NICE sends the name and contact details of the project manager assigned to an individual evaluation to all stakeholders. Stakeholders should send all correspondence about an individual evaluation to the project manager, unless requested otherwise.
NICE sends correspondence for an evaluation electronically (or in other formats on request) to key contacts identified by each stakeholder organisation. Stakeholders must notify the project manager of any change in contact details, or in organisation or company name, during the evaluation.
NICE charges companies for technology appraisal and highly specialised technologies evaluations. NICE reserves the right to pause the evaluation if payment is not received by the due date. See our published information on charging for more detail.
It is not possible to set absolute timelines for all stages of the evaluation. The length of time needed for each stage can vary depending on the nature of the particular evaluation. Additional time may be given to particular stages if they coincide with public holidays.
Throughout an evaluation, up-to-date information about timelines and progress will be published on the NICE website.
NICE informs stakeholders about timeline changes during an evaluation and the reasons for these changes. When the reasons are commercially sensitive, NICE works with the company to release as much information as possible to stakeholders and on the NICE website.
For technology appraisals and highly specialised technologies, scheduling of topics into the NICE work programme will be managed using information on expected regulatory approval dates and submission readiness. These will be provided through horizon scanning and topic selection activities, and directly to NICE by the company.
Topics in the same disease area, following the same regulatory timelines and so scheduled into the same (or closely aligned) committee meeting, may benefit from aligned internal processes. When appropriate, NICE may decide to hold a joint committee meeting covering more than 1 appraisal. A joint committee meeting is when the discussion of 2 separate topics is held in 1 committee session. Confidentiality will be strictly preserved. Also, the topics will remain as separate appraisals and considered independently, and recommendations will be made individually for each appraisal. Any regulatory changes or topic delays will result in the cancellation of internal process alignment.
NICE adheres to the principles and requirements of data protection legislation, including the General Data Protection Regulation and the Freedom of Information Act, when dealing with information received during an evaluation.
Organisations who want to be involved in an evaluation must sign a confidentiality agreement first (formally known as the confidentiality acknowledgement and undertaking) to be considered a participating stakeholder. After this, NICE can release evaluation documents to them.
NICE needs to meet the requirements of copyright legislation. If a company cites journal articles in its submission, it must include the full articles in its submission and have copyright clearance to do so.
If NICE needs journal articles for its own use during the evaluation, it will obtain the article, paying a copyright fee when necessary.
For company submissions, the medical director (or equivalent senior officer) of the company must sign a statement confirming that all clinical trial data necessary to address the scope has been disclosed to NICE or its authorised agents, as issued by the Department of Health and Social Care and NICE. This applies to data within the company's or any of its associated companies' possession, custody, or control in the UK or elsewhere in the world, within the meaning of section 256 of the Companies Act.
For technology appraisals and highly specialised technology guidance, companies must consent to regulatory authorities providing NICE directly with all clinical trial data necessary to address the scope of the evaluation. This includes all data that has been submitted to the regulatory authorities by the company or any of its associated companies and that was relevant to the granting of regulatory approval. Companies must also consent to NICE using that data to do the evaluation. NICE will only ask regulatory authorities directly after having first approached the company for the information if the company is unable or unwilling to provide the information in a timely manner.
Stakeholders should take care when submitting information about individual people. Personal and sensitive information, for example, the name of a person's clinician, should be removed from submissions. It is the responsibility of the submitting organisation to assess the risk of subject identification and handle depersonalised data accordingly. Further information on depersonalised data and how to assess the risk of identification can be found in the Information Commissioner's Office guide to data protection.
All evidence submissions and other information supplied as part of the evaluation process will be published on the NICE website and must therefore meet legislation to ensure content is accessible to everyone including users with impairments to vision, hearing, mobility, thinking and understanding. NICE requires stakeholders to ensure their submissions meet formal accessibility standards.
NICE also encourages stakeholders to make their submissions publicly available, for example, by putting them on their own websites after they have sent their submission to NICE.
NICE may comment publicly on the content of an evaluation during the process and when draft or final guidance has been published. The following circumstances may also apply:
NICE reserves the right to comment publicly if there has been an unauthorised disclosure from a confidential NICE document before it has been published on the NICE website. NICE will inform stakeholders of this decision as soon as possible.
NICE reserves the right to issue a correction if a public comment is made on draft guidance or final draft guidance that could mislead, misinform or offend.
Stakeholders are responsible for treating evaluation documents that are not in the public domain as confidential until NICE makes those documents, or the data within them, public. NICE considers individuals in a stakeholder organisation who views evaluation documents to be bound by the terms of the confidentiality agreement signed by the stakeholder organisation.
Any organisation or individual not directly employed by the stakeholder organisation is a third party. Stakeholders may release evaluation documents to third parties when:
it is necessary so the stakeholder can contribute to the evaluation and
the third party has seen and agreed to be bound by the terms of the NICE confidentiality agreement.
Stakeholders may discuss confidential evaluation documents with other stakeholders but, before doing so, they must be satisfied that the other parties have signed and returned their confidentiality agreement to NICE.
In the committee papers, draft guidance and final guidance, NICE reserves the right to use any material submitted during the evaluation that is not marked as confidential, or which ceases to be confidential. All confidential information will be clearly marked in the committee papers.
If changes are made to the technology's regulatory approval, NICE will discuss the implications with the external assessment group (EAG) and the company. NICE will agree how to incorporate the changes into any evidence submission and external assessment report.
NICE will not publish final guidance on a technology until UK regulatory approval has been granted and the technology's price is known or can be determined. NICE may share documents with participating stakeholders who have signed and returned a confidentiality agreement to NICE.
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. This is to ensure that the evaluation process is as transparent as possible. In some circumstances, NICE will accept evidence and information not in the public domain under agreement of confidentiality. NICE 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.
There are broad categories of data and information that are redactable and non-redactable. Evidence and information not in the public domain that may be redacted includes:
evidence that is commercially sensitive, including but not limited to, confidential price discounts, confidential information on market share and confidential regulatory or clinical trial timelines, and data that allows back calculation of commercially sensitive data (see section 5.4.9 for more information on confidential discounts)
clinical data that is not intended for publication in a scientific paper or in a publicly available regulatory document: the rationale for redacting this data should be explained and consideration should be given to the expected impact on the ability of NICE to explain the evidence that the committee's decisions are based on to stakeholders and the public (see section 5.4.4)
data provided to the stakeholder submitting to NICE by a third-party organisation, if there are stipulations from the third-party organisation on how the data may be disseminated by the stakeholder. For example, registry data or data from a trial when the stakeholder is not the sponsor; in these cases, the redaction stipulations of the third-party organisation will be adhered to
data that allows for subject identification, including depersonalised data (data that is stripped of direct identifiers) but for which there is still a high risk of subject identification.
Categories of information that cannot be redacted include:
methods used to do a study or to analyse data from a study
clinical data that is available in the public domain
clinical data awaiting publication, including in a journal or in documents supporting authorisations by regulatory agencies that are released at the time of marketing authorisation
data collected in NHS clinical practice as part of a managed access agreement and cannot be considered confidential unless it meets other criteria, for example, allows for subject identification
critical appraisal of clinical studies and indirect comparison
clinical opinion and assumptions (which are not based on empirical data).
The principles for handling confidential information are described in sections 5.4.4 to 5.4.21. 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.
Data that is likely to be fundamental to committee's decision making includes:
cost-effectiveness (incremental cost-effectiveness ratio, ICER) or cost-comparison (incremental cost) estimates
data informing the case for decision modifiers to be applied in technology appraisals and highly specialised technology evaluations
evidence allowing consideration of items listed in section 6.2.28 of the manual and, mainly, the generalisability, reliability and robustness of evidence informing an evaluation and plausibility of assumptions or model outcomes.
It is recognised that some of this evidence may fall under the categories of redactable data in section 5.4.2 such as:
data allowing back calculation of a confidential price discount (for example, price related to a patient access scheme [PAS] or a commercial access agreement, or from the Commercial Medicines Unit)
unpublished clinical data not intended for publication.
In most instances in which the stakeholder considers it necessary to mark this data as confidential, as a minimum, an accompanying descriptive summary of what the data shows must be provided. This is so that NICE can explain committee decision making to stakeholders and the public. Guidance is given in the principles for confidential information marking and redacting document. There are instances in which numerical data rather than a descriptive summary is needed to explain committee decision making. This includes data informing the case for decision modifiers and also health-state utility values, on-treatment utility increments or decrements, and utility decrements associated with adverse events. In these cases, numerical values should be shown. New flexibility on the redaction of ICERs has been introduced to allow the transparency of these numerical values to be prioritised.
