Cost-Effectiveness Modeling of Prostate-Specific Membrane Antigen Positron Emission Tomography with Piflufolastat F 18 for the Initial Diagnosis of Patients with Prostate Cancer in the United States.

BACKGROUND AND OBJECTIVES: Piflufolastat F 18 is a novel prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) radiotracer that is superior to standard of care (SOC) imaging for the initial staging of prostate cancer and the detection of biochemical recurrence. As piflufolastat F 18 has been approved in the United States (US) for this indication, this modeling study assessed the cost effectiveness of piflufolastat F 18 versus fluciclovine F-18, gallium68-PSMA-11 (PSMA 11), and SOC imaging (a mix of bone scans, computed tomography, and magnetic resonance imaging) for the diagnosis and staging of prostate cancer from a US healthcare system perspective. PERSPECTIVE: A US third-party payer perspective was used, which for this population reflects a mix of commercial and Medicare, considering only direct healthcare costs. SETTING: This study utilized a tertiary healthcare setting. METHODS: A decision tree was used to map the diagnostic/treatment pathway, consisting of the proportion of patients with local, regional, distant, or no disease; prostate-specific antigen (PSA) ≤ 1.0 or > 1.0; and accuracy of imaging modalities. A Markov model predicted the long-term outcomes of disease progression according to treatment decisions. Inputs to the model were informed by data from the OSPREY and CONDOR clinical trials, public data, and the literature. Treatment mix included active surveillance, radiation therapy, prostatectomy, androgen deprivation therapy (ADT), and radiation therapy + ADT, informed by expert opinion. Outcomes included life-years (LY), quality-adjusted life-years (QALY), and the incremental cost-effectiveness ratio (ICER). All costs were reported in 2021 US dollars, using the US Bureau of Labor Statistics Consumer Price Index. A willingness-to-pay (WTP) threshold of $150,000 was considered cost effective, consistent with the upper range used as the standard for price benchmarks by the Institute for Clinical and Economic Review. The robustness of the base-case results was assessed in deterministic and probabilistic sensitivity analyses. RESULTS: Over a lifetime horizon, piflufolastat F 18 had the greatest effectiveness in terms of LYs (6.80) and QALYs (5.33); for the comparators, LYs ranged from 6.58 (SOC) to 6.76 (PSMA 11) and QALYs ranged from 5.12 (SOC) and 5.30 (PSMA 11). Piflufolastat F 18 was more cost effective compared with fluciclovine F 18, PSMA 11, and SOC, with ICERs of $21,122, $55,836, and $124,330 per QALY gained, respectively. Piflufolastat F 18 was associated with the greatest net monetary benefit ($627,918) compared with the other options at a WTP threshold of $150,000. The results of the deterministic and probabilistic sensitivity analyses supported the robustness of the base-case results. CONCLUSIONS: This study suggests that piflufolastat F 18 is a cost-effective diagnostic option for men with prostate cancer in the US, with higher associated LY, QALY, and greater net monetary benefit than fluciclovine F 18, PSMA 11, and SOC imaging.

A Web-Based Sexual Health Intervention to Prevent Sexually Transmitted Infections in Hong Kong: Model-Based Cost-Effectiveness Analysis.

BACKGROUND: Sexually transmitted infections (STIs) remain a significant public health concern, particularly among young adults, and Chlamydia trachomatis (CT) infections are the most common STIs in young women. One of the most effective ways to prevent STIs is the consistent use of condoms during sexual intercourse. There has been no economic evaluation of the interactive web-based sexual health program, Smart Girlfriend, within the Chinese population. OBJECTIVE: This study aimed to evaluate the long-term cost-effectiveness of Smart Girlfriend in preventing STIs in the Chinese population. The evaluation compared the program with a control intervention that used a 1-page information sheet on condom use. METHODS: A decision-analytic model that included a decision tree followed by a Markov structure of CT infections was developed since CT is the most prevalent STI among young women. The model represents the long-term experience of individuals who received either the intervention or the control. One-way and probabilistic sensitivity analyses were conducted. The main outcomes were the number of CT infections and the incremental cost as per quality-adjusted life year (QALY). RESULTS: A cohort of 10,000 sexually active nonpregnant young women initially entered the model in a noninfectious state (ie, "well"). In the base-case analysis, the implementation of the Smart Girlfriend program resulted in the prevention of 0.45% of CT infections, 0.3% of pelvic inflammatory disease, and 0.04% of chronic pelvic pain, leading to a gain of 70 discounted QALYs and cost savings over a 4-year time horizon, compared to the control group. With more than 4548 users, the intervention would be cost-effective, and with more than 8315 users, the intervention would be cost saving. A 99% probability of being cost-effective was detected with a willingness to pay US $17,409 per QALY. CONCLUSIONS: Smart Girlfriend is a cost-effective and possibly cost-saving program over a 4-year time horizon. This result was particularly sensitive to the number of website users; launching the website would be cost-effective if more than 4548 people used it. Further work is warranted to explore if the findings could be expanded to apply to women who have sex with women and in the context of other STIs. TRIAL REGISTRATION: ClinicalTrial.gov NCT03695679; https://clinicaltrials.gov/study/NCT03695679.

