title: Spectra Optia®for Automated Red Blood Cell Exchange in Patients with Sickle Cell Disease: A NICE Medical Technology Guidance.
abstract: The Spectra Optia®automated apheresis system, indicated for red blood cell exchange in people with sickle cell disease, underwent evaluation by the National Institute for Health and Care Excellence, which uses its Medical Technologies Advisory Committee to make recommendations. The company (Terumo Medical Corporation) produced a submission making a case for adoption of its technology, which was critiqued by the Newcastle and York external assessment centre. Thirty retrospective observational studies were identified in their clinical submission. The external assessment centre considered these were of low methodological and reporting quality. Most were single-armed studies, with only six studies providing comparative data. The available data showed that, compared with manual red blood cell exchange, Spectra Optia reduces the frequency of exchange procedures as well as their duration, but increases the requirement for donor blood. However, other clinical and patient benefits were equivocal because of an absence of robust clinical evidence. The company provided a de novo model to support the economic proposition of the technology, and reported that in most scenarios Spectra Optia was cost saving, primarily through reduced requirement of chelation therapy to manage iron overload. The external assessment centre considered that although the cost-saving potential of Spectra Optia was plausible, the model and its clinical inputs were not sufficiently robust to demonstrate this. However, taking the evidence together with expert and patient advice, the Medical Technologies Advisory Committee considered Spectra Optia was likely to save costs, provide important patient benefits, and reduce inequality, and gave the technology a positive recommendation in Medical Technology Guidance 28.
authors.affiliation: Newcastle upon Tyne Hospitals National Health Service Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK. iain.willits@nuth.nhs.uk.|Regional Medical Physics Department, NICE External Assessment Centre, Freeman Hospital, High Heaton, NE7 7DN, UK. iain.willits@nuth.nhs.uk.
authors.forename: Iain
authors.initials: I
authors.lastname: Willits
authors.affiliation: Newcastle upon Tyne Hospitals National Health Service Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Cole
authors.affiliation: Newcastle upon Tyne Hospitals National Health Service Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: Roseanne
authors.initials: R
authors.lastname: Jones
authors.affiliation: National Institute for Health and Care Excellence, Manchester, UK.
authors.forename: Kimberley
authors.initials: K
authors.lastname: Carter
authors.affiliation: York Health Economics Consortium, Enterprise House, Innovation Way, University of York, Heslington, York, UK.
authors.forename: Mick
authors.initials: M
authors.lastname: Arber
authors.affiliation: York Health Economics Consortium, Enterprise House, Innovation Way, University of York, Heslington, York, UK.
authors.forename: Michelle
authors.initials: M
authors.lastname: Jenks
authors.affiliation: York Health Economics Consortium, Enterprise House, Innovation Way, University of York, Heslington, York, UK.
authors.forename: Joyce
authors.initials: J
authors.lastname: Craig
authors.affiliation: Newcastle upon Tyne Hospitals National Health Service Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Sims
mesh_terms: D000755:Anemia, Sickle Cell / Q000628:therapy*; D001781:Blood Component Removal / Q000295:instrumentation* / Q000379:methods; D017707:Erythrocyte Transfusion / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D013673:Technology Assessment, Biomedical; D016896:Treatment Outcome