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Appraisal meetings (NMG and AWMSG)

Why?

New Medicines Group (NMG) members consider the clinical effectiveness and cost-effectiveness of a medicine. AWMSG members are asked to apply a broad strategic and social overview when considering their recommendation. Refer to our AWMSG summary guidelines for appraising medicines (PDF, 422Kb) for further information.

When?

We will confirm the dates of the NMG and AWMSG meetings in the appraisal scope after receiving a Form A, Form B, or Form C, and reviewing the submission to make sure it's complete and appropriate.

How?

The NMG meeting is held in private and the applicant company is not invited to attend. NMG members will consider the AWMSG Secretariat Assessment Report (ASAR), the company response to the ASAR (CR/ASAR), the Form B or Form C, and written evidence from clinical experts and patient organisation(s) (when available). NMG members will review the appraisal documentation to make a Preliminary Appraisal Recommendation (PAR).

If a submission meets AWMSG’s criteria as a licence extension for paediatric use the medicine will only be appraised at the AWMSG meeting.

The AWMSG meeting is held in public although sometimes the appraisal of a particular medicine may be held in private. Please refer to the AWMSG appraisal process FAQs (PDF, 552Kb) for further information. The AWMSG meeting papers will be available on our website about 10 days before the meeting.

We encourage applicant companies to attend the AWMSG public meeting, especially for Form B/C submissions, although they are not obliged to do so. Before the meeting for Form B/C submissions, we will invite the company to nominate two representatives: one to answer questions about the case for cost-effectiveness, and one to answer questions about clinical effectiveness.

AWMSG will consider the ASAR, the PAR and the company's response to the PAR (CR/PAR) for a Form B/C submission. AWMSG will also take into account clinical expert views, any societal and budget impact issues, and will consider the patient’s perspective. AWMSG will consider an AWTTC assessment and draft recommendation for medicines that meet AWMSG’s criteria to be appraised as a licence extension for paediatric use. A Final Appraisal Recommendation (FAR) will be agreed. The AWMSG recommendation wording (PDF, 403Kb) document clarifies the wording of our recommendations.

For full details about the timelines in the appraisal process including applicant company opportunities to comment, please refer to our AWMSG appraisal process flow diagram and timeline (PDF, 385Kb).

What happens next?

The final stage of our process is for Welsh Government to ratify AWMSG's recommendation. Information about this stage is given our Stage 4 section.

Raising a concern

There may be circumstances where an applicant company may have concerns about differences in scientific opinion, or interpretation of data. Or an applicant company may feel that insufficient time or opportunity was given for discussion of relevant issues. In these cases they may wish to lodge a complaint based on process. In both cases, an independent review may be the most appropriate way to address their complaint.

What goes on the AWTTC website at this stage?

The listing of your medicine will be updated about 10 days before the AWMSG meeting. For Form B/C submissions, links to the AWMSG Secretariat Assessment Report (ASAR), the Preliminary Appraisal Recommendation (PAR) and the company's response to the PAR (CR/PAR) will be included. For medicines appraised as a licence extension for paediatric use, a link to the draft recommendation will be included.

Documents

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