Limited Societal Perspective Research Articles

Priority-setting for obesity prevention-The Assessing Cost-Effectiveness of obesity prevention policies in Australia (ACE-Obesity Policy) study.

The aim of the ACE-Obesity Policy study was to assess the economic credentials of a suite of obesity prevention policies across multiple sectors and areas of governance for the Australian setting. The study aimed to place the cost-effectiveness results within a broad decision-making context by providing an assessment of the key considerations for policy implementation. The Assessing Cost-Effectiveness (ACE) approach to priority-setting was used. Systematic literature reviews were undertaken to assess the evidence of intervention effectiveness on body mass index and/or physical activity for selected interventions. A standardised evaluation framework was used to assess the cost-effectiveness of each intervention compared to a ‘no intervention’ comparator, from a limited societal perspective. A multi-state life table Markov cohort model was used to estimate the long-term health impacts (quantified as health adjusted life years (HALYs)) and health care cost-savings resulting from each intervention. In addition to the technical cost-effectiveness results, qualitative assessments of implementation considerations were undertaken. All 16 interventions evaluated were found to be cost-effective (using a willingness-to-pay threshold of AUD50,000 per HALY gained). Eleven interventions were dominant (health promoting and cost-saving). The incremental cost-effectiveness ratio for the non-dominant interventions ranged from AUD1,728 to 28,703 per HALY gained. Regulatory interventions tended to rank higher on their cost-effectiveness results, driven by lower implementation costs. However, the program-based policy interventions were generally based on higher quality evidence of intervention effectiveness. This comparative analysis of the economic credentials of obesity prevention policies for Australia indicates that there are a broad range of policies that are likely to be cost-effective, although policy options vary in strength of evidence for effectiveness, affordability, feasibility, acceptability to stakeholders, equity impact and sustainability. Implementation of these policies will require sustained co-ordination across jurisdictions and multiple government sectors in order to generate the predicted health benefits for the Australian population.

PCN110 COST COMPARISON OF ADMINISTERING ORAL COMPARED TO INTRAVENOUS PACLITAXEL FOR PATIENTS WITH ADVANCED GASTRIC CANCER IN SOUTH KOREA: A MICRO-COSTING STUDY

To compare the costs of administering oral paclitaxel (oral-p) compared to IV paclitaxel (IV-p) as a second-line therapy for patients with advanced gastric cancer from a limited societal perspective in a South Korean environment.

Cost-utility of colorectal cancer screening at 40 years old for average-risk patients

The incidence of colorectal cancer (CRC) is increasing in patients under the age of 50. The purpose of this study was to assess the cost-utility of available screening modalities starting at 40 years in the general population compared to standard screening at 50 years old. A decision tree modeling average-risk of CRC in the United States population was constructed for the cost per quality-adjusted life year (QALY) of the five most common and effective CRC screening modalities in average-risk 40-year olds versus deferring screening until 50 years old (standard of care) under a limited societal perspective. All parameters were derived from existing literature. We evaluated the incremental cost-utility ratio of each comparator at a willingness-to-pay threshold of $50,000/QALY and included multivariable probabilistic sensitivity analysis. All screening modalities assessed were more cost-effective with increased QALYs than current standard care (no screening until 50). The most favorable intervention by net monetary benefit was flexible sigmoidoscopy ($3284 per person). Flexible sigmoidoscopy, FOBT, and FIT all dominated the current standard of care. Colonoscopy and FIT-DNA were both cost-effective (respectively, $4777 and $11,532 per QALY). The cost-effective favorability of flexible sigmoidoscopy diminished relative to colonoscopy with increasing willingness-to-pay. Regardless of screening modality, CRC screening at 40 years old is cost-effective with increased QALYs compared to current screening initiation at 50 years old, with flexible sigmoidoscopy most preferred. Consideration should be given for a general recommendation to start screening at age 40 for average risk individuals.

