The vast majority of products launching in the UK will be assessed by the National Institute for Health and Care Excellence (NICE) in a Single Technology Appraisal (STA) or a Highly Specialised Technology (HST), both of which we have covered in some detail in our recent articles. To access these please go to our website or LinkedIn page.
The NICE STA/HST appraisals are complex processes with several stages, beginning with the scoping process followed by the invitation to participate, dossier preparation and submission, through evidence assessment and committee meetings to consultation periods and final guidance. These stages can be supplemented by optional steps such as technical engagement. Each stage also has potential pitfalls that can regularly contribute to project delays.
Understanding the NICE appraisal timelines is crucial for effective planning and timely reimbursement. Therefore, this article breaks down the key stages and typical timeframes in the STA and HST processes. We highlight where delays often occur and share tips on managing each milestone to help company planning and help avoid last minute surprises.
Anatomy of a NICE Evaluation
Figure 1 shows the key elements of NICE technology appraisals and what is involved at each stage.
What is the timeline of a Single technology appraisal?
Table 1 presents a timeline of the typical NICE STA timeline based on experience working on submissions, the NICE manual on conducting Technology evaluations and analysis of past appraisals. For each of the commercial checkpoints during the appraisal, where NICE’s commercial liaison team may contact the submitting company regarding the PAS, see the NICE Health technology evaluations manual.1
Table 1: Typical NICE STA timelines
| Step | Typical duration* | Cumulative duration | Key deliverables |
|---|---|---|---|
| Pre-notification, decision problem and & scoping | 6 – 8 weeks | Week 6 – 8 | Final scope, stakeholder list, Decision Problem meeting |
| Invitation to participate ↔ evidence submission | 8 weeks (56 days) | Week 14 – 16 | Company dossier |
| Evidence review & clarification | 11 – 13 weeks | Week 25 – 29 | EAG clarification questions and responses, EAG report, clarification log |
| Optional Technical engagement | 6 – 7 weeks (max 49 days) | Week 31 – 36 | Stakeholder comments on external assessment report |
| Committee meeting #1 | Week 28 – 32 | Week 28 – 32 | Draft guidance |
| Public consultation (if draft guidance produced) | 4 – 6 weeks | Week 32 – 38 | Stakeholder comments to draft guidance |
| Committee meeting #2 / FAD | Week 35 – 41 | Week 35 – 41 | Final draft guidance |
| Appeals period | 3 weeks | Week 38 – 44 | Stakeholder comments on Final draft guidance |
| Ministerial sign-off & publication | ~3 weeks | Week 41 – 47 | NICE guidance issued (TA ###) |
Notes: *Independent analyses of oncology STAs show an average ~36-week (≈8.25 months) route from marketing authorisation to final draft guidance in 2023-24.2
Pre-notification, decision problem and & scoping
Prior to the invitation to participate being sent to the relevant stakeholders, the submitting company have the opportunity to comment on the draft scope and have the option to hold a decision problem meeting with NICE. This allows companies to discuss key uncertainties/questions related to the clinical data analysis and the cost effectiveness model with NICE. It is an optional step that is recommended in the majority of cases. Having this optional meeting is likely to reduce the number of uncertainties arising during the remainder of the process (e.g., as Clarification questions). It also allows companies to target their final evidence preparation.
During this stage, companies and other stakeholders are invited to comment on the draft scope issued by NICE. The NICE health technology evaluation manual states that consultations are either 28, 14 (most common) or 7 days depending on the level of uncertainty in the draft scope. All that companies can do here to ensure that the process moves smoothly is ensure they return the comments on the draft scope in a timely manner.1
Invitation to participate the evidence submission
After the publication of the final scope on the NICE website (approx. 2 weeks after the close of the draft scope consultation) the submitting company have 56 days (8 weeks) to submit the completed evidence submission to NICE.1 Although in our experience, the invitation to participate may be sent to the relevant stakeholders as soon as the consultation period on the draft scope ends, and therefore companies may effectively have 10 weeks to prepare their evidence submission.
Although NICE define this 8-to-10-week period as the time to produce the evidence submission, companies should in reality already have an economic model developed and a full draft of the main submission and supporting documentation already prepared. Instead, companies should spend this time refining their base case and the strategic argumentation/evidence to support this, to make sure they have the best possible chance of making the deadline with a high-quality submission.
Additionally, during this period prior to submission, the company is often invited to attend a clarification meeting with the EAG. It is advisable that the company considers in advance whether they would like to participate in this meeting (further details found later).
