinical setting. METHODS: At first presentation, patients with a provisional diagnosis of lung cancer without overt dissemination were randomly assigned to traditional work-up (TWU) according to international guidelines or early PET followed by histologic/cytologic verification of lesions, or imaging and follow-up. Patients with [18F] fluorodeoxyglucose (18FDG) -avid, noncentral tumors without suspicion of mediastinal or distant metastases on PET proceeded directly to thoracotomy. Follow-up in presumed benign lesions was at least 12 months. In patients treated with surgery or neoadjuvant therapy, the quality of staging was measured by comparing the clinical stage to the final stage (combination of peroperative staging and 6 months of follow-up). To investigate test substitution, we analyzed the number of (non)invasive tests to achieve clinical TNM staging, and its associated costs. RESULTS: Between 1999 and 2001, 465 patients (233 TWU, 232 PET) were enrolled at 22 hospitals. The mean (standard deviation) number of procedures to finalize staging was equal in the TWU arm and the PET arm: 7.9 (2.0) v 7.9 (1.9), P = .90, respectively. Mediastinoscopies occurred significantly less often in the PET arm. Agreement between clinical and final stage was good in both arms (kappa = .85 v .78; P = .07). Costs did not differ significantly. CONCLUSION: Up-front 18FDG-PET in patients with (suspected) lung cancer does not reduce the overall number of diagnostic test, but it maintains quality of TNM staging with the use of less invasive surgery.

The cost effectiveness of Apligraf treatment of diabetic foot ulcers.

BACKGROUND: Diabetic foot ulcers (DFUs) present a treatment challenge and result in a large economic burden, requiring careful evaluation of the clinical efficacy and cost effectiveness of new treatment modalities. DFU clinical trials of the bio-engineered skin substitute Apligraf (Novartis Pharma AG, Basel, Switzerland) have demonstrated improved clinical efficacy compared with good wound care (GWC) alone. OBJECTIVE: To determine the economic impact and cost effectiveness of Apligraf plus GWC compared with GWC alone in the treatment of DFUs. STUDY PERSPECTIVE: Societal. METHODS: A Markov-based simulation model was created to compare the costs and effects of Apligraf plus GWC to those of GWC alone over a 12-month period. The primary health states were 'uninfected ulcer', 'infected ulcer', 'gangrene', and 'healed ulcer'. Transition probabilities were based on clinical trial results, while cost estimates were based on estimates of resource utilisation in the Netherlands. The cost-effectiveness outcome measures were the incremental cost per ulcer-free month gained and the incremental cost per amputation avoided. RESULTS: Costs in the first year of treatment were Euro 4656 for Apligraf plus GWC and Euro 5310 for GWC alone (1999 values). Treatment with Apligraf led to lower costs since its greater effectiveness offset the added cost of the product. This benefit was realised after 5 months, the crossover point of the two cost curves. Apligraf use increased the amount of ulcer-free time by by 1.53 months (7.78 vs 6.25) and reduced the risk of amputation (6.3% vs 17.1%). Sensitivity analyses showed that cost parameters (e.g. units of Apligraf required, cost of treatment practice) and transition probabilities between health states affected the cost results. CONCLUSIONS: Treatment with Apligraf plus GWC resulted in a 12% reduction in costs over the first year of treatment compared with GWC alone. The increased ulcer-free time coupled with a reduced risk of amputation to a large extent offset the initial costs of the product.

Cost-effectiveness of FDG-PET in staging non-small cell lung cancer: the PLUS study.

