Impact of testing centralisation on patients in the UK

10/06/2020

From our series focusing on testing centralisation in the UK, we address here a major downstream effect, its impact on patients, and discuss how to overcome the current associated challenges.

As discussed in our previous articles, molecular testing centralisation in the UK has been steadily progressing since its 2018 announcement by NHS England. One of the main concerns surrounding centralisation is the knock-on effects that the transition period has had on patients. Increased turn-around times (TATs) of testing being the primary concern. Clinicians have reported a 2-4 fold increase in TATs for certain biomarkers tests in various genomic laboratory hub (GLH) networks. This large increase in TAT has forced some hospitals to perform time critical tests in-house instead of sending to the GLHs to prevent treatment delays. Trusts have indicated that new in-house machines can produce results much faster than sending samples to GLHs. Fast TATs open up more treatment options and allows early treatment which is crucial for time sensitive conditions. This effect will only be magnified by the continual development and introduction of cheaper, faster and smaller diagnostic laboratory machines. Going forward, this may cause a decentralisation effect if TATs do not improve and are not comparable to those achieved in-house.

As of April 20201, however, non GLHs will no longer receive central funding for such tests. Any tests performed in-house, therefore, will be at the cost of the trust (many of which cannot afford). Clinicians have indicated that patient outcomes always come first, and they will incur debt in order to perform these tests if necessary. To alleviate this, it may be possible for them to partner with the GLHs in an agreement to undertake some of the testing volume in exchange for a portion of the central funding. This would not solve the overall issue as non GLH/non partner trusts that will have to send samples away for testing which intrinsically increases TATs.

Furthermore, not all GLHs or partner trusts own the latest machinery. Instead most GLHs and partner trusts are performing tests via NGS/WGS, the TATs for which are invariably slower than other methods. Even the NHS National Genomic Testing Directory2 says that wherever possible large panel NGS or WGS sequencing should be used in cancer diagnostics to increase “the number of potentially actionable targets”. Not only does this recommendation dramatically increase TATs but is also ineffective given the current lack of drugs available on the NHS for the majority of mutations discovered. Where NGS/WGS is of interest to the NHS and patients is for research and clinical trials. The enormous amount of generated genome data from cancer patients is and will be used for future research to better target patients for treatments and trials. This is very much a potential drawback of trusts decentralising testing as it would unfairly restrict patient access to this. The directory does concede that if a rapid turn-around is required “targeted testing” can be performed alongside NGS for specific actionable mutations, the machinery for this is not specified as yet. Multiple tests do, however, pose challenges and room for error in patients with small tumour samples.

Performing multiple tests alongside each other at different rates (and potentially different laboratories depending on machine availability) poses further difficulties in test result reporting and analysis. This is already on top of centralisation breaking down the physical relationships between clinicians and pathologists. The NHS had begun exploring a National Genomics Informatics Systems (NGIS) that would enable ordering and reporting of test results as well as closer relationship between clinicians and pathologists. This was alongside an initiative exploring Virtual Tumour Boards to enable clinicians and pathologists at separate trusts to discuss patients via an online video conference system. Progress in both initiatives has stalled recently with neither currently on the NHS website.

Ultimately increased TAT of molecular testing and reporting affects patient outcomes. Clinicians have even, in time sensitive cases, resided to guessing the outcome of molecular tests, started patients on treatment then have to alter the treatment based on the real outcome. Putting patients through toxic drugs unnecessarily at large costs to the NHS. It is clear that TATs must be addressed especially given the availability of TAT reducing laboratory techniques. The NHS may ultimately wish to invest in digital infrastructure to counter this rise in TAT or they may indeed change their guidelines to boost clinically time pressured indications and patients.

 

If you are looking for more information on molecular testing centralisation and how to adapt your tactical plans, do get in touch.

 

Joe Joseph

Inflection Point Biomedical Advisors

 

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

2 https://www.england.nhs.uk/wp-content/uploads/2018/08/national-genomic-test-directory-faqs.pdf