PharmacoEconomics

Correction to: Are Quality-Adjusted Life Years a Good Proxy Measure of Individual Capabilities? Open Access This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0International License

Correction to: Different Methods for Modelling Severe Hypoglycaemic Events: Implications for Effectiveness, Costs and Health Utilities The Open Access license, which previously read

Correction to: Sensitivity Analysis for Not-at-Random Missing Data in Trial-Based Cost-Effectiveness Analysis: A Tutorial The Open Access license, which previously read.

Response to 'Comment on "Cost-Effectiveness of Niraparib Versus Routine Surveillance, Olaparib and Rucaparib for the Maintenance Treatment of Patients with Ovarian Cancer in the United States"'

Comment on "Cost-Effectiveness of Niraparib Versus Routine Surveillance, Olaparib and Rucaparib for the Maintenance Treatment of Patients with Ovarian Cancer in the United States"

Economic Evaluation of the 2016 Chinese Guideline and Alternative Risk Thresholds of Initiating Statin Therapy for the Management of Atherosclerotic Cardiovascular Disease Abstract Objective The 2016 Chinese guidelines for the management of dyslipidemia recommended mixed rules that centered around a 10% 10-year risk threshold to initiate statins for the primary prevention of atherosclerotic cardiovascular disease (ASCVD). The present study aimed to evaluate the cost-effectiveness of the guideline statin-initiation strategy and alternative strategies. Methods A decision analytic model using discrete event simulation with event probabilities based on a validated ASCVD risk prediction tool for Chinese was constructed. Risk factor inputs were from the dataset of a nationally representative survey of middle-aged and elderly Chinese. Data of statin treatment effectiveness were from a published meta-analysis. Other key input data were identified from the literature or relevant databases. The strategies we evaluated were the guideline strategy, a 15% 10-year risk threshold strategy and a 20% 10-year risk threshold strategy. After excluding any extended dominance strategies, the incremental costs per quality-adjusted life year (QALY) gained of each strategy was calculated. Results The 20% 10-year risk threshold strategy was an extended dominance option. The incremental costs per QALY gained from the 15% 10-year risk threshold strategy compared with no treatment and the guideline strategy compared with the 15% 10-year risk threshold strategy were CN¥69,309 and CN¥154,944, respectively. The results were robust in most sensitivity analyses. Conclusions The guideline strategy and the 15% 10-year risk threshold strategy are optimal when using the three times and the two times the gross domestic product per capita willingness-to-pay standards, respectively.

The Curve of Optimal Sample Size (COSS): A Graphical Representation of the Optimal Sample Size from a Value of Information Analysis Abstract Value of information (VOI) analysis quantifies the opportunity cost associated with decision uncertainty, and thus informs the value of collecting further information to avoid this cost. VOI can inform study design, optimal sample size selection, and research prioritization. Recent methodological advances have reduced the computational burden of conducting VOI analysis and have made it easier to evaluate the expected value of sample information, the expected net benefit of sampling, and the optimal sample size of a study design ( \(n^{*}\) ). The volume of VOI analyses being published is increasing, and there is now a need for VOI studies to conduct sensitivity analyses on VOI-specific parameters. In this practical application, we introduce the curve of optimal sample size (COSS), which is a graphical representation of \(n^{*}\) over a range of willingness-to-pay thresholds and VOI parameters (example data and R code are provided). In a single figure, the COSS presents summary data for decision makers to determine the sample size that optimizes research funding given their operating characteristics. The COSS also presents variation in the optimal sample size given variability or uncertainty in VOI parameters. The COSS represents an efficient and additional approach for summarizing results from a VOI analysis.

Estimating Quality of Life Decrements Due to Diabetes Complications in the United States: The Health Utility Index (HUI) Diabetes Complication Equation Abstract Objective Health utility decrements associated with diabetes mellitus complications are essential for calculating quality-adjusted life-years (QALYs) in patients for use in economic evaluation of diabetes interventions. Previous studies mostly focused on assessing the impact of complications on health utility at event year based on cross-sectional data. This study aimed to separately estimate health utility decrements associated with current and previous diabetes complications. Research Design and Methods The Health Utilities Index Mark 3 (HUI-3) was used to measure heath utility in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial (N = 8713). Five macrovascular complications (myocardial infarction [MI], congestive heart failure [CHF], stroke, angina, and revascularization surgery [RS]) and three microvascular complications (nephropathy [renal failure], retinopathy [severe vision loss], and neuropathy [severe pressure sensation loss]) were included in a set of alternative modelling approaches including the ordinary least squares (OLS) model, fixed effects model, and random effects model to estimate the complication-related health utility decrements. Results All macrovascular complications were associated with decrements of HUI-3 scores: MI (event year: − 0.042, successive years: − 0.011), CHF (event year: − 0.089, successive years: − 0.041), stroke (event year: − 0.204, successive years: − 0.101), angina (event year: − 0.010, successive years: − 0.032), and revascularization (event year: − 0.038, successive years: − 0.016) (all p < 0.05). For microvascular complications, severe vision loss (− 0.057), and severe pressure sensation loss (− 0.066) were significantly associated with decrements of HUI-3 scores (both p < 0.05). Hypoglycemia (both severe and symptomatic) was found to be associated with a 0.036 decrement of health utility at event year, and a 0.033 decrement of health utility at successive years. Results from an OLS model are preferred for supporting a microsimulation model while a fixed effects model is preferred to describe direct health impacts from complications. Conclusions Macrovascular and microvascular complications caused QALY decrements in patients with type 2 diabetes. While only part of the total impaired QALY is experienced during the event year, further QALY decrements for successive years were quite substantial.