Evidence review & clarification
After receiving the companies evidence submission, NICE pass the dossier onto the relevant EAG selected for the appraisal. If the EAG feel the evidence is incomplete, they will send clarification questions to the company 2 to 3 weeks after the submission deadline. Prior to receiving clarification questions, companies should refine their objection handling material and begin any additional analyses that may be needed to answer the EAGs questions, as once questions are received, the company only has 14 days to respond.1
After receiving the EAG clarification questions, the company has the option of participating in a 1-hour clarification meeting with the EAG and NICE assessors, to query any of the uncertainties that have been raised. This meeting allows the company to understand exactly what information is required from the clarification responses and to identify the main questions that should be prioritised.
As previously mentioned, companies have 14 days to respond. However, in situations where the requested analyses require longer than the allotted period, an extension can be requested. Any extension or delay in the EAG receiving company responses may consequently delay the NICE committee meeting. Therefore, companies should endeavour to respond to as many questions as possible within the given timeframe.
Once the company responses have been submitted, the EAG will take ~5 weeks to finalise its analysis before sending the EAG report to NICE, who will share a copy with the company. The company will have the opportunity to review the report for any factual inaccuracies.
Technical engagement
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 raised by the EAG, before the committee meeting. If technical engagement does go ahead, the EAG report is sent to stakeholders within 21 days (3 weeks) of NICE receiving the report, where they have 28 days (4 weeks) to submit any comments.1
During technical engagement, new evidence and analyses may be submitted only if the NICE technical team agrees that this information is likely to impact the committee’s judgments. Submitting new evidence at this stage may further delay the committee meeting, therefore, is generally not recommended. Instead, all evidence and analyses required for decision making should be included in the main submission and in the EAG clarification responses.
Committee meeting #1
Two weeks prior to the committee meeting, the committee papers (includes the company submission, EAG report, clarification questions/responses, final scope and input from organisations/experts) will be sent to all attendees. During the public section of the meeting the lead team committee members present the topic to the other committee members and attendees. Clinical experts, patient experts and any NHS commissioning experts are also encouraged to give their perspective on the evidence presented, including responding to and raising questions. Company representatives are also able to answer any questions from the committee members and comment on any instances of factual inaccuracies. During the private session the committee will consider any relevant commercial-in-confidence information and agree upon the recommendations.1
The outcomes of the committee meeting will be shared with the relevant stakeholders within 7 days. The company will confirm whether they accept the committee’s assumptions. If the product is not recommended, the company have an opportunity to increase the PAS at this stage. The chair reviews the company’s proposal on behalf of the committee and decides whether to accept it or issue a negative recommendation and publish the draft guidance.1
In the majority of cases, especially in oncology and rare diseases, the committee will issue the draft guidance. If NHS England and NHS Improvement confirm that they are willing to engage in discussions about a commercial access agreement, the company can request that NICE pause the publication of the draft guidance for 42 days. This allows discussions with NHS England and NHS Improvement to take place (must be requested within 14 days of the committee meeting).1
Public/stakeholder consultation
If draft guidance is produced, NICE will circulate this to stakeholders for consultation within 21 days of the committee meeting, who have 28 days to submit their comments. NICE will also publish the draft guidance on their website within 1 week of it being circulated to stakeholders.
The company are able to submit further evidence at this stage only if it is specifically requested by the committee. However, NICE prefers that any additional evidence be submitted during the technical engagement stage.
Committee meeting #2
If draft guidance is produced, the committee will meet a second time to discuss the responses to the draft guidance in the public portion of the meeting, followed by consideration of any confidential information and final recommendations in a closed session. If the technology is accepted for use, the final draft guidance will be developed based on discussions during the meeting and the committee’s final recommendations.
If after the second committee meeting the product is still not recommended, the company has another opportunity to make updates to the 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 a positive recommendation can be made and the final draft guidance is produced.1
NICE will circulate the final draft guidance to stakeholders and publish it on its website a maximum of one week later. An appeal period of 3 weeks is provided prior to preparing the guidance for publication as the final technology appraisal.
What is the timeline of a Highly Specialised Technology?
