On the integration of early health technology assessment in the innovation process: reflections from five stakeholders.

Early health technology assessment (HTA), which includes 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, has seen many applications in recent years. However, it is still unclear how such early value assessments can be integrated into the technology innovation process. This commentary contributes to the discussion on the purposes early HTA can serve. Similarities and differences in the perspectives of five stakeholders (i.e., the hospital, the patient, the assessor, the medical device industry, and the policy maker) on the purpose, value, and potential challenges of early HTA are described. All five stakeholders agreed that integrating early HTA in the innovation process has the possibility to shape and refine an innovation, and inform research and development decisions. The early assessment, using a variety of methodologies, can provide insights that are relevant for all stakeholders but several challenges, for example, feasibility and responsibility, need to be addressed before early HTA can become standard practice. For early evaluations to be successful, all relevant stakeholders including patients need to be involved. Also, nimble, flexible assessment methods are needed that fit the dynamics of medical technology. Best practices should be shared to optimize both the innovation process and the methods to perform an early value assessment.

Applying health economics for policy decision making: do devices differ from drugs?

Medical devices pose unique challenges for economic evaluation and associated decision-making processes that differ from pharmaceuticals. We highlight and discuss these challenges in the context of cardiac device therapy, based on a systematic review of relevant economic evaluations. Key challenges include practical difficulties in conducting randomized clinical trials, allowing for a 'learning curve' and user characteristics, accounting for the wider organizational impacts of introducing new devices, and allowing for variations in product characteristics and prices over time.

A health economic evaluation of concomitant surgical ablation for atrial fibrillation.

OBJECTIVE: Current drug treatment for atrial fibrillation is suboptimal and percutaneous catheter-based ablation techniques may be associated with complications. The aim of this study is to assess the cost-effectiveness of (1) high-intensity focused ultrasound (HIFU)-assisted surgical ablation, (2) the classic 'cut and sew' maze procedure and (3) percutaneous ablation, all concomitant to cardiac surgery (e.g. CABG, valve repair) in comparison with non-interventional (drug) treatment. METHODS: A Markov model was developed to predict the cost-effectiveness of the interventional approaches. The model consisted of four disease states (sinus rhythm without complications, atrial fibrillation without complications, stroke and death), allowing for 3-monthly transitions between these states and using direct UK costs from the National Health Service perspective. Clinical input data are obtained from literature and cost input data from National Health Service sources and literature. Five-year total and incremental costs are calculated. Incremental effects are expressed in quality-adjusted-life-years-gained (QALYG). RESULTS: All interventional treatments show good incremental cost-effectiveness ratios in all atrial fibrillation types, compared to drug treatment. For classic maze the incremental cost-effectiveness ratio compared to non-interventional atrial fibrillation treatment varies from 1343 to 3471 GBP/QALYG, for HIFU-assisted surgical ablation from 4005 to 7448 GBP/QALYG and for percutaneous ablation from 7041 to 17,372 GBP/QALYG depending on the atrial fibrillation type. Sensitivity analyses showed the robustness of the data. CONCLUSIONS: Performing a classic maze procedure or HIFU-assisted surgical ablation concomitant to a scheduled CABG or valve procedure is highly cost-effective. Performing a percutaneous ablation in a subsequent procedure is also cost-effective, but to a lower extent. Both the maze procedure and the HIFU-assisted surgical ablation are cheaper and more effective than percutaneous ablation in a subsequent procedure.

Influence of adducting and abducting muscle forces on the subacromial space width.

PURPOSE: Strengthening of the shoulder depressors is an important component in the treatment of impingement syndrome. However, the quantitative effect of various muscle forces on the width of the subacromial space has never been demonstrated in vivo. Therefore, the purpose of this study was to analyze the influence of adducting and abducting muscle forces on the subacromial space width in healthy volunteers in various arm positions. METHODS: The shoulders of 12 healthy volunteers were imaged with an open MR system at 30 degrees, 60 degrees, 90 degrees, 120 degrees, and 150 degrees of arm elevation under both isometric adducting and abducting muscle activity (15 N). After segmentation and three-dimensional reconstruction of anatomically relevant structures, the minimal spatial acromiohumeral and claviculohumeral distances were quantified. RESULTS: Adducting muscle forces led to a significant increase of the acromiohumeral distance in all arm positions (P < 0.01), varying from 32% (30 degrees ) to 138% (90 degrees ) relative to abducting muscle forces. The claviculohumeral distance showed an increase of 9% (30 degrees ) to 24% (90 degrees ), this increase being also statistically significant at all positions (P < 0.05). During elevation of the arm (30-120 degrees ), the absolute subacromial space width was reduced significantly (P = 0.001) by 30% under isometric contraction of the adductors compared with 53% (P = 0.001) under activation of the abductors. CONCLUSION: This in vivo study shows for the first time that adducting muscle forces lead to a significant increase of the subacromial space width compared with abducting muscle activity. In the future, this technique and data can be used to objectively quantify the effect of physical therapy protocols focused on increasing the depressor effect of adducting muscles in the postoperative and conservative treatment of impingement syndrome of the shoulder.

Dynamic MR mammography: three-dimensional real-time visualization of contrast enhancement in virtual reality.

RATIONALE AND OBJECTIVES: In view of the increasing use of breast magnetic resonance (MR) imaging to supplement x-ray mammography. the authors developed a method for fast and efficient analysis of dynamic MR images of the female breast. MATERIALS AND METHODS: The MR image data sets were acquired with a saturation-recovery turbo fast low-angle shot sequence to detect the kinetics of the contrast agent concentration in the whole breast at a high temporal and spatial resolution. A morphologic three-dimensional fast low-angle shot data set was also acquired. The dynamic image data sets were analyzed with tracer kinetic modeling to describe the physiologic processes underlying the contrast enhancement in mathematical terms and enable the estimation of functional tissue-specific parameters, which reflect the status of microcirculation. To display morphologic and functional tissue information simultaneously, the authors developed a multidimensional real-time visualization system (with three-dimensional texture mapping), which enables a practical and intuitive human computer interface in virtual reality. RESULTS: The spatially differentiated representation of the computed functional tissue parameters superimposed on the anatomic information offers several possibilities: (a) more discernible contrast enhancement, (b) inspection of the data volume in three-dimensional space by means of rotation and transparency variation, (c) location of lesions in space and thus faster and more natural recognition of topologic coherencies, and (d) fast and efficient overview in compressed form. CONCLUSION: A feasibility study demonstrated that multidimensional visualization of contrast enhancement in virtual reality is a practicable idea. Detection and location of multiple breast lesions may be an important application.

Health technology assessment for medical devices in Europe. What must be considered.

OBJECTIVE: To inform about the specifics of medical devices and the resulting consequences for health technology assessment (HTA) and to present the European industry position on this topic. METHODS: The paper is based on an intensive debate within Eucomed, the European trade association in the field of medical devices, informed by an HTA Experts Group, comprising experts from within and outside the medical device industry. RESULTS: Based on the specifics of medical devices, there are a number of methodologic considerations that require a tailored HTA, differing from the approach taken for, for example, pharmaceutical products. These differences have an impact on the selection of the technology, the timing of the assessment, the study design, and the patient population. CONCLUSION: The European medical device industry can commit to an HTA that takes into consideration the specifics of medical technologies, which is appropriate and fair, and which is done under full participation of industry. Under these circumstances HTA can be a useful tool to support rational decision making in health care.