There are instances in which the exact decision-making ICER, or incremental costs in cost-comparison analyses, cannot be published in NICE documentation or in public committee meetings. This includes when there are confidential PAS for combination treatments, comparators and subsequent treatments. In these cases, NICE will state in its public committee meetings and postmeeting documentation 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 and highly specialised technologies evaluations. This means that there is flexibility that allows redaction of ICERs and incremental costs if:
there are confidential PAS for combination treatments used alongside the intervention under evaluation, comparators or subsequent treatments
a new confidential price for the intervention under evaluation is expected or the confidential price is expected to change over the course of the evaluation, and reporting of results including different prices will allow calculation of the final confidential price
a case for a severity modifier is being made, or
it allows utility values to be transparent.
When ICERs are redacted, incremental quality-adjusted life year (QALYs) should not be redacted.
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. But, by adhering to the principles for confidential information handling, the need for negotiation is considered exceptional. The data owner retains the right to make a final decision about the release of confidential information into the public domain.
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.
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 5.4.2), 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.
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 an element(s) of a commercial access agreement needs to be known to the NHS for the agreement to be operationalised, the NHS must have access to the details.
NICE will not share confidential 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 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.
The EAG will use the list price, or alternative publicly available price such as 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, but not limited to, 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 documentation (section 5.4.6).
Executable economic models used in the evaluation will be made available on request to stakeholders who have signed a confidentiality agreement.
Committee and EAG members attending the committee meeting will be provided with all confidential information submitted.
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).
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 enable effective and transparent discussions.
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.
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:
a version for NICE, the committee, the EAG, experts and the NHS England clinical leads and commissioning experts with all the confidential information marked with turquoise highlighting and underlined
a version in which all the confidential information is redacted.
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.
Data owners may be asked to check that confidential information is correctly marked in documents created by others in the evaluation before release.
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.
After scoping, the guidance development process consists of 3 distinct phases: start of the evaluation and evidence submission, evidence review, and evaluation.
It is the responsibility of the company to inform NICE as soon as possible of any potential related regulatory developments or delays by contacting the project manager.
Before the start of the evaluation, for technology appraisals and highly specialised technologies, the company has the opportunity to discuss the decision problem that follows from the draft scope with the NICE team and EAG representatives. The company must submit an outline of how it intends to approach the decision problem when preparing the evidence submission. This outline should include, but is not limited to, evidence sources to be used, evidence likely to become available during the evaluation and how this might be managed, the planned approach to disease and economic modelling, potential challenges in interpreting the evidence, and the proposed approach to handling of uncertainty. The meeting will also allow companies to discuss potential handling of patient access schemes or commercial access agreements and proposals for using the cost-comparison evaluation process. Changes to the scope will not be considered.
NICE will publish the final scope, the name of the EAG and the stakeholder list on its website at the start of an evaluation.
NICE sends stakeholders the invitation to participate and a list of key dates in the evaluation.
NICE aims to make sure that companies bringing technologies forward for possible use in the NHS can make the best plausible case for its product, to the ultimate benefit of the NHS and patients. Therefore, NICE works closely with relevant stakeholders at key stages of the NICE technology appraisal and highly specialised technologies processes to inform their commercial activities and allow timely discussions between NHS England and NHS Improvement and the company. This interaction between NICE, NHS England and NHS Improvement and the company is key to ensuring the guidance is produced as quickly as possible allowing faster patient access to cost-effective technologies.
From this stage forward in the evaluation, companies are expected to proactively pursue an appropriate commercial arrangement to ensure their technology is cost effective when evaluated (see section 5.9).
NICE invites the company to provide an evidence submission using a detailed submission template.
For topics identified as cost comparison, submissions should be made using the cost-comparison submission template. Submissions made using the single technology appraisal template after cost comparison has been referred will be rejected and the topic may be delayed.
For technology appraisals and highly specialised technologies, the deadline for receipt of the evidence submission is:
28 calendar days from the invitation to participate for cost-comparison evaluations
56 calendar days from the invitation to participate for single technology evaluations
84 calendar days from the invitation to participate for multiple technology evaluations.
For medical technologies evaluations, the evidence submission is provided 42 days from the publication of the final scope.
For diagnostic technologies, the company is not asked to provide a formal evidence submission, but the company is asked to provide information on its technology and evidence base to allow the EAG to prepare its report accurately.
After receiving the submission, NICE sends it to the EAG for review.
The information needed for the evidence submission is derived from the approach NICE uses to evaluate the clinical and economic value of health technologies.
The evidence must be submitted in the template provided by NICE for the type of evaluation selected.
NICE will provide an opportunity for the company to discuss key issues with NICE and, if needed, the EAG before the company's submission date. NICE will ask the company to provide an update on their submission before the meeting. This engagement will also allow companies to discuss potential regulatory developments during the evaluation and the potential inclusion and handling of commercial proposals. Before the company evidence submission deadline, companies can request additional engagement with NICE. Engagement will depend on availability of the NICE team at the time of request.
If the company plans to submit an economic model or is required to do so, it should inform NICE which software will be used. NICE accepts fully executable economic models using standard software, that is, Excel, DATA/Treeage, R or WinBUGs. If the company plans to submit a model in a different software package, it should tell NICE in advance. NICE, with the EAG, will investigate if the requested software is acceptable. When the company submits a fully executable electronic copy of the model, it must give NICE full access to the programming code. It should ensure that the submitted versions of the model program and the written content of the evidence submission match.
NICE offers to send the economic model (in its executable form) to stakeholders during any technical engagement or consultation. If the model contains confidential material that the data owner is unwilling to share with stakeholders, despite the assurances provided through the signed confidentiality agreements, NICE will ask the company to redact the model if this can be done without severely limiting the model's function. Stakeholders must make requests for a copy of the model in writing. NICE provides the model on the basis that the stakeholder agrees, in writing, to the following conditions of use:
The economic model and its contents are confidential and are protected by intellectual property rights, which are owned by the relevant company or EAG. It cannot be used for any purpose other than to inform understanding of the committee papers.
The economic model cannot be published by stakeholders (except by the company who owns the model), in whole or in part, or be used to inform the development of other economic models.
The model must not be run for purposes other than to test its reliability.
The model is deleted from the stakeholder's records upon publication of final NICE guidance.
When technologies are being evaluated at the same time as regulatory approval, sufficient details of the clinical trial evidence should be made available so NICE can do the evaluation according to the defined scope. For medical devices and diagnostic technologies with limited published evidence, unpublished data could support the evidence base.
If the company wishes to include a patient access scheme or commercial access agreement proposal as part of its submission, specific requirements apply (see section 5.8).
Managed access is only for medicines evaluated through technology appraisals and highly specialised technologies. For medicines where immature evidence or evidence gaps are likely to result in significant uncertainty for committee decision making and the company wishes to have the option of a recommendation with managed access, a managed access proposal should be included within their submission.
A company may opt to make a managed access proposal for any medicines that may be considered eligible through the Cancer Drugs Fund or the Innovative Medicines Fund. Early engagement with NICE about a managed access proposal is encouraged to allow exploration of the potential for further data collection to address significant uncertainties in the evidence. Multiple touch points within the evaluation process provide opportunities for NICE, the company and other stakeholders to identify if a medicine may be suitable for managed access, and that a managed access proposal could be submitted, including:
At scoping, during the decision-problem stage where the company is considering making a managed access proposal.
At submission, a managed access proposal as part of the company's submission.
At technical engagement (if held) when significant uncertainties are highlighted, and a managed access proposal could be submitted.
Managed access proposals should be submitted at the evidence submission stage. A managed access proposal has 2 components:
a data collection proposal
a commercial access proposal.
The committee will always first consider whether a case for recommendation (as an option) is met. If the committee concludes that recommendation (as an option) is not supported, then it will consider whether a recommendation with managed access is appropriate. To consider this, a committee will need a managed access proposal, along with a feasibility assessment from NICE.
The company must submit a commercial access proposal with its data collection proposal. The process for submitting a PAS or commercial access agreement is outlined in section 5.9.