Cost-effectiveness of the PDSAFE personalised physiotherapy intervention for fall prevention in Parkinson's: an economic evaluation alongside a randomised controlled trial.

BACKGROUND: PDSAFE is an individually-tailored, physiotherapist-delivered, balance, strength and strategy training programme aimed at preventing falls among people with Parkinson's. We evaluated the cost-effectiveness of PDSAFE compared with usual care for people with Parkinson's at higher risk of falling, from a UK National Health Service and Personal Social Service perspective. METHODS: Resource use and quality of life data (EQ-5D-3L) were collected from 238 participants randomised to the PDSAFE intervention and 236 participants randomised to control, at baseline, 3 months, 6 months (primary outcome), and 12 months. Adjusted cost and quality-adjusted life-years (QALYs) were estimated using generalised linear models and uncertainty estimated using a non-parametric bootstrap. RESULTS: Over 6 months, the PDSAFE intervention was associated with an incremental cost of £925 (95% CI £428 to £1422) and a very small and statistically insignificant QALY gain of 0.008 (95% CI - 0.006 to 0.021). The resulting incremental cost-effectiveness ratio (ICER) was £120,659 per QALY and the probability of the intervention being cost-effective at a UK threshold of £30,000/QALY was less than 1%. The ICER varied substantially across subgroups although no subgroup had an ICER lower than the £30,000 threshold. The result was sensitive to the time horizon with the ICER reducing to £55,176 per QALY when adopting a 12-month time horizon and assuming a sustained treatment effect on QoL, nevertheless, the intervention was still not cost-effective according to the current UK threshold. CONCLUSIONS: Evidence from this trial suggests that the PDSAFE intervention is unlikely to be cost-effective at 6 months. The 12-month analysis suggested that the intervention became closer to being cost-effective if quality of life effects were sustained beyond the intervention period, however this would require confirmation. Further research, including qualitative studies, should be conducted to better understand the treatment effect of physiotherapy and its impact on quality of life in people with Parkinson's given existing mixed evidence on this topic. TRIAL REGISTRATION: ISRCTN48152791. Registered 17 April 2014. http://www.isrctn.com/ISRCTN48152791.

Type 2 diabetes remission: 2 year within-trial and lifetime-horizon cost-effectiveness of the Diabetes Remission Clinical Trial (DiRECT)/Counterweight-Plus weight management programme.

AIMS/HYPOTHESIS: Approximately 10% of total healthcare budgets worldwide are spent on treating diabetes and its complications, and budgets are increasing globally because of ageing populations and more expensive second-line medications. The aims of the study were to estimate the within-trial and lifetime cost-effectiveness of the weight management programme, which achieved 46% remissions of type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT). METHODS: Within-trial analysis assessed costs of the Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet), along with glucose-lowering and antihypertensive medications, and all routine healthcare contacts. Lifetime cost per quality-adjusted life-year (QALY) was estimated according to projected durations of remissions, assuming continued relapse rates as seen in year 2 of DiRECT and consequent life expectancy, quality of life and healthcare costs. RESULTS: Mean total 2 year healthcare costs for the intervention and control groups were £3036 and £2420, respectively: an incremental cost of £616 (95% CI -£45, £1269). Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314). Net remission at 2 years was 32.3% (95% CI 23.5%, 40.3%), and cost per remission achieved was £1907 (lower 95% CI: intervention dominates; upper 95% CI: £4212). Over a lifetime horizon, the intervention was modelled to achieve a mean 0.06 (95% CI 0.04, 0.09) QALY gain for the DiRECT population and mean total lifetime cost savings per participant of £1337 (95% CI £674, £2081), with the intervention becoming cost-saving within 6 years. CONCLUSIONS/INTERPRETATION: Incorporating the lifetime healthcare cost savings due to periods of remission from diabetes and its complications, the DiRECT intervention is predicted to be both more effective (QALY gain) and cost-saving in adults with type 2 diabetes compared with standard care. This conclusion appears robust to various less favourable model scenarios, providing strong evidence that resources could be shifted cost-effectively to support achieving remissions with the DiRECT intervention. TRIAL REGISTRATION: ISRCTN03267836 Graphical abstract.

Effectiveness and cost-effectiveness of a loyalty scheme for physical activity behaviour change maintenance: results from a cluster randomised controlled trial.

