Value in Health

Virtual Collections: Medical Devices

Effect of Adherence and Insulin Delivery System on Clinical and Economic Outcomes among Patients with Type 2 Diabetes Initiating Insulin Treatment

Rajeev Ayyagari, Wenhui Wei, David Cheng, Chunshen Pan, James Signorovitch, Eric Q. Wu
Value in Health. 2015.18(2):198–205.

OBJECTIVE
This study aimed to estimate the effects of insulin adherence and delivery device on real-world health outcomes.

METHODS
This study included adults with type 2 diabetes mellitus initiating insulin, with continuous health plan insurance for 6 or more months before initiation (baseline) and 1 or more year after. Measured outcomes included glycosylated hemoglobin (Hb A1c) reduction, hospitalization rate, total health care costs, and pharmacy costs over 1 year of follow-up. Adherence (defined as having insulin fills sufficient for the entire quarter), pen or vial/syringe use, and disease-related patient characteristics were assessed in each quarter. To account for the time-varying relationship between adherence, patient characteristics, and outcomes, marginal structural generalized linear models were used to estimate the effect of adherence and device use. Mean outcomes were predicted for different combinations of adherence and device choice.

RESULTS
Among the 13,428 patients (mean age 54 years; 46% women; baseline Hb A1c 9.3%), adherent pen users had greater reductions in Hb A1c (−0.35%; P = 0.045), lower hospitalization rates (−0.36; P < 0.01), and higher pharmacy costs ($2923; P < 0.01) than did nonadherent vial users, and similar total health care costs ($3906 lower; P = 0.1). Pen use and adherent vial use decreased hospitalization rate and increased pharmacy but not total costs.

CONCLUSIONS
Adherence and pen use have beneficial effects on patients' real-world outcomes, with the most favorable effects attributable to adherent pen use.

Goal-Directed Fluid Therapy Guided by Cardiac Monitoring During High-Risk Abdominal Surgery in Adult Patients: Cost-Effectiveness Analysis of Esophageal Doppler and Arterial Pulse Pressure Waveform Analysis

Guillaume Legrand, Laura Ruscio, Dan Benhamou, Nathalie Pelletier-Fleury
Value in Health. 2015.18(5):605–613.

BACKGROUND
Several minimally invasive techniques for cardiac output monitoring such as the esophageal Doppler (ED) and arterial pulse pressure waveform analysis (APPWA) have been shown to improve surgical outcomes compared with conventional clinical assessment (CCA).

OBJECTIVE
To evaluate the cost-effectiveness of these techniques in high-risk abdominal surgery from the perspective of the French public health insurance fund.

METHODS
An analytical decision model was constructed to compare the cost-effectiveness of ED, APPWA, and CCA. Effectiveness data were defined from meta-analyses of randomized clinical trials. The clinical end points were avoidance of hospital mortality and avoidance of major complications. Hospital costs were estimated by the cost of corresponding diagnosis-related groups.

RESULTS
Both goal-directed therapy strategies evaluated were more effective and less costly than CCA. Perioperative mortality and the rate of major complications were reduced by the use of ED and APPWA. Cost reduction was mainly due to the decrease in the rate of major complications. APPWA was dominant compared with ED in 71.6% and 27.6% and dominated in 23.8% and 20.8% of the cases when the end point considered was "major complications avoided" and "death avoided," respectively. Regarding cost per death avoided, APPWA was more likely to be cost-effective than ED in a wide range of willingness to pay.

CONCLUSIONS
Cardiac output monitoring during high-risk abdominal surgery is cost-effective and is associated with a reduced rate of hospital mortality and major complications, whatever the device used. The two devices evaluated had negligible costs compared with the observed reduction in hospital costs. Our comparative studies suggest a larger effect with APPWA that needs to be confirmed by further studies.

Health Technology Assessment for Molecular Diagnostics: Practices, Challenges, and Recommendations from the Medical Devices and Diagnostics Special Interest Group

Susan Garfield, Julie Polisena, Daryl S. Spinner, Anne Postulka, Christine Y. Lu, Simrandeep K. Tiwana, Eric Faulkner, Nick Poulios
Value in Health. 2016.19(5):577–587.

BACKGROUND
Health technology assessments (HTAs) are increasingly used to inform coverage, access, and utilization of medical technologies including molecular diagnostics (MDx). Although MDx are used to screen patients and inform disease management and treatment decisions, there is no uniform approach to their evaluation by HTA organizations.

OBJECTIVES
The International Society for Pharmacoeconomics and Outcomes Research Devices and Diagnostics Special Interest Group reviewed diagnostic-specific HTA programs and identified elements representing common and best practices.

METHODS
MDx-specific HTA programs in Europe, Australia, and North America were characterized by methodology, evaluation framework, and impact. Published MDx HTAs were reviewed, and five representative case studies of test evaluations were developed: United Kingdom (National Institute for Health and Care Excellence's Diagnostics Assessment Programme, epidermal growth factor receptor tyrosine kinase mutation), United States (Palmetto's Molecular Diagnostic Services Program, OncotypeDx prostate cancer test), Germany (Institute for Quality and Efficiency in Healthcare, human papillomavirus testing), Australia (Medical Services Advisory Committee, anaplastic lymphoma kinase testing for non–small cell lung cancer), and Canada (Canadian Agency for Drugs and Technologies in Health, Rapid Response: Non-invasive Prenatal Testing).

