Advice
The technology
The technology
icobrain ms (icometrix) supports the objective tracking of disease progression in people with active relapsing–remitting multiple sclerosis (MS). The software quantifies brain MRI scans and summarises clinically relevant findings related to white matter lesions and brain atrophy.
icobrain ms allows objective assessment of lesion dissemination in space and time by detecting, quantifying, and tracking the evolution of FLAIR/T2 white matter hyperintensities and T1 white matter hypointensities. It also contrast-enhances T1 hyperintensities to evaluate disease activity and reports the distribution following the McDonald criteria (juxtacortical, periventricular and infratentorial).
The technology provides precise and relevant brain atrophy measures by tracking yearly brain volume changes for whole brain and grey matter. It compares brain volumes and volume changes to a population without MS matched for age and gender.
Innovations
The technology aids the quicker detection of sub-optimal response to treatment in people with active relapsing–remitting MS. It could therefore enable earlier switching to an alternative more efficacious agent. icobrain ms summarises the findings in structured electronic radiological reports with annotated images. This may reduce the time a radiologist needs to make an assessment and could allow assessment by staff working at lower grades.
Current care pathway
People with MS who have had 2 or more clinical relapses in the last 2 years are diagnosed with active relapsing–remitting MS. Individuals with active relapsing–remitting MS start disease-modifying therapy (DMT). This can be with a drug of moderate efficacy (interferon beta, glatiramer acetate, teriflunomide, dimethyl fumarate) or with a drug of high efficacy. People are then monitored, and their MS may be reclassified as more active by frequent clinical relapses or MRI activity, or both. Criteria for disease activity are based on MRI (white matter lesions) and clinical evidence (relapses and disability progression). The MRI evidence is qualitatively assessed by the clinician. Structural Image Evaluation using Normalisation of Atrophy (SIENA) analysis is a validated method for automatic analysis, but has only been used in research settings and assesses brain atrophy only. If people on a low efficacy drug continue to experience disease activity, a switch to a drug of higher efficacy is considered (ocrelizumab, cladribine, natalizumab, fingolimod, ofatumumab, alemtuzumab).
The following publications have been identified as relevant to this care pathway:
Population, setting and intended user
icobrain ms is intended for people with active relapsing–remitting MS, based on radiological and clinical grounds. Relapsing–remitting MS is the most prevalent form of MS with up to 85% of cases of that phenotype (GP Notebook, 2020). A delay to switching from an ineffective DMT may result in disability. The company specifically acknowledges that the technology can be used for other forms of MS, but because of the lack of multiple DMTs it will not have a high clinical value.
icobrain ms is for use in secondary care. Specifically, the technology is for use in radiology departments by a radiologist or neuroradiologist to assist in analysing and reporting of MRI scans during the assessment of disease activity in people with active relapsing–remitting MS. The radiological report is to be used by the neurologist or care teams during follow-up visits to evaluate patient disease activity status and to inform decisions about DMTs. The company states that a training manual is provided that gives guidance on how to use the software and interpret reports. It further states that it does a clinical and technical test phase before using the technology in clinical practice. The duration is estimated to vary from 1 to 3 months, as 30 to 40 cases are needed to complete the test phase.
Costs
Technology costs
The cost of icobrain ms ranges from £30,000 to £60,000 per year depending on volume (excluding VAT). This covers the licence fee only, but the company states that there are no additional costs. The company estimates a broad patient volume range of 100 to 1,000, but states that there is no linear correlation between the volume and price range. User training and customer support are included in the licence fee, with training estimated to take 3 to 6 hours of radiologist time. The company states that there are no additional costs for software updates or any other intervention for the correct functioning of the software, except for installation of the icobridge software used for data pseudonymisation and transferring. The company estimates that the cost of installing this software is minimal.
Resource consequences
The company states that the technology is currently not routinely used in the NHS. It suggests that adopting icobrain ms will reduce the time needed to assess MRI results and the level of expertise needed to assess MRI scans, therefore releasing clinician resource. The technology enhances the detection of lesions and brain atrophy, which signal disease progression. This would lead to better patient outcomes because of the timelier switch to more effective DMTs and could contribute to additional cost savings. This claim is supported by an early cost–utility analysis done by the company (Sima et al. 2021). The study estimated quality-adjusted life-year gains of 0.23 and 0.37 over 10 and 15 years respectively, and average cost savings of $1,500 to $2,200 per patient in the US. The effects of uncertainty were not assessed.
Adopting icobrain ms does not need any changes in facilities or infrastructure. The software does not need any additional equipment to be purchased.