BACKGROUND: We evaluated the effectiveness and cost-effectiveness of a loyalty scheme based intervention involving rewards for increasing physical activity in public sector employees. METHODS: A cluster randomised wait-list controlled trial in public sector organisations in Northern Ireland. We randomly assigned clusters (1:1) using a computer generated random sequence. Researchers were masked to allocation, but participants were not. Employees aged 18-65 years with no self-reported medical contraindications to physical activity were included. The Physical Activity Loyalty Scheme (PAL) intervention was based on high-street loyalty cards where participants earned points for minutes of activity that could be redeemed for rewards, complemented by evidence-based behaviour change techniques. The primary outcome was objectively measured mean steps/day at 6 months using a validated pedometer (Yamax Digi-Walker CW-701) over 7 days, assessed with intention to treat analysis. Secondary outcomes included health, mental wellbeing, quality of life, work absenteeism and presenteeism, and use of healthcare resources. Cost-effectiveness, cost-benefit and mediation analyses were conducted. Trial registered with Current Controlled Trials, number ISRCTN17975376. RESULTS: Between September 2014 and October 2015, we recruited and randomly assigned 37 clusters (from nine organisations; mean clusters per organisation = four) and 853 participants to the intervention (n = 19 with 457 participants) or control group (n = 18 with 396 participants). Primary outcome data were available for 249 (54·4%) intervention and 236 (59·6%) control participants. Mean steps/day were significantly lower in the intervention vs control group (adjusted mean difference = - 336, 95% CI: -612 to - 60, p = 0·02) at 6 months. Participants redeemed only 39% (SD 43%) of their earned points. Using the Quality Adjusted Life Year outcome, the intervention was not cost effective from an NHS/PSS perspective. A net cost analysis from an employer perspective demonstrated the intervention group was associated with a mean of 2·97 h less absenteeism over a 4 week period (p = 0·62), which could result in net savings ranging from £66 to £735 depending on the wage rate employed. At 4-weeks post-baseline there were significant increases in identified regulation, integrated regulation, intrinsic motivation, social norms and intentions in intervention compared to control participants. CONCLUSIONS: Our mixed results pose challenges that are too infrequently exposed in public heath intervention trials. Although the intervention successfully altered several hypothesised mediating constructs it did not translate into long-term behaviour change. Our incentive level may have been too low to incentivise change, despite being designed a priori by a Contingent Valuation Survey. There were also major re-structuring of several organisations which presented significant implementation challenges, and technical limitations. TRIAL REGISTRATION: ISRCTN17975376 (Registered 19/09/2014).

Cost-effectiveness analysis of vaccinations and decision makings on vaccination programmes in Hong Kong: A systematic review.

OBJECTIVES: To describe and systematically review the modelling and reporting of cost-effectiveness analysis of vaccination in Hong Kong, and to identify areas for quality enhancement in future cost-effectiveness analyses. METHODS: We conducted a comprehensive and systematic review of cost-effectiveness studies related to vaccination and government immunisation programmes in Hong Kong published from 1990 to 2015, through database search of Pubmed, Web of Science, Embase, and OVID Medline. Methodological quality of selected studies was assessed using Consolidated Health Economic Evaluation Reporting Standards checklist (CHEERS). Decision making of vaccination was obtained from Scientific Committee on Vaccine Preventable Diseases (SCVPD) and Department of Health in Hong Kong. RESULTS: Nine eligible studies reporting twelve comparative cost-effectiveness comparisons of vaccination programme for influenza (n=2), pneumococcal disease (n=3), influenza plus pneumococcal disease (n=1), chickenpox (n=2), Haemophilus influenzae b (n=1), hepatitis A (n=1), cervical cancer (n=1) and rotavirus (n=1) were identified. Ten comparisons (83.3%) calculated the incremental cost-effectiveness ratio (ICER) of a vaccination strategy versus status quo as outcomes in terms of cost in USD per life-years, cost per quality-adjusted life-years, or cost per disability-adjusted life-years. Among those 10 comparisons in base-case scenario, 4 evaluated interventions were cost-saving relative to status quo while the ICER estimates in 3 of the 6 remaining comparisons were far below commonly accepted threshold and WHO willingness-to-pay threshold, suggestive of very cost-effective. Seven studies were of good quality based on the CHEERS checklist; one was of moderate quality; and one was of excellent quality. The common methodological problems were characterisation of heterogeneity and reporting of study parameters. CONCLUSIONS: There was a paucity of cost-effectiveness models evaluating vaccination targeted to the Hong Kong population. All evaluated vaccinations and immunisation interventions in Hong Kong, except for Haemophilus influenzae b, hepatitis A and HPV vaccinations, were considered either cost-saving or very cost-effective when compared to status quo.

Assessment of the construct validity and responsiveness of preference-based quality of life measures in people with Parkinson's: a systematic review.