RESULTS
Overall, the few HTA programs that have MDx-specific methods do not provide clear parameters of acceptability related to clinical and analytic performance, clinical utility, and economic impact. The case studies highlight similarities and differences in evaluation approaches across HTAs in the performance metrics used (analytic and clinical validity, clinical utility), evidence requirements, and how value is measured. Not all HTAs are directly linked to reimbursement outcomes.

CONCLUSIONS
To improve MDx HTAs, organizations should provide greater transparency, better communication and collaboration between industry and HTA stakeholders, clearer links between HTA and funding decisions, explicit recognition of and rationale for differential approaches to laboratory-developed versus regulatory-approved test, and clear evidence requirements.

New French Coverage with Evidence Development for Innovative Medical Devices: Improvements and Unresolved Issues

Nicolas Martelli, Hélène van den Brink, Isabelle Borget
Value in Health. 2016.19(1):17–19.

We describe here recent modifications to the French Coverage with Evidence Development (CED) scheme for innovative medical devices. CED can be defined as temporary coverage for a novel health product during collection of the additional evidence required to determine whether definitive coverage is possible. The principle refinements to the scheme include a more precise definition of what may be considered an innovative product, the possibility for device manufacturers to request CED either independently or in partnership with hospitals, and the establishment of processing deadlines for health authorities. In the long term, these modifications may increase the number of applications to the CED scheme, which could lead to unsustainable funding for future projects. It will also be necessary to ensure that the study conditions required by national health authorities are suitable for medical devices and that processing deadlines are met for the scheme to be fully operational. Overall, the modifications recently applied to the French CED scheme for innovative medical devices should increase the transparency of the process, and therefore be more appealing to medical device manufacturers.

Development of an Official Guideline for the Economic Evaluation of Drugs/Medical Devices in Japan

Takeru Shiroiwa, Takashi Fukuda, Shunya Ikeda, Tomoyuki Takura, Kensuke Moriwaki
Value in Health. 2017.20(3):372–378.

OBJECTIVES
In Japan, cost-effectiveness evaluation was implemented on a trial basis from fiscal year 2016. The results will be applied to the future repricing of drugs and medical devices. On the basis of a request from the Central Social Insurance Medical Council (Chuikyo), our research team drafted the official methodological guideline for trial implementation. Here, we report the process of developing and the contents of the official guideline for cost-effectiveness evaluation.

METHODS
The guideline reflects discussions at the Chuikyo subcommittee (e.g., the role of quality-adjusted life-year) and incorporates our academic perspective. Team members generated research questions for each section of the guideline and discussions on these questions were carried out. A draft guideline was prepared and submitted to the Ministry of Health, Labour and Welfare (MHLW), and then to the subcommittee. The draft guideline was revised on the basis of the discussions at the subcommitte, if appropriate.

RESULTS
Although the "public health care payer's perspective" is standard in this guideline, other perspectives can be applied as necessary depending on the objective of analysis. On the basis of the discussions at the subcommittee, quality-adjusted life-year will be used as the basic outcome. A discount rate of 2% per annum for costs and outcomes is recommended. The final guideline was officially approved by the Chuikyo general assembly in February 2016.

CONCLUSIONS
This is the first officially approved guideline for the economic evaluation of drugs and medical devices in Japan. The guideline is expected to improve the quality and comparability of submitted cost-effectiveness data for decision making.

Budget Impact of Increasing Market Share of Patient Self-Testing and Patient Self-Management in Anticoagulation

Jelena Stevanović, Maarten J. Postma, Hoa H. Le
Value in Health. 2016.19(4):383–390.

BACKGROUND
Patient self-testing (PST) and/or patient self-management (PSM) might provide better coagulation care than monitoring at specialized anticoagulation centers. Yet, it remains an underused strategy in the Netherlands.

OBJECTIVES
The International Society for Pharmacoeconomics and Outcomes Research Devices and Diagnostics Special Interest Group reviewed diagnostic-specific HTA programs and identified elements representing common and best practices.

METHODS
Budget-impact analyses of current and new market-share scenarios of PST and/or PSM compared with monitoring at specialized centers were performed for a national cohort of 260,338 patients requiring long-term anticoagulation testing. A health care payer perspective and 1- to 5-year time horizons were applied. The occurrence of thromboembolic and hemorrhagic complications in the aforementioned patient population was assessed in a Markov model. Dutch-specific costs were applied, next to effectiveness data derived from a meta-analysis on PST and/or PSM. Sensitivity and scenario analyses were performed to assess uncertainty on budget-impact analysis results.

RESULTS
Increasing PST and/or PSM usage in the national cohort from the current 15.4% to 50% resulted in savings ranging from €8 million after the first year to €184 million after 5 years. Further increases in the use of PST and/or PSM produced greater savings. Sensitivity analyses revealed budget-impact model sensitivity to the baseline and relative risks of thromboembolic complications. Unfavorable budget impact was found in scenarios exploring an increase in the use of PST alone as well as an increase in the market share of PST and PSM in patients with atrial fibrillation.

CONCLUSIONS
Overall study findings indicated that PST and PSM are more favorable alternatives to monitoring at specialized centers in patients without atrial fibrillation.


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