Expert comments

Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.

All experts were familiar with using biomarkers for the surveillance of non‑muscle-invasive bladder cancer (NMIBC) but none had used the Bladder EpiCheck test before.

Level of innovation

Four experts felt the technology is innovative, while 1 felt that it is a minor variation on existing biomarker tests for NMIBC. Three experts said that the technology is unlikely to replace standard care. Two stated that it might be used as an adjunct in some people, to reduce the frequency of more invasive tests such as cystoscopy in people with low and intermediate risk. One stated that it could augment current standard care, and another said the technology has the potential to replace urine cytology. Four experts noted that there are several other commercially available urine biomarker tests for diagnosing NMIBC. Two noted that although in use, these tests have not become standard care in the NHS. One expert noted that the main difference between Bladder EpiCheck and other biomarker tests is that it tests for multiple biomarkers. Another noted that some alternatives are point-of-care biomarker tests, have similar diagnostic accuracy to Bladder EpiCheck and are possibly less expensive.

Potential patient impact

Three of the experts said that the main patient benefit would be a possible reduction in the frequency of repeated cystoscopies, which are invasive and can be burdensome for the patient. Two experts said the technology may also help reduce the use of urine cytology, with 1 noting that cytology has a low sensitivity and specificity in low-grade bladder cancer. One expert said the main benefit to patients is that the technology provides a non-invasive and rapid diagnosis at the primary care level, possibly leading to earlier referral to a urologist. Two experts said that all people having surveillance for NMIBC could potentially benefit from the test. One said that people with high-risk NMIBC and elderly patients would benefit most from the test. One said that elderly people diagnosed with urinary tract infections would benefit most. Another said that people with intermediate-risk NMIBC would benefit most through a reduced frequency of cystoscopies. This expert noted that a reduction in cystoscopies is less likely to occur for people with high-risk cancer because of the consequences of missed cancer detection.

Potential system impact

Two experts said the test has the potential to improve outcomes and reduce hospital visits. Another expert agreed with this, provided there is further evidence showing improved specificity. One expert said the test may help triage patients awaiting cystoscopy for NMIBC, but noted that more data was needed to confirm this. One expert said it could free health system resources if used in a select group of patients (intermediate risk). One expert thought the technology would cost more than standard care, while 3 felt it could cost less than standard care overall. One of these experts noted that using the test may reduce the need for surgery. The expert highlighted that surgery is associated with increased morbidity and a minimum of 5 to 7 days of recovery, and that cystectomy is associated with impaired quality of life for patients. One expert felt the test would cost the same as standard care but may reduce urologist and pathologist time. Four experts noted that some minor changes to clinical facilities may be needed to adopt the technology in the NHS. This included access to laboratory testing for sample analysis, sample storage facilities and laboratory staff training. One of the experts said that because it is a simple urine test, no additional facilities or changes to existing facilities would be needed.

General comments

All experts noted that the technology is not currently widely used in the NHS. Three experts were not aware of any issues that would prevent it being adopted in the NHS. Two experts felt that the cost of the technology was a potential barrier to adoption. One of these experts also noted that the test is relatively new and has not shown a significant advantage over other available biomarker tests. One expert stated that the true positive and negative rates would need to be established in widespread clinical practice and another had uncertainties around the efficacy of the test because of the limited evidence available. The other 3 experts had no concerns around the efficacy of the test. Three experts thought the test has the potential to be used in most or all district general hospitals, 1 said it would be used in a minority of hospitals, and another said that it was not possible to predict this at present.