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The Political Sociology of NICE: Investigating Pharmaceutical Cost-Effectiveness Regulation in the UK.
Sociol Health Illn
January 2025
Department of Global Health and Social Medicine, King's College London, London, UK.
The National Institute for Health and Care Excellence (NICE) was established a quarter of a century ago in 1999 to regulate the cost-effectiveness of pharmaceuticals (and other health technologies) for the NHS. Drawing on medical sociology theories of corporate bias, neoliberalism, pluralism/polycentricity and regulatory capture, the purpose of this article is to examine the applicability of those theories to NICE as a key regulatory agency in the UK health system. Based on approximately 7 years of documentary research, interviews with expert informants and observations of NICE-related meetings, this paper focuses particularly on NICE's relationship with the interests of the pharmaceutical industry compared with other stakeholder interests at the meso-organisational level.
View Article and Find Full Text PDFCorrection: NICE's Pathways Pilot: Pursuing Good Decision Making in Difficult Circumstances.
Pharmacoecon Open
September 2024
PenTAG, University of Exeter Medical School, University of Exeter, St Luke's Campus, Exeter, EX1 2LU, UK.
Author Correction: NICE's rejection of pembrolizumab for platinum-refractory urothelial carcinoma: is there a greater good?
Nat Rev Urol
September 2020
The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
An amendment to this paper has been published and can be accessed via a link at the top of the paper.
View Article and Find Full Text PDFFSHD1 and FSHD2 form a disease continuum.
Neurology
May 2019
From the Peripheral Nervous System (S.S., M.G., C.C., A.P.), Muscle & ALS Department, Pasteur 2 Hospital, Centre Hospitalier Universitaire de Nice, and Institute for Research on Cancer and Aging of Nice (S.S., C.B., N.L., P.N., G.C.), CNRS, INSERM, Université Côte d'Azur; Department of Genetics and Molecular Biology (A.B.-S., S.R., M.J.), Cochin Hospital, Paris, France; Department of Human Genetics (R.J.L.F.L., S.M.v.d.M.), Leiden University Medical Center, the Netherlands; Rare Neuromuscular Diseases Centre (C.C.), Department of Human Neuroscience, Sapienza University of Rome, Italy; Pathology Department (F.C.), CHRU of Caen, INSERM U1075, University of Caen, Normandy; Myology Institute (T.S., A.B., B.E.), Center of Research in Myology, APHP, Sorbonne Université, UPMC Univ Paris 06, INSERM UMRS974, CNRS FRE3617, Paris; Electromyography and Neuromuscular Department (C.V., F.B., P.P.), Neurologic Hospital, Lyon East Hospital Group, Lyon-Bron, France; Neuromuscular Center, Department of Neuroscience (M.C., E.P.), and Clinical Genetics Unit, Department of Women's and Children's Health (L.S.), University of Padova, Italy; Institut Imagine, Imagine Bioinfomatics Platform (M.B.), Paris Descartes University; Département de Neurologie (A.E.-L.), Hôpitaux Universitaires, Strasbourg; Nord/Est/Ile de France Neuromuscular Center (P.L.), Neurology Department, Raymond Poincaré Teaching Hospital, Garches; INSERM U1179 (P.L.), END-ICAP, Versailles Saint-Quentin-en-Yvelines University, Montigny-le-Bretonneux, France; and IRP Città della Speranza (L.S.), Padova, Italy.
Article Synopsis
- - The study aimed to compare clinical features of patients with classical facioscapulohumeral muscular dystrophy (FSHD) against the genetic and epigenetic profiles of FSHD1 and FSHD2.
- - Researchers examined 103 patients, identifying 64 with FSHD1 and 20 with FSHD2, noting that those with a D4Z4 repeat length of 9-10 units showed significant clinical severity compared to other FSHD1 patients.
- - The findings suggest a continuum between FSHD1 and FSHD2 due to overlap in patient characteristics, prompting a reevaluation of the established repeat size thresholds for these conditions.
Pomalidomide with Dexamethasone for Treating Relapsed and Refractory Multiple Myeloma Previously Treated with Lenalidomide and Bortezomib: An Evidence Review Group Perspective of an NICE Single Technology Appraisal.
Pharmacoeconomics
February 2018
Institute for Medical Technology Assessment (iMTA), Institute of Health Policy and Management (iBMG), Erasmus University Rotterdam, Rotterdam, The Netherlands.
The National Institute for Health and Care Excellence (NICE), as part of the institute's single technology appraisal (STA) process, invited the manufacturer of pomalidomide (POM; Imnovid, Celgene) to submit evidence regarding the clinical and cost effectiveness of the drug in combination with dexamethasone (POM + LoDEX) for the treatment of relapsed and refractory multiple myeloma (RRMM) after at least two regimens including lenalidomide (LEN) and bortezomib (BOR). Kleijnen Systematic Reviews Ltd (KSR) and Erasmus University Rotterdam were commissioned as the Evidence Review Group (ERG) for this submission. The ERG reviewed the evidence submitted by the manufacturer, validated the manufacturer's decision analytic model, and conducted exploratory analyses in order to assess the robustness and validity of the presented clinical and cost-effectiveness results.
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