Additional Life Years Research Articles

Comparative Assessment of Preventable Socioeconomic Damage in Different Approaches to the Prevention of Vaccine-Controlled Infections in the Framework of the National Vaccination Schedule

Relevance. The strategy for the development of vaccine prevention in the Russian Federation among other areas involves improving the National schedule of preventive vaccinations and ensuring its flexibility, taking into account the current epidemic situation and the emergence of new vaccines. Goal: to Assess the socio-economic damage from five vaccine-controlled infections in different vaccine prevention scenarios. Materials and methods : a simulated retrospective model was constructed with a time horizon of 3 years (2016-2018), which assumes an assessment of changes in lost/ saved years of life including in monetary terms in the context of differentiated disease outcomes and vaccine costs under different scenarios of vaccination coverage and the vaccine prevention algorithm. Results: if the established algorithm is maintained and the age cohort of children under 2 years of age is covered by vaccination, the annual loss of years of life will remain at a high level. Extending the five-component vaccine coverage to 60% of children in the 3-to 18-month age group will reduce losses to 20,215 years, saving 10,263 years of life (33.7% more than the current algorithm), and even more if coverage is close to 100%: annual losses will decrease to 2,134 years, which can provide 28,344 saved years of life (93% more than the current algorithm). The study showed that the more widely the combined pentavalent vaccine is used, the lower the average cost of saving each additional year of life. Conclusions. Expanding the coverage of a combination vaccine provides the greatest additional benefits due to a faster increase in the number of saved years of life (benefits) compared to the increase in costs (cost of vaccines).

Systems analysis and improvement approach to optimize the hypertension diagnosis and care cascade for PLHIV individuals (SAIA-HTN): a hybrid type III cluster randomized trial

BackgroundAcross sub-Saharan Africa, evidence-based clinical guidelines to screen and manage hypertension exist; however, country level application is low due to lack of service readiness, uneven health worker motivation, weak accountability of health worker performance, and poor integration of hypertension screening and management with chronic care services. The systems analysis and improvement approach (SAIA) is an evidence-based implementation strategy that combines systems engineering tools into a five-step, facility-level package to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). As hypertension screening and management are integrated into chronic care services in sub-Saharan Africa, an opportunity exists to test whether SAIA interventions shown to be effective in improving efficiency and coverage of HIV services can be effective when applied to the non-communicable disease services that leverage the same platform. We hypothesize that SAIA-hypertension (SAIA-HTN) will be effective as an adaptable, scalable model for broad implementation.MethodsWe will deploy a hybrid type III cluster randomized trial to evaluate the impact of SAIA-HTN on hypertension management in eight intervention and eight control facilities in central Mozambique. Effectiveness outcomes include hypertension cascade flow measures (screening, diagnosis, management, control), as well as hypertension and HIV clinical outcomes among people living with HIV. Cost-effectiveness will be estimated as the incremental costs per additional patient passing through the hypertension cascade steps and the cost per additional disability-adjusted life year averted, from the payer perspective (Ministry of Health). SAIA-HTN implementation fidelity will be measured, and the Consolidated Framework for Implementation Research will guide qualitative evaluation of the implementation process in high- and low-performing facilities to identify determinants of intervention success and failure, and define core and adaptable components of the SAIA-HTN intervention. The Organizational Readiness for Implementing Change scale will measure facility-level readiness for adopting SAIA-HTN.DiscussionSAIA packages user-friendly systems engineering tools to guide decision-making by front-line health workers to identify low-cost, contextually appropriate chronic care improvement strategies. By integrating SAIA into routine hypertension screening and management structures, this pragmatic trial is designed to test a model for national scale-up.Trial registrationClinicalTrials.gov NCT04088656 (registered 09/13/2019; https://clinicaltrials.gov/ct2/show/NCT04088656).

Has working-age morbidity been declining? Changes over time in survey measures of general health, chronic diseases, symptoms and biomarkers in England 1994–2014

ObjectivesAs life expectancy has increased in high-income countries, there has been a global debate about whether additional years of life are free from ill-health/disability. However, little attention has been given...

