Health technology evaluations: interim methods and process guide for the proportionate approach to technology appraisals

3.1.1 Scheduling of topics into the NICE work programme will be managed using information on expected regulatory approval dates and submission readiness which will be provided through horizon scanning and topic selection activities and directly to NICE by the company.

3.1.2 Topics may benefit from aligned internal processes when they are in the same disease area, follow similar regulatory timelines and are scheduled into the same (or closely aligned) committee meeting.

3.1.3 When appropriate, NICE may decide to hold a joint committee meeting covering more than 1 appraisal. A joint committee meeting is when 2 separate topics are discussed in 1 committee session. Confidentiality will be strictly preserved; the topics will remain as separate appraisals and recommendations will be made individually for each appraisal.

3.2.1 Section 3.2 of this interim guide supersedes section 5.4 of the NICE health technology evaluations manual on the handing of confidential information for medicines only. All other elements of handling confidential information remain as described in section 5.3 of the manual.

3.2.2 See the principles for confidential information marking and redaction for further information and best practice in marking and redacting documents. This also outlines the additional descriptive reporting requirements for data that is to be redacted, to ensure transparent reporting of committee decision making. It provides advice and information for stakeholders but is not a formal process guide.

3.2.3 To ensure that the evaluation process is transparent, it is essential that as much of the evidence as possible informing the committee's decision making is made available to stakeholders and is publicly available. In some circumstances, NICE will accept evidence and information not in the public domain under agreement of confidentiality. The NICE health technology evaluations manual defines 3 categories of confidential information: commercial-in-confidence, academic-in-confidence and depersonalised data. Academic-in-confidence is not used for medicines evaluated through the technology appraisals or highly specialised technologies programmes.

3.2.4 There are broad categories of data and information which are redactable and non-redactable. Evidence and information not in the public domain that may be redacted includes:

3.2.5 Categories of information that cannot be redacted include:

3.2.6 Information marked as confidential should be kept to an absolute minimum and reasons for confidentiality must be stated clearly. Marking must allow evidence and information that is likely to be fundamental to the committee's decision making to be sufficiently explained to stakeholders and users of NICE guidance.

3.2.7 Data that is likely to be fundamental to committees' decision making includes:

3.2.8 There are instances in which the exact decision-making ICER, or incremental costs in cost comparison analyses, cannot be published in NICE documents or in public committee meetings. This includes when there are confidential patient access schemes for combination treatments, comparators and subsequent treatments. In these cases, NICE will state in its public committee meetings and post-meeting documents whether the values are above or below a level at which the technology may provide value for money. Given the high proportion of evaluations in which this is the case, NICE will consider this approach across all technology appraisals and highly specialised technologies evaluations. This means that there is flexibility allowing redaction of ICERs and incremental costs if:

3.2.9 If NICE wishes to publish or publicly share data regarded by the data owner as confidential, both NICE and the data owner will negotiate to find a mutually acceptable solution. This will recognise the need for NICE to support its recommendations with evidence and the data owner's right to confidentiality. The need for negotiation is considered exceptional when the principles for confidential information handling are adhered to. The data owner retains the right to make a final decision about the release of confidential information into the public domain.

3.2.10 NICE could be challenged that confidential information it has received should be publicly released in the interests of fairness during an evaluation, at appeal or resolution, through judicial review or otherwise. If this happens then data owners must, on request, promptly reconsider whether it is necessary to maintain confidentiality. If disclosure is not possible, the data owner must be prepared to assert publicly that the information is confidential and must submit evidence justifying why NICE should maintain that confidentiality. Without such assertion and evidence, NICE is entitled to conclude that the information is no longer confidential.

3.2.11 Details of a PAS, once referred to NICE for consideration in an evaluation, are not confidential except when NHS England has agreed that a simple discount PAS is confidential. All other types of commercial access agreements, once referred to NICE for consideration in an evaluation, are confidential. In these cases (as outlined in section 3.2.4), the discount and any data that could lead to back-calculation of the discount will not be shared with stakeholders or released into the public domain.

3.2.12 When the details of the PAS are not published in final NICE guidance, the NHS must have access to the details. This is so providers and commissioners can properly account for the PAS and commercial agreement. Details of commercial access agreements will not be published in final guidance. When elements of a commercial access agreement need to be known to the NHS for the agreement to be operationalised, the NHS must have access to the details.

