1.1
Two technologies can be used in the NHS during the evidence generation period as options to diagnose endometriosis in primary care. The technologies are:
EndoSure
Endotest.
Guidance assessment consultation document for HTG10877 Technologies for diagnosing endometriosis in primary care
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1 Recommendations
Can be used during the evidence generation period
These technologies can only be used if the evidence outlined in the evidence generation plan for technologies for diagnosing endometriosis in primary care is being generated.
1.2
The technologies should only be used in primary care when endometriosis is suspected and:
clinical (abdominal and pelvic) examination is normal, and
imaging (transvaginal or transabdominal ultrasound) is either negative for endometriosis or inconclusive, or is declined or not suitable.
1.3
The companies are responsible for ensuring that data collection and analysis take place. They must confirm that agreements are in place to generate the evidence. NICE will contact the companies annually to confirm that evidence is being generated and analysed as planned. NICE may revise or withdraw the guidance if these conditions are not met.
1.4
At the end of the evidence generation period (3 years), the companies should submit the evidence to NICE in a format that can be used for decision making. NICE will review the evidence and assess if the technology can be routinely adopted in the NHS.
More research is needed
1.5
More research is needed on DotEndo to diagnose endometriosis in primary care before it can be funded by the NHS.
What this means in practice
Can be used during the evidence generation period
EndoSure and Endotest can be used as options in the NHS during the evidence generation period (3 years) and paid for using core NHS funding. During this time, more evidence will be collected to address any uncertainties. Companies are responsible for organising funding for evidence generation activities.
After this, NICE will review this guidance and the recommendations may change. Take this into account when negotiating the length of contracts and licence costs.
Potential benefits of use in the NHS during the evidence generation period
Access: Variations in ultrasound expertise may affect the accuracy of diagnosing endometriosis in primary care. EndoSure and Endotest are not dependent on operator expertise and may help identify endometriosis not previously detected on ultrasound. This could reduce uncertainty for women, trans men and non-binary people with female reproductive organs who might otherwise remain undiagnosed. The technologies may offer an alternative, non-invasive method of diagnosis.
System benefit: The technologies may enable earlier diagnosis and treatment of endometriosis in primary care, through management within primary care where appropriate or earlier referral to specialist services.
Patient outcomes: Earlier diagnosis and treatment of endometriosis in primary care may enable people to get the support, treatment and care that they need sooner, through either management in primary care or prompt referral to specialist services. This may help reduce symptom burden and improve quality of life. In addition, these technologies may be an alternative to transvaginal ultrasound if it is not suitable or declined, potentially improving patient experience.
Equality: The technologies may support more equitable access to diagnosis for women, trans men or non-binary people with female reproductive organs for whom transvaginal ultrasound is not suitable or acceptable, by providing an alternative diagnostic option.
Managing the risk of use in the NHS during the evidence generation period
Costs: Early economic modelling shows that EndoSure and Endotest could be cost effective over a long time horizon. But this is uncertain because of the lack of evidence on clinical benefits after using these tests and quality of life before and after diagnosis.
Clinical risk: The diagnostic accuracy of the technologies in primary care (including false positives and false negatives) is unclear. The tests results could influence treatment decisions. This has potential risks of both overtreatment and undertreatment of endometriosis. The technologies should be used alongside standard practice and should not replace clinical judgement. Their impact on downstream patient outcomes is currently unknown.
Resources: Implementation of the technologies in primary care may have resource implications. Both technologies require healthcare professionals to be trained in their use and interpretation, and in communicating results. EndoSure needs additional clinic space and time to undertake testing, while Endotest requires resources for sample collection. Positive test results from EndoSure and Endotest may increase referrals to secondary care because more people could be diagnosed with endometriosis.
More research is needed
There is not enough evidence to support funding DotEndo in the NHS.
Access to DotEndo should be through company, research or non-core NHS funding, and clinical or financial risks should be managed appropriately.
What evidence generation and research is needed
Evidence generation and more research is needed on the technologies':
diagnostic accuracy, including their sensitivity, specificity, negative predictive value and positive predictive value, when used in primary care
impact on the diagnostic pathway and resource use
impact on patient-reported outcomes and patient experience
associated training costs and cost savings associated with avoided downstream tests.
The evidence generation plan gives further information on the prioritised evidence gaps and outcomes, ongoing studies and potential real-world data sources. It includes how the evidence gaps could be resolved through real-world evidence studies.
Why the committee made these recommendations
It can take 4 to 10 years to confirm a diagnosis of endometriosis. These delays may result from late initial presentation, delays in the referral pathway, variation in expertise in transvaginal ultrasound in primary care, and long waiting times for gynaecology services. Delays in diagnosis lead to prolonged ill health and a condition that is more difficult to treat. Diagnostic tests in primary care could enable earlier diagnosis of endometriosis, treatment in primary care if appropriate and earlier referral to gynaecology services.
Evidence on the diagnostic accuracy of these technologies is limited and varies between the technologies. All the studies are from secondary or tertiary care. Evidence from multiple studies suggests that EndoSure and Endotest have higher diagnostic accuracy than transvaginal ultrasound done in primary care. This would help identify endometriosis if transvaginal ultrasound results are negative or inconclusive, or if transvaginal ultrasound is not suitable or declined. There is no evidence on clinical outcomes or how these technologies could affect the diagnostic pathway or resource use. Despite this, the technologies have the potential to address a high unmet need in the NHS by enabling endometriosis diagnosis in primary care.
Early economic modelling suggests that EndoSure and Endotest are likely to be cost effective over a 60-year time horizon. So, they are recommended for use with evidence generation.
Economic modelling also suggests that DotEndo is likely to be cost effective over the same time horizon. But the evidence for DotEndo is insufficient because it comes from only 1 study of 100 people from 1 centre. So, more research is needed.
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