A feasibility assessment will be done by NICE to identify if the proposed data collection can produce new evidence to address the significant uncertainties, without undue burden on the NHS. The feasibility assessment process will involve engagement with a range of stakeholders, including the company, clinicians, patients and their representatives, and NHS data custodians. The extent of engagement activities will be proportionate to the complexity of the data collection proposal.
The feasibility assessment will be shared with the committee, company, and stakeholders 28 days before the committee meeting.
The data collection proposal should identify:
The key clinical uncertainties that might result in the committee concluding that the case for adoption cannot be supported.
The outcome data that may be needed to sufficiently support the case for adoption.
The potential data sources that could be used to collect this outcome data.
The proposed duration of the data collection period.
How the data collected would be analysed and incorporated for a NICE guidance update.
Any considerations around information governance and data sharing that may need to be addressed.
NICE will assess whether:
it is feasible to collect and analyse the proposed outcome data within a reasonable timeframe.
the additional burden of data collection on patients, clinicians, and the NHS is proportionate.
there is a reasonable likelihood that the proposed outcome data will be sufficient to support the case for adoption at the guidance update.
the data collection can be started when patients get access to the technology.
there are any ethical, equality, or patient safety concerns with the proposed data collection and analysis.
there are other substantive barriers to implementing managed access.
The company will have the opportunity to amend its managed access proposal, before the first committee meeting to address issues identified during the feasibility assessment or in response to EAG feedback. However, substantial revisions or a new proposal during or after technical engagement are likely to delay the evaluation process.
If a company submission includes a base-case ICER that is significantly higher than the standard threshold, and this level of ICER has not been sufficiently addressed through a PAS or commercial discussions between the company and NHS England and NHS Improvement, NICE may pause progression of the topic to consider the most efficient and appropriate course of action. NICE will discuss with the company how to progress the evaluation but reserves the right to make the final decision about progressing to the next stage of the evaluation. NICE will also ensure that all other stakeholders involved in the process are fully informed of the rationale for the decision.
NICE invites non-company stakeholders to make a submission providing information on the potential clinical effectiveness and value for money of a technology, using the appropriate templates available on the NICE website. The submission should reflect the experience of patients, healthcare professionals and commissioners of current standard treatment in the NHS in England. It should also reflect the potential impact of using the new technology on health-related quality of life. Implementation issues, such as staffing and training needs, should also be included. Stakeholders are given the same number of days and deadline to provide their submission to NICE after the invitation to participate. After receiving the evidence submissions, NICE sends them to the EAG and technical team for consideration.
For multiple technology evaluations, the EAG develops an assessment protocol, derived from the final scope of the evaluation. The assessment protocol outlines what the EAG will do during the evaluation and the information it will provide in the external assessment report.
After receiving the company's evidence submission (when needed), the NICE technical lead and the EAG assess whether the submission is complete and whether the decision problem is specified appropriately with reference to the final scope.
If the company evidence submission is incomplete or the decision problem is not specified appropriately, the technical lead consults with the EAG and sends a letter of clarification and any requests for additional analyses to the company within 21 days of receiving the submission. The company has 14 days from the date of the correspondence to respond to points of clarification and provide any additional analyses. When the company provides additional analyses, it should include full descriptions of the analyses as appendices to the original submission. If necessary, NICE will organise a clarification meeting between the NICE team, the company and the EAG to resolve any issues.
For cost-comparison evaluations, the company has 10 working days from the date of the correspondence to respond to the points of clarification and provide any additional analyses.
If requests for clarification and any additional analyses delay the published timelines, NICE will inform stakeholders and publish the reason for the delay on its website.
At the same time as the response to the clarification request, the company should review the confidential status of information in its evidence submission before the committee meeting.
The company should not submit additional evidence during the evidence review phase unless NICE requests or agrees to this in advance.
NICE aims to ensure that the company prepares the best possible evidence submission for the committee. NICE will not validate the submission, but it will help to clarify substantive issues. NICE will consider whether the evaluation should be terminated if, after all reasonable requests for clarification, NICE is not satisfied that the evidence submission is adequate for the committee to make a decision.
NICE will also consider whether to terminate an evaluation if no evidence submission has been received or, for a technology appraisal or highly specialised technologies evaluation, payment has not been received.
When an evaluation is to be terminated, NICE will share termination publication timings and agree appropriate wording with the company. NICE will advise the NHS that it is unable to make a recommendation about using the technology because no evidence submission was received from the company and the evaluation has been terminated. NICE will also provide an explanation to help the NHS make local decisions on making the technology available.
For evaluations that are terminated after a period of managed access because of non-submission, the company will be required to participate in an engagement event with all stakeholders and provide information about the reasons for not proceeding with the guidance update.
NICE may also use the termination process to manage a company submission with a significantly high ICER.
A terminated evaluation can be restarted if the company indicates that it will make a full evidence submission.
The EAG prepares a report on the clinical and cost effectiveness or cost savings of the technology. The report is usually based on a review of the company's evidence submission (except for diagnostics guidance and multiple technology evaluations in technology appraisals and highly specialised technologies) and advice from the EAG's clinical experts. The EAG prepares the report using a template agreed with the NICE team. The EAG is responsible for the content and quality of the report for all guidance types.
The EAG critically evaluates any evidence submissions. If the EAG, as part of exploratory analyses, amends the company's model, NICE will make the analyses available to the company at any technical engagement stage. All other stakeholders may request, in writing, the EAG analyses during technical engagement or consultation.
For diagnostic guidance, companies do not normally provide an evidence submission. For multiple technology evaluations in technology appraisals and highly specialised technologies, the companies are invited to provide an evidence submission but are not formally required to do so. The EAG does an assessment of the clinical outcomes and cost effectiveness of the technologies, and diagnostic test accuracy where relevant. The assessment is based on systematic reviews of the literature, data provided by the companies, information from the experts or specialist committee members, and modelling of patient outcomes, costs and cost effectiveness. The EAG's assessment highlights the uncertainties in the evidence and may include an analysis of the value of reducing those uncertainties.
After receiving the external assessment report, NICE will share a copy with the company for fact checking. This will allow the company time to prepare for any technical engagement. NICE may seek advice from experts at this stage if additional clarification on the submitted individual expert statement is needed. There is no fact checking stage in diagnostics evaluations.
If sent out for technical engagement, the external assessment report will be accompanied by:
any company submission (and model when appropriate)
any clarification questions and company responses
any external assessment report factual accuracy check.
After receiving the external assessment report, NICE will assess the evidence submissions and external assessment report and make a decision on how the appraisal will progress. At this stage an appraisal can:
continue as a single technology appraisal and progress to committee preparation
continue as a single technology appraisal and progress to technical engagement before committee preparation
be appropriate for a streamlined committee decision process in selected low-risk circumstances, with a committee decision outside of a formal meeting
pause while NICE considers the most efficient and appropriate course of action (see section 5.5.31: managing company submissions with high base-case ICERs).
Technical engagement will only be included if NICE considers that it is appropriate, helpful and proportionate, taking into account whether the technical engagement process is likely to resolve key issues before the committee meeting.
If technical engagement is included, timelines will be amended to allow for engagement time with stakeholders.
Decisions to streamline topics into a committee decision outside of a formal meeting will be made by NICE.
When deciding on the suitability for streamlined decision making, NICE will take into account the risks associated with the evaluation and the decision to streamline. This may include:
the likelihood of decision error in the guidance, and its consequences
the complexity of the technology, clinical pathway or evidence, and associated uncertainties
the potential impact of the decision to streamline on:
resources for NICE, committees and stakeholders
service readiness
consistency and predictability of NICE decision making
openness and transparency in decision making.
The progression decision and relevant timelines will normally be communicated to stakeholders within 14 days of receipt of the external assessment report into NICE. Information will also be published on the NICE website once stakeholders have been informed.
The purpose of the technical engagement is to note and consider any evidence gaps and potential resolution ahead of the committee meeting and to consider any commercial or managed access proposals. Technical engagement is not normally needed in medical technologies evaluations.
Technical engagement is not a mandatory stage of the evaluation process. When it is identified that the evaluation would benefit from additional engagement before the committee meeting, NICE may decide that the technical engagement process step should be included. A decision to progress to technical engagement will be discussed in advance with the company and communicated to stakeholders.
The external assessment report is sent to stakeholders for comment within 21 days of NICE receiving the external assessment report and after completion of any factual accuracy check. NICE will notify stakeholders if a delay is expected.