Cost Assessment Modelling of Treatments for Highly Active Relapsing Multiple Sclerosis

IntroductionCost assessment modelling (CAM) of treatments in highly active relapsing multiple sclerosis was conducted.MethodsThe CAM was developed using the R programming language. The PICOSTEPS health technology assessment framework was applied in the CAM. Modelled patients were 280 adults with highly active relapsing multiple sclerosis eligible for disease-modifying treatment. Intervention was cladribine tablets, a new and reimbursed oral treatment for highly active relapsing multiple sclerosis in Finland. Comparators included fingolimod, the most used oral reimbursed treatment for the highly active disease, and natalizumab, the most used intravenous treatment, and a treatment mix (80% use fingolimod, 20% use natalizumab) in Finland. Outcomes presented expected annual and cumulative drug-associated costs in the overall population and per patient. Setting was modelled public specialist care in Finland. Time was set to 4 years, without discounting. Effects covered expected drug-associated costs (screening, acquisition, administration, monitoring, adverse events, travelling, productivity). Perspective was a limited societal perspective. Sensitivity analyses regarding all PICOSTEPS components were conducted.ResultsCladribine tablets were projected to be cost saving in comparison to fingolimod, natalizumab and treatment mix. The respective modelled savings were €4,598,742, €16,249,701 and €6,928,934 in the overall population, and €16,424, €58,035 and €24,746 per patient, respectively, during the 4 years. The most important cost driver was drug costs, representing 96.3%, 96.0% and 83.4% of modelled costs associated with cladribine tablets, fingolimod and natalizumab, respectively. Cladribine tablets sustained their affordability in the sensitivity analyses. From the perspective of health care payer, cladribine tablets’ savings were projected to be €4,514,509, €15,145,366 and €6,640,680 in the overall population, and €16,123, €54,091 and €23,717 per patient in comparison to fingolimod, natalizumab and treatment mix, respectively.ConclusionBased on the CAM, cladribine tablets were projected to robustly save modelled drug-associated costs in comparison to fingolimod, natalizumab and their mix in Finland.

The potential cost-effectiveness of mandatory restrictions on price promotions for sugar-sweetened beverages in Australia.

Restricting price promotions on unhealthy foods and beverages has been identified by governments as a promising approach for improving population diets. Using a limited societal perspective, this study assessed the potential cost-effectiveness of mandatory restrictions on price promotions for sugar-sweetened beverages (SSBs) in Australia. Australian dietary consumption data, together with UK data on the SSB sales uplift associated with price promotions, were used to estimate reductions in SSB purchases and consequent changes in body mass index following the intervention. A multi-state, multiple-cohort Markov model was used to estimate the obesity-related health and cost impacts over the lifetime of the 2010 Australian population. Costs included passing legislation, assisting retailer implementation, and compliance monitoring. The intervention was estimated to result in a mean change in daily energy intake of -12.52 kJ (95% Uncertainty Interval, UI: -15.91 to -9.58) per person, which translated to a mean body weight change of -0.11 kg (95%UI: -0.14 to -0.08) per person. Total Health Adjusted Life Years gained were estimated at 34,260 (95%UI: 24,922-45,504). Estimated costs were AUD17.0 million, with estimated healthcare cost savings of AUD376.0 million. The intervention was considered dominant (cost-saving and health promoting). The intervention remained cost-effective if retailers reduced average non-discounted SSB prices in response to the intervention by less than 5.36%. Restricting price promotions on SSBs is likely to be highly cost-effective, although its impact would depend on how industry and shoppers respond. Although Australian data are used, these results are likely to be transferable and highly relevant to the UK context. Policies for restricting price promotions should be considered as part of a comprehensive obesity prevention strategy.

Cost–utility analysis of reslizumab for patients with severe eosinophilic asthma inadequately controlled with high-dose inhaled corticosteroids and long-acting β2-agonists in South Korea

