The State of Centralisation of Pathology and Molecular Testing in England

02/04/2020

This second article, from our series deciphering the evolution of the testing landscape in the UK, analyses the current centralisation of tests of both Pathology and Genomics, its origin and the challenges yet to be solved for a fully operational and compliant centralised system.

Over the past few years, NHS England has experienced major changes in the delivery of both molecular testing and anatomic pathology services. To consolidate genomic testing, seven Genomic Laboratory Hubs (GLHs, Fig.1) were established in October 20181, each covering a specific region of England, as well as the National Genomic Test Directory for Cancer and Rare Diseases2, which outlines all the tests that would be performed by the GLHs. One year before, NHS Improvement created the Pathology Consolidation Programme3, centralising 122 pathology units into 29 hub and spoke networks, with the goal of saving at least £200 million pounds by 2020/2021. Those programmes underline the pressing need to standardise testing service across the UK, improve collaboration of clinical expertise as well as the use of capital equipment and ultimately provide better treatment and access for patients.

The Pathology Consolidation Programme is promising, with 97% of all trusts making progress4. Despite some networks being more behind in the transition, overall 76% of the trusts are on target for 2020/2021 in terms of the milestones met and governance put in place. Completely transitioned networks have seen a drop of 20% in the average cost per test and some trusts have agreed on a saving of £18 million over 5 years by a joint purchase of laboratory equipment.

As for the Genomic Medicine Service, however, there is discrepancy in the transition stages of molecular testing across the 7 GLH networks, where different levels of centralisation exist. This has led to a multitude of different scenarios that can create some degree of confusion about where a given biomarker is tested (Fig. 2). For some laboratories, centralisation is yet to be initiated and genomic tests are still being performed locally. Meanwhile, centralisation has partially taken place for some laboratories, meaning only some biomarkers have been transferred to the GLHs. In some cases, local laboratories have re-started testing especially due to increased turnaround time at the GLHs.  In additional situation, tests are being sent to reference laboratories other than the designated GLH.

Eventually, the NHS shall only commission tests outlined in the National Genomic Test Directory and performed in the GLHs, after a transition period of 18 months (i.e. by April 2020)5. This should act as a key driver to enforce transition of molecular tests from local laboratories to their respective hubs, and lead to the end of current multiple scenarios. Moreover, budget for the tests in the directory is strictly allocated to the GLH, which in turn can decide on using other laboratories within the network to perform specific tests and sub-allocate the budget accordingly. Nevertheless, considering the wide spectrum of transition stages involving quality control, assurance compliance, NICE and Best Practice guidelines compliance, training and qualifications of scientists, appropriate equipment control, sample transportation verification as well as proved security of, and access to electronic data6, it seems unlikely that all laboratories would meet the deadline of April 2020. Additionally, there are still biomarkers like BRAF and NRAS that despite being in the National Genomic Test Directory, can still be reimbursed to the labs via the “exclusion from tariff” route7. This alternative reimbursement ensured regardless of centralisation, opens up a way to grant reimbursement.

Apart from delays on turn-around time, other factors contribute to the different levels of centralisation including: integration initiatives of molecular and anatomic pathology test results, IT harmonisation, the increasing role of multidisciplinary tumour boards (MTB) incorporating molecular biologists and pathologists. Well organized and compliant testing IT infrastructure and logistics are of utmost importance for a fully operational centralized testing system. However, there is a disconnection between histopathology and GLHs now, due to inadequate IT infrastructure, which fails to meet the increased demand for cloud-based workflow and data sharing. Furthermore, the National Genomics Informatics System (NGIS)8, which is supposed to include an interactive test ordering tool, is still not in place, meaning the laboratories would have to resort to paperwork. This can even be aggravated by regional sample workflows and triage as well as sample transportation, not well-established.

In the end, consolidating genomic and pathology services triggers a significant change in clinical pathways. Hence, this inevitably resulted in uncertainty and doubts during this transition period, notably in regards on funds allocation and adoption of new biomarkers. Moving forward, this landscape analysis underlies the need for NHS England and NHS Improvement to work together, and engage more with the labs and solution’s providers, in order to fulfil the goal of ‘ensuring the right test is available at the right time’ for each patient.

To get our free report with all details and complementary information about testing centralisation in the UK, just send us a mail with your name, surname, institution, at: info@ipbadvisors.com

Look out for our next article in the series, exploring the impact of molecular testing centralisation on turn-around time which can be a major concern for the adequate treatment of patient.

If you are looking for more information on specific testing landscapes and/or how IPBA can help you with your strategy to enable better and broader patient access to biomarker testing, do get in touch.

 

Ka Wan Leong

Inflection Point Biomedical Advisors

 

https://www.england.nhs.uk/genomics/genomic-laboratory-hubs/

2 https://www.england.nhs.uk/publication/national-genomic-test-directories/

3 https://improvement.nhs.uk/resources/pathology-networks/

4 https://improvement.nhs.uk/documents/6113/Pathology_networking_state_of_the_nation.pdf

5 https://www.england.nhs.uk/wp-content/uploads/2020/01/2020-21-NHS-Operational-Planning-Contracting-Guidance.pdf

6 https://www.engage.england.nhs.uk/consultation/genomic-laboratories/user_uploads/genom-lab-serv-desgn-serv-spec.pdf

7 https://improvement.nhs.uk/documents/6257/2021_NTPS_statutory_consultation_notice.pdf

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/725632/Government_Response_to_the_Genomics_and_Genome_....pdf