The potential global gains in health and revenue from increased taxation of tobacco, alcohol and sugar-sweetened beverages: a modelling analysis

IntroductionGlobally, a growing burden of morbidity and mortality is attributable to lifestyle behaviours, and in particular to the consumption of tobacco, alcohol and sugar-sweetened beverages (SSB). In low-income and middle-income...

Strategies to improve survival outcomes of out-of-hospital cardiac arrest (OHCA) given a fixed budget: A simulation study

BackgroundOur study aimed to identify a strategy that maximizes survival upon hospital discharge or 30-days post out-of-hospital cardiac arrest (OHCA) in Singapore for fixed investments of S$1, S$5, or S$10 million. Four strategies were compared: (1) no additional investment; (2) reducing response time via leasing of more ambulances; (3) increasing number of people trained in cardiopulmonary resuscitation (CPR); and (4) automated external defibrillators (AED). MethodsWe estimated the effect of ambulance response time, bystander CPR and AED on survival based on Singapore’s 2010–2015 OHCA registry data. We simulated the changes in ambulance response times and likelihood of (1) CPR and (2) AED usage as a function of their increased availability, which was then combined with the effect of each factor to determine the increase in survival for each strategy. ResultsSurvival given no additional investment was 4.03% (95% CI: 3.96%, 4.10%). The investments in ambulances, CPR training and AEDs for a given budget of S$1M changed survival to 4.03% (95% CI: 3.96%, 4.10%), 4.04% (95% CI: 3.98%, 4.11%), and 4.44% (95% CI: 4.35%, 4.54%), respectively. This generated 0, 2 and 102 additional life years saved respectively. Given a budget of S$5M or S$10M, 509 or 886 additional life years could be saved, by investing in an additional 10,000 or 20,000 AEDs respectively. The strategies reached a saturation effect whereby improvement in survival was marginal when the budget was increased to ≥S$5M for investment in ambulances and CPR training. ConclusionsInvesting in AEDs had the most gain in survival.

Índice HOMA-IR como predictor de reducción de exceso de peso en pacientes con índice de masa corporal (IMC) ≥ 35 kg/m2 sometidos a gastrectomía vertical

IntroductionBariatric surgery is considered the most effective treatment for severe obesity. However, it is not clear if patients with diabetes mellitus or insulin resistance have the same response than patients without those conditions. Our objective was to evaluate association between pre-surgical HOMA-IR index and percentage of excess weight loss (EWL%) one year after bariatric surgery using sleeve gastrectomy. MethodsRetrospective cohort including patients ≥18 years old with BMI≥35kg/m2, who underwent primary sleeve gastrectomy between 2014-2017 at the Avendaño Medical Center, Peru. Only patients with Type 2 Diabetes, Hypertension, or Dyslipidemia were included. EWL% ≥60% one year after surgery was considered satisfactory. Crude and adjusted Lineal and Poisson regression with robustness was used to assess statistical associations with EWL%. ResultsNinety-one patients were included with a median of 34 years, and 57.1% were women. 85.7% had insulin resistance as per HOMA-IR. One year after surgery, 76.9% had a satisfactory EWL%. The lineal model showed .29% less EWL% per each extra year of life (P=.019), and .93% more EWL% per each extra HOMA-IR point (P=.004). The adjusted Poisson model showed 2% lower risk of having a satisfactory EWL% per each additional year of life (P=.050), and 2% more chance of success per each additional HOMA-IR point (P=.038). ConclusionsThere was association between a higher pre-surgical HOMA-IR index and increased EWL% one year after surgery. It is possible that insulin resistance does not affect negatively sleeve gastrectomy outcomes.

Cost-effectiveness of FOLFIRI + cetuximab vs FOLFIRI + bevacizumab in the first-line treatment of RAS wild-type metastatic colorectal cancer in Germany: data from the FIRE-3 (AIO KRK-0306) study

