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Appraisal process

Click on each of the stages below for a brief overview of the AWMSG appraisal process


Submission

When a medicine meets AWMSG criteria for appraisal the company is requested to submit either a full submission (Form B) or a limited submission (Form C) depending on the amount of information required.

The submission should be received within three months of the medicine receiving its marketing authorisation. The appraisal date can not be confirmed until the requested submission is made and consistent with the scope agreed. The confirmed appraisal schedule will be displayed on the AWMSG website.

Funding for use of a medicine that falls within the AWMSG appraisal criteria within NHS Wales is very unlikely prior to an AWMSG appraisal.

Clinical expert opinion

Consideration of the views of clinical experts is an integral part of the AWMSG health technology appraisal process. AWMSG seek up to six clinical expert nominations via the appropriate Welsh Professional Society or Clinical Network or Medicines and Therapeutics Committees. On receipt of Form B/C, AWTTC invites clinical experts to submit their views in the form of a questionnaire.  Clinical experts set the clinical scene and outline where, in their view, the new medicine sits within current therapy in NHS Wales. Nominated clinical experts are asked to complete and return a declaration of interest form with their questionnaire (a declaration of interest form is attached to the clinical expert questionnaire). Completed questionnaires are shared with committee members to inform decision making. These questionnaires will be treated as confidential and are not uploaded to the AWMSG website.

What happens if a submission is requested but not received by AWMSG?

In the event that a company submission is not forthcoming within three months of receipt of the marketing authorisation, AWMSG will issue a Statement of Advice (available on the AWMSG website) confirming the medicine cannot be endorsed for use within NHS Wales unless directed by the AWMSG Steering Committee to appraise the medicine using publicly available information.