Are Medical Device Characteristics Included in HTA Methods Guidelines and Reports? A Brief Review.

It is well accepted that medical devices (MDs) and procedures have several unique characteristics compared with pharmaceuticals, such as learning curve (LC), incremental innovation (II), dynamic pricing (DP), and organizational impact (OI). The objective of this study was to determine the extent to which these MD characteristics are routinely assessed by health technology assessment (HTA) agencies and incorporated in their guidelines and reports. Three approaches were taken. First, a review of the most recent HTA methods guidelines from 14 selected HTA agencies and 5 HTA networks was undertaken. Next, HTA reports from these agencies were reviewed for inclusion of MD-specific characteristics for 16 selected MDs. Finally, a narrative literature review on this topic was conducted. A total of 13 of the included HTA organizations, and some HTA networks (2/5), have published either general or MD-specific method guidelines, whilst several addressed MD-specific characteristics. NICE included all four MD characteristics in their guidelines, but this did not equate to their inclusion in published HTA evaluations. European Network HTA (EUnetHTA) described the inclusion of LC (within patient safety) and OI within their guidance. The results highlight a lack of consistency. For the narrative review, 10/149 articles identified were reviewed. Most provided recommendations on challenges faced by HTAs, proposed steps to address uncertainties around MD characteristics and reported a lack of methodological guidance for evaluating MDs. A lack of inclusion of MD characteristics in HTA is a complex interplay of several important factors. For these characteristics to become a formal part of HTA of MDs in the future, clear guidance and frameworks are required to enable manufacturers to develop appropriate evidence, and HTA practitioners to assess their impact more broadly.

Assessing the Cost and Resource Use Impact of Implantable Cardiac Defibrillator Shocks in the UK CareLink Population.

Objective: High voltage devices (implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators referred to jointly as ICDs) reduce rates of sudden cardiac death in patients with cardiovascular disease. However, shocks from ICDs may be associated with healthcare resource use (HCRU) and costs. The aim of this study was to estimate the costs associated with both appropriate and inappropriate shocks from ICDs. Methods: Patients with appropriate and inappropriate shocks from ICDs were identified via CareLink data from Liverpool Heart and Chest Hospital between March 2017 and March 2019. The devices were SmartShock activated, with anti-tachycardia pacing. Costs were estimated according to the dominant episode of healthcare, from an NHS payer perspective. Results: There were 2445 patients on the CareLink system with ICDs. Over the two-year period, HCRU data from 143 shock episodes among 112 patients were reported. The total cost for all shocks was £252,552 with mean costs of £1608 and £2795 for appropriate and inappropriate shocks respectively. There was substantial variation in HCRU between shock episodes. Conclusion: While there was a low rate of inappropriate shocks from ICDs, there were still substantial HCRU and costs incurred. In this study, the specific HCRU was not costed independently, meaning the costs reported are likely to be a conservative estimate. Whilst every attempt to reduce shocks should be made, appropriate shocks cannot be avoided. Strategies to reduce the incidence of inappropriate and unnecessary shocks should be implemented to reduce overall health care costs associated with ICDs.

The cost-effectiveness of sacral nerve stimulation (SNS) for the treatment of idiopathic medically refractory overactive bladder (wet) in the UK.

OBJECTIVE: To estimate the long-term cost-effectiveness of specialised treatment options for medically refractory idiopathic overactive bladder (OAB) wet. PATIENTS AND METHODS: The cost-effectiveness of competing treatment options for patients with medically refractory idiopathic OAB wet was estimated from the perspective of the National Health Service in the UK. We compared sacral nerve stimulation (SNS) with percutaneous nerve evaluation (PNE) or tined-lead evaluation (TLE) with optimal medical therapy (OMT), botulinum toxin type A (BoNT-A) injections, and percutaneous tibial nerve stimulation (PTNS). We used a Markov model with a 10-year time horizon for all treatment options with the exception of PTNS, which has a time horizon of 5 years. Costs and effects (measured as quality-adjusted life years) were calculated to derive incremental cost-effectiveness ratios (ICERs). Direct medical resources included are: device and drug acquisition costs, pre-procedure and procedure costs, and the cost of managing adverse events. Deterministic sensitivity analyses were performed to test robustness of results. RESULTS: At 5 years, SNS (PNE or TLE) was more effective and less costly than PTNS. Compared with OMT at 10 years, SNS (PNE or TLE) was more costly and more effective, and compared with BoNT-A, SNS PNE was less costly and more effective, and SNS TLE was more costly and more effective. Decreasing the BoNT-A dose from 150 to 100 IU marginally increased the 10 year ICERs for SNS TLE and PNE (SNS PNE was no longer dominant). However, both SNS options remained cost-effective. CONCLUSION: In the management of patients with idiopathic OAB wet, the results of this cost-utility analysis favours SNS (PNE or TLE) over PTNS or OMT, and the most efficient treatment strategy is SNS PNE over BoNT-A over a 10-year period.

Impact of the National Institute for Health and Care Excellence (NICE) guidance on medical technology uptake: analysis of the uptake of spinal cord stimulation in England 2008-2012.

BACKGROUND: The National Institute for Health and Care Excellence (NICE) Technology Appraisal Guidance on spinal cord stimulation (SCS) was published in 2008 and updated in 2012 with no change. This guidance recommends SCS as a cost-effective treatment for patients with neuropathic pain. OBJECTIVE: To assess the impact of NICE guidance by comparing SCS uptake in England pre-NICE (2008-2009) and post-NICE (2009-2012) guidance. We also compared the English SCS uptake rate with that of Belgium, the Netherlands, France and Germany. DESIGN: SCS implant data for England was obtained from the Hospital Episode Statistics (HES) database and compared with other European countries where comparable data were available. RESULTS: The HES data showed small increases in SCS implantation and replacement/revision procedures, and a large increase in SCS trials between 2008 and 2012. The increase in the total number of SCS procedures per million of population in England is driven primarily by revision/replacements and increased trial activity. Marked variability in SCS uptake at both health regions and primary care trust level was observed. CONCLUSIONS: Despite the positive NICE recommendation for the routine use of SCS, we found no evidence of a significant impact on SCS uptake in England. Rates of SCS implantation in England are lower than many other European countries.