Proposed changes to NICE health technology evaluations: the manual (PMG36)

For assessments of HealthTech, requests for information may be sent to companies during scoping if they have technologies that could be included in the assessment or otherwise be relevant to it. A request for information does not mean that a technology will be included in the scope for the assessment. Information provided is often used to determine if a technology is suitable to include in the scope.

Company evidence submissions are not made for evaluations of HealthTech. Instead, companies can be asked to provide responses to requests for information from NICE. Requests for information may be made as needed throughout the guidance development process, including during the scoping stage.

Unpublished evidence can be provided with a request for information.

A completed checklist of confidential information must be provided with a returned request for information.

Economic models can be provided as part of the response to a request for information. The same requirements apply as for models provided with an evidence submission (see section 5.5.15).

HealthTech will not automatically be withdrawn from a scope or guidance because a response to a request for information has not been received. But not providing information needed by NICE may affect the assessment of a technology or procedure and consequently the recommendation.

NICE's commercial liaison team (CLT) activities will be aligned with key steps in the evaluation processes. The procedures are summarised below. This information is for guidance only because the time needed, and information available, for each stage may vary for some evaluations.

If the NICE CLT identifies that a technology or technologies is/are unlikely to be cost effective at the existing price before the first committee meeting, liaison can take place with relevant NHS bodies and companies to explore any commercial challenges.

The NICE CLT attend committee meetings for topics where a risk has previously been identified relating to cost-effectiveness in the evaluation.

After the committee meeting the NICE CLT provides further information to the company(s) and relevant NHS bodies, to support further commercial activity if required. Additional time may be granted at this stage of the process to allow further commercial activity.

Companies can provide prices relevant to using their technology in their response to a request for information and updated costs at consultation on draft guidance. Outside of these times it may not be possible to consider new or updated prices.

Section 4.4.4 describes considerations for prices used in reference case analyses. If companies believe there are extenuating circumstances for why the technology cost cannot be disclosed in public documents, further information on these circumstances must be provided for NICE to consider whether this is acceptable. In circumstances when NICE agrees to accept a price marked as confidential, a further price that can be publicly disclosed should also be provided.

Section 4.4.5 details how prices that differ between regions are handled. This is in the context of the MPSC prices, however the principles of handling a situation where there is no single price that is universally available across the NHS applies to HealthTech.

The committee will be made aware when confidential prices are used that are not guaranteed for the duration of the guidance.