AWTTC will inform the marketing authorisation (MA) holder which route will be used to assess their medicine, and will invite them to engage in the assessment process.
For licensed medicines, AWTTC will ask the MA holder to fill in a submission form and provide supportive information. Details of the information needed, including guidance notes and the forms to fill in, will be available in mid January 2025.
The AWMSG Steering Committee reserves the right to recommend that a Statement of Advice is issued for medicines that meet the criteria for assessment by AWMSG but are unable to progress due to non-engagement by the MA holder. This Statement is notification that the medicine is not endorsed for routine use in NHS Wales. Statements of Advice are ratified by Welsh Government.
The AWMSG also reserves the right to instruct that an assessment is conducted using information in the public domain if the MA holder does not engage in the assessment process and considers the medicine to be a high priority for NHS Wales.
For the assessment of medicines for off-label use, AWTTC will invite the MA holder to submit supportive information, including any evidence or experience of using the medicine that demonstrates its safety, efficacy, and clinical and cost-effectiveness in the indication or specified patient population.
The MA holder is expected to inform AWTTC of any plans to license the medicine for the indication/patient group under consideration by AWMSG. There will be an obligation for the company to submit for HTA by AWMSG or NICE if a marketing authorisation is granted.
For medicines that already have a commercial arrangement (including PAS, CAA, WPAS) AWTTC will ask the MA holder to confirm the existing arrangement can be extended to the medicine or indication under consideration.
For medicines without a commercial arrangement, AWTTC will ask companies to consider submitting a simple discount.
Sometimes, AWMSG may endorse an interim positive recommendation while further evidence is collected to support a later full HTA, on the expectation that the MA holder will offer a commercial arrangement for this interim period.
Commercial arrangements should be agreed by the Commercial Arrangement Scheme Wales Group (CASWG) before an assessment proceeds. Any decisions will involve the Medicines Value Unit (MVU) and will be considered by the AWMSG Scrutiny Panel. For more information contact AWTTC at awttc@wales.nhs.uk.
AWTTC produces an assessment report summarising and critiquing the available evidence, this may include the clinical and cost-effectiveness evidence and the budget and societal impact submitted by the company.
If the MA holder has not engaged with the assessment, this report is written from information in the public domain gathered by AWTTC.
AWTTC asks clinicians to provide additional information, such as: potential patient numbers; place in therapy; and suitable comparators. AWTTC invites patient organisations to provide a patient perspective on the unmet clinical need for the medicine; in particular, the potential impact on quality of life for patients and their families and carers.
The draft report is provided to the MA holder and clinicians for comment before finalising for consideration by the Licensed One Wales Medicines Assessment Group (LOWMAG).
AWTTC will carry out a comprehensive literature search and compile all available evidence into an evidence summary report. The clinicians who requested the assessment will be asked for additional information, such as potential patient numbers, place in therapy and suitable comparators.
AWTTC will invite the MA holder to provide clinical and cost-effectiveness evidence and budget impact information if available. Patient organisations will be invited to provide a patient perspective on the unmet clinical need for the medicine, in particular the potential impact on quality of life for patients and their families and carers.
The draft report is provided to the MA holder and clinicians for comment before finalising for consideration by the One Wales Medicines Assessment Group (OWMAG).