Objectives: We aimed to assess the cost-utility of reslizumab for patients with severe eosinophilic asthma uncontrolled with high-dose inhaled corticosteroids and long-acting β2-agonists (ICS/LABAs) in Korea.Methods: A Markov model with limited societal perspective was used to compare the costs and quality-adjusted life years (QALYs) of reslizumab add-on therapy with standard-of-care (high-dose ICS/LABA) and standard-of-care alone. The model adopted a 4 week cycle with the following six health states over a lifetime (60 years): controlled asthma, uncontrolled asthma, moderate exacerbation, severe exacerbation, all-cause death and asthma-related death. The population comprised adult patients (age ≥18 years) with severe eosinophilic asthma (eosinophils ≥400 cells/μL) at Global Initiative for Asthma (GINA) step 4 or 5 who had experienced at least three exacerbations in the preceding year. Model inputs were sourced from individual patient-level data from two 52 week randomized controlled trials of reslizumab (NCT01287039, NCT01285323). The model included discontinuation rules where patients uncontrolled with reslizumab add-on therapy were transitioned to the standard-of-care arm. Costs and QALYs were annually discounted at 5%. Deterministic and probabilistic sensitivity analyses were performed.Results: Reslizumab add-on therapy was associated with increased cost (US$119,394) and improved QALYs (5.17) compared with standard-of-care alone, resulting in an incremental cost-effectiveness ratio of US$23,081 per QALY gained. Body weight, time horizon and discount rate were influential factors in the model.Conclusions: The addition of reslizumab to high-dose ICS/LABA was cost-effective in Korean patients with severe eosinophilic asthma uncontrolled with high-dose ICS/LABA, based on the threshold of 1 gross domestic product in Korea.Trial registration: ClinicalTrials.gov identifier: NCT01285323.Trial registration: ClinicalTrials.gov identifier: NCT01287039.

Cost-effectiveness of community-based childhood obesity prevention interventions in Australia.

The objective of this study is to examine, from a limited societal perspective, the cost-effectiveness of community-based obesity prevention interventions (CBIs)-defined as a programme of community-level strategies to promote healthy eating and physical activity for Australian children (aged 5-18 years). The effectiveness of CBIs was determined by undertaking a literature review and meta-analysis. Commonly implemented strategies to increase physical activity and improve nutrition were costed (in 2010 Australian dollars) to determine the average cost of a generic programme. A multiple cohort Markov model that simulates diseases associated with overweight and obesity was used to estimate the health benefits, measured as health-adjusted life years (HALYs) and healthcare-related cost offsets from diseases averted due to exposure to the intervention. Health and cost outcomes were estimated over the lifetime of the target population. Monte-Carlo simulation was used to assess second-order uncertainty of input parameters to estimate mean incremental cost-effectiveness ratios (ICER) with 95% uncertainty intervals (UIs). Scenario analyses tested variations in programme intensity, target population, and duration of effect. The meta-analysis revealed a small but significant difference in BMI z-score (mean difference of - 0.07 (95% UI: - 0.13 to - 0.01)) favouring the CBI community compared with the control. The estimated net cost of implementing CBIs across all local government areas (LGAs) in Australia was AUD426M (95% UI: AUD3M to AUD823M) over 3 years. This resulted in 51,792 HALYs gained (95% UI: 6816 to 96,972) over the lifetime of the cohort. The mean ICER was AUD8155 per HALY gained (95% UI: AUD237 to AUD81,021), with a 95% probability of being cost-effective at a willingness to pay threshold of AUD50,000 per HALY. CBIs are cost-effective obesity prevention initiatives; however, implementation across Australia will be (relatively) expensive when compared with current investments in preventive health.

Cost-Utility Analysis of Biologic and Biosynthetic Mesh in Ventral Hernia Repair: When Are They Worth It?

Biologic and biosynthetic meshes typically cost more than synthetic meshes for use in ventral hernia repair (VHR), with unknown comparative effectiveness. Cost-utility analysis was performed from a limited societal perspective assessing direct medical costs and outcomes for open, elective, retromuscular VHR. Short-term and 5-year major complications and costs were modeled using best available evidence from published studies, Healthcare Cost and Utilization Project data, and Americas Hernia Society Quality Collaborative data. Costs were analyzed in 2017 US dollars, and utilities were assessed using quality adjusted life years (QALYs). Sensitivity analyses were performed to determine threshold probabilities of long-term complications favoring particular mesh types. Synthetic mesh was the preferred strategy, with a cost of $15,620 and QALYs of 18.85, assuming a baseline 5.6% rate of long-term complications for all meshes. One-way sensitivity analysis demonstrated that biosynthetic and biologic mesh became the better choice as long-term complication rates for synthetic mesh increased to 15.5% and 26.2%, respectively. Two-way sensitivity analysis demonstrated that biologic and biosynthetic meshes became favorable as the cost of biologic mesh decreased and long-term synthetic mesh complication rates increased. Biologic and biosynthetic meshes also became more cost-effective when their relative long-term complication rates decreased and long-term synthetic mesh complication rates increased. Using modeling techniques, synthetic mesh is the best option for retromuscular VHR given currently available evidence. We established long-term complication thresholds, possibly justifying the higher up-front costs for biologic or biosynthetic meshes. This emphasizes the critical need to obtain long-term complication surveillance data to help individualize mesh choice in VHR.