PURPOSE: Generic preference-based quality of life (PbQoL) measures are sometimes criticized for being insensitive or failing to capture important aspects of quality of life (QoL) in specific populations. The objective of this study was to systematically review and assess the construct validity and responsiveness of PbQoL measures in Parkinson's. METHODS: Ten databases were systematically searched up to July 2015. Studies were included if a PbQoL instrument along with a common Parkinson's clinical or QoL measure was used, and the utility values were reported. The PbQoL instruments were assessed for construct validity (discriminant and convergent validity) and responsiveness. RESULTS: Twenty-three of 2758 studies were included, of which the majority evidence was for EQ-5D. Overall good evidence of discriminant validity was demonstrated in the Health Utility Index (HUI)-3, EQ-5D-5L, EQ-5D-3L, 15D, HUI-2, and Disability and Distress Index (DDI). Nevertheless, HUI-2 and EQ-5D-3L were shown to be less sensitive among patients with mild Parkinson's. Moderate to strong correlations were shown between the PbQoL measures (EQ-5D-3L, EQ-5D-5L, 15D, DDI, and HUI-II) and Parkinson's-specific measures. Twelve studies provided evidence for the assessment of responsiveness of EQ-5D-3L and one study for 15D, among which six studies reached inconsistent results between EQ-5D-3L and the Parkinson's-specific measures in measuring the change overtime. CONCLUSIONS: The construct validity of the PbQoL measures was generally good, but there are concerns regarding their responsiveness to change. In Parkinson's, the inclusion of a Parkinson's-specific QoL measure or a generic but broader scoped mental and well-being focused measure to incorporate aspects not included in the common PbQoL measures is recommended.

Cost-Effectiveness of HBV and HCV Screening Strategies--A Systematic Review of Existing Modelling Techniques.

INTRODUCTION: Studies evaluating the cost-effectiveness of screening for Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) are generally heterogeneous in terms of risk groups, settings, screening intervention, outcomes and the economic modelling framework. It is therefore difficult to compare cost-effectiveness results between studies. This systematic review aims to summarise and critically assess existing economic models for HBV and HCV in order to identify the main methodological differences in modelling approaches. METHODS: A structured search strategy was developed and a systematic review carried out. A critical assessment of the decision-analytic models was carried out according to the guidelines and framework developed for assessment of decision-analytic models in Health Technology Assessment of health care interventions. RESULTS: The overall approach to analysing the cost-effectiveness of screening strategies was found to be broadly consistent for HBV and HCV. However, modelling parameters and related structure differed between models, producing different results. More recent publications performed better against a performance matrix, evaluating model components and methodology. CONCLUSION: When assessing screening strategies for HBV and HCV infection, the focus should be on more recent studies, which applied the latest treatment regimes, test methods and had better and more complete data on which to base their models. In addition to parameter selection and associated assumptions, careful consideration of dynamic versus static modelling is recommended. Future research may want to focus on these methodological issues. In addition, the ability to evaluate screening strategies for multiple infectious diseases, (HCV and HIV at the same time) might prove important for decision makers.

Comparative effectiveness of antiviral treatment for hepatitis B: a systematic review and Bayesian network meta-analysis.

OBJECTIVE: A wide variety of competing drugs are available to patients for the treatment of chronic hepatitis B. We update a recent meta-analysis to include additional trial evidence with the aim of determining which treatment is the most effective. METHODS: Twelve monotherapy or combination therapy were evaluated in treatment-naive individuals with hepatitis B e antigen (HBeAg) positive or negative patients. Databases were searched for randomized controlled trials in the first year of therapy. Bayesian random effects network meta-analysis was used to calculate the pairwise odds ratios, 95% credible intervals and ranking of six surrogate outcomes. RESULTS: In total, 22 studies were identified (7508 patients): 12 studies analysed HBeAg-positive patients, six analysed HBeAg-negative patients, and four evaluated both. Tenofovir was most effective at increasing efficacy in HBeAg-positive patients, ranking first for three outcomes and increased odds of undetectable levels of hepatitis B virus (HBV) DNA compared with seven other therapies (such as lamivudine: odds ratio 33.0; 95% credible interval 7.0-292.7). For HBeAg-negative patients, the large network (seven therapies) ranked entecavir alone or in combination with tenofovir highly for reduction in HBV DNA and histologic improvement. In the smaller network (three therapies), tenofovir ranked first for undetectable HBV DNA and histologic improvement. No data existed to directly or indirectly compare these treatments. CONCLUSION: For HBeAg-positive patients tenofovir is the most effective at increasing efficacy, whereas for HBeAg-negative patients, either tenofovir or entecavir is most effective. Further research should focus on strengthening the network connections, in particular comparing tenofovir and entecavir in HBeAg-negative patients.