Primary care referrals and patient eligibility for biologics

By the end of October 2022, 28 GP practices had been visited by the nurse educator and the SPECTRA tool run on their systems to identify patients who may be potentially eligible for biologics treatment. Across these practices, 564 patients were reviewed for eligibility, and 125 were referred to the biologics clinic in secondary care for further assessment (22.2%). By November 2022, 87 of these 125 patients had either started on asthma biologics, or were scheduled to start by the end of the year (69.6%). A total of 64/87 were (or would be once initiated) self-administering their treatments through the home care service (73.6%). The reasons that 38/125 patients did not start biologics during the study period were: ineligibility (n = 21), eligibility decision still awaited (n = 8), patient non-adherence with appointments (n = 4), patient declined biologics (n = 3), and patient diagnosed with Chronic Obstructive Pulmonary Disease (COPD) (n = 2).

Patient waiting times

When wait times for discrete stages of the severe asthma pathway were compared for the ‘standard’ pathway (historic patients referred from primary care before between 11/2020 and 11/2021, n = 37) vs. the enhanced pathway (patients referred from primary care from 11/2021 onwards, n = 143), the time patients spent at each pathway stage were substantially lower within the enhanced pathway compared to the standard pathway (Table 1). The mean wait between referral and first secondary care appointment was 59% shorter under the enhanced pathway compared to the standard pathway (10.7 weeks vs. 21.2 weeks; p = 0.002). The time from the first appointment in secondary care to first secondary care follow-up appointment and/or severe asthma diagnosis was shorter by 45% under the enhanced pathway. The time from follow-up/diagnosis and MDT discussion showed mean waiting times under the enhanced pathway of 6.7 weeks, compared with 17.9 weeks under the standard pathway (a 63% reduction; p = 0.004). Although wait times between MDT meeting and biologics initiation reduced by around half (from 15.9 to 8.0 weeks), this was not statistically significant. Taking the pathway from referral to biologics initiation as a whole, mean waiting time was 76.4 weeks for the standard pathway, compared with 26.7 weeks for the enhanced pathway (p < 0.001).

Table 1 Comparison of severe asthma pathway waiting times between patient cohorts.Clinical outcomes

Of the 87 patients in the cohort deemed eligible for biologics treatment under the enhanced pathway, 41 were excluded as incomplete cases (19 patients were yet to begin treatment; 22 had fewer than three months of follow-up data). This left 46 patients with pre- and post-biologics initiation data for comparison. The mean length of follow-up for patients following the enhanced pathway was 6.3 months.

Data demonstrated significant post-initiation improvements in key service and patient-related outcomes (Table 2). Inhaled corticosteroid prescribing rates increased non-significantly by 8% from a mean of 1.37 per patient per month to 1.48 (p = 0.210). Rates of SABA prescribing significantly reduced (p = 0.037), from a mean of 0.93 to 0.76 per month. Oral steroid prescribing reduced by 60%, from a pre-biologics mean of 0.37 per month to a post-treatment monthly mean of 0.12 (p < 0.001). The mean monthly rate of asthma-related exacerbations experienced by patients after starting biologic treatments significantly reduced from 0.36 to 0.13 (p < 0.001). Rates of hospital admission (although small in number both before and after biologics initiation) also reduced significantly, from 0.12 to 0.01 (p < 0.001). ACQ6 scores, denoting changes over time in symptom control, showed a statistically and clinically significant improvement for patients starting biologics. In the pre-biologics period, the mean ACQ6 score was 3.13. This reduced to 1.89 after biologics initiation, significant to the p < 0.001 level. Across all patients with a pre- and post-biologics ACQ6 score, the average difference over time was a reduction of 1.2 points (range −4.8 to +1.1), with 27 patients (62.8%) improving their ACQ6 score over time by the clinically important minimum difference of 0.5 points.

Table 2 Clinical outcomes for patients initiating biologics treatment under the enhanced pathway.Qualitative data

A total of 12 semi-structured interviews were carried out with key stakeholders (respiratory consultants (n = 3), respiratory nurses (n = 3), GPs (n = 1), pharmacists (n = 1), practice nurses (n = 1), project managers (n = 2) and directorate managers (n = 1)). Headline qualitative findings are summarised below, with detailed mapping of data against the CFIR domains shown in Table 3.

