Deploying a spreadsheet tool for early economic value assessment of medical device innovations with healthcare decision makers

Early stage evaluation of medical device innovations is important for healthcare decision-makers as much as for manufacturers, meaning that a wider application of a basic cost-effectiveness analysis is becoming necessary outside the usual expert base of health technology assessment specialists. Resulting from an academic-industry-healthcare professional collaboration, a spreadsheet tool is described that was designed to be accessible both to professionals in healthcare delivery organisations and to innovators in the healthcare technology industry who are non-experts in the field of health economics. The tool enables a basic cost-effectiveness analysis to be carried out, using a simplified decision-tree model to compare costs and patient benefit for a new device-related procedure with that of standard care employing an incumbent device or other alternative. Such a tool is useful to healthcare professionals because it enables them to rapidly elucidate the cost-effectiveness of heterogeneous innovations by means of the standard quality adjusted life year (QALY) measure of clinical outcome, which is intended to be broadly comparable across treatments. For the innovator or manufacturer it helps them focus on what is required for future stages of development, in order to fill gaps in the input data and so further strengthen their case from a health economics perspective. Results are presented of first experiences from deploying the tool on three medical device exemplars, in face-to-face meetings of the NHS National Innovation Centre (NIC) along with the innovator or clinical champion. The results show that mapping of device-related innovations to the tool is achievable in a short meeting between the NIC and the innovator using expected costs, outcomes data from the literature and estimates of ranges for unknown input data. Whilst the result of a simplified analysis is not expected to be definitive, the process of reasoning is found to be illuminating for the parties involved, enabling innovators to articulate the benefits of their innovations and for all parties to highlight gaps in data and evidence that will be required to take the innovation forward. The partnership model of the authors’ organisation supports the kind of cooperative design approach that is necessary to produce the kind of tool described.---------------------------7dd39101208fa Content-Disposition: form-data; name="c14_creators_1_name_family" Crave

The Future of Drug Development: The Economics of Pharmacogenomics

This paper models how the evolving field of pharmacogenomics (PG), which is the science of using genomic markers to predict drug response, may impact drug development times, attrition rates, costs, and the future returns to research and development (R&D). While there still remains an abundance of uncertainty around how PG will impact the future landscape of pharmaceutical and biological R&D, we identify several likely outcomes. We conclude PG has the potential to significantly reduce both expected drug development costs (via higher probabilities of technical success, shorter clinical development times, and smaller clinical trials) and returns. The impact PG has on expected returns is partially mitigated by higher equilibrium prices, expedited product launches, and longer effective patent lives. Our conclusions are, of course, accompanied by numerous caveats.

Economic evaluations of non-communicable disease interventions

Background Demographic projections suggest a major increase in non-communicable disease (NCD) mortality over the next two decades in developing countries. In a climate of scarce resources, policy-makers need to know which interventions represent value for money. The prohibitive cost of performing multiple economic evaluations has generated interest in transferring the results of studies from one setting to another. This paper aims to bridge the gap in the current literature by critically evaluating the available published data on economic evaluations of NCD interventions in developing countries. Methods We identified and reviewed the methodological quality of 32 economic evaluations of NCD interventions in developing countries. Developing countries were defined according to the World Bank classification for low- and lower middle-income countries. We defined NCDs as the 12 categories listed in the 1993 World Bank report Investing in Health. English language literature was searched for the period January 1984 and January 2003 inclusive in Medline, Science Citation Index, HealthStar, NHS Economic Evaluation Database and Embase using medical subheading terms and free text searches. We then assessed the quality of studies according to a set of pre-defined technical criteria. Results We found that the quality of studies was poor and resource allocation decisions made by local and global policy-makers on the basis of this evidence could be misleading. Furthermore we have identified some clear gaps in the literature, particularly around injuries and strategies for tackling the consequences of the emerging tobacco epidemic. Conclusion In the face of poor evidence the role of so-called generalised cost-effectiveness analyses has an important role to play in aiding public health decision-making at the global level. Further research is needed to investigates the causes of variation among cost, effects and cost-effectiveness data within and between settings. Such analyses still need to take a broad view, present data in a transparent manner and take account of local constraints

Using stepped-care approaches within internet-based interventions for youth anxiety: Three case studies.

