NHS England has opened a consultation on the proposed approach to updating the National Genomic Test Directory set out in the consultation document.
The National Genomic Test Directory (Test Directory) was established in 2018 within a new NHS Genomic Medicine Service (GMS) framework. Test Directory identifies the full range of genomic tests – from whole-genome sequencing (WGS) to tests for single genes and molecular markers – that are commissioned by the NHS in England. The Test Directory sets out the technology by which tests are available and the patients who will be eligible to access a test. The Test Directory was updated in 2019 and 2020 with minor changes.
The proposed new approach for the annual Test Directory update is summarized below.
- Test Directory will be updated on an annual basis supported by the most up-to-date scientific, clinical, and economic evidence
- Updates to the Test Directory will be overseen by the Genomics Clinical Reference Group (CRG) represented by professionals, patients, and public
- Three test evaluation working groups will provide clinical and scientific support to the Genomics CRG and will cover rare disease, cancer, and pharmacogenomics
- Updates to the Test Directory may be mandated in a year by the following policy decisions:
- Medicines approval by Technology Apprisale program by the National Institute for Health and Care Excellence (NICE), where a genomic test forms part of the access criteria for a drug
- Urgent policy statements issued by NHS Specialised Commissioning, where NHS England and NHS Improvement needs to urgently implement a commissioning policy involving genomic tests
- Publication of NICE Diagnostics Assessment Programme (DAP) guidance
- NHS England and NHS improvement will set aside a portion of its budget each year to pay for the implementation of new tests or implementing other changes to the Test Directory. The total funding envelope for updating the Test Directory will be determined on an annual basis, taking into account the spending from the previous and other spending commitments within the year
- Applications for amendments to the Test Directory must be submitted to the NHS Genomics Unit (england.genomics@nhs.net) from January to April (to come into effect by April of the following year)
- From April 2021 onwards, NHS England and NHS Improvement will follow the full approach and annual timescales to inform the update to the Test Directory to be published in April 2022
Stakeholders are invited to review the proposed approach and provide feedback on the following key topics
- Appropriate involvement of patients and the public throughout the process
- The proposed timelines for submission of applications
- Any potential impact the proposal may have on health equalities.
Comments should be submitted through the consultation survey via the consultation hub till November 17, 2020.
See more information here
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