Stakeholders have 28 days to submit comments on the external assessment report for technology appraisals and highly specialised technologies or 14 days for diagnostics or medical technologies evaluations. Comments must be submitted electronically. During the engagement period, NICE may meet with any company who has made an evidence submission and with selected experts when the technical team thinks this is necessary.
NICE will ask the company to re-confirm the expected timing of regulatory approval in the UK (if not already received).
If a comment contains confidential information, the organisation or person who submitted the comment should provide 2 versions; one with all confidential information marked and another with the confidential information redacted (to be published on NICE's website), with a checklist of the confidential information. Detailed instructions on sending NICE confidential information are available from the project manager.
During technical engagement, new evidence and analyses can only be accepted if the NICE technical team agrees that this information is likely to affect the committee's judgements. The new evidence must be presented in a separate appendix to the comments on the external assessment report. NICE may need to extend timelines and reschedule the subsequent committee meeting to allow the new evidence to be considered. The company must inform NICE, in writing, of its intention to submit new evidence and analyses, as early as possible and before the deadline for comments on the external assessment report.
Any EAG review of new evidence will not normally be sent out for additional technical engagement before the committee meeting.
If comments received on the economic model need a company or EAG response, NICE sends those comments to the company or EAG. Their responses will be tabled at the next committee discussion.
The evaluation phase of the process has 4 possible stages:
consideration of the evidence at a committee meeting to discuss the content of either the draft guidance or final draft guidance
development of, and consultation on, the draft guidance (if needed)
review of the draft guidance (if produced) after comments from consultation at a second committee meeting, if needed
development of the final draft guidance.
The technical team and the EAG may meet to discuss the results of any technical engagement, if needed, and prepare for the committee meeting.
The committee papers are usually circulated to all attendees (except members of the public) 2 weeks before the first committee meeting, and consist of:
A link to the final scope of the evaluation and the stakeholder list.
The external assessment report, clarification comments and responses, comments from technical engagement (if held) and the technical team's summary of them.
The evidence submissions from organisations and experts.
If produced, the managed access or further evidence generation assessment report.
If produced, the draft data collection agreement.
Committee meetings are primarily held virtually and usually open to members of the public, stakeholders and the press. This supports NICE's commitment to openness and transparency. It allows stakeholders and the public to understand how evidence is evaluated and interpreted and how consultation comments are considered. Some committee discussions take place in private when there is a need to discuss confidential data and when a technology has not yet received regulatory approval.
To promote public attendance, the meetings in public team at NICE publish a notice and draft agenda on the website at least 21 days before the committee meeting. Members of the public and stakeholders who wish to attend as observers can register on NICE's website. The closing date for registration is 7 days before the meeting and late registrations may not always be accepted. NICE aim to contact registrants with the joining links and joining instructions 1 to 2 days before the meeting and publish the final agenda on its website 7 days before the meeting.
When the committee meets for the first time to discuss the technology, final draft guidance will be developed when it is possible to do so. Sometimes the committee may develop draft guidance if recommendations meet the criteria set out in section 5.7.41. The committee will consider the written evidence and verbal evidence, drawn from discussions with experts, EAG representatives, specialist committee members, and national clinical directors or advisers.
Committee decisions are normally based on consensus. If a vote is taken, it will be noted in the minutes.
Members of the committee and people having direct input into the discussions declare their interests, which are recorded in the minutes.
The lead team committee members present the topic to the other committee members and attendees. This introduction does not pre-empt the committee's debate or drafting of the guidance.
Clinical experts, patient experts and any NHS commissioning experts will be encouraged to help clarify issues about the evidence presented, including responding to and raising questions, but they do not make a presentation to the committee.
Company representatives respond to questions from the committee and comment on any matters of factual accuracy.
The committee considers the evidence during the public session. However, it will not discuss commercial-in-confidence information, or information contained in a statement from a clinical expert, NHS commissioning expert or patient expert that has been marked as confidential during this part of the meeting.
The EAG representatives answer questions from the committee and provide clarification on the external assessment report.
Representatives from other guidance-producing teams (for example, guidelines and public health) at NICE who are responsible for developing NICE guidance in areas related to the evaluation may also attend the meeting to observe and advise the committee. These representatives must declare their interests.
NICE staff may present additional evidence, provide advice on NICE policies and procedures, and respond to questions from the committee.
During the private session, the committee considers commercial-in-confidence information and agrees the recommendations. All other attendees, except the NICE team, are asked to leave the meeting before this discussion takes place.
The chair may ask certain experts, company representatives or EAG representatives to remain when confidential information is discussed but the chair will ask them to leave before the committee agrees the recommendations.
A patient expert can ask to have any personal, sensitive or confidential information heard by the committee in private. The patient expert should formally request this through the project team at NICE and it must be agreed with the chair of the committee before the meeting.
NICE staff remain at the meeting while the committee agree the recommendations, but they play no part in decision making.
The committee concludes the discussions and agrees the content of either the draft guidance, which sets out its draft recommendations, or the final draft guidance, which sets out its final recommendations (subject to fact checking, appeal or resolution). After the meeting, the guidance is drafted based on the discussions at the meeting. NICE may issue draft guidance or final draft guidance on a technology before that technology receives final UK regulatory approval.
The outcome of the committee meeting will be shared with stakeholders within 7 days of the committee meeting. This will be a brief statement of the committee decision.
NICE publishes unconfirmed minutes of the committee meeting on its website within 28 days of the meeting. When the committee has approved them, NICE publishes the confirmed minutes on its website normally within 6 weeks of the meeting. The minutes of a committee meeting provide a record of the proceedings and a list of the issues discussed.
For cost-comparison appraisals and those streamlined for committee decision outside of a formal meeting, a subset of committee members will review the evidence. They will be able to make a recommendation outside of a full committee meeting and no stakeholders will be asked to attend a meeting.
Experts who have been selected to take part in the appraisal (see sections 1.3.17 to 1.3.19) or other members of the committee may be invited to contribute on a case-by-case basis. This will be if, in the opinion of the subset of committee or the NICE team, they are needed to address specific questions.
If the subset of committee concludes it cannot make a recommendation, this will result in a full committee meeting. This will not alter standard governance or appeal processes, and maintains the independence of the committee as a decision-making body.
If a full committee meeting is needed for a streamlined appraisal, then clinical experts, patient experts and non-company stakeholders will not normally be invited to take part in the committee meeting discussion. In exceptional circumstances, the committee chair and NICE may agree to invite clinical or patient experts to the meeting to help address specific uncertainties.
If the subset of committee concludes that a cost-comparison recommendation cannot be made, then they have the option of proceeding to a full committee meeting or rerouting to the standard process. The company will then need to provide a new evidence submission using the full cost-utility template provided by NICE. The topic will be rescheduled into the work programme at the earliest opportunity.
If the committee do not recommend the technology at the first committee meeting and the committees' preferences and assumptions are clear, NICE will provide the opportunity for companies to improve their commercial offer in certain circumstances.
Shortly after the committee meeting, NICE will inform the company of the committees' recommendation and key assumptions. The company will confirm to NICE within 7 days of the first committee meeting whether they accept the committees' preferences and assumptions and if they will increase their simple PAS discount in line with those preferences.
Companies will have a single opportunity to increase their simple discount PAS at this stage in the process.
When an increased simple discount PAS has been submitted and is regarded as low risk by NICE, the committee chair can review and decide on behalf of the committee, whether the company's proposal is likely to result in a recommendation as an option.
This review may result in:
a recommendation (as an option) or an optimised recommendation that is in line with company and expert opinion. In these circumstances, the chair may decide that another committee meeting is not needed. Final draft guidance is drafted, and the final recommendations are agreed by the committee electronically. The final recommendations will be shared with stakeholders within 7 days of sign-off. This will be a brief statement of the committee's decision.
the chair being unable to make a recommendation without a full committee meeting. NICE will proceed to a second committee meeting. NICE will be unable to accommodate any further requests for delay to its process to accommodate PAS discussions for these topics.
a technology being not recommended, recommended only in a research context, recommended (as an option) or an optimised recommendation that is not in line with company or expert opinion. NICE will issue draft guidance and will be unable to commit to a date for a subsequent committee meeting for the topic. NICE will be unable to accommodate any further requests for delay to its process to accommodate PAS discussions for these topics.