Aims: This analysis evaluates the cost-effectiveness of first-line treatment with FOLFIRI + cetuximab vs FOLFIRI + bevacizumab for patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) in Germany based on the randomized phase 3 FIRE-3 trial. For patients with RAS wt mCRC, FOLFIRI + cetuximab yielded statistically significant median overall survival gains over FOLFIRI + bevacizumab.Materials and methods: A standard 3-state partitioned survival cost-utility model was developed to compare the health benefits and costs of treatment from a German social health insurance perspective using individual patient–level trial data. Health outcomes were reported in life-years (LYs) and quality-adjusted life-years (QALYs) gained. Survival was estimated based on Kaplan-Meier (KM) curves supplemented with best-fitting parametric survival model extrapolations. Subgroup analyses of patients with a left-sided primary tumor location or patients with metastases confined to the liver were performed.Results: In the modified intention-to-treat analysis, FOLFIRI + cetuximab, providing 0.68 additional LYs (0.53 QALYs), yielded incremental cost-effectiveness ratios (ICERs) of €36,360/LY and €47,250/QALY. In subgroup analyses, patients experienced improved survival gains without a corresponding increase in costs, resulting in lower ICERs. Our model was most sensitive to changes in treatment duration across all lines of therapy, utility of progressive disease, as well as patients’ weight and body surface area.Limitations: This cost-effectiveness analysis was based on patient-level data from the FIRE-3 trial. Trial outcomes may not adequately reflect those in the real-world setting. Additionally, resource use and costs were obtained from tariff lists, which do not account for differences in treatment practice. These considerations limit generalizability of outcomes to other countries, or within the German healthcare setting.Conclusions: Based on our analyses, FOLFIRI + cetuximab is cost-effective compared with FOLFIRI + bevacizumab in patients with RAS wt mCRC, with ICERs well below willingness-to-pay thresholds for diseases with a high burden.

Social Security, Labor Supply and Health of Older Workers: Quasi-Experimental Evidence from a Large Reform

We study the effects of public pension systems on the retirement timing of older workers and, in turn, the health consequences of delaying retirement by those workers. Causal inference relies on a social security reform in Israel that shifted payments from husbands to their (non-working) wives, thereby substantially reducing the implied tax on the husband's employment while keeping overall household wealth constant. Using administrative social security data, we estimate extensive-margin labor supply elasticities w.r.t. the average net-of-tax rate of about 0.43 for men over 65. Using the reform to instrument for employment, we find that working an additional full year at old age decreases longevity. This mortality effect occurs after age 75 and is driven by workers holding blue-collar jobs. Finally, we evaluate the effect of the reform on earnings. The results imply a small value for an additional year of life, suggesting that workers underestimate the health cost of employment at older ages.

Economic Evaluation of Ticagrelor in Treating Patients with Acute Coronary Syndrome in Hong Kong: A Cost-Utility Analysis

This study aimed to evaluate the long-term cost-effectiveness of ticagrelor plus aspirin versus generic clopidogrel plus aspirin in acute coronary syndrome patients in Hong Kong (HK) from a public hospital’s perspective. The study has adapted a previously developed two-component prediction model. The first component is a simple decision tree corresponding to the first year. Afterwards events in the second year onwards were estimated using a state-transition Markov model incorporating the potential of recurrent events such as myocardial infarction and strokes that could lead to death for estimating the long-term economic and health outcomes measured as cost per quality-adjusted life year (QALYs). Kaplan Meier survival analysis was employed to determine the risk of events. Probabilistic sensitivity analysis was used to estimate the probability of ticagrelor being cost-effective. A cost-effectiveness acceptability curve was used to estimate the willingness-to-pay of patients. The use of ticagrelor led to improved clinical outcomes by gaining additional life-years and QALYS over 5-year and lifetime time horizons. The incremental cost-effectiveness ratio was above 1 Gross Domestic Product (GDP) per capita only for the 1-year results. By replacing clopidogrel with ticagrelor for life-time, the incremental drug costs were offset by the substantial reduction in other direct costs, leading to an overall cost-savings of HK 2,878 per patient. The probabilistic sensitivity analysis showed that ticagrelor has 53.5% chance of being dominant and 34.7% being cost-effective at a threshold of 1 GDP per capita for Hong Kong. A cost-effectiveness acceptability curve also showed that the willingness-to-pay for ticagrelor was 90% at 1 GDP per capita. Ticagrelor plus aspirin appeared to be cost-effective over 5-year and life-time projection periods compared to clopidogrel plus aspirin.

