AWTTC interprets and collates horizon scanning information and stakeholder submissions, requesting and sourcing additional information if needed; this is then provided to the AWMSG Scrutiny Panel for consideration.
The AWMSG Scrutiny Panel considers the information, which includes:
Each medicine is considered on a case-by-case basis.
The AWMSG Scrutiny Panel is responsible for deciding if AWMSG should proceed with the assessment of a licensed or an off-label medicine. The AWMSG Scrutiny Panel will prioritise requests and decide on the route of assessment for medicines by using pre-defined criteria as detailed in Section 2.3 below. The Terms of Reference and decision records of the AWMSG Scrutiny Panel are published online and available from the Our committees webpage.
The AWMSG Scrutiny Panel decisions will be communicated to the marketing authorisation holder and the person submitting the medicine request before review and endorsement by AWMSG Steering Committee. In the instance that the marketing authorisation holder or person submitting the medicine request disagree with the AWMSG Scrutiny Panel decision they will have 10 working days to respond to AWTTC. AWTTC will inform the AWMSG Steering Committee and they will make the final decision.
All endorsed decisions will be published on the AWTTC website. If the AWMSG Steering Committee disagree with the AWMSG Scrutiny Panel decision, the AWMSG Steering Committee will provide their rationale to the AWMSG Scrutiny Panel. Any new information provided by the AWMSG Scrutiny Panel will be considered by the AWMSG Steering Committee and a final decision made.
AWMSG will consider a medicine for assessment in Wales only if there is a clear identified clinical need or benefit to NHS Wales and the people it serves.
It is expected that most licensed medicines will process through Health Technology Assessment (HTA) by NICE. However, when there is a clinical need or benefit to NHS Wales and a licensed medicine has not been prioritised or processed for HTA assessment by NICE, or the NICE HTA has been terminated, the AWMSG Scrutiny Panel will determine whether assessment is required and, if so, decide on the most appropriate route for assessment in Wales.
Available routes will either be full or interim HTA or a limited assessment all via the Licensed One Wales Medicine Assessment Group (LOWMAG). For a visual representation of the available routes please see the Overview of the available routes of AWMSG assessment for licensed medicines flowchart.
Medicines which require a clinical and cost-effectiveness assessment may meet the criteria for full HTA if they are likely to have a significant impact (service and/or budget) to the NHS in Wales and when one of the following apply:
Interim HTA may be suitable for some licensed medicines or for some license extensions if there is a delay in NICE advice and they are likely to have a significant impact (service and/or budget) to the NHS in Wales when at least one of the following apply:
If a medicine meets the criteria for interim HTA, AWMSG will assess the clinical and cost-effectiveness of the medicine using the best available evidence and provide an interim recommendation. There is an expectation that the company holding the medicine’s marketing authorisation (the MA holder) will offer NHS Wales a commercial arrangement for this interim period.
The outcome of AWMSG interim assessments for licensed medicines will be time limited and subject to regular review, especially if alternative licensed medicines are awarded positive HTA guidance for the same indication.
The AWMSG Scrutiny Panel may also consider medicines that have previously received a negative recommendation from NICE or if NICE HTA has been terminated. In these situations, the applicant company must submit additional evidence showing added value or benefit to NHS Wales over and above that considered by NICE. The company’s application will be expected to include additional information that may not have been submitted to NICE, for example, information specific to NHS Wales (highlighting a specific patient population or other societal benefit), a commercial arrangement (Wales Patient Access Scheme [WPAS] or a commercial access agreement [CAA]).
In some circumstances an assessment may be required but review of the clinical evidence and budget impact may be sufficient. This more limited assessment might be suitable for some licensed medicines or for extensions of a medicine’s licence.
A limited assessment is likely if there is a clear need for AWMSG advice, if the medicine and its indication is not on the NICE work programme and there is no anticipated service impact to NHS Wales and at least one of the following apply:
AWMSG will consider assessment of off-label medicines when;
The assessment of an off-label medicine (or medicine combination) considers nationally agreed criteria, including the suitability of any licensed medicine for the same patient group, and evaluation of the clinical efficacy versus the clinical risk of off-label medicines that may help patients with life-threatening, long-lasting or seriously debilitating conditions.
All recommendations for off-label medicines after AWMSG assessment are interim and subject to regular review. See Section 9.2.