PRS54 - COST-EFFECTIVENESS ANALYSIS OF RESLIZUMAB FOR PATIENTS WITH SEVERE EOSINOPHILIC ASTHMA INADEQUATELY CONTROLLED WITH HIGH-DOSE INHALED CORTICOSTEROIDS AND LONG-ACTING B2-AGONISTS IN SOUTH KOREA

This study aims to assess the cost-effectiveness of reslizumab for patients with severe eosinophilic asthma uncontrolled with high-dose inhaled corticosteroids and long-acting β2-agonists (ICS/LABA) in Korea. A Markov model with a limited societal perspective was used to compare the costs and quality-adjusted life years (QALYs) of add-on therapy of reslizumab with usual care (i.e., high-dose ICS/LABA) versus usual care alone. The model adopted a cycle length of four weeks with six health states over a lifetime horizon (60 years): controlled asthma, uncontrolled asthma, moderate exacerbation, severe exacerbation, all-cause death, and asthma-related death. The population was adult patients (≥18 years) with severe eosinophilic asthma (eosinophils ≥400 cells/μL) at Global Initiative for Asthma (GINA) steps 4/5 who had experienced at least three exacerbations in the preceding year. Model inputs were largely sourced from individual patient-level data from two 52-week randomized controlled trials of reslizumab (NCT01287039/NCT01285323). Cost data was mainly from National insurance statistical data and survey from asthma specialists in Korea. Utility values were derived from survey results from general population to capture the Korean-specific values. The model included discontinuation rules where patients uncontrolled with reslizumab add-on therapy were transitioned to the usual care arm. The outcome of interest was incremental cost-effectiveness ratio (ICER), expressed as cost per QALYs gained using 5% discount rate and 2018 currency value. Both deterministic and probabilistic sensitivity analyses were performed. Add-on therapy of reslizumab with usual care was associated with both increased cost (US$114,110) and improved QALYs (5.17) compared with usual care alone, resulting in an ICER of US$22,060 per QALY gained. Body weight, time horizon, and discount rate were influential factors in the model. The addition of reslizumab to high-dose ICS/LABA was found to be cost-effective in Korean with severe eosinophilic asthma uncontrolled with high-dose ICS/LABA, based on the threshold of 1 GDP in Korea.

GASTROINTESTINAL DISORDERS - Cost StudiesPGI2 - Cost-Effectiveness Of Internet-Delivered Cognitive Behaviour Therapy For Adolescents With Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is the most frequently reported functional abdominal pain disorder in the pediatric population, impacting about 8% of children and adolescents. The existing evidence supports the effectiveness of exposure-based internet-delivered cognitive behavior therapy (i-CBT) delivered to pediatric populations, but there is yet no evidence on its cost effectiveness. This study assessed whether exposure-based i-CBT is cost effective compared to a waitlist control, from a limited societal perspective. This cost effectiveness study was based on data from a randomized controlled trial examining the efficacy of exposure-based i-CBT delivered to adolescents with IBS, compared with a waitlist control. Eligible participants were adolescents aged 13 to 17 years old with IBS. Cost per point improvement on the PedsQL scale was used as measure of effectiveness. Resource use was measured prospectively using the TIC-P health service receipt inventory. Multiple imputation was used to handle missing data. Adolescents in the i-CBT group showed an average improvement of 5.647 points on the PedsQL scale compared to the waitlist, and an additional cost of $288.60. The incremental cost effectiveness ratio was US$119.74 per one point improvement on the PedsQL scale. The results of the base-case cost effectiveness analyses demonstrated that i-CBT resulted in higher costs but also a significant improvement in health-related quality of life, compared with the waitlist control. i-CBT has the potential of being cost effective but given the absence of a willingness to pay value for a one point improvement on the PedsQL scale, fuller economic evaluations are needed to provide stronger evidence for decision-making.

