ORCID Profile
0000-0003-1694-8106
Current Organisations
Flinders University
,
University of Liverpool
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Publisher: Springer Science and Business Media LLC
Date: 17-05-2023
DOI: 10.1007/S41669-023-00408-Z
Abstract: As part of the Single Technology Appraisal (STA) process, the UK National Institute for Health and Care Excellence (NICE) invited Apellis Pharmaceuticals/Sobi to submit evidence for the clinical and cost effectiveness of pegcetacoplan versus eculizumab and pegcetacoplan versus ravulizumab for treating paroxysmal nocturnal haemoglobinuria (PNH) in adults whose anaemia is uncontrolled after treatment with a C5 inhibitor. The Liverpool Reviews and Implementation Group at the University of Liverpool was commissioned as the Evidence Review Group (ERG). The company pursued a low incremental cost-effectiveness ratio (ICER) Fast Track Appraisal (FTA). This was a form of STA processed in a shorter time frame and designed for technologies with company base-case ICER £10,000 per quality-adjusted life-year (QALY) gained and most plausible ICER £20,000 per QALY gained. This article summarises the ERG’s review of the company's evidence submission, and the NICE Appraisal Committee’s (AC’s) final decision. The company presented clinical evidence from the PEGASUS trial that assessed the efficacy of pegcetacoplan versus eculizumab. At Week 16, patients in the pegcetacoplan arm had statistically significantly greater change from baseline in haemoglobin levels and a higher rate of transfusion avoidance than patients in the eculizumab arm. Using the PEGASUS trial and Study 302 data (a non-inferiority trial that assessed ravulizumab versus eculizumab), the company conducted an anchored matching-adjusted indirect comparison (MAIC) to indirectly estimate the efficacy of pegcetacoplan versus ravulizumab. The company identified key differences between trial designs and populations that could not be adjusted for using anchored MAIC methods. The company and ERG agreed that the anchored MAIC results were not robust and should not inform decision making. In the absence of robust indirect estimates, the company assumed that ravulizumab had equivalent efficacy to eculizumab in the PEGASUS trial population. Results from the company base-case cost-effectiveness analysis showed that treatment with pegcetacoplan dominated eculizumab and ravulizumab. The ERG considered that the long-term effectiveness of pegcetacoplan was uncertain and ran a scenario assuming that after 1 year the efficacy of pegcetacoplan would be the same as eculizumab treatment with pegcetacoplan continued to dominate eculizumab and ravulizumab. The AC noted that treatment with pegcetacoplan had lower total costs than treatment with eculizumab or ravulizumab because it is self-administered and reduces the need for blood transfusions. If the assumption that ravulizumab has equivalent efficacy to eculizumab does not hold, then this will affect the estimate of the cost effectiveness of pegcetacoplan versus ravulizumab however, the AC was satisfied that the assumption was reasonable. The AC recommended pegcetacoplan as an option for the treatment of PNH in adults who have uncontrolled anaemia despite treatment with a stable dose of a C5 inhibitor for ≥ 3 months. Pegcetacoplan was the first technology recommended by NICE via the low ICER FTA process.
Publisher: Institute of Electrical and Electronics Engineers (IEEE)
Date: 08-2016
Publisher: IEEE
Date: 08-2014
Publisher: MDPI AG
Date: 13-07-2020
DOI: 10.3390/S20143885
Abstract: This paper presents forcecardiography (FCG), a novel technique to measure local, cardiac-induced vibrations onto the chest wall. Since the 19th century, several techniques have been proposed to detect the mechanical vibrations caused by cardiovascular activity, the great part of which was abandoned due to the cumbersome instrumentation involved. The recent availability of unobtrusive sensors rejuvenated the research field with the most currently established technique being seismocardiography (SCG). SCG is performed by placing accelerometers onto the subject’s chest and provides information on major events of the cardiac cycle. The proposed FCG measures the cardiac-induced vibrations via force sensors placed onto the subject’s chest and provides signals with a richer informational content as compared to SCG. The two techniques were compared by analysing simultaneous recordings acquired by means of a force sensor, an accelerometer and an electrocardiograph (ECG). The force sensor and the accelerometer were rigidly fixed to each other and fastened onto the xiphoid process with a belt. The high-frequency (HF) components of FCG and SCG were highly comparable (r 0.95) although lagged. The lag was estimated by cross-correlation and resulted in about tens of milliseconds. An additional, large, low-frequency (LF) component, associated with ventricular volume variations, was observed in FCG, while not being visible in SCG. The encouraging results of this feasibility study suggest that FCG is not only able to acquire similar information as SCG, but it also provides additional information on ventricular contraction. Further analyses are foreseen to confirm the advantages of FCG as a technique to improve the scope and significance of pervasive cardiac monitoring.
Publisher: Institute of Electrical and Electronics Engineers (IEEE)
Date: 09-2015
Publisher: Elsevier BV
Date: 11-2015
Publisher: IEEE
Date: 08-2015
Publisher: Institute of Electrical and Electronics Engineers (IEEE)
Date: 2016
Publisher: Institute of Electrical and Electronics Engineers (IEEE)
Date: 03-2015
Publisher: MDPI AG
Date: 22-10-2019
DOI: 10.3390/S19204596
Abstract: Upper limb utation is a condition that significantly restricts the utees from performing their daily activities. The myoelectric prosthesis, using signals from residual stump muscles, is aimed at restoring the function of such lost limbs seamlessly. Unfortunately, the acquisition and use of such myosignals are cumbersome and complicated. Furthermore, once acquired, it usually requires heavy computational power to turn it into a user control signal. Its transition to a practical prosthesis solution is still being challenged by various factors particularly those related to the fact that each utee has different mobility, muscle contraction forces, limb positional variations and electrode placements. Thus, a solution that can adapt or otherwise tailor itself to each in idual is required for maximum utility across utees. Modified machine learning schemes for pattern recognition have the potential to significantly reduce the factors (movement of users and contraction of the muscle) affecting the traditional electromyography (EMG)-pattern recognition methods. Although recent developments of intelligent pattern recognition techniques could discriminate multiple degrees of freedom with high-level accuracy, their efficiency level was less accessible and revealed in real-world ( utee) applications. This review paper examined the suitability of upper limb prosthesis (ULP) inventions in the healthcare sector from their technical control perspective. More focus was given to the review of real-world applications and the use of pattern recognition control on utees. We first reviewed the overall structure of pattern recognition schemes for myo-control prosthetic systems and then discussed their real-time use on utee upper limbs. Finally, we concluded the paper with a discussion of the existing challenges and future research recommendations.
Publisher: IEEE
Date: 08-2015
Publisher: IEEE
Date: 07-2013
Publisher: IEEE
Date: 08-2006
Publisher: Elsevier BV
Date: 09-2014
Publisher: Institute of Electrical and Electronics Engineers (IEEE)
Date: 03-2018
Publisher: IEEE
Date: 07-2013
Publisher: American Thoracic Society
Date: 03-2022
Location: United Kingdom of Great Britain and Northern Ireland
Location: Australia
No related grants have been discovered for Devarshi Bhattacharyya.