The pharmacoeconomic analysis of the cost efficiency of trastuzumab in the adjuvant therapy of HER2 + early breast cancer

Breast cancer (BC) is the first among all oncological diseases in women and is one of the main causes of female mortality worldwide, including in Ukraine. The HER2 + subtype of breast cancer is characterized by the most unfavorable prognosis. The targeted drug trastuzumab significantly improves the 10-year survival rate of patients with HER2 + breast cancer, but at the same time significantly increases the cost of treatment.Aim. To assess pharmacoeconomically the adjuvant therapy of the early stage of HER2 + breast cancer with trastuzumab (Herceptin® medicine) from the perspective of the Ukrainian healthcare system.Materials and methods. The method of analytical modeling by Markov was used. Modeling was carried out on the basis of the results of a randomized, multicenter open clinical trial of phase III HERA. The time horizon of the model is 10 years. As an alternative to trastuzumab the standard adjuvant therapy regimens for breast cancer given in the current Protocol for the care of breast cancer patients were considered. According to the results of modeling by Markov the methods of “cost-effectiveness” and “cost-utility” were used. The efficiency criterion was the life years gained (LYG). The utility criterion was QALY. The cost of direct medical expenses was taken into account. The cost structure was determined by the Protocol. The cost of drugs was determined by the Register of the Ministry of Health of Ukraine as of 08/07/2019. The cost of medical services was determined by price lists. The cost of correcting side effects of chemotherapy was also taken into account. The discount was 3 % annually. The analysis of the sensitivity of the results was conducted to change the price of trastuzumab and the price of drugs of alternative adjuvant therapy regimens.Results. According to the modeling the average life expectancy of patients with HER2 + breast cancer in the trastuzumab group was 7.32 years, in the standard chemotherapy group it was 6.43 years. In the trastuzumab group, patients received 6.72 QALYs, while in the standard chemotherapy group – 5.80. The adjuvant therapy with trastuzumab gave the patients an additional 0.89 LYG and 0.92 QALY. The costs of treatment during the study in the trastuzumab group averaged 627115.5 UAH per one patient, in the group of the standard chemotherapy it was 501939.6 UAH. The incremental ratios ICER (the cost of 1 additional year of life) and ICUR (the cost of 1 additional QALY) were 140,833.8 UAH and 136088.8 UAH, respectively.Conclusions. The targeted drug trastuzumab is a medicine for the adjuvant therapy of the early stage HER2 + breast cancer with the evidence-based effectiveness. The adjuvant therapy regimen for HER2 + breast cancer with trastuzumab compared to the standard adjuvant chemotherapy with HER2 + is expensive, but gives better results. It gives an average of an additional 0.89 years of life and 0.92 QALY. The pharmacoeconomic analysis based on modeling by Markov and “cost-effectiveness” and “cost-utility”calculations allows considering the early stage adjuvant therapy of HER2 breast cancer with trastuzumab (Herceptin®) as an economically feasible medical technology in the healthcare of Ukraine today.

LIFE EXPECTANCY WITH CHRONIC DISEASE AMONG OLDER MEXICAN AMERICANS

The Hispanic Paradox research consistently shows a survival advantage among Hispanics, where they have significantly longer life expectancy compared to non-Hispanic Whites. However, less is known about the quality of these additional years of life. Our goal was to calculate life expectancy for older Hispanics in the US, and to determine what proportion of their lives they could expect to live with chronic conditions. We used data from 2004-5 of the Hispanic Established Population for the Epidemiological Study of the Elderly (Hispanic-EPESE), linked to vital status data through 2016. To determine life expectancy with/without chronic conditions, we used Sullivan’s method. Chronic conditions included: diabetes, stroke, heart attack, arthritis, hypertension, and cancer. Finally, we mapped life expectancy without chronic conditions across neighborhood characteristics. The sample consisted of 2,069 Mexican Americans aged 75 and older. Results showed that at age 75, Mexican Americans could expect to live a large portion of their lives with at least one chronic condition (88%). The largest proportion of life lived with disease was for hypertension (61%), arthritis (59%), and diabetes (33%). There was no pattern by neighborhood characteristics for disease-free life expectancy. Gender differences could not be examined because of small sample sizes. Our findings show that regardless of neighborhood characteristics, Mexican Americans can expect to live a high proportion of their life with at least one chronic condition. This is particularly high for hypertension, diabetes, and arthritis. It is important to consider quality as well as quantity of life when exploring the Hispanic Paradox.