Modelled Cost-Effectiveness of a Package Size Cap and a Kilojoule Reduction Intervention to Reduce Energy Intake from Sugar-Sweetened Beverages in Australia.

Interventions targeting portion size and energy density of food and beverage products have been identified as a promising approach for obesity prevention. This study modelled the potential cost-effectiveness of: a package size cap on single-serve sugar sweetened beverages (SSBs) >375 mL (package size cap), and product reformulation to reduce energy content of packaged SSBs (energy reduction). The cost-effectiveness of each intervention was modelled for the 2010 Australia population using a multi-state life table Markov model with a lifetime time horizon. Long-term health outcomes were modelled from calculated changes in body mass index to their impact on Health-Adjusted Life Years (HALYs). Intervention costs were estimated from a limited societal perspective. Cost and health outcomes were discounted at 3%. Total intervention costs estimated in AUD 2010 were AUD 210 million. Both interventions resulted in reduced mean body weight (package size cap: 0.12 kg; energy reduction: 0.23 kg); and HALYs gained (package size cap: 73,883; energy reduction: 144,621). Cost offsets were estimated at AUD 750.8 million (package size cap) and AUD 1.4 billion (energy reduction). Cost-effectiveness analyses showed that both interventions were “dominant”, and likely to result in long term cost savings and health benefits. A package size cap and kJ reduction of SSBs are likely to offer excellent “value for money” as obesity prevention measures in Australia.

Is the Salut Programme an effective and cost-effective universal health promotion intervention for parents and their children? A register-based retrospective observational study

ObjectivesThis study investigates the effectiveness and cost-effectiveness of the Salut Programme, a universal health promotion intervention, compared with care-as-usual, over the periods of pregnancy, delivery and the child’s first 2...

Obesity-related health impacts of fuel excise taxation- an evidence review and cost-effectiveness study

BackgroundReducing automobile dependence and improving rates of active transport may reduce the impact of obesogenic environments, thereby decreasing population prevalence of obesity and other diseases where physical inactivity is a risk factor. Increasing the relative cost of driving by an increase in fuel taxation may therefore be a promising public health intervention for obesity prevention.MethodsA scoping review of the evidence for obesity or physical activity effect of changes in fuel price or taxation was undertaken. Potential health benefits of an increase in fuel excise taxation in Australia were quantified using Markov modelling to simulate obesity, injury and physical activity related health impacts of a fuel excise taxation intervention for the 2010 Australian population. Health adjusted life years (HALYs) gained and healthcare cost savings from diseases averted were estimated. Incremental cost-effectiveness ratios (ICERs) were reported and results were tested through sensitivity analysis.ResultsLimited evidence on the effect of policies such as fuel taxation on health-related behaviours currently exists. Only three studies were identified reporting associations between fuel price or taxation and obesity, whilst nine studies reported associations specifically with physical activity, walking or cycling. Estimates of the cross price elasticity of demand for public transport with respect to fuel price vary, with limited consensus within the literature on a probable range for the Australian context. Cost-effectiveness modelling of a AUD0.10 per litre increase in fuel excise taxation using a conservative estimate of cross price elasticity for public transport suggests that the intervention would be cost-effective from a limited societal perspective (237 HALYs gained, AUD2.6 M in healthcare cost savings), measured against a comparator of no additional increase in fuel excise. Under “best case” assumptions, the intervention would be more cost-effective (3181 HALYs gained, AUD34.2 M in healthcare cost savings).ConclusionsExploratory analysis suggests that an intervention to increase fuel excise taxation may deliver obesity and physical activity related benefits. Whilst such an intervention has significant potential for cost-effectiveness, potential equity and acceptability impacts would need to be minimised. A better understanding of the effectiveness and cost-effectiveness of a range of transport interventions is required in order to achieve more physically active transport environments.

