Clinical studies of innovative medical devices: what level of evidence for hospital-based health technology assessment?

2013 ◽  
Vol 19 (4) ◽  
pp. 697-702 ◽  
Author(s):  
Aurélie Boudard ◽  
Nicolas Martelli ◽  
Patrice Prognon ◽  
Judith Pineau
Keyword(s):  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Clinical Studies ◽  
Health Technology ◽  
Level Of Evidence

scholarly journals Validity of Surrogate Endpoints and Their Impact on Coverage Recommendations: A Retrospective Analysis across International Health Technology Assessment Agencies

2021 ◽  
pp. 0272989X2199455
Author(s):  
Oriana Ciani ◽  
Bogdan Grigore ◽  
Hedwig Blommestein ◽  
Saskia de Groot ◽  
Meilin Möllenkamp ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Health ◽  
Surrogate Endpoint ◽  
Health Technology ◽  
Surrogate Endpoints ◽  
Patient Centered ◽  
Statistical Validation ◽  
Level Of Evidence ◽  
The Impact

Background Surrogate endpoints (i.e., intermediate endpoints intended to predict for patient-centered outcomes) are increasingly common. However, little is known about how surrogate evidence is handled in the context of health technology assessment (HTA). Objectives 1) To map methodologies for the validation of surrogate endpoints and 2) to determine their impact on acceptability of surrogates and coverage decisions made by HTA agencies. Methods We sought HTA reports where evaluation relied on a surrogate from 8 HTA agencies. We extracted data on the methods applied for surrogate validation. We assessed the level of agreement between agencies and fitted mixed-effects logistic regression models to test the impact of validation approaches on the agency’s acceptability of the surrogate endpoint and their coverage recommendation. Results Of the 124 included reports, 61 (49%) discussed the level of evidence to support the relationship between the surrogate and the patient-centered endpoint, 27 (22%) reported a correlation coefficient/association measure, and 40 (32%) quantified the expected effect on the patient-centered outcome. Overall, the surrogate endpoint was deemed acceptable in 49 (40%) reports ( k-coefficient 0.10, P = 0.004). Any consideration of the level of evidence was associated with accepting the surrogate endpoint as valid (odds ratio [OR], 4.60; 95% confidence interval [CI], 1.60–13.18, P = 0.005). However, we did not find strong evidence of an association between accepting the surrogate endpoint and agency coverage recommendation (OR, 0.71; 95% CI, 0.23–2.20; P = 0.55). Conclusions Handling of surrogate endpoint evidence in reports varied greatly across HTA agencies, with inconsistent consideration of the level of evidence and statistical validation. Our findings call for careful reconsideration of the issue of surrogacy and the need for harmonization of practices across international HTA agencies.

PP206 Health Technology Assessment Guidance In The United Kingdom: Addressing Issues Specific To Medical Devices

2021 ◽  
Vol 37 (S1) ◽  
pp. 26-26
Author(s):  
Scott Gibson ◽  
Sita Saunders ◽  
Amanda Hansson Hedblom ◽  
Maximilian Blüher ◽  
Rafael Torrejon Torres ◽  
...  
Keyword(s):  
United Kingdom ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Healthcare Providers ◽  
Economic Assessment ◽  
Health Technology ◽  
Training Costs ◽  
Medical Technologies ◽  
The United Kingdom

IntroductionThe United Kingdom spends approximately GBP4.2 billion (USD5.6 billion; EUR4.7 billion) each year on medical devices, but healthcare providers receive little health technology assessment (HTA) guidance on cost-effective device procurement. Our objective was to assess the availability of HTA guidance for medical technologies and to identify key challenges related to the economic assessment of these technologies.MethodsNational Institute for Health and Care Excellence technology appraisal (TA) and Medical Technologies Evaluation Programme (MTEP) appraisals published online between November 2009 and October 2020 were identified. The “case for adoption” recommendation, type of devices, and critiques of economic analyses for each MTEP appraisal were extracted and categorized.ResultsIn comparison to 415 publicly available TAs for pharmaceuticals, only 45 medical technologies have been appraised through the MTEP. MTEP-submitted technologies can be categorized into diagnostic (7), monitoring (3), prophylaxis (5), therapeutic (28), and other (2). Furthermore, 11 were implants, seven were used by patients, and 27 had provider interaction. Major points of MTEP criticism were a failure to model cost consequences, training costs, and organizational impact. There was also the barrier of transferring costs across budgeting divisions.ConclusionsIn comparison to HTA guidance for pharmaceuticals, there is a dearth of medical device guidance. Therapeutic and implantable devices appear to be disproportionately overrepresented in the MTEP process. This may be because their appraisal is most akin to pharmaceuticals, for which HTA processes are well established. To encourage more HTAs of medical devices, HTA guidance should elaborate on issues specifically related to medical devices.