If a company informs NICE that it does not accept the committees' preferences and assumptions, the draft guidance will be published for consultation. The subsequent committee meeting will be scheduled according to normal NICE timelines. NICE will be unable to accommodate any further requests for delay to its process to accommodate PAS discussions for these technologies.
If NHS England and NHS Improvement confirm before the first committee meeting that they are willing to engage in discussions about a commercial access agreement after the meeting, NICE may also agree to pause publication of the draft guidance to allow the company and NHS England and NHS Improvement to negotiate on a commercial access agreement so that, subject to subsequent committee approval, final draft guidance may be issued.
NICE will inform the company of the committees' recommendation and key assumptions. The company will confirm to NICE within 14 days of the first committee meeting whether they accept the committees' preferences and assumptions and if they wish to request a delay to publication of the draft guidance for up to 42 days to allow discussions with NHS England and NHS Improvement.
NICE will provide a commercial briefing to NHS England and NHS Improvement and the company within 7 days of the company confirming it is willing to accept the committees' preferences and assumptions. The briefing includes the committee's preferred assumptions for the evaluation and the implications for the company's value proposition.
The final commercial access agreement must be in line with the committee's preferred assumptions as documented in the NICE commercial briefing.
NHS England and NHS Improvement will confirm to NICE within 49 days of the committee meeting if a commercial access agreement has been agreed in principle.
If NHS England and NHS Improvement and the company are unable to agree a commercial access agreement within the above timescale, or earlier, NICE will issue draft guidance for consultation. NICE will be unable to accommodate any further requests for delay to its process to accommodate PAS or commercial access agreement discussions for these topics.
When a commercial access agreement has been agreed in principle and is regarded as low risk by NICE, the committee chair can review and decide on behalf of the committee, whether the company's proposal is likely to result in a recommendation as an option. The potential outcomes of this review are the same as those listed in section 5.8.43, with the conditions applying to PASs also applying to commercial access agreements.
If NHS England and NHS Improvement and the company are unable to finalise any arrangement within 21 days of an agreement in principle being confirmed, NICE will proceed to issue draft guidance. NICE will be unable to commit to a date for a subsequent committee meeting for topics proceeding to draft guidance at this point. NICE will also be unable to accommodate any further requests for delay to its process to accommodate PAS or commercial access agreement discussions for these topics.
If a company informs NICE that it does not accept the committees' preferences and assumptions, the subsequent committee meeting will be scheduled according to normal NICE timelines. NICE will be unable to accommodate any further requests for delay to its process to accommodate a PAS or commercial access agreement discussions for these technologies.
Normally, consultation on draft guidance takes place only if the draft recommendations for the technology are either:
not recommended
recommended only in a research context
recommended for data collection
recommended (as an option) in specific circumstances, which is not in line with the company submission and expert opinion
there is sufficient uncertainty in the cost case for a cost-saving technology or
if the company is asked to provide further clarification on the commercial arrangements in their evidence submission.
NICE usually circulates the draft guidance to stakeholders for consultation within 21 days of the committee meeting. NICE informs stakeholders if a delay is expected.
The draft guidance summarises the evidence and views that have been considered by the committee and sets out preliminary recommendations. The draft guidance is not NICE's final guidance on a technology. The recommendations may change after consultation. The draft guidance usually contains:
the committee's preliminary recommendations to the NHS on the technology and how it should be used
a description of the technology, including its licensed indication and dosage or intended use and cost
a description of how the committee has interpreted the evidence together with the key issues raised by experts
the committee's preferred assumptions and maximum acceptable ICER, if appropriate
expectations about implementation of the recommendations, if appropriate
proposed recommendations for further research, if appropriate.
When a technology has the potential to be recommended with managed access, the committee will state the conditions for its use in the draft or final draft guidance and will identify the nature of the clinical uncertainty that should be addressed through data collection. Details of data collection, including a protocol and analysis plan (when applicable), will be set out in a data collection arrangement.
The draft guidance and committee papers are sent to stakeholders for consultation. These documents are confidential until NICE publishes them on its website. Information designated as confidential will be redacted from the documents.
The purpose of the consultation is to seek views on the draft recommendations and to determine whether they are an appropriate interpretation of the evidence considered. NICE invites comments on whether:
all the evidence available to the committee has been appropriately taken into account
the summaries of clinical and cost effectiveness are reasonable interpretations of the evidence
the draft recommendations are sound and constitute a suitable basis for guidance to the NHS
there are any equality issues that need special consideration that are not considered in the draft guidance.
Stakeholders have 28 days from the date of sending to submit comments on the draft guidance. They must submit their comments in writing, preferably electronically.
NICE publishes the draft guidance and any additional committee papers not already shared on its website with an electronic comment facility within 7 days of circulation to stakeholders. Confidential information is redacted for public consultation.
If a comment contains confidential information, the organisation or person who submitted the comment should provide 2 versions, a complete version and another with the confidential information redacted (to be published on NICE's website), with a checklist of the confidential information. Detailed instructions on sending NICE confidential information about an evaluation are available from the project manager.
After the draft guidance has been developed, new evidence will not be accepted unless specifically requested by the committee, or if a stakeholder requests that NICE considers additional evidence and NICE specifically confirms it will accept it in writing. It is preferrable for available additional evidence to be submitted in response to the technical engagement stage (when held).
The committee may be unable to develop recommendations for the technology without further scrutiny or further evidence submission. If this is the case, the evaluation can be paused. NICE may request that the company or EAG submit specific information, further analyses or an updated economic model. When the committee seeks such clarification, NICE will inform stakeholders within 7 days of the committee meeting. After this pause, the committee will make a recommendation.
For cost-comparison evaluations with a funding requirement, final draft guidance will normally be developed after committee ratification or a full meeting. In exceptional circumstances, the committee may be unable to develop recommendations for the technology without further scrutiny or further evidence submission. If this is the case, NICE will publish a statement advising that the committee is unable to make a recommendation. If a company wishes to resubmit after the committee has stated that it is unable to make a recommendation, the topic will be rescheduled into the committee work programme. It will not always be possible to prioritise the topic for immediate review.
Where the committees' preferences and key assumptions are clear after the first committee meeting and a pause implemented to allow for further commercial consideration, NICE will issue final draft guidance after a second committee meeting according to its normal timelines. NICE will be unable to accommodate additional requests for delay to accommodate PAS or commercial access agreement discussions at this final stage of guidance production.
If draft guidance is produced the committee usually meets again, with members of the public and press observing. This is to consider the preliminary recommendations in the draft guidance with comments received. Before the meeting, NICE sends the committee members the full text of the comments from the stakeholders.
Representatives from the company, the EAG and from other teams at NICE (for example, guidelines and public health) who are responsible for developing NICE guidance in areas related to the evaluation, may attend the meeting. The chair of the committee may invite 1 or more of the clinical experts, NHS commissioning experts or patient experts to attend.
The committee discusses the responses to the draft guidance consultation in the public part of the meeting and moves to a private session to consider any confidential information and to agree the content of the final draft guidance, which sets out the final recommendations. After the meeting, the final draft guidance is drafted based on the discussions at the meeting and the final recommendations agreed by the committee.
When stakeholders submit comments that lead to a substantial revision of the committee's previous decision, involving a significant change in the recommendations, discussions or the evidence base, NICE and the chair of the committee will decide whether it is necessary to repeat the draft guidance consultation. The decision to hold another consultation will extend the timelines for the evaluation. NICE will distribute the committee papers with the second draft guidance, together with consultation comments and any new evidence not circulated with the previous draft guidance.
For technology appraisals and highly specialised technologies, the company can respond to the consultation by making an updated commercial offer. If the revised ICER is below the maximum acceptable ICER specified by the committee in the draft guidance, the chair can decide on behalf of the committee whether the company's proposal is likely to result in the technology being recommended as an option. In these circumstances, the chair may decide that another committee meeting is not needed. Final draft guidance is drafted, and the final recommendations are agreed by the committee electronically.
For technology appraisals and highly specialised technologies, when the committee has requested new analyses, this has been provided using the committee's preferred assumptions, and if the revised ICER is below the maximum acceptable ICER specified by the committee in the draft guidance, the chair may decide that another committee meeting is not needed. Final draft guidance is drafted, and the final recommendations are agreed by the committee electronically.