Cost-Effectiveness of Acceptance and Commitment Therapy and a Workplace Intervention for Employees on Sickness Absence due to Mental Disorders.

The aim of this study was to evaluate cost-effectiveness of Acceptance and Commitment Therapy (ACT) and workplace dialogue intervention (WDI), both as stand-alone interventions and in combination, compared with treatment as usual (TAU), for employees on sickness absence with mental disorders. Employees (n = 352, 78.4% females) on sickness absence were randomized to one of four groups. Cost-utility analyses were conducted from a health care perspective and a limited societal perspective. All groups reported significant improvements in health-related quality-of-life (HRQoL) and there were no significant differences in HRQoL or costs between groups. The probability of cost-effectiveness for ACT+WDI was 50% compared with ACT, indicating that both treatment alternatives could be considered equally favorable for decision-makers. TAU and WDI were rejected due to less economic efficiency. Adding WDI to ACT cannot be recommended on the basis of our study results.

Cost-effectiveness of vortioxetine versus venlafaxine (extended release) in the treatment of major depressive disorder in South Korea

ABSTRACTObjective: To assess the cost-effectiveness of vortioxetine versus venlafaxine XR (extended-release) in major depressive disorder (MDD) patients in South Korea.Methods: A 1-year cost-effectiveness analysis from a limited societal perspective was performed using a combined model consisting of a decision-tree and a Markov model. Patients entered the model when initiating or switching antidepressant treatment following inadequate response to previous treatment. Remission, relapse and recovery were the main health states.Results: Vortioxetine dominated venlafaxine XR, with quality-adjusted life year (QALY) gains of 0.0131 and cost savings of KRW 623,229/year [US$530/year] from a limited societal perspective. Safety contributed more than efficacy to the incremental QALY gains. More patients were in recovery after initial treatment and after 1 year with vortioxetine (31%, 40%) compared to venlafaxine XR (23%, 36%). Vortioxetine remained dominant in 98% of probabilistic simulations.Conclusion: Vortioxetine dominated venlafaxine XR in South Korea and is a relevant treatment option for MDD patients initiating or switching therapy.

進行再発大腸がんのFOLFIRI療法およびmFOLFOX6療法に対するIRIS療法の経済評価 ― 費用最小化分析

To evaluate the economic impact of regimens including the oral anticancer drug S-1 (a combination of tegafur, gimeracil, and oteracil), we performed cost-minimization analysis to compare the medical costs of S-1 plus irinotecan (IRIS) with those of conventional intravenous treatment with oxaliplatin or irinotecan plus fluorouracil and folinic acid (mFOLFOX6/FOLFIRI) in patients with advanced colorectal cancer. Patients with advanced colorectal cancer were extracted from the ordering system database for outpatients in Showa University Hospital. Direct medical costs and patients' time-related costs were calculated from the hospital billing data and the average Japanese labor wage, respectively. The results were analyzed from a limited societal perspective. Twenty-nine patients with advanced colorectal cancer were identified, and 25 IRIS regimens, 11 mFOLFOX6 regimens, and 5 FOLFIRI regimens were registered. Mean (± SE) monthly costs of treatment were 183,682 (± 4,767) yen for IRIS regimens and 279,077(± 13,345) yen for mFOLFOX6/FOLFIRI regimens. The monthly cost of IRIS regimens was significantly lower than that of mFOLFOX6/FOLFIRI regimens (P < 0.0001). IRIS regimens are cost-saving compared to mFOLFOX6 or FOLFIRI regimens for the management of advanced colorectal cancer.