Background There are a lack of clear guidelines for the dissemination of Internet-based cognitive behaviour therapy (ICBT) for childhood and adolescent anxiety in routine care. While self-guided ICBT has greater reach than therapist-guided ICBT, it is plagued by problems of low program adherence and many young people are not successfully treated. It is important that we identify models of ICBT that are accessible, but provide the right support, at the right time to those who need it. Stepped-care models of ICBT offer one potential solution. Objective This case study examined the application of stepped-care within an ICBT intervention for childhood and adolescent anxiety, in which young people were stepped up from self-guided to therapist-guided ICBT. Methods Three case studies are presented and include young males (aged 11–12 years) who participated in BRAVE Stepped-Care, a new ICBT program incorporating two treatment steps: Step 1 – five sessions of self-guided ICBT and Step 2 – five sessions of therapist-guided ICBT. Participants completed diagnostic assessments at pre- and post-treatment, along with a battery of self-report questionnaires. Step-up requirements were determined at a mid-treatment assessment. Treatment response was determined by change on diagnostic severity and presence of diagnosis and changes in self-reported anxiety symptoms (through T-scores and Reliable Change Indices). Results In-depth examination of the three case studies showed that decisions to step-up from Step 1 to Step 2 were complex and required consideration of program engagement and adherence, as well as changes on self-reported anxiety, behavioural indicators of anxiety and parent perspectives. Results showed that non-responders at mid-treatment who were stepped-up to therapist-guided ICBT after Step 1 were able to increase engagement and response to treatment in Step 2, such that they were free of their primary anxiety diagnosis at post-treatment. Conclusions The findings highlight the importance of early assessment of engagement and non-response within self-guided ICBT programs for youth anxiety and the positive changes that can subsequently occur when therapist-guidance is introduced mid-treatment for non-responders. The efficacy of stepped-care ICBT models needs to be confirmed in larger randomised controlled trials

ERS statement on standardisation of cardiopulmonary exercise testing in chronic lung diseases

The objective of this document was to standardise published cardiopulmonary exercise testing (CPET) protocols for improved interpretation in clinical settings and multicentre research projects. This document: 1) summarises the protocols and procedures used in published studies focusing on incremental CPET in chronic lung conditions; 2) presents standard incremental protocols for CPET on a stationary cycle ergometer and a treadmill; and 3) provides patients’ perspectives on CPET obtained through an online survey supported by the European Lung Foundation. We systematically reviewed published studies obtained from EMBASE, Medline, Scopus, Web of Science and the Cochrane Library from inception to January 2017. Of 7914 identified studies, 595 studies with 26 523 subjects were included. The literature supports a test protocol with a resting phase lasting at least 3 min, a 3-min unloaded phase, and an 8- to 12-min incremental phase with work rate increased linearly at least every minute, followed by a recovery phase of at least 2–3 min. Patients responding to the survey (n=295) perceived CPET as highly beneficial for their diagnostic assessment and informed the Task Force consensus. Future research should focus on the individualised estimation of optimal work rate increments across different lung diseases, and the collection of robust normative data.The document facilitates standardisation of conducting, reporting and interpreting cardiopulmonary exercise tests in chronic lung diseases for comparison of reference data, multi-centre studies and assessment of interventional efficacy. http://bit.ly/31SXeB

Contemporary NSTEMI management: the role of the hospitalist.

Non-ST-segment elevation myocardial infarction (NSTEMI) is defined as elevated cardiac biomarkers of necrosis in the absence of persistent ST-segment elevation in the setting of anginal symptoms or other acute event. It carries a poorer prognosis than most ST-segment elevation events, owing to the typical comorbidity burden of the older NSTEMI patients as well as diverse etiologies that add complexity to therapeutic decision-making. It may result from an acute atherothrombotic event (\u27Type 1\u27) or as the result of other causes of mismatch of myocardial oxygen supply and demand (\u27Type 2\u27). Regardless of type and other clinical factors, the hospital medicine specialist is increasingly responsible for managing or coordinating the care of these patients. Following published guidelines for risk stratification and basing anti-anginal, anticoagulant, antiplatelet, other pharmacologic therapies, and overall management approach on that individualized patient risk assessment can be expected to result in better short- and long-term clinical outcomes, including near-term readmission and recurrent events. We present here a review of the evidence basis and expert commentary to assist the hospitalist in achieving those improved outcomes in NSTEMI. Given that the Society for Hospital Medicine cites care of patients with acute coronary syndrome as a core competency for hospitalists, it is essential that those specialists stay current on optimal NSTEMI care