Myogenes Test Could Save NHS over £1.7 billion

We recently published a research report on Myogenes, a UK biotech business we represent. This company has developed a unique pharmacogenetic test designed to remove some of the most important barriers to the wider use of clozapine, the only effective, approved therapeutic for the treatment of refractory schizophrenia.

This is an area of psychiatry with especially high unmet need because clozapine is so underutilised across the world in this difficult-to-treat patient population. This chronic underuse is a direct result of widespread misconceptions, ignorance and a lack of confidence across the global prescriber community, combined with inconsistent standards related to clozapine's side effects and how to monitor and manage them effectively. To help address this significant global healthcare challenge, Myogenes has developed the clozapine pharmacogenetic test in collaboration with Professor David Taylor (Director of Pharmacy and Pathology at the Maudsley Hospital in London and Professor of Psychopharmacology at Kings College London).

The clozapine test is easy to use, non-invasive, and only needs to be done once. A sample of the patient's saliva is all that is required to determine a range of genetic factors that will give clinicians critical information about their patient's likely response to clozapine treatment, information about their risk of developing side effects and the appropriate dose at the start of treatment and the optimal target dose. The test is suitable for treatment-resistant patients, patients already receiving clozapine that have had only a partial treatment response, patients where a low neutrophil count has interrupted treatment and patients of African or Middle Eastern heritage with possible benign ethnic neutropenia (BEN) but whose status is uncertain.

The global underuse of clozapine doesn't only have a significant adverse effect on refractory schizophrenia patients and their families. It also has a huge impact on healthcare providers and payers because treatment-resistant schizophrenia is a particularly serious disorder that can be severely disabling, and so patients are highly dependent with very high associated service costs. For example, in the UK, despite the fact that schizophrenia has a much lower incidence than either depressive or anxiety disorders, it accounts for 30% of total spending on adult mental health services.

Myogenes is, understandably, very keen to draw healthcare providers' and payers' attention to this major issue, not just from the patient’s perspective. A key argument supporting the widespread adoption of the Myogenes pharmacogenetic test is the very significant health and economic benefits that would follow its adoption. In order to highlight the scale of these cost savings, Myogenes commissioned CorEvitas (now part of Thermo Fisher), a leading provider of regulatory-grade, real-world evidence for approved medical treatments and therapies, to produce a health economic analysis of the potential savings to the NHS in England alone, if it implemented the Myogenes test when a patient with schizophrenia is determined to be treatment resistant.

The report only covers savings that would accrue to NHS England and also only includes two elements of the Myogenes test: benign ethnic neutropenia and dosage. The other two important elements of the test covering the metabolism of clozapine and the risk of agranulocytosis were excluded from the analysis but would clearly increase the potential benefits if they were included.

The budget impact model (BIM) compares the costs associated with the clinical pathways of clozapine prescription with and without the Myogenes novel genetic test. The model inputs are based on a review of literature conducted in February 2024 and on information sourced from expert clinicians in the field.

In summary, the report highlights the following benefits that would accrue to NHS England and TRS patients over a three-year period.

• £1.745bn in cost savings
• Over 44,000 fewer hospital admissions
• Over 2.1 million fewer bed days
• Over 920,000 more blood monitoring appointments – better patient monitoring, in other words
• Over 1,800 fewer self-harm incidents

These benefits are staggering in scale and impact on the NHS, patients and their families. Myogenes, in collaboration with Health Innovation East, an organisation that is funded by the NHS and the Office for Life Sciences, aims to bring together academia, citizens, health services and industry to realise the value of health innovations more quickly, which is supporting this project, will be presenting the BIM's results to NHS experts and commissioners on the 15th March. The aim is to make key decision makers within the NHS aware of the huge savings that could flow from the widespread adoption of the Myogenes test as well as the considerable benefits for TRS patients and their families who should be getting access to clozapine but currently aren't.

If this initiative is successful, it will, of course, accelerate the commercialisation of the Myogenes test in the UK. It would also serve as an important example to other health systems around the world of the multiple benefits that follow the widespread use of this unique test.