The Impact of Colonoscopy Screening Guidelines that Incorporate Precursors in the Serrated Pathway: A Cost-Effectiveness Analysis

Abstract Background: In 2012, the U.S. Multi-Society Task Force on CRC published guidelines that include sessile serrated polyps (SSPs) as important new precursors to target during a screening colonoscopy. Previously, adenomas were the only polyp precursor targets of colonoscopy. Objective: The purpose of this study is to estimate the incremental cost-effectiveness ratio for colonoscopy comparing the new guidelines to the former guidelines. Methods: We developed a Markov model for CRC that included three pathways: 1) de novo from colonic epithelium without a polyp precursor, 2) through the adenoma-carcinoma sequence, and 3) through an SSP precursor. Then, we simulated the effect of screening colonoscopy on CRC incidence and mortality applying the new guidelines vs. the old guidelines in a hypothetical US cohort of 100,000 adults who began screening at age 50 and ended screening at age 75. Adults progressed through the model for 50 one-year cycles until death or age 100. Costs for CRC detection and treatment were estimated from a limited societal perspective using Medicare reimbursement data. We calculated the cost per life-year (LY) gained for the new CRC screening guidelines and the old guidelines compared to no intervention. Then we compared the two sets of guidelines to one another. Preliminary Results: CRC screening via colonoscopy in this hypothetical cohort of 100,000 adults using the old guidelines prevented 4,161 new CRC cases and 1,901 deaths. Implementing the new guidelines avoided an additional 452 CRC cases and 178 deaths. The old guidelines resulted in 0.064 LY-gained and an $800 increase in costs per person compared to the natural history of CRC with no intervention, with a cost-effectiveness ratio of $12,500/LY. The new guidelines resulted in 0.068 LY-gained and a $405 increase in costs per person compared to no intervention, with a cost-effectiveness ratio of $5,956/LY. Comparing the new guidelines to the old guidelines, the difference in LY-gained was 0.004, and the difference in costs was -$395 per person. Conclusion: CRC screening that includes evaluation of SSPs may be cost-effective, and potentially cost-saving, compared to prior guidelines.

Cost Effectiveness of a Pharmacy-Only Refill Program in a Large Urban HIV/AIDS Clinic in Uganda

BackgroundHIV/AIDS clinics in Uganda and other low-income countries face increasing numbers of patients and workforce shortages. We performed a cost-effectiveness analysis comparing a Pharmacy-only Refill Program (PRP), a form of task-shifting, to the Standard of Care (SOC) at a large HIV/AIDS clinic in Uganda, the Infectious Diseases Institute (IDI). The PRP was started to reduce workforce shortages and optimize patient care by substituting pharmacy visits for SOC involving monthly physician visits for accessing antiretroviral medicines.Methodology/Principal FindingsWe used a retrospective cohort analysis to compare the effectiveness of the PRP compared to SOC. Effectiveness was defined as Favorable Immune Response (FIR), measured as having a CD4 lymphocyte count of over 500 cells/µl at follow-up. We used multivariate logistic regression to assess the difference in FIR between patients in the PRP and SOC. We incorporated estimates of effectiveness into an incremental cost-effectiveness analysis performed from a limited societal perspective. We estimated costs from previous studies at IDI and conducted univariate and probabilistic sensitivity analyses. We identified 829 patients, 578 in the PRP and 251 in SOC. After 12.8 months (PRP) and 15.1 months (SOC) of follow-up, 18.9% of patients had a FIR, 18.6% in the PRP and 19.6% in SOC. There was a non-significant 9% decrease in the odds of having a FIR for PRP compared to SOC after adjusting for other variables (OR 0.93, 95% CI 0.55–1.58). The PRP was less costly than the SOC (US$ 520 vs. 655 annually, respectively). The incremental cost-effectiveness ratio comparing PRP to SOC was US$ 13,500 per FIR. PRP remained cost-effective at univariate and probabilistic sensitivity analysis.Conclusion/SignificanceThe PRP is more cost-effective than the standard of care. Similar task-shifting programs might help large HIV/AIDS clinics in Uganda and other low-income countries to cope with increasing numbers of patients seeking care.