3.2.13 NICE will not share details of confidential price discounts for other medicines with the company for a new technology being evaluated. For each medicine, and for each indication included in the treatment pathway, the company must include a 'discount' field in its economic model. This should allow the user to input any value between 0% and 100%, which is then applied as a percentage discount to the list price of the medicine. By providing this feature in its model, the company will be responsible for the initial programming, which the external assessment group (EAG) will check. All parties should then be confident that the discount is programmed correctly. The EAG will be authorised to know the exact level of discount for commercial arrangements in the evaluation.

3.2.14 The EAG will use the list price, or an alternative publicly available price such as the eMIT price, for any other technologies with confidential price discounts in its external assessment report when reproducing the company's analyses and for any exploratory analyses. To allow the committee to explore the effect of using the actual cost of the technologies in the analyses, the EAG will also create a confidential appendix to its report. This will reproduce all analyses from the external assessment report using the exact level of discount. When the results of the EAG analyses are classed as confidential because of existing confidential commercial mechanisms, including PAS and commercial access agreements, NICE will state whether the ICERs are above or below a decision-making threshold in its public committee meetings and post-meeting documents (see section 3.2.8).

3.2.15 Executable economic models used in the evaluation will be made available on request to stakeholders who have signed a confidentiality agreement.

3.2.16 Committee and EAG members attending the committee meeting will be provided with all confidential information submitted.

3.2.17 The clinical and patient experts who attend the committee will be provided with all confidential information submitted, except confidential PAS for combination treatments, comparators and subsequent treatments, and commercial access agreements (or other similar confidential price arrangements).

3.2.18 In committee meetings, confidential information will be redacted from the slides. Committee and EAG members, clinical and patient experts and company representatives will also be given an unredacted version of the slides presented in the public part of the meeting. When necessary, for appraisals in which more than 1 technology is being evaluated, NICE may agree with the relevant data owners additional arrangements for handling clinical data not intended for publication during public meetings, to allow effective and transparent discussions.

3.2.19 If a technical engagement happens, all information marked as confidential will not be released to stakeholders even though they have signed a confidentiality agreement. Patient, clinical and commissioning experts will be able to see unredacted documents.

3.2.20 If an evidence submission or a statement from a non-company stakeholder contains confidential information, it is the responsibility of the submitting organisation to provide 2 versions:

3.2.21 The stakeholder must complete a confidential information checklist at the time of submission. This should list all confidential information included in the submission or statement and the reason for its confidentiality. If NICE does not receive a completed checklist with a document, none of the information will be considered confidential.

3.2.22 Data owners may be asked to check that confidential information is correctly marked in documents created by others in the evaluation before release.

3.2.23 NICE releases all documents that are presented to committee in committee papers to stakeholders during the evaluation. NICE publishes these documents on its website within 7 days after they have been sent to stakeholders. After NICE has published these documents on its website, they are no longer confidential. Confidential information within published documents is redacted.

3.3.1 For topics identified as cost comparison, submissions should be made using the cost comparison submission template. Submissions made using the standard single technology appraisal template after cost comparison has been referred will be rejected and the topic may be delayed.

3.3.2 For cost comparison appraisals, the deadline for receipt of the evidence submission is 28 days from the invitation to participate.

3.3.3 During a cost comparison appraisal, the selected clinical and patient experts will not be asked to complete a formal statement or attend a committee meeting. Experts are requested to be available to answer questions that may arise during the appraisal process.

3.4.1 For cost comparisons, the EAG prepares an evidence assessment report based on a proportionate review of the company's evidence submission.

3.5.1 After receiving the external assessment report, NICE will assess the evidence submissions and report and decide how the appraisal will progress. At this stage an appraisal can:

3.5.2 Technical engagement will only be included if NICE considers that it is appropriate, helpful and proportionate. NICE will take into account whether the technical engagement process is likely to resolve key issues before the committee meeting.

3.5.3 If technical engagement is included timelines will be amended to allow for engagement time with stakeholders.

3.5.4 NICE will make decisions about whether to streamline topics into a committee decision outside of a formal meeting.

3.5.5 When deciding on the suitability for streamlined decision making, NICE will take into account the risks associated with the appraisal and the decision to streamline. This may include:

3.5.6 The progression decision and relevant timelines will be communicated to stakeholders within 2 weeks of receipt of the external assessment report. Information will also be published on the NICE website once stakeholders have been informed.