Summary
The genomic tests funded by the NHS England are outlined in the National Genomic Test Directory, which is split into genomic tests for oncology and rare disorders
From 2021/2022 on the Test Directory will be updated annually with an evidence-based process in place
Some key evaluation criteria include clinical utility and analytical validity, cost-effectiveness, and workforce required to deliver testing
The advent of genomic testing such as next-generation sequencing has led to improvements in medicine. Recognizing this, the NHS, in its NHS Long Term Plan has articulated several ambitious key goals relating to genomic testing including:
To be the first national health care system which may offer whole genome sequencing as part of routine care and
To provide extended access to molecular diagnostics and routinely offer genomic testing to all cancer patients for the early detection and treatment of high-risk conditions
Genomic testing in the UK is provided through so-called Genomic Laboratory Hubs. There are a total of seven Genomic Laboratory Hubs, each serving a different region with its respective NHS trusts.
The genomic tests funded by the NHS England are outlined in the National Genomic Test Directory. The directory is split into genomic tests for oncology and rare disorders, and shows eligibility criteria for these tests.
Applications to include a test in the NGTD for a new indication or to amend an existing indication or to even fast-track a submission, can be made through online submissions.
From 2021/2022 on the Test Directory will be updated annually with an evidence-based process in place:
The Genomics Clinical Reference Group (CRG) oversees the update process of the Test Directory and holds the clinical oversight together with expert genomic test evaluation groups
The CRG holds three meetings a year to review the applications that are received on an ongoing basis
The CRG provides recommendations to the NHS England and NHS Improvement’s Genomics Programme Board on updates to the Test Directory once per year
The genomic test evaluation working groups consist of scientists, clinicians, health economists and patient and public representatives. The working groups provide clinical and scientific support and report to the CRG.
In addition to the annual update process, in-year updates of the Test Directory are possible if for example a medicine was approved by NICE, where a genomic test is part of the access criteria
Any stakeholder may apply for an amendment to the Test Directory
Some key evaluation criteria are:
Clinical utility and analytical validity
Cost-effectiveness
Workforce required to deliver testing
More information may be found on the NHS – National Genomic Test Directory website
Interested in market access for genomic testing? Contact us at info@centivis.com