Table 2 is a timeline of the typical NICE HST timeline based on the NICE manual on conducting Technology evaluations and analysis of past appraisals. For each of the commercial checkpoints during the appraisal, where NICE’s commercial liaison team may contact the submitting company regarding the PAS, see the NICE Health technology evaluations manual.1
Table 2: Typical NICE HST timelines
| Phase | Typical duration | Cumulative duration* | Key deliverables |
|---|---|---|---|
| Pre-notification, decision problem & Scoping | 8 -10 weeks | week 8 -10 | Final scope, stakeholder list, Decision Problem meeting |
| Invitation to participate ↔ evidence submission | 8 weeks (official timeline) | Week 16 – 18 | Company dossier |
| Evidence review & clarification | 11 – 13 weeks | Week 27 – 31 | EAG clarification questions and responses, EAG report, clarification log |
| Optional Technical engagement | 6 – 7 weeks (max 49 days) | Week 33 – 38 | Stakeholder comments on external assessment report |
| Committee meeting #1 | Week 30 – 34 | Week 30 – 34 | Evaluation consultation document |
| Public consultation (if Evaluation consultation document produced) | 4 – 6 weeks | Week 34 – 40 | Stakeholder comments to draft guidance |
| Committee meeting #≥2 / FED | The timelines in this stage, as described below, are very heterogeneous, potentially taking several years | The timelines in this stage, as described below, are very heterogeneous, potentially taking several years | Final Evaluation Determination |
| Appeals period | The timelines in this stage, as described below, are very heterogeneous, potentially taking several years | The timelines in this stage, as described below, are very heterogeneous, potentially taking several years | Stakeholder comments on Final draft guidance |
| Ministerial sign-off & publication | The timelines in this stage, as described below, are very heterogeneous, potentially taking several years | The timelines in this stage, as described below, are very heterogeneous, potentially taking several years | NICE guidance issued (HST ###) |
Note: *This is the official timelines, however, as described later this may not be what occurs in reality.
Pre-notification, decision problem & Scoping
Topics that are being considered for HST assessments, in the main, are identified by the National Institute for Health Research Innovation Observatory at the Department Health and Social Care. NICE will work with the Department of health to produce a draft scope which is sent to stakeholders for comment. This consultation period lasts 28 days, an extension compared to STAs.1,3 Similar to STAs, companies can attend a decision problem meeting with NICE before the finalisation of the scope during an HST. Alternatively, companies can submit a completed HST checklist/proforma during an STA decision problem meeting and may be given the option to be routed to an HST.
Invitation to participate, evidence submission and EAG review
Once the invitation to participate is received, companies should have 56 days to make their evidence submission, as per NICEs health technology evaluations manual. However, a review of recent reveals that this timeline is not reflected in reality.
For example, in the recently published HST of Leniolisib for APDS in people 12 years and over [HST33], the invitation to participate/final scope is dated August 2023, but the evidence submission was not submitted until May of the 2024. Therefore, companies should work with NICE to agree upon realistic timelines for evidence submissions. Companies are advised to begin preparatory work well in advance of receiving the invitation to participate, as recommended for STAs.
Similar to the STA process, the HST dossier submitted to NICE is forwarded to the EAG assigned to the appraisal, who reviews the dossier and may request further clarification questions from the submitting company according to the same timeline as an STA. Technical engagement is also available during the HST process and follows the same timelines as during the STA.
Evaluation Committee Meetings and Consultation
The independent HST evaluation committee (HSTEC) meets to make a provisional recommendation as part of the Evaluation Consultation document (ECD). Similarly to STAs, the committee papers (includes the company submission, EAG report, clarification questions/responses, final scope and input from organisations/experts) will be sent to all attendees 2 weeks before this meeting.
Once the ECD is produced this is sent out to consultees and commentators (full list found here) who have 4 weeks to comment on the content. Once comments have been collected, the HSTEC will meet again to discuss the feedback on the ECD. If the technology is accepted for use, the final evaluation determination (FED) is drafted based on the discussions during the meeting and the final recommendations agreed by the committee. Once produced, the FED goes into the appeal period for 3 weeks in the same manner as an STA, before the guidance is prepared for publication as the final HST.
The process described above is mainly aligned with what is stated in NICEs health technology evaluations manual. However, when reviewing the ~30 HSTs that have taken place, it is clear that the process takes a significantly longer time to complete than what is expected based on the manual. The duration of assessment can vary from 1-6 years, with a large portion of the extension being dictated by the number of required committee meetings. For example, HST6 (Asfotase alfa) required 5 committee meetings before the FED was issued.
Conclusion
Timelines for both STA and HST appraisals are variable. However, early planning for each stage is key regardless of whether additional steps such as draft guidance or technical engagement are required. Being prepared for the crunch points in the submission timelines is also key, whether this be bringing on additional resources or making sure that the available resources are used in the most effective way possible.
At Remap, we support clients through every stage of the NICE process, from early strategic planning to final submission. To learn more about how we can help, get in touch.
References
- National Institute of Health and Care Excellence. NICE health technology evaluations: the manual Accessed 07/07/2025, https://www.nice.org.uk/process/pmg36/chapter/developing-the-guidance-2#topic-progression-single-technology-appraisal
- PharmaPhorum. Who delays NICE technology appraisals anyway? Accessed 07/07/2025, https://pharmaphorum.com/market-access/who-delays-nice-technology-appraisals-anyway
- National Institute for Health and Care Excellence. Highly specialised technologies guidance Accessed 09/07/2025, https://www.nice.org.uk/About/What-we-do/Our-Programmes/NICE-guidance/NICE-highly-specialised-technologies-guidance