PHP235 – Combining Headroom and Return on Investment Analysis To Rank Potential Commercial Value of Six Medical Devices in Development

Objectives: The development process of medical devices strongly depends on the financial resources available and the expected return on investment to manufacturers. The aim of this paper is to analyse the potential commercial viability of two disruptive and four incremental medical devices in different stages of development. Methods: The headroom method combined with the return on investment analysis was performed for one therapeutic and five diagnostic devices for different clinical target areas. Information regarding maximum additional benefit that could be obtained with new device, the estimated production price and expected sales volume was gathered from literature and expert opinions. A willingness-to-pay threshold for one additional QALY of € 30,000 was assumed for headroom analysis. Results: The devices were ranked according to their potential commercial viability. The analysis showed that two disruptive and two incremental devices had reasonably good balance between headroom and unit cost, and two incremental devices had no good balance. The device with the highest potential commercial viability was a disruptive therapeutic device for the cartilage repair treatment in the first clinical trial stage, with estimated headroom for the cost of the new treatment: € 74,600 and an expected production cost of the therapy: € 8,000 per unit. The market volume size was calculated based on the incidence of cartilage defects: 65% in routine knee arthroscopies. The disruptive diagnostic device for home brain monitoring of epilepsy patients in the prototype stage of development had the lowest potential commercial viability, with an estimated headroom of € 81,000 and an expected production costs per unit: € 120,000 that resulted in the unfavorable return on investment. Conclusions: The headroom method combined with a return on investment analysis, offers insight in the potential commercial viability of medical devices under development. The research on the impact of that analysis on actual R&D decision making will still be determined

Cost-effectiveness of shifting breast cancer surveillance from a hospital setting to a community-based national screening programme setting

Background: In the Netherlands, breast cancer surveillance after breast conserving surgery (BCS) takes place in a hospital setting for at least five years to detect possible recurrences in early stage. As breast cancer incidence rises and mortality decreases, surveillance expenses increase. This study explores the effectiveness and cost-effectiveness of BCS surveillance as delivered in a hospital setting versus providing BCS surveillance as part of the community-based National Breast Cancer Screening Program (NBCSP). We hypothesise that the NBCSP-based strategy leads to lower costs and a lower proportion of true test results (TTR) compared to the hospital-based strategy and determine to what extent potential lower effectiveness may be balanced with expected cost savings. Materials and Methods: Both strategies are compared on effectiveness and cost-effectiveness in a decision tree from a healthcare perspective over a 5-year time horizon. Women aged 50–75 without distant metastases that underwent BCS in the years 2003–2006 with complete 5 year follow-up were selected from the Netherlands Cancer Registry (n = 14,093). Key input variables were mammography sensitivity and specificity, risk of loco regional recurrence (LRR), and direct healthcare costs. The primary outcome measure was the overall predictive value (measured in true test results). Secondary effectiveness measures were the positive predictive value (PPV) (LRRs detected or true positive test results) and the negative predictive value (NPV) (true negative test results) detected within five years post-treatment. Results are presented for low and high risk patients separately and expressed in incremental cost-effectiveness ratios (ICERs). Results: For low risk patients (with grade 1 tumours, no node involvement, and hormonal treatment), the PPV and NPV for the NBCSP strategy were 3.31% and 99.88%, and 2.74% and 99.95% for the hospital strategy respectively. For high risk patients (grade 3 tumours, over three nodes involved, without hormonal treatment), the PPV and NPV for the NBCSP strategy were 64.1% and 98.9%; and 51.0% and 99.7% for the hospital strategy respectively. For low risk patients the NBCSP saves €202 per patient leading to an ICER of €109/accurate test result. For high risk patients the cost savings are €72 per patient, leading to an ICER of €43/accurate test result. Conclusion: Although the NBCSP-based strategy is cheaper, it cannot replace the hospital-based strategy, since it leads to only half of the accurate test results compared to hospital-based strategy. This contradicts the goal of early detection of LRRs and improving outcomes