Leisure-time physical activity and life expectancy in people with cardiometabolic multimorbidity and depression.

Whether and to what extent leisure-time physical activity at the recommended levels of 150-min moderate activity is associated with survival in people with cardiometabolic multimorbidity and depression is unknown. UK Biobank participants were classified into groups: (i) no disease; (ii) diabetes; (iii) cardiovascular disease (CVD); (iv) depression; (v) diabetes and CVD; (vi) diabetes and depression; (vii) CVD and depression; (viii) diabetes, CVD and depression. Leisure-time physical activity was categorized as active (meeting recommendations) or inactive. Survival models were applied to estimate life expectancy. A total of 480940 participants were included (median age, 58years; 46% men; 95% white), of whom 74% with cardiometabolic multimorbidity and depression were inactive. During a mean follow-up of 7years, 11006 deaths occurred. At age of 45years, being physically active was associated with 2.34 (95% confidence interval: 0.93, 3.54) additional years of life compared with being inactive in participants with diabetes; corresponding estimates were 2.28 (1.40, 3.16) for CVD; 2.15 (0.05, 4.26) for diabetes and CVD; and 1.58 (1.27, 1.89) for no disease. Participants with a combination of diabetes, CVD and depression, being active was associated with 6.81 (-1.50, 15.31) additional years compared with being inactive; corresponding estimates were 3.07 (-2.46, 8.59) for diabetes and depression; 2.34 (-1.24, 5.91) for CVD and depression; and 0.80 (-0.46, 2.05) for depression. A similar pattern was found at 65years. Meeting the recommended level of physical activity was associated with a longer life expectancy in people with cardiometabolic multimorbidity but not in those with depression.

Disparities in Acceptance of Deceased Donor Kidneys Between the United States and France and Estimated Effects of Increased US Acceptance

Approximately 3500 donated kidneys are discarded in the United States each year, drawing concern from Medicare and advocacy groups. To estimate the effects of more aggressive allograft acceptance practices on the donor pool and allograft survival for the population of US wait-listed kidney transplant candidates. A nationwide study using validated registries from the United States and France comprising comprehensive cohorts of deceased donors with organs offered to kidney transplant centers between January 1, 2004, and December 31, 2014. Data were analyzed between September 1, 2018, and April 5, 2019. The primary outcome was kidney allograft discard. The secondary outcome was allograft failure after transplantation. We used logistic regression to model organ acceptance and discard practices in both countries. We then quantified using computer simulation models the number of kidneys discarded in the United States that a more aggressive system would have instead used for transplantation. Finally, based on actual survival data, we quantified the additional years of allograft life that a redesigned US system would have saved. In the United States, 156 089 kidneys were recovered from deceased donors between 2004 and 2014, of which 128 102 were transplanted, and 27 987 (17.9%) were discarded. In France, among the 29 984 kidneys recovered between 2004 and 2014, 27 252 were transplanted, and 2732 (9.1%, P < .001 vs United States) were discarded. The mean (SD) age of kidneys transplanted in the United States was 36.51 (17.02) years vs 50.91 (17.34) years in France (P < .001). Kidney quality showed little change in the United States over time (mean [SD] kidney donor risk index [KDRI], 1.30 [0.48] in 2004 vs 1.32 [0.46] in 2014), whereas a steadily rising KDRI in France reflected a temporal trend of more aggressive organ use (mean [SD] KDRI, 1.37 [0.47] in 2004 vs 1.74 [0.72] in 2014; P < .001). We applied the French-based allocation model to the population of US deceased donor kidneys and found that 17 435 (62%) of kidneys discarded in the United States would have instead been transplanted under the French system. We further determined that a redesigned system with more aggressive organ acceptance practices would generate an additional 132 445 allograft life-years in the United States over the 10-year observation period. Greater acceptance of kidneys from deceased donors who are older and have more comorbidities could provide major survival benefits to the population of US wait-listed patients. ClinicalTrials.gov identifier: NCT03723668.

