PP128 Regional Guidance On Spinal Cord Stimulation For Chronic Pain

2017 ◽  
Vol 33 (S1) ◽  
pp. 132-132
Author(s):  
Anna Cavazzana ◽  
Anna Redomi ◽  
Elena Poerio ◽  
Francesca Bassotto ◽  
Rita Mottola ◽  
...  

INTRODUCTION:Chronic Pain (CP) is the uncontrolled pain that affects patients for a long time. CP can be caused by many conditions, sometimes still poorly understood, and its levels can vary from moderate to intense. The management of resistant CP requires a stepwise approach and spinal cord stimulation (SCS) could be considered an extreme strategy. With the aim of ensuring the economic sustainability, the Veneto Region usually establishes rigorous access criteria to high-cost medical devices through its Regional Technical Committee on Medical Devices (CTRDM) and a Health Technology Assessment (HTA) procedure.METHODS:The Regional Health Technology Assessment Unit (CRUF) conducted through Pubmed a literature review of randomized controlled trials, systematic reviews, meta-analysis on SCS published from March 2006 to February 2016. International and national clinical guidelines were included in the analysis as well. The regional multidisciplinary Working Group on CP, which involved local clinicians, pharmacists, clinical engineer and health economist, discussed the collected evidence by consensus. Final recommendations on the appropriate use were submitted to the CTRDM for final approval.RESULTS:The regional guidance describes the type of pain that can be treated with spinal neurostimulators and the criteria which determine the success of the test procedure. A comparative analysis of spinal neurostimulators available on the market and related patients eligibility criteria have been also included. Moreover, the guidelines stated a list of compulsory requirements in order to become a regional center authorized in performing spinal neurostimulation procedure. Finally, the document describes some indicators for appropriateness monitoring. The CTRDM approved the final version in October 2016.CONCLUSIONS:The regional guidance on SCS aims at ensuring the appropriate use of neurostimulators in patients affected by resistant CP. The strict monitoring of agreed indicators is essential for appropriateness and consequently the sustainability of medical devices expenditure throughout the Regional Health Service.

2017 ◽  
Vol 33 (S1) ◽  
pp. 121-121
Author(s):  
Anna Redomi ◽  
Marika Torbol ◽  
Anna Cavazzana ◽  
Rita Mottola ◽  
Margherita Andretta ◽  
...  

INTRODUCTION:The Veneto Region established a Technical Panel for Continence (TPC) with the purpose of producing guidance for aids based on a Health Technology Assessment (HTA) approach. TPC is a multidisciplinary experts group that involves local clinicians, pharmacists, health economist and patients associations. Among its tasks, TPC can issue recommendations in the field of appropriate use, purchasing and distribution for aids. Currently the TPC is investigating aids for ostomy patients in order to provide the first regional guidance on appropriateness and disease management for ostomy.METHODS:The Regional Health Technology Assessment Unit (CRUF) conducted a literature review of the evidence on aids for ostomy. Grey literature, and National and Regional laws and regulations were also included in the analysis. TPC discussed the collected evidence by consensus. Final recommendations have been sent to the Regional Technical Committee on Medical Devices (CTRDM) for eventual remarks, before final approval.RESULTS:The literature review did not retrieve any relevant international studies on the topic, except for the Canadian clinical guidelines on ostomy. The upcoming regional guidance will suggest recommendations on: (i) appropriate patient disease management based on a multidisciplinary team evaluation; (ii) characteristics and selection criteria for ostomy aids and related accessories; (iii) prescribing medical specialists, authorization and distribution features; and (iv) specific indicators for appropriateness monitoring.CONCLUSIONS:The regional guidance on aids and accessories for ostomy aim at ensuring the appropriateness throughout the Regional Health Service. The strict monitoring of agreed indicators is essential for appropriateness compliance and consequently the sustainability of regional medical devices expenditure.


2021 ◽  
Vol 37 (S1) ◽  
pp. 26-26
Author(s):  
Scott Gibson ◽  
Sita Saunders ◽  
Amanda Hansson Hedblom ◽  
Maximilian Blüher ◽  
Rafael Torrejon Torres ◽  
...  

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.


2016 ◽  
Vol 40 (3) ◽  
pp. 257 ◽  
Author(s):  
Mathilde Billaux ◽  
Isabelle Borget ◽  
Patrice Prognon ◽  
Judith Pineau ◽  
Nicolas Martelli

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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