For medical technologies and diagnostics guidance, the chair will review the consultation comments received. When the comments will not change the recommendations, the chair can decide that another committee meeting is not needed. Factual changes and corrections to the guidance are made and final draft guidance and recommendations are agreed by the committee electronically.
The chairs decision will be shared with stakeholders within 7 days of sign-off. This will be a brief statement of the decision.
The final draft guidance contains:
the committee's final recommendations to the NHS on the technology and how it should be used
a description of the technology, its cost and, when relevant, its licensed indication and dosage
a description of how the committee has interpreted the evidence together with the key issues raised by experts
the committee's preferred assumptions and maximum acceptable ICER, when applicable
expectations about implementation of the recommendations, if appropriate
proposed recommendations for further research, if appropriate.
After internal sign off of the final draft guidance, a report is submitted to NICE's guidance executive. The guidance executive checks that the committee has evaluated the technology in accordance with the terms of the Secretary of State for Health and Social Care's referral (for technology appraisal and highly specialised technologies) and the scope. If satisfied, the guidance executive approves the final draft guidance for publication on behalf of the NICE Board.
NICE issues the final draft guidance to consultees so that they can consider whether to appeal or raise a resolution request against the final recommendations. They can also highlight any factual errors. Other stakeholders receive the final draft guidance for information and can also highlight any factual errors. Details of the appeal and resolution processes are set out in finalising and publishing the guidance chapter.
When NICE sends the final draft guidance to stakeholders, any further analysis done by the company, NICE or the EAG during development of the final draft guidance will be made available to stakeholders. Comments received on the draft guidance (if produced), together with NICE's responses to them are also provided.
NICE usually sends the final draft guidance within 35 days of the committee meeting to stakeholders. NICE notifies stakeholders if a delay is expected. NICE publishes the final draft guidance and the committee papers on its website, with confidential material redacted, within 7 days of circulation to stakeholders. NICE notifies stakeholders if a delay is expected.
In exceptional circumstances NICE may do further analysis. The EAG or Decision Support Unit normally does this further analysis before NICE circulates the final draft guidance. This is to ensure that NICE can provide robust guidance to the NHS. The centre director or programme director decides whether this is needed, with the chair of the committee and the NICE team. If further analysis is done, NICE will inform stakeholders. NICE will distribute any such analysis to stakeholders and publish it on the website at the same time as the final draft guidance.
After a medicine is recommended with managed access by the committee, the data collection agreement must be finalised between the relevant stakeholders for publication alongside the final draft guidance 35 days after the committee meeting.
NICE will invite the company to provide a draft data collection agreement document using a proforma template. NICE may ask the company to begin developing this document at any point during its assessment of the managed access proposal.
Depending on the complexity of the topic, the data collection agreement will be developed in collaboration with stakeholders. It will set out:
the key clinical uncertainties identified by the committee
eligibility of the patient population
outcome data that could sufficiently support the case for adoption
sources of data
the duration of data collection
the analytical outputs needed
information governance, ethics and data sharing considerations
monitoring arrangements
publication considerations.
The NHS commercial framework for new medicines enables companies to submit proposals for patient access schemes (PAS) and, in addition, allows NHS England and NHS Improvement to offer companies the potential opportunity to enter into complex confidential agreements. NICE endorses the principles outlined in the framework in its commercial and managed access activities.
These arrangements allow companies to improve their value proposition as part of the evaluation process when NICE's assessment of value, on the current evidence base, is unlikely to support the list price.
The NHS commercial framework for new medicines describes 2 key types of commercial arrangement:
Patient access schemes (PAS)
Commercial access agreements
A PAS can be proposed by a member company of the 2019 voluntary scheme for branded medicines pricing and access. A PAS proposal is submitted to NHS England and NHS Improvement. This is then referred to NICE for advice on the feasibility of implementing the scheme in England. The advice from NICE informs NHS England and NHS Improvement's decision on whether the proposed PAS can be considered in the NICE evaluation. The PAS review process is not part of the NICE evaluation process.
Unlike a PAS, a commercial access agreement is only expected to be used in specific circumstances. The feasibility of implementing a commercial access agreement is assessed directly by NHS England and NHS Improvement, with a commercial access agreement being agreed between NHS England and NHS Improvement and the company. This includes commercial access agreements contained within managed access agreements.
NICE will only consider a PAS or commercial access agreement proposal after NHS England and NHS Improvement approval.
All references to the NHS are to the NHS in England and Wales.
A PAS is the starting point or default option for companies to consider when developing their value proposition for evaluation by NICE. Unless a technology is to be considered at list price, companies should always include a PAS when making their initial evidence submission to NICE. This is to ensure enough time for full consideration in advance of the committee meeting.
There are 2 types of PAS:
simple discount patient access scheme (confidential)
complex patient access scheme (non-confidential).
For further details, see NICE's arrangements for patient access schemes.
A simple discount PAS scheme must meet the simple discount criteria which ensure that a PAS does not cause a significant ongoing additional burden on the NHS, as set out in the NICE's arrangements for patient access schemes and the relevant PAS proposal template.
A complex PAS scheme includes all other type of PAS and can include a wide range of mechanisms. In contrast to a simple PAS, a complex PAS is non-confidential. This is because transparency is needed to make sure the administrative burden and cost to the service of implementing such schemes within the NHS is minimised and helps to make sure the value of the treatment, as determined by NICE, is achieved. A complex PAS scheme must meet the criteria which ensure that a PAS should be operationally manageable for the NHS without unduly complex monitoring, disproportionate additional costs and bureaucracy, as set out in the NICE's arrangements for patient access schemes and the relevant PAS proposal template.
NHS England and NHS Improvement is unlikely to agree to more than 1 PAS for a single technology, because of the complexity this would introduce for the NHS. Therefore, a PAS proposal should be designed so that it could apply across all relevant indications of a technology.
In line with the 2019 voluntary scheme for branded medicines pricing and access, simple confidential and complex non-confidential PASs continue to be available in accordance with the criteria and terms as originally set out in the 2014 Pharmaceutical Price Regulation Scheme. NICE considers the key principles contained in this document when assessing a PAS.
Changes may be made to a PAS proposal after NHS England and NHS Improvement has referred it to NICE, but these must be discussed and agreed with NHS England and NHS Improvement.
As described in NHS commercial framework for new medicines, a commercial access agreement is a confidential agreement and is agreed at NHS England and NHS Improvement's discretion, with the default arrangement of offering a PAS (simple or complex) always being available to companies.
As stated in the NHS commercial framework for new medicines, a PAS is the starting point or default option for companies developing their value proposition for evaluation by NICE; therefore a commercial access agreement may build upon a PAS included in a company's initial evidence submission to NICE.
For further details of the circumstances in which NHS England and NHS Improvement may consider a commercial access agreement, please see the NHS commercial framework for new medicines.
The process for assessing the impact of a PAS or commercial access agreement proposal on the cost effectiveness of a technology depends on when the proposal is submitted to NICE. When proposing a PAS or commercial access agreement as part of a NICE evaluation, companies should make sure that:
Unless a treatment is to be considered at list price, a PAS should always be included in the initial evidence submission to NICE to ensure enough time for full consideration and approval in advance of the first committee meeting.
In certain circumstances, a revision to an existing simple discount PAS proposal or a new commercial access agreement proposal may be accepted at other times during the NICE evaluation process. A revision can be proposed:
in response to technical engagement (when held)
in response to the draft guidance
at the end of the process, once any appeals have been heard and NICE's final guidance has been issued to the NHS. This may generate a rapid review of the published guidance.
There will be a single opportunity to revise a simple discount PAS or propose a commercial access agreement at each of these points.
The approval of a complex PAS may be possible when proposed in response to technical engagement (when held) or the draft guidance. It is the company's responsibility to ensure that NHS England and Improvement has enough time to complete its consideration in time for the committee meeting. Please note, for cost-comparison evaluations companies must include an NHS England and NHS Improvement approved PAS or commercial access agreement proposal in their initial evidence submission.
Significant or structural changes to, or new proposals for a PAS or commercial access agreement will not be accepted after release of the final draft guidance.
A company interested in submitting a PAS or discussing a commercial access agreement proposal should first contact the NICE commercial liaison team. The company should also consult the Commercial Medicines Directorate at NHS England and NHS Improvement.
In line with the NHS commercial framework for new medicines, initial discussions with NICE will focus on submission of a simple PAS proposal, as the default commercial proposal.