Cervical cancer prevention in Morocco: a model-based cost-effectiveness analysis

Objective: Cervical cancer is a huge public health issue in Morocco which represents the second most frequent and fatal cancer among women. Countries that have not yet introduced the HPV vaccine could benefit greatly, but before implementation it is necessary to perform country-specific economic assessments that include current screening practices.Methods: A Markov model was developed to simulate the natural history of HPV and cervical cancer so as to calculate the long-term health benefits and costs of HPV vaccination and current screening by visual inspection with acetic acid (VIA). Starting from a previous transition probability matrix used for a model from Spain, the present model was calibrated to cervical cancer incidence from Morocco. Cost survey data was used to estimate the cost of screening and clinical procedures from the public healthcare perspective. Incremental cost-effectiveness ratios were calculated as 2018US$ per additional year of life saved (YLS) and both costs and health outcomes were discounted at 3%.Results: The expected reduction in lifetime risk of cervical cancer for current screening would be 14% at a cost of US$551/YLS compared with no intervention, assuming VIA every 3 years in women aged 30–49 at 10% coverage. HPV vaccination of pre-adolescent girls at 70% coverage would reduce the lifetime risk of cervical cancer by 62% at a cost of US$1,150/YLS, compared with no intervention. When implementing HPV vaccination in combination with current screening, vaccination would be dominated, and the combined strategy would provide a 69% reduction at a cost of US$2,843/YLS, compared with screening alone. Current screening would be dominated by vaccination when screening coverage is higher than 15%, whereas the combined strategy rapidly exceeds US$4,000/YLS.Conclusions: HPV vaccination could be highly effective and cost-effective in Morocco. Current screening would be good value for money compared with no intervention, but scaling-up screening coverage would make it inefficient compared with vaccination.

Physical activity, multimorbidity, and life expectancy: a UK Biobank longitudinal study

BackgroundMultimorbidity is an emerging public health priority. Physical activity (PA) is recommended as one of the main lifestyle behaviours, yet the benefits of PA for people with multimorbidity are unclear. We assessed the benefits of PA on mortality and life expectancy in people with and without multimorbidity.MethodsUsing the UK Biobank dataset, we extracted data on 36 chronic conditions and defined multimorbidity as (a) 2 or more conditions, (b) 2 or more conditions combined with self-reported overall health, and (c) 2 or more top-10 most common comorbidities. Leisure-time PA (LTPA) and total PA (TPA) were measured by questionnaire and categorised as low (< 600 metabolic equivalent (MET)-min/week), moderate (600 to < 3000 MET-min/week), and high (≥ 3000 MET-min/week), while objectively assessed PA was assessed by wrist-worn accelerometer and categorised as low (4 min/day), moderate (10 min/day), and high (22 min/day) walking at brisk pace. Survival models were applied to calculate adjusted hazard ratios (HRs) and predict life expectancy differences.Results491,939 individuals (96,622 with 2 or more conditions) had a median follow-up of 7.0 (IQR 6.3–7.6) years. Compared to low LTPA, for participants with multimorbidity, HR for mortality was 0.75 (95% CI 0.70–0.80) and 0.65 (0.56–0.75) in moderate and high LTPA groups, respectively. This finding was consistent when using TPA measures. Using objective PA, HRs were 0.49 (0.29–0.80) and 0.29 (0.13–0.61) in the moderate and high PA groups, respectively. These findings were similar for participants without multimorbidity. In participants with multimorbidity, at the age of 45 years, moderate and high LTPA were associated with an average of 3.12 (95% CI 2.53, 3.71) and 3.55 (2.34, 4.77) additional life years, respectively, compared to low LTPA; in participants without multimorbidity, corresponding figures were 1.95 (1.59, 2.31) and 1.85 (1.19, 2.50). Similar results were found with TPA. For objective PA, moderate and high levels were associated with 3.60 (− 0.60, 7.79) and 5.32 (− 0.47, 11.11) life years gained compared to low PA for those with multimorbidity and 3.88 (1.79, 6.00) and 4.51 (2.15, 6.88) life years gained in those without. Results were consistent when using other definitions of multimorbidity.ConclusionsThere was an inverse dose-response association between PA and mortality. A moderate exercise is associated with a longer life expectancy, also in individuals with multimorbidity.