Autologous Chondrocyte Implantation with Chondrosphere for Treating Articular Cartilage Defects in the Knee: An Evidence Review Group Perspective of a NICE Single Technology Appraisal Abstract Chondrosphere (Spherox) is a form of autologous chondrocyte implantation (ACI). It is licensed for repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee with defect sizes up to 10 cm2 in adults. In a single technology appraisal (STA) [TA508] undertaken by the National Institute of Health and Care Excellence (NICE), Warwick Evidence was the Evidence Review Group (ERG) invited to independently review the evidence submitted by the manufacturer, Co.Don. The clinical effectiveness data came from their COWISI randomised controlled trial (RCT), which compared Chondrosphere with microfracture (MF). The timing of this appraisal was unfortunate given that MF was no longer the most relevant comparator because NICE had contemporaneously published guidance approving ACI in place of MF. Moreover, the COWISI RCT enrolled mostly patients with small defect sizes. Evidence of clinical effectiveness for Chondrosphere used in people with larger defect size came from another RCT, which compared three doses of Chondrosphere and that by design could not provide evidence comparing Chondrosphere to any other forms of ACI. To estimate the relative clinical performance of Chondrosphere versus other ACI, Co.Don conducted an indirect treatment comparison by network meta-analyses (NMA). The NMA was flawed in that the distribution of population characteristics that are effect modifiers greatly differed across the treatment comparisons of the network. The ERG questioned both the appropriateness of the NMA and the validity of the resulting estimates. Co.Don estimated the cost-effectiveness of Chondrosphere using a lifetime Markov model with all patients receiving the first repair during the first cycle of the model then moving into one of three health states: success, no further repair (NFR), or a second repair, if necessary. Subsequent to the first cycle, those who were a success either remained a success or moved to second repair. All those in NFR remained in NFR. The cost-effectiveness of Chondrosphere compared to other ACI forms relied on the clinical effectiveness estimates of success and failure rates obtained from the company's indirect comparisons, the validity of which the ERG questioned. The company revised cost-effectiveness estimates for Chondrosphere versus MF and for Chondrosphere versus matrix-applied characterised autologous cultured chondrocyte implant (MACI) were £4360 and around £18,000 per quality-adjusted life year gained, respectively. NICE recommended ACI using Chondrosphere for treating symptomatic articular cartilage defects of the femoral condyle and patella of the knee in adults only if certain requirements were met.

A Systematic Review of Direct Cardiovascular Event Costs: An International Perspective Abstract Introduction There is a lack of comprehensive cost information for cardiovascular events since 2013. Objective A systematic review on the contemporary cost of cardiovascular events was therefore undertaken. Methods Methods complied with those recommended by the Cochrane Collaboration and the Centre for Reviews and Dissemination. Studies were unrestricted by language, were from 2013 to 23 December 2017, and included cost-of-illness data in adults with the following cardiovascular conditions: myocardial infarction (MI), stroke, transient ischaemic attack (TIA), heart failure (HF), unstable angina (UA), coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or peripheral artery disease (PAD). Seven electronic databases were searched, namely Embase (Ovid), MEDLINE (Ovid), MEDLINE In-Process Citations and Daily Update (Ovid), NHS Economic Evaluation Database (NHS EED), Health Technology Assessment (HTA) database, Cochrane Central Register of Controlled Trials (CENTRAL), and PubMed. The included studies reported data from a variety of years (sometimes prior to 2013), so costs were inflated and converted to $US, year 2018 values, for standardization. Results After de-duplication, 29,945 titles and abstracts and then 403 full papers were screened; 82 studies (88 papers) were extracted. Year 1 average cost ranges were as follows: MI ($11,970 in Sweden to $61,864 in the USA), stroke ($10,162 in Spain to $46,162 in the USA), TIA ($6049 in Sweden to $25,306 in the USA), HF ($4456 in China to $49,427 in the USA), UA ($11,237 in Sweden to $31,860 in the USA), PCI ($17,923 in Italy to $45,533 in the USA), CABG ($17,972 in the UK to $76,279 in the USA). One Swedish study reported PAD costs in a format convertible to $US, 2018 values, with a mean annual cost of $15,565. Conclusions There was considerable unexplained variation in contemporary costs for all major cardiovascular events. One emerging theme was that average costs in the USA were considerably higher than anywhere else.

Alexandros Sfakianakis
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alsfakia@gmail.com