If at any point in the evaluation process, NICE identifies that a technology is not likely to be cost effective with a simple or complex PAS, NICE and NHS England and NHS Improvement will liaise to assess the potential for a commercial access agreement proposal. A commercial access agreement proposal can only be considered if a PAS proposal has been fully explored.
The committee can consider a revised simple or complex PAS proposal before formal approval from NHS England and NHS Improvement when the risk of non-approval is considered low (for example when the NICE advice to NHS England and NHS Improvement supports the proposal). A new commercial access agreement can only be considered when NHS England and NHS Improvement informs NICE that a deal in principle has been agreed. NICE will not release draft or final draft guidance until formal approval of the PAS increase or commercial access agreement is received from NHS England and NHS Improvement.
If a company submits a revised simple discount PAS proposal or NHS England and NHS Improvement approve a commercial access agreement proposal after the initial evidence submission, the following conditions apply:
For a simple discount PAS revision, the company must inform the project team in writing of its intention to submit an amended proposal, as early as possible.
For a commercial access agreement, NHS England and NHS Improvement must inform the NICE commercial liaison team in writing of its intention to agree a commercial access agreement, as early as possible.
The company must provide information on the revised proposal in a separate submission, using the NICE PAS submission template.
The revised proposal must be received by NICE at least 14 days before the next committee meeting, to allow time for review.
NICE's commercial liaison team activities are aligned with key steps in the technology evaluation processes and focus on key commercial checkpoints. The procedures and minimum timescales are summarised below. This information is for guidance only because the time needed for each stage can vary.
If NICE's commercial liaison team identifies that a technology is unlikely to be cost effective with a simple or complex PAS alone at checkpoints 1 to 4, it will liaise with NHS England and NHS Improvement to assess the potential for a commercial access agreement proposal. This may result in NHS England and NHS Improvement contacting the company directly. A commercial access agreement proposal can only be considered if a PAS proposal has been fully explored.
This checkpoint allows for early engagement. NICE's commercial liaison team uses this checkpoint to have informal discussions with a company about their commercial intentions. The team will:
explore the need for submission of a simple discount PAS as the starting point or default option
explore any commercial challenges that mean the technology may not be cost effective with a simple or complex PAS.
NICE's commercial liaison team reviews the decision-problem meeting documents submitted by the company for details of the company's commercial intentions. This review is usually a few weeks before the invitation to participate is issued. The team will:
assess whether the company intends to submit a simple discount PAS as the starting point or default option
assess any commercial challenges that mean the technology may not be cost effective with a simple or complex PAS.
When the company's evidence submission is made, NICE's commercial liaison team:
checks that a simple discount PAS proposal has been submitted
checks that a budget impact test submission has been made
assesses any commercial challenges that mean that the technology may not be cost effective with a simple or complex PAS or is likely to breach the budget impact test.
When the EAG report is received, NICE's commercial liaison team re-assesses any commercial challenges the company may have that mean the technology is not likely to be cost effective with a simple or complex PAS or is likely to breach the budget impact test.
NICE's commercial liaison team may join the project team at the technical engagement meeting with the company.
NICE's commercial liaison team prepares a commercial summary which is shared with the project team, the company, and NHS England and NHS Improvement. This summary is usually available 4 weeks before the committee meeting.
If the topic is identified as high risk of not being cost effective with a simple or complex PAS alone, NICE's commercial liaison team will seek formal confirmation from NHS England and NHS Improvement that they would be willing to discuss a commercial access agreement after the committee meeting if necessary.
The commercial summary covers the following points:
confirms the commercial arrangement that will be considered by committee
identifies any risks relating to cost effectiveness in the evaluation or budget impact test that the arrangement may carry
confirms NHS England and NHS Improvement's position on their willingness to offer commercial discussions about a commercial access agreement after the committee meeting.
There is no opportunity for a company to change the structure of its PAS or commercial access agreement proposal or to make substantial revisions after this point and before the committee meeting. In exceptional cases, minor revisions to the structure of an existing PAS or commercial access agreement may be considered.
The NICE commercial liaison team will attend committee meetings for topics where NHS England and NHS Improvement's indicate they are willing to offer commercial discussions about a commercial access agreement after the committee meeting.
When a company and NHS England and NHS Improvement agree to enter additional commercial discussions (see sections 5.8.33 to 5.8.41) NICE's commercial liaison team will provide a commercial briefing to NHS England and NHS Improvement and the company within 7 days of the company confirming it is willing to accept the committees' main assumptions. The briefing includes the committee's preferred assumptions for the evaluation and the implications for the company's value proposition.
Any commercial access agreement agreed must be in line with the committee's preferred assumptions in the commercial briefing.
Within 16 weeks of publication of the final guidance, companies can request a rapid review to consider new PAS or commercial access agreement proposals. The rapid review of the guidance is planned into the work programme. NICE can only consider a new PAS or commercial access agreement proposal with NHS England and NHS Improvement's agreement. The committee will usually consider the proposal within 6 months of the company request.
The rapid review of guidance will normally be used to consider a new approved PAS or commercial access agreement only. If the company wishes to submit additional new evidence other than a new approved PAS or commercial access agreement proposal, NICE will consider whether this would be acceptable in the context of a rapid review or whether it would trigger a full review proposal.
The company must provide details of the new proposal, a revised economic model incorporating the proposal, and an updated checklist of confidential information, if necessary. This is in addition to the information that must be submitted to NHS England and NHS Improvement as part of a submission for a PAS or commercial access agreement proposal.
When a new PAS or commercial access agreement proposal has been approved and is regarded as low risk by NICE, a subset of the committee will review the evidence and will be able to make a recommendation outside of the context of a full committee meeting. The full committee will be asked to ratify the decision ahead of the release of any draft guidance document. Any concerns from the lead team or committee, or classification of high risk will result in a full committee meeting.
Although NICE will include a PAS or commercial access agreement proposal submitted for rapid review on the relevant committee meeting agenda, NICE makes no public announcement about the specific topics and will hold the committee meeting in private. PAS and commercial access agreement proposals submitted as a rapid review are treated by NICE as commercial in confidence and all matters about the proposed scheme (except the existence of the scheme proposal) will usually remain confidential unless consideration by the committee results in a change to guidance recommendations. In this situation, NICE will issue final draft guidance for appeal. NICE releases information with the final draft guidance so that the proposed scheme and its impact on the clinical effectiveness, cost effectiveness and the recommendations can be understood.
If, in exceptional circumstances, NHS England and NHS Improvement approves a PAS or commercial access agreement proposal more than 16 weeks after guidance publication, the topic could be considered under the rapid review arrangements. However, it would not be prioritised in the work programme and NICE would need to be assured that the principles of rapid review apply.
As referred to in sections 1.3 to 1.5, of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 (the 'Regulations'), expect NICE to:
"recommend […] that relevant health bodies provide funding within a specified period to ensure that the health technology be made available for the purposes of treatment of patients" and
"specify in a technology appraisal recommendation the period within which the recommendation […] should be complied with", which "must be a period that begins on the date the recommendation is published by NICE and ends on the date 3 months from that date".
The regulations state that if NICE considers it appropriate, NICE must specify a longer period, when:
the health technology cannot be appropriately administered until:
training is given to staff involved in the delivery of the drug to patients
certain health service infrastructure needs including goods, materials or other facilities are in place
other appropriate health services resources, including staff, are in place; or
the health technology is not yet available in England.
The regulations require NICE, when it is minded to specify a longer period, to consult with "such persons with an interest in the appraisal of a health technology…about the appropriate period that may be specified in a technology appraisal recommendation", and that this consultation must include "the Secretary of State and the [Commissioning] Board [now referred to as NHS England and NHS Improvement]".
NHS England and NHS Improvement may request a longer time to implement the statutory funding requirements for technologies funded through its specialised commissioning budgets. This may happen when the potential net budget impact is expected to exceed £20 million per year in any of the first 3 financial years of its use in the NHS. NHS England and NHS Improvement will also do this on behalf of clinical commissioning groups, for locally commissioned technologies that NICE has evaluated.
If the potential net budget impact is expected to exceed £20 million per year in any of the first 3 financial years of a technology's use in the NHS, NHS England and NHS Improvement will offer to engage in commercial discussions with companies whose technologies are being evaluated by NICE before requesting a variation to the funding requirement.