Table 3 Qualitative data mapped onto the Consolidated Framework for Intervention Research (CFIR) framework.Benefits of the enhanced severe asthma pathway

All interview participants highlighted multiple benefits of the enhanced pathway for patients and staff. The standard severe asthma pathway was felt to be disjointed, with many patients with severe and difficult asthma managed in primary care without being referred to specialist services:

“I think we have failings throughout the whole of the pathway, and that is the responsibility of both primary care and secondary care. It’s a mess.” (Respiratory consultant, secondary care)

Interviewees felt that the time between patient referral from primary care and the first appointment at the severe asthma clinic in secondary care had been shortened considerably by the enhanced pathway. Members of the secondary care respiratory team felt that the enhanced pathway had also improved the proportion of patients appropriately referred into secondary care for assessment, although potential future capacity issues were recognised associated with a greater number of referrals being made:

“I think one of the positives, because of the way the clinic was set up is you didn’t get caught up in the whole waiting list system for secondary care, but I think that is going to become more of a problem as you refer more patients in.” (General practitioner, primary care)

A significant strength of the enhanced pathway was agreed by several participants to be the proactive element in a nurse educator supporting general practices to identify patients who may be eligible for biologic treatments by working closely with the practices and searching practice lists:

“So this project is absolutely amazing – what it’s doing is it proactively goes out to the GP practices, and – I am going to use the word in a friendly term – hunts down patients. So they are really out to scoop up those patients and refer them to secondary care.” (Operational manager, non-clinical)

The training and education component of the enhanced pathway was favourably received by those working in primary care, and was felt to be effective in helping to identify patients with severe asthma who would benefit from specialist assessment:

“So I think certainly the education that’s been provided in primary care now is highlighting that need, that unmet need if you like…they get an appointment quicker than they would have done if they had gone through the traditional route.” (Asthma nurse, secondary care)

Challenges associated with enhanced pathway implementation

The participation of primary care in the enhanced pathway was recognised as a challenge, and there were difficulties engaging primary care providers in the project. This was particularly due to concerns over time and staff resources, and worries that focusing resources on identifying patients for referral could entail increased workloads for over-stretched practice staff:

“First of all, is we’re only able to target some GP practices, and there are far more practices who are eligible for us to get involved with…some practices are not necessarily welcoming, some practices are welcoming but we don’t have the nurse resource to actually go and do the digging.” (Respiratory consultant, secondary care)

Interviewees from some primary care practices also expressed reluctance to use the SPECTRA software tool on their practice systems because this has been developed by a pharmaceutical company. Furthermore, several interviewees noted that administration and co-ordination of the enhanced pathway, although straightforward logistically, was more time-consuming than the standard pathway because elements of the standard and enhanced pathways were running in parallel rather than one having replaced the other. This was particularly evident in relation to the ongoing maintenance of the standard ‘Choose and Book’ system for facilitating patient referrals from primary care, which was perceived as creating an unhelpful two-tier referral system for severe asthma. Participants from primary care also highlighted that asthma management was just one of the clinical areas that needed attention, and that handling competing priorities was an ongoing challenge:

“Because what we are doing with respiratory, we’ve got to do with diabetes, we’ve got to do with heart disease, we have to do everything at the same level these days…there’s only so much we can do.” (Advanced Nurse Practitioner, primary care)

Finally, the ongoing sustainability of the severe asthma pathway was highlighted by a number of interview participants. This was seen as important both in terms of the need for greater ‘ownership’ of the pathway by primary care providers once the resource of the nurse educator was no longer available and it became the sole responsibility of practices to proactively identify patients for referral, and the need for staff resources across the pathway to ensure that it could continue to operate effectively once the targeted funding that allowed it to be introduced had ceased:

“So, I think that our worry is more around sustainability, and if there are opportunities to create the service in terms of nursing staff, physicians etc., that would be wonderful.” (Respiratory consultant, secondary care)