myCOPD to self-manage chronic obstructive pulmonary disease

The clinical evidence comprises 4 UK comparative studies and real-world evidence from 10 local evaluations

3.1 There were 4 peer-reviewed studies on myCOPD, including 3 randomised controlled trials (RCTs) and 1 observational study. Of the 3 RCTs, TROOPER used a non-inferiority design comparing myCOPD with a face-to-face pulmonary rehabilitation programme (Bourne et al. 2017). RESCUE was a feasibility trial that compared myCOPD with usual care plus additional written support (North et al. 2020). EARLY was a superiority RCT that compared myCOPD with standard care (Crooks et al. 2020). All trials were done in the NHS with 6 weeks or 3 months of follow-up. The sample sizes ranged from 41 to 90 people with mild, moderate or severe chronic obstructive pulmonary disease (COPD).

Real-world evidence is generalisable to the NHS

3.2 There was real-world evidence on clinical benefits, health service use, patient experience and usage of the app. Most evidence was from interim evaluations designed to inform commissioning decisions or service developments. The methodology, patient numbers or characteristics, clinical outcomes and follow-up periods were not fully reported in these evaluations. However, the EAC concluded that the real-world evidence reflected the use of myCOPD in clinical practice and the findings of these evaluations would be generalisable to local health services.

Evidence shows that myCOPD has clinical benefits

3.3 Using myCOPD improved COPD assessment test (CAT) scores, 6‑minute walking test (6MWT) distances and inhaler techniques. RESCUE showed a CAT score reduction of 2.94 (95% confidence interval [CI] -6.92 to 1.05, n=35) with myCOPD at the 3‑month follow-up. This difference was clinically important but not statistically significant (North et al. 2020). It also showed a significant reduction in inhaler errors in people using myCOPD compared with people having usual care (relative risk, 0.38; 95% CI 0.18 to 0.80). TROOPER reported no statically significant difference in the 6MWT between the intervention groups, showing myCOPD was not inferior to face-to-face care for pulmonary rehabilitation (Bourne et al. 2017). Real-world evidence reported clinically important improvements in CAT scores with myCOPD (NHS Southend clinical commissioning group [CCG] evaluations, NHS Grampian evaluation and Mid and South Essex NHS Foundation Trust evaluation). A commission expert from Dorset clinical commissioning group also reported that 39.3% of people who activated the app (n=108) had their CATs score improved by 5 points or more. The NHS Grampian evaluation in primary care reported that 'good inhaler technique' had increased from 48% to 91% (n=64) at 5‑month follow up. The clinical trial evidence showed an improvement in health-related quality of life but the differences between people using myCOPD and people having standard care were not statistically significant.

Evidence on myCOPD's effect on acute exacerbations and healthcare resource use is inconclusive

3.4 RESCUE showed that people using myCOPD were less likely to have exacerbations (relative risk, 0.58; 95% CI 0.32 to 1.04) compared with people having usual care (not statistically significant). But, EARLY showed that people using myCOPD were more likely to have exacerbations (not statistically significant). The arms were unbalanced for baseline rates, making interpretation difficult. Real-world evidence showed a reduced number of people had exacerbations after 6 months of using myCOPD (NHS Grampian evaluation). The EAC concluded that evidence was inconclusive on rates of exacerbations, noting that the RCTs were limited by short follow-up periods (3 months) and small sample sizes (<70). The 12‑month NHS Highland evaluation found no statistically significant differences in hospital admissions, inpatient bed days, or other health service use before and after myCOPD app activation (Cooper et al. 2021). However, a subgroup analysis found that those people with the greatest degree of myCOPD engagement did show a reduction in bed days. The NHS Grampian evaluation based on self-reported data found that hospital admissions dropped from 6 to 0 at 5 months, compared with patient data before myCOPD (n=23 patients). In primary care, people had fewer unscheduled GP appointments after using myCOPD (NHS Grampian evaluation).

Adherence to myCOPD declines over time

3.5 TROOPER showed that adherence to using the app declined during the study period (Bourne et al. 2017). After 6 weeks, only 22% of people using myCOPD had completed the recommended 5 or more sessions compared with 77% of people in the comparator group who attended face-to-face sessions. Usage data reported in the RESCUE and EARLY trials showed a continuing decline in using myCOPD. Real-world evidence showed varying use of the app. Evidence on the effect of adherence on clinical benefits is limited.

myCOPD is easy to use but its effect on people's daily life is unclear

3.6 NICE's patient involvement programme did a survey of people using myCOPD. In this, people reported that myCOPD was easy to use (n=297/359, 82.7%) and helped improve their understanding of the condition and manage their symptoms. Three-quarters of responders (n=267/358, 74.6%) felt confident in managing COPD symptoms after using the app. Of those who used the app to control COPD symptoms, 66.1% (n=220/333) of responders felt a reduction in the number of exacerbations they experienced after using the app. People thought that myCOPD was a helpful tool and provided useful information, but some thought that using myCOPD had a limited effect on their daily lives.

The company developed the cost models in 2 population groups

3.7 The company submitted 2 cost models comparing the costs and health outcomes associated with using myCOPD and standard care in 2 groups. These were people:

The company modelled a typical CCG purchasing an unlimited myCOPD licence package based on the size of the CCG population. For people eligible for pulmonary rehabilitation, the company presented an alternative costing scenario in which a pulmonary rehabilitation service provider could purchase the myCOPD licence specifically for pulmonary rehabilitation services. The company models showed that myCOPD was cost-saving by £204,641 per CCG when compared with standard care in the AECOPD group over 1 year. Using the app for pulmonary rehabilitation saved £20,269 per CCG over a 1-year time horizon.

The EAC's changes to the cost models more accurately reflect the uptake rate of myCOPD

3.8 The EAC considered the company's model structure to be appropriate. But, it thought that not all people eligible for myCOPD will use it. RESCUE showed that 46% of people eligible for myCOPD agreed to use it (North et al. 2020). The EAC included this uptake rate of myCOPD in the AECOPD model. For the pulmonary rehabilitation model, it also:

Using myCOPD is cost-saving in 2 groups of people with COPD

3.9 The EAC base-case results showed that myCOPD saved £86,297 per CCG per year in the AECOPD group. This saving was influenced by the uptake rate of myCOPD. The cost difference between myCOPD and standard care is depended on the uptake rate. The EAC's threshold analysis suggested that using myCOPD becomes cost incurring If the uptake rate is below 26%. In the pulmonary rehabilitation subgroup, the EAC's base case resulted in a saving of

The EAC did an additional analysis to calculate the cost person reporting a saving of £170 and £179 per person using myCOPD in the AECOPD and pulmonary rehabilitation groups respectively.

The key drivers for the cost savings included:

There is uncertainty around the values used to inform clinical inputs in the model.