A commercial discussion may not result in a budget impact of less than £20 million per year in each of the first 3 financial years of the technology's use in the NHS in England. In such cases, and when NHS England and NHS Improvement requests a variation to the funding requirement, NICE will take into account any relevant aspects of the commercial discussion in responding to the variation request.
After receiving submissions from the company and NHS England and NHS Improvement, NICE will assess the potential budget impact of the technology by estimating the net annual cost to the NHS (see the assessing resource impact process manual for further details).
Where submissions have been received from both the company and NHS England and NHS Improvement, NICE will also share the initial company budget impact test submission with NHS England and NHS Improvement. Conversely NICE will share any budget impact test submission from NHS England and NHS Improvement with the company.
NICE will share a draft budget impact test with the company and NHS England and NHS Improvement, normally within 17 days after receiving the company submission.
NHS England and NHS Improvement and the company will have 7 days to comment on the draft budget impact test.
NICE will update and finalise the budget impact test within 7 days of receiving any additional information and re-issue a final budget impact test to NHS England and NHS Improvement and the company.
Within 7 days after receiving the final net budget impact estimate, NHS England and NHS Improvement must inform NICE whether it intends to have a commercial discussion with the company. This will allow NICE to plan for potential changes to the timelines of a technology evaluation.
If there remains a material difference of opinion between NHS England and NHS Improvement, the company and the NICE budget impact test, details will be submitted to the NICE executive team for resolution. NHS England and NHS Improvement and the company will be informed of progression to this step, and anticipated timelines for the decision.
NHS England and NHS Improvement and the company will be informed of the final decision with 7 days of NICE's executive team discussion. The budget impact test approved by NICE's executive team will be used for commercial negotiations and should any variation to the funding requirement be sought by NHS England and NHS Improvement.
The budget impact commercial discussion between the company and NHS England and NHS Improvement will be done in parallel with the evaluation timescales. NHS England and NHS Improvement must provide a progress update to NICE at least 7 days before the first committee meeting. Any budget impact commercial agreements confirmed at this point will be to specifically manage the net budget impact of the technology and will not be reviewed by the committee.
For a rapid review, the time frame for the budget impact commercial discussion between the company and NHS England and NHS Improvement will be readjusted accordingly.
If the committee recommends the technology as an option or makes a recommendation for optimised use of the technology, NICE will update its budget impact assessment of the technology.
When draft guidance is issued for consultation after the committee meeting NICE will inform the company and NHS England and NHS Improvement of the (new) estimate for budget impact, at the same time the draft guidance or final draft guidance is published.
If NHS England and NHS Improvement and the company intend to pursue a commercial access agreement after the first committee meeting, and they anticipate that it will need more time than the next phase of the NICE process provides, NHS England and NHS Improvement must formally notify NICE. They must do this 7 days after receiving details of the potential budget impact of the committee's recommendations. NICE will suspend the evaluation for a maximum of 12 weeks, to allow a second opportunity for commercial engagement and inform stakeholders. NICE will decide when the evaluation will restart. The subsequent committee meeting will be rescheduled in line with the time needed for concluding the commercial engagement.
If NHS England and NHS Improvement intends to apply for a variation to the funding requirement after the first committee meeting, it must do so at the earliest opportunity, and no later than the end of the suspension period.
If the committee chooses to alter the draft recommendations, NICE will update its assessment of the budget impact of the technology, when appropriate (see NICE's assessing resource impact process manual). NHS England and NHS Improvement and the company will be informed of the updated budget impact before the release of the final draft guidance and will have an opportunity for commercial engagement before final draft guidance is issued to stakeholders.
If the potential net budget impact is expected to significantly exceed £20 million per year in any of the first 3 financial years of a technology's use in the NHS, NICE may consider a request from NHS England and NHS Improvement to allow a pause after release of the final draft guidance to stakeholders before publication of the final guidance.
Requests will be considered on a case-by-case basis and must be received within 7 days of NHS England and NHS Improvement and the company being informed of the net budget impact.
If NHS England and NHS Improvement intends to apply for a variation to the funding requirement, it must do so at the earliest opportunity, and no later than the end of the period for consideration and lodging an appeal.
NHS England and NHS Improvement can advise NICE that it may need to apply to vary the funding requirement directly after receiving the estimate of the net budget impact at the evidence submission stage or at later stages in the evaluation.
When requesting a variation to the funding requirement, NHS England and NHS Improvement should provide:
the duration of, and the justification for, the proposed variation.
the relevant provisions of any commercial arrangement reached with the company.
in the case of a technology funded from the national specialised commissioning budgets, the amount and phasing of funding that will be made available and how this will be applied to patients eligible for treatment.
in the case of technologies funded by clinical commissioning groups, the direction it intends to give about the phasing of funding during the deferred funding period.
an assessment of the impact on patients who are eligible for treatment under the guidance, but whose treatments will be delayed because of the funding variation, taking into account NHS England and NHS Improvement's and NICE's responsibilities under equalities legislation.
details of the interim commissioning policy that would be applied to phase in funding and to manage access to the technology during the extended funding variation period.
NICE will present the application for a variation to the funding requirement to NICE's guidance executive at the earliest opportunity. This can be at the stage of developing the draft guidance (to allow for consultation on guidance executive's decision to vary the timescale for the funding requirement at the same time as consultation on draft recommendations), with final draft guidance, or during the appeal period.
At each of these stages, guidance executive will decide whether it will vary the timescale for the funding requirement taking into account whether:
the budget impact test has been met
all reasonable opportunities for reaching a commercial arrangement have been pursued
the request is in proportion to the size of the budget impact
the request takes account of the severity and acuity of the condition that the guidance relates to
NHS England and NHS Improvement's and NICE's duties under equalities legislation have been considered
an interim commissioning policy has been developed to provide phased funding for, and access to, the technology during the extended funding period.
Regardless of the duration of the variation requested, all applications will need to contain proposals for a phased allocation of funding.
For technologies for which the budget impact test is met, guidance executive will consider applications to vary the funding requirement, normally for up to a maximum of 3 years. In exceptional circumstances, a longer period may be considered.
Applications to vary the funding requirement are specific to each evaluation. However, when considering technologies with indications for which a treatment has already been recommended and a funding variation is in place, NICE will take into account the combined budget impact for both technologies when considering an application for a funding variation for the second (and subsequent) technologies.
When guidance executive decides to vary the timescale for the funding requirement, this decision will be shared with stakeholders, including NHS England and NHS Improvement and the Secretary of State for Health and Social Care, for a 21-day consultation period. The provisional decision will be published for information on the NICE website 7 days later.
Comments received during consultation from stakeholders will be presented to guidance executive to reach a final decision on the timescale for the funding requirement. The decision and comments received will be published on the NICE website at the next appropriate step in the process.
The final guidance will refer to the variation to the funding requirement (when appropriate).
After the completion of surveillance in section 8.7, NICE will schedule a rapid update of the guidance to coincide with NHS Commercial Medicines Unit tenders for these technologies. The rapid update will focus on the active substance rather than the individual products. A rapid update cannot be used to update terminated guidance.
Companies that produce the biosimilar or generic technologies (including the originator company) will not need to provide an evidence submission to support a rapid update to guidance after loss of marketing exclusivity.
An EAG will develop a report that evaluates the economic model against a predetermined checklist. The report will include a targeted literature review and clinical expert engagement. It will determine whether:
there have been changes to the evidence base since the guidance was published
there have been changes to the care pathway since the guidance was published
cost was the key factor resulting in the technology not being recommended or recommended for optimised use.
NICE will not issue the report for technical engagement.
Participating companies will have 14 days to consider the report before it is considered by representatives of the committee who will act on behalf of the full committee. This will normally be the committee chair and a 3-member lead team.
The committee representatives will use the report to assess if there have been significant changes since the original guidance and whether the economic model can still be used for decision making. They will also decide on the threshold ICER for the technology to be considered cost effective, if this is not clearly identified in the original guidance.
If the committee concludes that the economic model can be used for decision making, final draft guidance will be developed using standard development timelines. New guidance will be published that will replace the original guidance.
If the committee concludes that the economic model cannot be used for decision making, no updated guidance will be produced. NICE will produce a statement indicating that the committee is unable to update the recommendations for the technology.
The implementation of the budget impact assessment within the evaluation will not affect publication of the advice and tools to support the local implementation of NICE guidance. This includes resource impact tools or statements for most evaluations and additional tools for some technology evaluations.