Good Research Practices for Measuring Drug Costs in Cost Effectiveness Analyses: Issues and Recommendations: The ISPOR Drug Cost Task Force Report—Part I

Objectives The assignment of prices or costs to pharmaceuticals can be crucial to results and conclusions that are derived from pharmacoeconomic cost effectiveness analyses (CEAs). Although numerous pharmacoeconomic practice guidelines are available in the literature and have been promulgated in many countries, these guidelines are either vague or silent about how drug costs should be established or measured. This is particularly problematic in pharmacoeconomic studies performed from the “societal” perspective, because typically the measured cost of a brand name pharmaceutical is not a true economic cost but also includes transfer payments from some members of society (patients and third party payers) to other members of society (pharmaceutical manufacturer stockholders) in large part as a reward for biomedical innovation. Moreover, there are numerous and complex institutional factors that influence how drug costs should be measured from other CEA perspectives, both internationally and within the domestic US context. The objective of this report is to provide guidance and recommendations on how drug costs should be measured for CEAs performed from a number of key analytic perspectives. Methods ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (Drug Cost Task Force [DCTF]) was appointed with the advice and consent of the ISPOR Board of Directors. Members were experienced developers or users of CEA models, worked in academia, industry, and as advisors to governments, and came from several countries. Because how drug costs should be measured for CEAs depend on the perspectives, five Task Force subgroups were created to develop drug cost standards from the societal, managed care, US government, industry, and international perspective. The ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost Effectiveness Analysis (DCTF) subgroups met to develop core assumptions and an outline before preparing six draft reports. They solicited comments on the outline and drafts from a core group of 174 external reviewers and more broadly from the membership of ISPOR at two ISPOR meetings and via the ISPOR web site. Results Drug cost measurements should be fully transparent and reflect the net payment most relevant to the user's perspective. The Task Force recommends that for CEAs of brand name drugs performed from a societal perspective, either 1) CEA analysts use a cost that more accurately reflects true societal drug costs (e.g., 20–60% of average sales price), or when that is too unrealistic to be meaningful for decision-makers, 2) refer to their analyses as from a “limited societal perspective.” CEAs performed from a payer perspective should use drug prices actually paid by the relevant payer net of all rebates, copays, or other adjustments. When such price adjustments are confidential, the analyst should apply a typical or average discount that preserves this confidentiality. Conclusions Drug transaction prices not only ration current use of medication but also ration future biomedical research and development. CEA researchers should tailor the appropriate measure of drug costs to the analytic perspective, maintain clarity and transparency on drug cost measurement, and report the sensitivity of CEA results to reasonable drug cost measurement alternatives.

Cost-effectiveness analysis of vaccination against rotavirus with RIX4414 in France

It is estimated that annually 300 000 cases of rotavirus-induced gastroenteritis (RVGE) occur in children aged up to 5 years in France. A two-dose vaccine against rotavirus infection (RIX4414; Rotarix, GlaxoSmithKline), has been shown to be highly effective against severe RVGE. This study evaluated the cost effectiveness of general vaccination against rotavirus using RIX4414 in France. A Markov model simulated RVGE events and the associated outcomes and costs relating to general vaccination of infants against rotavirus infection using RIX4414 (Rotarix) in a birth cohort of children aged up to 5 years in France with a combined adjustment for age distribution with the seasonality of the infection. Costs and outcomes were estimated from a limited societal perspective, including direct medical costs paid out of pocket or by third-party payers, as well as the proportion of direct medical costs reimbursed by the health authorities. Indirect costs were not included in the base-case analysis. The primary outcome measure was the incremental cost per QALY. Vaccination with RIX4414 incurred an incremental cost of 44 583 Euro per QALY at a public price of 57 Euro per vaccine dose. Univariate sensitivity analyses showed that the parameters with the largest influence on the results were the transition probabilities of severe diarrhoea, seeking medical advice and emergency visits, utility scores of diarrhoea (mild) in children and infants, and the discount rate for benefits. Probabilistic multivariate sensitivity analysis confirmed these results. The acceptability curve indicated that 94% of the results were under an informal threshold of 50 000 Euro per QALY. Comparing our results with those of a recently published study using pooled data for two rotavirus vaccine products in France, the main differences are explained by differences in model structure and in data input values. They include a different age distribution of the infection, shorter duration of the at-risk period (3 years instead of 5 years), different vaccine efficacy, different unit cost data, different disease duration, and different disutility values for the health states in the model. There is a need for agreed standards to improve comparability of results from different studies. The results demonstrate that a generalized vaccination strategy with RIX4414 would be cost effective in France from a limited societal perspective, depending on the baseline assumptions for disease progression and on utility scores selected.