MO4 - Using AHP weights to fill missing gaps in Markov decision models

OBJECTIVES:\ud We propose to combine the versatility of the analytic hierarchy process (AHP) with the decision-analytic sophistication of health-economic modeling in a new methodology for early technology assessment. As an illustration, we apply this methodology to a new technology to diagnose breast cancer.\ud \ud METHODS:\ud The AHP is a technique for multicriteria analysis, relatively new in the fi eld of technology assessment. It can integrate both quantitative and qualitative criteria in the assessment of alternative technologies. We applied the AHP to prioritize a more versatile set of outcome measures than most Markov models do. These outcome measures include clinical effectiveness and costs, but also weighted estimates of patient comfort and safety. Furthermore, as no clinical data are available for this technology yet, the AHP is applied to predict the performance of the new technology with regard to all these outcome measures. Results of the AHP are subsequently integrated in a Markov model to make an early assessment of the expected incremental cost-effectiveness of alternative technologies.\ud \ud RESULTS:\ud We systematically estimated priors on the clinical effectiveness and wider impacts of the new technology using AHP. In our illustration, AHP estimates for sensitivity and specifi city of the new diagnostic technology were used as probability parameters in the Markov model. Moreover, the prioritized outcome measures including clinical effectiveness (weight = 0.61), patient comfort (weight = 0.09), and safety (weight = 0.30) were integrated into one outcome measure in the Markov model.\ud \ud CONCLUSIONS:\ud Combining AHP and Markov modelling is particularly valuable in early technology assessment when evidence about the effectiveness of health care technology is still limited or missing. Moreover, combining these methods is valuable when decision makers are interested in other patient relevant outcomes measures besides the technology’s clinical effectiveness, and that may not (adequately or explicitly) be captured in mainstream utility measures

Identifying potentially cost effective chronic care programs for people with COPD

Objective: To review published evidence regarding the cost effectiveness of multi-component COPD programs and to illustrate how potentially cost effective programs can be identified. Methods: Systematic search of Medline and Cochrane databases for evaluations of multicomponent disease management or chronic care programs for adults with COPD, describing process, intermediate, and end results of care. Data were independently extracted by two reviewers and descriptively summarized. Results: Twenty articles describing 17 unique COPD programs were included. There is little evidence for significant improvements in process and intermediate outcomes, except for increased provision of patient self-management education and improved disease-specific knowledge. Overall, the COPD programs generate end results equivalent to usual care, but programs containing ≥3 components show lower relative risks for hospitalization. There is limited scope for programs to break-even or save money. Conclusion: Identifying cost effective multi-component COPD programs remains a challenge due to scarce methodologically sound studies that demonstrate significant improvements on process, intermediate and end results of care. Estimations of potential cost effectiveness of specific programs illustrated in this paper can, in the absence of 'perfect data', support timely decision-making regarding these programs. Nevertheless, well-designed health economic studies are needed to decrease the current decision uncertainty

The health economic impact of disease management programs for COPD: A systematic literature review and meta-analysis

__Abstract__ Background: There is insufficient evidence of the cost-effectiveness of Chronic Obstructive Pulmonary Disease (COPD) Disease Management (COPD-DM) programs. The aim of this review is to evaluate the economic impact of COPD-DM programs and investigate the relation between the impact on healthcare costs and health outcomes. We also investigated the impact of patient-, intervention, and study-characteristics.Methods: We conducted a systematic literature review to identify cost-effectiveness studies of COPD-DM. Where feasible, results were pooled using random-effects meta-analysis and explorative subgroup analyses were performed.Results: Sixteen papers describing 11 studies were included (7 randomized control trials (RCT), 2 pre-post, 2 case-control). Meta-analysis showed that COPD-DM led to hospitalization savings of €1060 (95% CI: €2040 to €80) per patient per year and savings in total healthcare uti

Effect of obesity on constant workrate exercise in hyperinflated men with COPD

<p>Abstract</p> <p>Background</p> <p>Chronic obstructive pulmonary disease (COPD) and a high body mass index (BMI) can both affect pulmonary volumes as well as exercise tolerance, but their combined effect on these outcomes is not well known. The aim of this study was to investigate the effects of increased BMI during constant workrate cycle ergometry in patients with COPD.</p> <p>Methods</p> <p>Men with COPD and hyperinflation were divided according to World Health Organization BMI classification: 84 normal BMI (NBMI), 130 overweight (OW) and 64 obese (OB). Patients underwent spirometric and lung volumes assessment and an incremental cycling exercise test. This was followed by a constant workrate exercise test (CET) at 75% of peak capacity. Inspiratory capacity and Borg dyspnea scores were measured at baseline, during and at the end of CET.</p> <p>Results and discussion</p> <p>FEV₁% predicted was not different across BMI classes. Total lung capacity and functional residual capacity were significantly lower in OB and OW compared to NBMI patients. Peak VO₂in L·min^-1was significantly higher in OB and OW patients than in NBMI patients. CET time was not different across BMI classes (p = 0.11). Changes in lung volumes and dyspnea during CET were not different between BMI categories.</p> <p>Conclusions</p> <p>OB and OW patients with COPD had a higher peak VO₂than their lean counterparts. Endurance time, dyspnea and changes in lung volumes during CET were similar between BMI categories.</p