The health technology assessment of the compulsory accident insurance scheme of hand transplantation in Switzerland

2014 ◽  
Vol 40 (9) ◽  
pp. 914-923 ◽  
Author(s):  
U. Brügger ◽  
R. Plessow ◽  
S. Hess ◽  
A. Caballero ◽  
K. Eichler ◽  
...  
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Accident Insurance ◽  
Base Case ◽  
Insurance Scheme ◽  
Hand Transplantation ◽  
Level Of Evidence ◽  
Prosthesis Fitting

Recently the decision-making committee of the compulsory Swiss accident insurance scheme needed to make a basic decision as to whether to fund hand transplantation under that scheme or not. A Health Technology Assessment was commissioned to inform decision-making and gain experience with applicability of the method. The following were main findings from various domains. Compared with prosthesis fitting, the outcome of hand transplantation is satisfactory for function and sensibility. Complications due to immunosuppression are frequent, sometimes severe and potentially life-shortening. The direct medical costs over the entire life span calculated for a 35-year-old unilaterally amputated base case patient were CHF 528,600 (EUR 438,500) higher than for a prosthesis. There are challenging ethical, legal and organizational issues. The committee decided not to reimburse hand transplantation for ethical reasons. The Health Technology Assessment has been shown to be a useful tool for decision-making in the context of Swiss accident insurance. Level of evidence: IV

Innovative medical devices and hospital decision making: a study comparing the views of hospital pharmacists and physicians

2016 ◽  
Vol 40 (3) ◽  
pp. 257 ◽  
Author(s):  
Mathilde Billaux ◽  
Isabelle Borget ◽  
Patrice Prognon ◽  
Judith Pineau ◽  
Nicolas Martelli
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Evaluation Criteria ◽  
Health Technology ◽  
Local Health ◽  
University Hospitals ◽  
Hospital Pharmacists ◽  
Current Practices

Objectives Many university hospitals have developed local health technology assessment processes to guide informed decisions about new medical devices. However, little is known about stakeholders’ perceptions and assessment of innovative devices. Herein, we investigated the perceptions regarding innovative medical devices of their chief users (physicians and surgeons), as well as those of hospital pharmacists, because they are responsible for the purchase and management of sterile medical devices. We noted the evaluation criteria used to assess and select new medical devices and suggestions for improving local health technology assessment processes indicated by the interviewees. Methods We randomly selected 18 physicians and surgeons (nine each) and 18 hospital pharmacists from 18 French university hospitals. Semistructured interviews were conducted between October 2012 and August 2013. Responses were coded separately by two researchers. Results Physicians and surgeons frequently described innovative medical devices as ‘new’, ‘safe’ and ‘effective’, whereas hospital pharmacists focused more on economic considerations and considered real innovative devices to be those for which no equivalent could be found on the market. No significant difference in evaluation criteria was found between these groups of professionals. Finally, hospital pharmacists considered the management of conflicts of interests in local health technology assessment processes to be an issue, whereas physicians and surgeons did not. Conclusions The present study highlights differences in perceptions related to professional affiliation. The findings suggest several ways in which current practices for local health technology assessment in French university hospitals could be improved and studied. What is known about the topic? Hospitals are faced with ever-growing demands for innovative and costly medical devices. To help hospital management deal with technology acquisition issues, hospital-based health technology assessment has been developed to support decisions. However, little is known about the different perceptions of innovative medical devices among practitioners and how different perceptions may affect decision making. What does this paper add? This paper compares and understands the perceptions of two groups of health professionals concerning innovative devices in the university hospital environment. What are the implications for practitioners? Such a comparison of viewpoints could facilitate improvements in current practices and decision-making processes in local health technology assessment for these medical products.

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