Life expectancy and disparities in survival among HIV-infected people receiving antiretroviral therapy: an observational cohort study in Kathmandu, Nepal

IntroductionThe advent of antiretroviral therapy (ART) has dramatically slowed down the progression of HIV. This study assesses the disparities in survival, life expectancy and determinants of survival among HIV-infected people...

Sleeve Gastrectomy Compared with Gastric Bypass for Morbidly Obese Patients with End Stage Renal Disease: a Decision Analysis

IntroductionThe use of bariatric surgery has increased for morbidly obese patients with end stage renal disease (ESRD) for whom listing on the waitlist is often restricted until a certain BMI threshold is achieved. Effective weight loss for this population improves access to life-saving renal transplantation. However, it is unclear whether sleeve gastrectomy (SG) vs Roux-en-Y gastric bypass (RYGB) is a more effective therapy for these patients. MethodsA decision analytic Markov state transition model was created to simulate the life of morbidly obese patients with ESRD who were deemed ineligible to be waitlisted for renal transplantation unless they achieved a BMI less than 35 kg/m2. Life expectancy following weight management (MWM), RYGB, and SG were estimated. Base case patients were defined as having a pre-intervention BMI of 45 kg/m2. Sensitivity analysis of initial BMI was performed. Markov parameters were extracted from literature review. ResultsRYGB improved survival compared with SG and MWM. RYGB patients had higher rates of transplantation, leading to improved mean long-term survival. Base case patients who underwent RYGB gained 1.3 additional years of life compared with patient’s who underwent SG and 2.6 additional years of life compared with MWM. ConclusionsRYGB improves access to renal transplantation and thereby increases long-term survival compared with SG and MWM. The use of SG may be incongruent with the goal of improving access to renal transplantation for morbidly obese patients.

PMD9 CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE COMPARED TO USUAL CARE FOR SEVERE OBSTRUCTIVE SLEEP APNEA: A COST-EFFECTIVENESS ANALYSIS

To estimate the incremental cost-effectiveness ratio (ICER) of incorporating continuous positive airway pressure device (CPAP) for the treatment of patients with severe obstructive sleep apnea (OSA), compared to the usual care in the Brazilian Private Healthcare System (PHS). A Markov model was constructed with the following health states: Event-free OSA, non-fatal stroke, non-fatal myocardial infarction (MI) and death, in addition to the events: traffic accident, MI and stroke. Eligible population consisted of patients with severe OSA (apnea-hypopnea index ≥ 30) in PHS. The analysis considered a lifetime horizon with a discount of 5% for costs and clinical outcomes. Direct medical costs for each health state/event were considered, as well as the cost of device acquisition/maintenance and medical follow-up of patients. Probabilistic sensitivity analyses were performed to explore parametric uncertainties. CPAP treatment is more expensive and more effective than the usual care, presenting 2.85 incremental life years and 3.21 incremental quality-adjusted life-years (QALY) and a cost of BRL 19,255. ICER was BRL 6,733/life years gained and BRL 5,995/QALY. That means the payer would disburse BRL 6,733 to promote one additional year of life and BRL 5,995 to promote an additional quality-adjusted life year for the patient using CPAP. Deterministic results are corroborated by the probabilistic analyses. OSA has a major impact on patients’ health, resulting in high costs for the health system. Although it is indicated for the treatment of patients with severe disease, treatment with CPAP is not available in the Brazilian PHS. This study shows that CPAP is a potential device to promote health benefits at low costs for payers. Although there is no cost-effectiveness threshold in Brazil, it is known that ICERs here presented are considered low for the analyzed outcomes.

PCN318 REAL WORLD TREATMENT DATA BASED PROJECTION OF PATIENT NUMBER ELIGIBLE FOR IMMUNO-ONCOLOGY THERAPIES IN TAIWAN AND ESTIMATION OF TOTAL LIFE YEARS GAINED