Cost effectiveness of support for people starting a new medication for a long term condition through community pharmacies: an economic evaluation of the New Medicine Service (NMS) compared with normal practice

Background: The English community pharmacy New Medicine Service (NMS) significantly increases patient adherence to medicines, compared with normal practice. We examined the cost-effectiveness of NMS compared with normal practice by combining adherence improvement and intervention costs with the effect of increased adherence on patient outcomes and healthcare costs. Methods: We developed Markov models for diseases targeted by the NMS (hypertension, type 2 diabetes, chronic obstructive pulmonary disease, asthma and antiplatelet regimens) to assess the impact of patients’ non-adherence. Clinical event probability, treatment pathway, resource-use and costs were extracted from literature and costing tariffs. Incremental costs and outcomes associated with each disease were incorporated additively into a composite probabilistic model and combined with adherence rates and intervention costs from the trial. Costs per extra quality-adjusted-life-year(QALY) were calculated from the perspective of NHS England, using a lifetime horizon. Results: NMS generated a mean of 0.05 (95%CI: 0.00, 0.13) more QALYs per patient, at a mean reduced cost of -£144 (95%CI: -769, 73). The NMS dominates normal practice with probability of 0.78 (ICER: - £3166 per QALY). NMS has a 96.7% probability of cost-effectiveness compared with normal practice at a willingness-to-pay of £20000 per QALY. Sensitivity analysis demonstrated that targeting each disease with NMS has a probability over 0.90 of cost-effectiveness compared with normal practice at a willingness-to-pay of £20000 per QALY. Conclusions: Our study suggests that the New Medicine Service increased patient medicine adherence compared with normal practice, which translated into increased health gain at reduced overall cost

Assessment of a primary and tertiary care integrated management model for chronic obstructive pulmonary disease

<p>Abstract</p> <p>Background</p> <p>The diagnosis and treatment of patients with chronic obstructive pulmonary disease (COPD) in Spain continues to present challenges, and problems are exacerbated when there is a lack of coordinated follow-up between levels of care. This paper sets out the protocol for assessing the impact of an integrated management model for the care of patients with COPD. The new model will be evaluated in terms of 1) improvement in the rational utilization of health-care services and 2) benefits reflected in improved health status and quality of life for patients.</p> <p>Methods/Design</p> <p>A quasi-experimental study of the effectiveness of a COPD management model called COPD PROCESS. The patients in the study cohorts will be residents of neighborhoods served by two referral hospitals in Barcelona, Spain. One area comprises the intervention group (n = 32,248 patients) and the other the control group (n = 32,114 patients). The study will include pre- and post-intervention assessment 18 months after the program goes into effect. Analyses will be on two datasets: clinical and administrative data available for all patients, and clinical assessment information for a cohort of 440 patients sampled randomly from the intervention and control areas. The main endpoints will be the hospitalization rates in the two health-care areas and quality-of-life measures in the two cohorts.</p> <p>Discussion</p> <p>The COPD PROCESS model foresees the integrated multidisciplinary management of interventions at different levels of the health-care system through coordinated routine clinical practice. It will put into practice diagnostic and treatment procedures that are based on current evidence, multidisciplinary consensus, and efficient use of available resources. Care pathways in this model are defined in terms of patient characteristics, level of disease severity and the presence or absence of exacerbation. The protocol covers the full range of care from primary prevention to treatment of complex cases.</p

Emerging Use of Early Health Technology Assessment in Medical Product Development: A Scoping Review of the Literature

Early health technology assessment is increasingly being used to support health economic evidence development during early stages of clinical research. Such early models can be used to inform research and development about the design and management of new medical technologies to mitigate the risks, perceived by industry and the public sector, associated with market access and reimbursement. Over the past 25 years it has been suggested that health economic evaluation in the early stages may benefit the development and diffusion of medical products. Early health technology assessment has been suggested in the context of iterative economic evaluation alongside phase I and II clinical research to inform clinical trial design, market access, and pricing. In addition, performing early health technology assessment was also proposed at an even earlier stage for managing technology portfolios. This scoping review suggests a generally accepted definition of early health technology assessment to be “all methods used to inform industry and other stakeholders about the potential value of new medical products in development, including methods to quantify and manage uncertainty”. The present review also aimed to identify recent published empirical studies employing an early-stage assessment of a medical product. With most included studies carried out to support a market launch, the dominant methodology was early health economic modeling. Further methodological development is required, in particular, by combining systems engineering and health economics to manage uncertainty in medical product portfolios