Re: Patients with type 1 diabetes are missing out on flash glucose devices, finds BMJ investigation
Equity of access to healthcare has been an underpinning theme of the NHS since its inception.
The concerns raised in this area by Freestyle Libre® encapsulate many of the wider issues facing non-medicines technologies. Unlike medicines, the published evidence base supporting adoption is often weak. This issue is not unique to the UK but for a variety of reasons, is unlikely to change.
Does this then mean that resources should be committed only to areas where there is strong evidence in the form of randomised controlled trials and meta-analyses, even if the gains demonstrated are marginal? Were this to be the case, there is an associated opportunity cost which may prevent patients from gaining access to devices and technologies of great benefit to them.
For Freestyle Libre, the main evidence is from 2 randomised controlled trials (RCT) (1,2). Methodological weaknesses mean the risk of bias in these studies cannot be excluded. In such circumstances, alternative sources of evidence and measures of value may be valid and useful.
The Scottish Health Technologies Group used a bespoke economic model to inform their advice (3). Initial findings from a de novo cost effectiveness analysis showed that Freestyle Libre® is cost-effective for people with Type 1 diabetes mellitus (T1 DM) and for people with Type 2 diabetes mellitus (T2 DM) who are intensive insulin users and self-monitor their blood glucose levels. The incremental cost-effectiveness ratio (ICER) for Freestyle Libre® compared with standard self monitoring of blood glucose (SMBG) ranged from £2,459 to £12,340 per quality-adjusted life year (QALY) in T1 DM and from £4,498 to £18,125 in T2 DM, depending on the modelling approach considered. One-way sensitivity analyses indicated Freestyle Libre® was still likely to be cost-effective under a wide range of scenarios and cost saving against SMBG when a mean number of eight blood glucose tests per day was considered. Their probabilistic sensitivity analysis also indicated that Freestyle Libre® is likely to be cost-effective.
This modelling could be supported by real world data if users share data with their care team.
Additional evidence of benefit may come from patient experience and treatment satisfaction. These are increasingly recognised by health technology assessment bodies as independent measures of value when making recommendations. Diabetic patients and their carers have been diligent in making a strong case.
Freestyle Libre® highlights the challenges facing patients, health technology assessment agencies and key decision makers in first recognising the value (or otherwise) of new non - drug technologies and subsequently achieving equity of access. Evidence should inform decision making wherever possible but if patients are to gain access to new technologies which are not medicines, the search for that evidence may need to go beyond the conventional gold standard RCT, systematic review or meta-analysis.
1. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Lancet. 2016;388(10057):2254-63.
2. Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline J-P, Rayman G. Diabetes Therapy. 2017;8(1):55-73.
Competing interests: No competing interests