Currently, up to 50% of the operations in early-stage non-small cell lung cancer (NSCLC) are futile owing to the presence of locally advanced tumour or distant metastases. More accurate pre-operative staging is required in order to reduce the number of futile operations. The cost-effectiveness of fluorine-18 fluorodeoxyglucose positron emission tomography ((18)FDG-PET) added to the conventional diagnostic work-up was studied in the PLUS study. Prior to invasive staging and/or thoracotomy, 188 patients with (suspected) NSCLC were randomly assigned to conventional work-up (CWU) and whole-body PET or to CWU alone. CWU was based on prevailing guidelines. Pre-operative staging was followed by 1 year of follow-up. Outcomes are expressed in the percentage of correctly staged patients and the associated costs. The cost price of PET varied between 736 and 1,588 depending on the (hospital) setting and the procurement of (18)FDG commercially or from on-site production. In the CWU group, 41% of the patients underwent a futile thoracotomy, whereas in the PET group 21% of the thoracotomies were considered futile ( P=0.003). The average costs per patient in the CWU group were 9,573 and in the PET group, 8,284. The major cost driver was the number of hospital days related to recovery from surgery. Sensitivity analysis on the cost and accuracy of PET showed that the results were robust, i.e. in favour of the PET group. The addition of PET to CWU prevented futile surgery in one out of five patients with suspected NSCLC. Despite the additional PET costs, the total costs were lower in the PET group, mainly due to a reduction in the number of futile operations. The additional use of PET in the staging of patients with NSCLC is feasible, safe and cost saving from a clinical and from an economic perspective.

Staging of non-small-cell lung cancer and application of FDG-PET. A cost modeling approach.

BACKGROUND: The presence of (distant) metastases affects the therapy (operation) and prognosis of patients with non-small-cell lung cancer (NSCLC). Fifty percent of the operations are futile due to the presence of a locally advanced tumor or distant metastases. Therefore, more accurate preoperative staging is required with respect to the outcomes (reduction of futile operations) and costs. This study examines current staging procedures and assesses possible situations for incorporating positron emission tomography (PET). METHODS: A retrospective analysis was performed to assess actual clinical practice in the staging procedure of 337 patients with NSCLC in two Dutch hospitals. Consequently, by combining these data of actual clinical practice with a literature review, a model was developed to determine the influence of PET on the staging outcomes and the costs. In this model the accuracy and costs of PET can be varied as well as the extent of substitution of conventional diagnostic tests by PET. RESULTS: Practice variation was found between the two hospitals with regard to the setting in which the diagnostic staging took place (hospitalization, outpatient setting) and the extent of the use of mediastinoscopy. This was reflected in the costs and in the number of (futile) operations. CONCLUSION: Hospitalization is the major cost driver in these patients. From a cost viewpoint, the evaluation of PET in a strategy after diagnostic imaging but prior to invasive staging seems most optimal.

Effectiveness of positron emission tomography in the preoperative assessment of patients with suspected non-small-cell lung cancer: the PLUS multicentre randomised trial.

BACKGROUND: Up to 50% of curative surgery for suspected non-small-cell lung cancer is unsuccessful. Accuracy of positron emission tomography (PET) with 18-fluorodeoxyglucose (18FDG) is thought to be better than conventional staging for diagnosis of this malignancy. Up to now however, there has been no evidence that PET leads to improved management of patients in routine clinical practice. We did a randomised controlled trial in patients with suspected non-small-cell lung cancer, who were scheduled for surgery after conventional workup, to test whether PET with 18FDG reduces number of futile thoracotomies. METHODS: Before surgery (mediastinoscopy or thoracotomy), 188 patients from nine hospitals were randomly assigned to either conventional workup (CWU) or conventional workup and PET (CWU+PET). Patients were followed up for 1 year. Thoracotomy was regarded as futile if the patient had benign disease, explorative thoracotomy, pathological stage IIIA-N2/IIIB, or postoperative relapse or death within 12 months of randomisation. The primary outcome measure was futile thoracotomy. Analysis was by intention to treat. FINDINGS: 96 patients were randomly assigned CWU and 92 CWU+PET. Two patients in the CWU+PET group did not undergo PET. 18 patients in the CWU group and 32 in the CWU+PET group did not have thoracotomy. In the CWU group, 39 (41%) patients had a futile thoracotomy, compared with 19 (21%) in the CWU+PET group (relative reduction 51%, 95% CI 32-80%; p=0.003). INTERPRETATION: Addition of PET to conventional workup prevented unnecessary surgery in one out of five patients with suspected non-small-cell lung cancer.