Inequality of access to advanced therapies for patients with inflammatory arthritis: a postcode lottery?

Objectives Advanced therapies (AT) including biologics, biosimilars and JAK inhibitors have dramatically improved the quality of life of patients with Rheumatoid arthritis (RA), Psoriatic Arthritis (PsA) and Axial spondyloarthritis (axSpA). Evidence-based criteria for prescribing these drugs in England and Wales is formulated by the National Institute for Health and Care Excellence (NICE) through Health Technology Appraisals (HTAs) and guidelines with the aim of providing equitable access to AT for patients with severe or resistant disease. Similar bodies exist in some, but not all European countries with disparities in AT access between countries in AT access for RA. We examined whether this disparity was mirrored in England for RA, PsA and axSpA despite the NHS in England and Wales being legally obliged to provide funding for AT recommended by NICE’s HTA board, through commissioning bodies, Clinical Commissioning Groups (CCGs). Methods We requested AT pathways from CCGs in England. Where these were not available, individual hospital Trusts were contacted using Freedom of Information (FOI) requests. Results We found marked variability in the way that CCGs in England interpret NICE guidance. We found 41, 29 and 25 different pathways for RA, PsA and axSpA respectively. Similar disparities existed with sequential prescribing where one AT did not work, with limits on numbers of sequential AT in 54%, 59% and 59% of CCGs for RA, PsA and axSpA respectively, with these limits being different for the same condition between CCGs. Conclusion While patients at identical stages of their disease course should have access to the same NICE approved AT, we found this is not the case for large parts of England. Inequality of access was found between regions mirroring the variability which occurs between countries throughout Europe. Harmonisation of access needs to be addressed by policymakers, ensuring fairness in the way that clinicians and patients can access AT.

Justice, Transparency and the Guiding Principles of the UK’s National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (NICE) is the UK’s primary healthcare priority-setting body, responsible for advising the National Health Service in England on which technologies to fund and which to reject. Until recently, the normative approach underlying this advice was described in a 2008 document entitled ‘Social value judgements: Principles for the development of NICE guidance’ (SVJ). In January 2020, however, NICE replaced SVJ with a new articulation of its guiding principles. Given the significant evolution of NICE’s methods between 2008 and 2020, this study examines whether this new document (‘Principles’) offers a transparent account of NICE’s current normative approach. It finds that it does not, deriving much of its content directly from SVJ and failing to fully acknowledge or explain how and why NICE’s approach has since changed. In particular, Principles is found to offer a largely procedural account of NICE decision-making, despite evidence of the increasing reliance of NICE’s methods on substantive decision-rules and ‘modifiers’ that cannot be justified in purely procedural terms. Thus, while Principles tells NICE’s stakeholders much about how the organisation goes about the process of decision-making, it tells them little about the substantive grounds on which its decisions are now based. It is therefore argued that Principles does not offer a transparent account of NICE’s normative approach (either alone, or alongside other documents) and that, given NICE’s reliance on transparency as a requirement of procedural justice, NICE does not in this respect satisfy its own specification of a just decision-maker.

The management of suspected scaphoid fractures in the UK: a national cross-sectional study

Aims Current National Institute for Health and Clinical Excellence (NICE) guidance advises that MRI direct from the emergency department (ED) should be considered for suspected scaphoid fractures. This study reports the current management of suspected scaphoid fractures in the UK and assesses adherence with NICE guidance. Methods This national cross-sectional study was carried out at 87 NHS centres in the UK involving 122 EDs and 184 minor injuries units (MIUs). The primary outcome was availability of MRI imaging direct from the ED. We also report the specifics of patient management pathways for suspected scaphoid fractures in EDs, MIUs, and orthopaedic services. Overall, 62 of 87 centres (71%) had a guideline for the management of suspected scaphoid fractures. Results A total of 11 of 87 centres (13%) had MRI directly available from the ED. Overall, 14 centres (17%) used cross-sectional imaging direct from the ED: MRI in 11 (13%), CT in three (3%), and a mixture of MRI/CT in one (1%). Four centres (6%) used cross-sectional imaging direct from the MIU: MRI in three (4%) and CT in two (2%). Of 87 centres’ orthopaedic specialist services, 74 (85%) obtained repeat radiographs, while the most common form of definitive imaging used was MRI in 55 (63%), CT in 16 (19%), mixture of MRI/CT in three (3%), and radiographs in 11 (13%). Conclusion Only a small minority of centres currently offer MRI directly from the ED for patients with a suspected scaphoid fracture. Further research is needed to investigate the facilitators and barriers to the implementation of NICE guidance. Cite this article: Bone Jt Open 2021;2(11):997–1003.

Relative benefits of extracorporeal shockwave lithotripsy (ESWL) compared to observation in acute renal colic

Miss Catherine Lovegrove1,2Mandy Spencer1Prof Ben Turney1,2Ms Naomi Neal1 1 Department of Urology, Oxford University Hospitals NHS Trust, Oxford, Oxfordshire, UK2 University of Oxford Nuffield Department of Surgical Sciences, Oxford, Oxfordshire, UK Background NICE guidance recommends patients with renal colic be offered surgical treatment, including extracorporeal shockwave lithotripsy (ESWL), within 48 hours if pain is uncontrolled or stones unlikely to pass. We compared outcomes for ureteric stone passage after ESWL with those of observation to ascertain the relative benefits of ESWL. Methods We collected data on stone location, size and number of ESWL treatments required prospectively over 18 months. Stone passage was confirmed radiologically. Data were compared with MIMIC, a multi-centre collaborative study examining spontaneous stone passage after observation alone. Results 166 patients had ESWL for ureteric stones. Median size was 6.5mm (IQR 5.0-8.0mm). 57.2% (N=95) were proximal stones. Smaller stones required fewer treatments (P=0.003). Patients with a ureteric stone <5mm required median 1.0 ESWL treatments (IQR 1.0-2.0). Ureteric stones 5-7mm had median 1.0 treatments (IQR 1.0-2.0) and stones >7mm median 2.0 treatments (IQR 1.0-2.0). Compared to MIMIC, patients with ESWL for stones <5mm were 11% more likely to achieve stone clearance (100.0% vs 89.0%, P=0.001). ESWL for 5-7mm stones had 28.1% greater clearance compared to observation (77.1% vs. 49.0%, P<0.001) and ESWL for stones >7mm 21% greater likelihood of clearance (50.0% vs. 29.0%, P<0.001). Proximal ureteric stones were 16.4% more likely to pass with ESWL than observation (68.4% vs 52%, P=0.02). Distal stones showed similar passage with ESWL (77.5%) and observation (83.0%), P=0.43. Conclusions Proximal ureteric stones and those >5mm stones benefit most from ESWL. Results aid identification of patients whose stones are less likely to pass and warrant urgent review to consider ESWL.