PD1/PD-L1 blockers are regarded as new SoC for certain cancer types. We aimed to project the potential national number of cancer patients who would be eligible for PD1/PD-L1 inhibitors in Taiwan and also to estimate additional total life years gained with these therapies. The indications of PD1/PD-L1 inhibitors approved by Taiwan FDA as 07-09-2018 were reviewed to finalize the scope of projection. Newly diagnosed cancer patients were identified in the 2012-14 dataset of National Cancer Registry for these indications. Using the ID codes of these patients, their individual treatment history data was extracted from the 2012-15 dataset of National Health Insurance Database. Patient level data was analyzed to estimate the number of patients remained in each treatment line. The population census and historical growth rate of patient number was estimated and applied together with PDL1 prevalence rate for projection of eligible patient numbers. The reported incremental median overall survival gain for PD-1/PD-L1 inhibitors was applied accordingly to each projected patient number by indication to estimate the additional total life years gained. Based on the real world datasets, the annual number of patients who are eligible for PD1/PD-L1 inhibitors from 2019 to 2023 were projected to be 101 to 115 for MEL 1L; 1,200 to 1,520 for NSCLC 1L with TPS≥50%; 1,556 to 1,849 for NSCLC 2L; 1,440 to 1,574 for HNSCC 2L, 285 for GC 3L; and 152 to 193 for UC 2L. A total gain of additional 2,499 to 3,073 life-years was estimated for treatment with PD-1/PD-L1 inhibitors instead of chemotherapies for eligible patients in Taiwan. This study informs an annual total of 4,734 to 5,536 cancer patients who were estimated to be eligible for PD-1/PD-L1 inhibitors in Taiwan. This projection will be useful in future related research and policy planning such as resource and budget allocation.

Tisagenlecleucel for the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukaemia in People Aged up to 25Years: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

As part of the National Institute for Health and Care Excellence's (NICE's) Single Technology Appraisal (STA) process, Novartis submitted evidence on the clinical effectiveness and cost-effectiveness of tisagenlecleucel for treating paediatric and young adult patients (under the age of 25years) with relapsed or refractory (r/r) B-cell acute lymphoblastic leukaemia (ALL). This article presents a summary of the Evidence Review Group's (ERG's) independent review of the evidence submission, the committee's deliberations, and the subsequent development of NICE guidance for the use of tisagenlecleucel on the National Health Service (NHS) in England. Tisagenlecleucel is a chimeric antigen receptor-modified T-cell (CAR-T) product, the first of this emerging therapeutic class to be considered by NICE in this indication. The company's evidence submission was based upon three single-arm, phase II studies: ELIANA, ENSIGN, and B2101J. These trials demonstrated a beneficial effect of tisagenlecleucel, with significant extensions in event-free survival (EFS) and overall survival (OS) compared to historical control datasets on blinatumomab and salvage chemotherapy. Adverse events were common; 77% of patients suffered from cytokine release syndrome (CRS), 56% of whom required intensive care unit-level care. The ERG did not consider clofarabine monotherapy an appropriate proxy for salvage chemotherapy. The company presented a hybrid cost-effectiveness model, combining a decision tree and three-state partitioned survival model structure. The majority of quality-adjusted life-years (QALYs) gained were generated through additional life-years in the extrapolated 'long-term survival' phase of the model, where patients were assumed to be 'cured'. The ERG considered the results to be subject to substantial uncertainty, due in part to immature trial data, unresolved long-term treatment effects, and a lack of appropriate comparator data. The ERG implemented a number of changes to the company's model in an alternative base case, producing deterministic incremental cost-effectiveness ratios (ICERs) of £45,397 per QALY gained versus salvage chemotherapy, and £27,732 versus blinatumomab. The probabilistic model produced ICERs of £48,265 per QALY gained versus salvage chemotherapy, and £29,501 versus blinatumomab. The committee considered the ERG's analysis to be most closely aligned with their preferred assumptions, and did not consider tisagenlecleucel to meet both of the end-of-life (EoL) criteria. In recognition of the innovative nature of tisagenlecleucel, and the present immaturity of ongoing clinical trials, the committee considered further data collection would be valuable in resolving uncertainties around OS, the technology's novel mechanism of action, and the management of CRS and B-cell aplasia. The committee therefore recommended tisagenlecleucel for use in the Cancer Drugs Fund (CDF) until the conclusion of the ELIANA study (June 2023). This appraisal highlighted the difficulty of interpreting EoL criteria in the context of curative therapies and the valuation of cure versus extension of life. Further clarification of NICE's position in these situations may be necessary to ensure consistency and equity in their decision-making.