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

Participation of general practitioners in disease management: experiences from the Netherlands

OBJECTIVE: To investigate the extent to which GPs in the Netherlands participate in disease management and how personal opinions, impeding and promoting incentives as well as physician characteristics influence their attitude towards disease management. METHODS: The attitude-model of Fishbein and Ajzen was used to describe the attitude of GPs towards disease management and main influencing factors. After interviewing seventeen representatives of the GPs and testing a questionnaire, the final questionnaire was sent to all GPs in the Netherlands (7680 GPs) barring those involved in the testing of the questionnaire. RESULTS: At least 10.4% of all Dutch GPs are active in disease management. The main factors predicting a positive attitude towards disease management are the following: GPs' opinion that they are improving quality and efficiency of care when executing disease management, presence of a good quality network between actors involved prior to the start of disease management, working in a health centre, and performing sideline activities besides their daily activities as GPs. The main factors predicting a negative attitude are: GPs' opinion that the investment-time is too high, lack of reimbursement for disease management activities, working in a solo practice, and not performing any sideline activities beside their daily activities as GP. CONCLUSIONS: The factors predicting a negative attitude of Dutch GPs towards disease management dominate the factors predicting a positive attitude. The arguments in favour of disease management are matters of belief, for example concerning improvements in the quality of care, while arguments against are more concrete barriers e.g. high workload and financial reimbursement. Placed on the innovation timeline, the 10.4% participation might be taken to represent the start of a trend