Interim methods and process statement for late-stage assessment

Many groups and individuals take part in developing guidance within NICE and externally. The groups and their roles are summarised in section 1 of NICE's health technology evaluation manual.

Participants will have roles and responsibilities as described in section 1 of NICE's health technology evaluations manual, except:

• Companies are not asked to make an evidence submission. They will be asked to provide information on their technologies and the evidence base to inform scoping and to be used by the EAG in developing the external assessment report.

• Companies will be invited to take part in the scoping process. This can include being invited to a scoping workshop, to provide feedback during scope consultation and providing clarity on information the company provides to the NICE team.

• Experts and specialist committee members will be recruited alongside standing committee members for each LSA topic. They typically include clinicians or researchers using the technology or practising in the care pathway, as well as lay people with a perspective on the condition and experience of using the technology being considered. For LSA, additional expertise may be needed and recruited, for example, procurement, commissioning, and technical experts.

• Specialist committee members have the same decision-making role as standing members of the committee. Any reference to the committee includes the specialist committee members. Specialist committee members are recruited in accordance with the appointments to advisory bodies policy and procedure.

• NHS Supply Chain will be asked for relevant information about the technologies and their use including the respective procurement frameworks and processes.

• NICE can invite commissioning and procurement experts from NHS England, NHS Supply Chain, and clinical commissioning groups (or other relevant commissioning organisations) to help clarify issues about the scope and submitted evidence. They may be asked to provide advice before, during and after committee meetings on different aspects including:

  • their views and experiences of the technology

  • the condition and care pathway

  • considerations about how the technology could be delivered in the NHS

  • when treatment eligibility criteria may be used in the NHS for high-cost treatments

  • aligning with procurement and commissioning decisions in the NHS.