Wider use of the UK’s real-time Dexcom G6 continuous glucose monitoring system (RT-CGM) would be cost-effective in the long term, new research suggests.
The analysis is published in the October issue Diabetes Care. The lead author of this article is Stéphane Roze, chief executive of the Vyoo Agency (formerly HEVA HEOR), which conducts a medical cost-effectiveness analysis.
The UK’s National Institute for Health and Care Excellence (NICE) allows real-time use of CGM for people who have it type 1 diabetes who experience it is often severe hypoglycemiahypoglycemia, extreme fear of hypoglycemia, or A1c levels> 9.0% (75 mmol / mol) despite frequent self-monitoring of blood glucose (SMBG).
Up to 25% of people with type 1 diabetes in the United Kingdom meet at least one of these criteria. However, funding is limited, and paying for it yourself is common.
“For type 1 diabetes patients based in the UK, the G6 RT-CGM device was associated with a significant improvement in clinical outcomes and, over the patient’s lifetime, is a cost-effective disease management option relative to SMBG on the basis of a willingness to pay threshold of GBP 20,000 [USD 26,032] per QALY [quality-adjusted life year] obtained, “wrote Roze and colleagues.
Asked for comment, Partha Kar, MD, national special adviser, diabetes, at the UK’s National Health Service (NHS), called the new data “welcome news, and will hopefully help as NICE is currently reviewing evidence surrounding Dexcom.”
Today, says Kar, more people in the UK are using the cheaper 14-day Abbott Libre FreeStyle “flash” glucose monitoring system. The first version of the system, approved in Europe in 2014, did not include alarms for high and low glucose levels. A newer version with an optional alarm, Libre 2, Approved in 2018 but not yet available in the UK. A newer version, Libre 3, recently cleaned for use in Europe.
According to Kar, Libre 2 will arrive in the UK in early 2021. “The NHS is happy to welcome it, when it arrives. We hope Libre 3 will follow soon after,” he said.
New data suggest that Libre may have competition in the UK.
CGM Dexcom Meets the Desire-to-Pay Threshold
The analysis by Roze and colleagues was performed using validated computer simulations that project long-term outcomes for patients with type 1 or type 2 diabetes, including cardiovascular, ophthalmic, and renal complications, as well as peripheral neuropathy, leg ulcers, amputations, and hypoglycemic events.
Patient data used in the model comes from previous data DIAMOND trial, which includes 158 people with type 1 diabetes who received it several times a day insulin injection. The patients were randomly assigned to RT-CGM or SMBG (mean 4.6 tests / day) for 24 weeks. The mean age of the patients was 48 years, the mean duration of diabetes was 20 years, and the mean A1c level was 8.6% (70 mmol / L).
Based on the DIAMOND results, the cost-effectiveness analysis assumes an average A1c reduction of 1.0 percentage points with RT-CGM, vs 0.4 with SMBG. The rate of severe hypoglycemia was 4.2, vs 12.2 per 100 patient years.
This result translates to a 1.49 increase in mean increase in QALYs for RT-CGM compared to SMBG (11.47 vs 9.99).
Over lifetime, this means total average cost was £ 14,234 higher with RT-CGM (£ 102,468 vs £ 88,234), resulting in an additional cost-effectiveness ratio (ICER) of £ 9,558 per QALY earned for RT-CGM vs SMBG.
Most of the higher costs were attributable to the RT-CGM system itself, but savings resulted from improvements in the long-term reduction in complications and hypoglycemic events. At the willingness to pay threshold of £ 20,000, the likelihood that RT-CGM would be considered cost-effective was around 99%.
In a secondary analysis of patients with baseline A1c ≥8.5% (69 mmol / L; mean, 9.1% per 76 mmol / L), use of RT-CGM was associated with an increase of 1.39 QALYs compared to SMBG, and the total lifetime cost on average is £ 13,176 higher than that of SMBG, resulting in an ICER of £ 9,478 / QALY and a 98% probability of being considered cost effective.
“The findings presented here indicate that RT-CGM improves long-term yield relative to SMGD and that initial acquisition costs are at least partially offset by savings due to a reduction in the incidence of long-term complications,” Roze and colleagues wrote.
The sensitivity analysis, they said, “revealed that RT-CGM was most cost-effective in the group of patients who met the NICE eligibility criteria for RT-CGM, in particular, those with high A1c at baseline, FoH. [fear of hypoglycemia], often SHE [severe hypoglycemia episodes], and the use of high-level SMGD. “
The G6 May Be More Cost Effective Than the G4 Used in Diamond Testing
The authors also suggest that the findings may be conservative, as the RT-CGM used in the DIAMOND trial was the older Dexcom G4.
That system has been replaced by the G6, which incorporates an “as soon as possible” warning that allows the user to take action to prevent hypoglycemia.
“It is therefore plausible that the effect of treatment in this analysis in terms of the incidence rate of hypoglycemic, and potentially also FoH. [fear of hypoglycemia], in patients using RT-CGM may have been underestimated, “write the authors.
“The findings presented here provide valuable information to UK-based payers and policymakers regarding the cost-effectiveness of RT-CGM in T1D. [type 1 diabetes], “they concluded.
The study was funded by Dexcom, which paid Roze’s company for the analysis. Kar did not disclose the relevant financial relationships.
Diabetes Care. October 2020; 43: 2411-2417. Abstract