NICE’s ‘Proportionate Approach to Technology Appraisals (PATT)’: The Story So Far

What is the ‘proportionate approach’?

The proportionate approach to technology appraisals (PATT) aims to apply light-touch, faster approaches to simpler, low-risk treatments, allowing the National Institute for Health and Care Excellence (NICE) to produce rapid guidance for some topics, free up their capacity for complex areas that need tailored support, and ultimately deliver on their commitment to appraise all new medicines and indications.

On the 31st October 2023, NICE released the first modular update to the health technology evaluations manual, including updates to methods and processes to reflect NICE’s proportionate approach to technology appraisals. Costello Medical have now supported the development of over 10 appraisals under the proportionate approach and participated in the public consultation on the interim methods and process update in summer 2023.

We have reflected on our experience developing appraisals under these new methods and processes, their impact so far and the associated challenges and opportunities we have encountered, focusing on those topics that have been formally incorporated into the modular update to the health technology evaluations manual. We have also outlined some recommendations for manufacturers. A summary of our reflections is presented below.

*This commitment has been retained in the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG).

  • A streamlined approach to appraisal and decision-making process for cost-comparison and low-risk appraisals.
  • Pilot concluded: Included in the first modular update to the health technology evaluations manual in October 2023.
  • Improvements within the scope of established methods and processes, such as proportionate use of technical engagement, paired appraisals and handling of confidential information.
  • Pilot concluded: Included in the first modular update to the health technology evaluations manual in October 2023.
  • Pre-specifying the assumptions in economic analyses based on committee preferences from past appraisals, reducing time required to assess and present key issues.
  • Not taken forward: A retrospective pilot based on three breast cancer appraisals from 2022 demonstrated that this approach was not appropriate, as there was not enough consistent precedent to establish pre-specified assumptions.
  • A single, ongoing appraisal for medicines across a whole disease pathway, including a NICE-built, owned and maintained pathway model.
  • Pilot ongoing: based on feedback from consultees on the NICE ‘pathways’ pilot appraisal in renal cell carcinoma, NICE shared that they intend to revise their approach to “make use of ‘reference models’ that can be implemented within the current STA framework”.1
    • The model developed by an academic group as part of this ‘pathways’ pilot appraisal was deemed not fit for purpose by the companies involved, with concerns raised over complexity and transparency.
    • In order to characterise the full disease pathway and the impact of treatment sequences, the academic group developed a cost-effectiveness model in R that was considered overly complex by the companies involved, to the extent that the probabilistic sensitivity analyses could not be run due to computational burden.
    • Additionally, the model was based on large quantities of unpublished and confidential real-world evidence analyses, such that consultees were unable to validate the EAG’s economic analyses; it was argued that submission of such an evidence package by a company would not have been permitted or accepted by NICE.
  • Streamlined decision-making for treatments likely to rely on a managed access agreement.
  • Pilot ongoing.

Cost-Comparison Appraisals

What is the cost-comparison appraisal route?

  • To improve efficiency in the route to reimbursement for next-in-class or similar medicines, NICE have further streamlined the cost-comparison route (introduced in January 2022 to replace the fast-track appraisal [FTA] process). The cost-comparison route is suitable for technologies associated with similar or greater health benefits, at similar or lower costs, than technologies already recommended by NICE for the same indication.
  • Time savings highlighted in the interim methods and process guide include:
    • A proportionate review of the evidence package by an external assessment group (EAG)
    • A reimbursement decision made outside of a full committee meeting (sub-committee sign-off)
      • If the subset of the committee cannot make a recommendation, a full committee meeting will be required2
  • The interim methods and process guide states that a technology will be selected for the cost-comparison route at the scoping meeting stage (following discussion on the population, treatment pathway, benefit and clinical similarity to existing treatments in UK clinical practice)

What impact have we seen?

So far, our experience of supporting submissions that have undergone the cost-comparison route has been broadly positive, resulting in significant time savings in the route to reimbursement compared to both the prior FTA and STA processes. These findings were corroborated by the results of NICE’s pilot learnings on the proportionate approach, presented at their March 2023 webinar, which found that the cost-comparison route reduced the appraisal process to 23 weeks (compared to 34 weeks and 44 weeks for the former FTA process and the existing STA process, respectively).3

What challenges and opportunities have we faced?

Whilst these findings are positive, technologies suitable for a cost comparison could be further differentiated on the basis of risk at the scoping stage. Further streamlining this process could result in faster reimbursement for novel medicines, free up NICE’s capacity to focus on more complex appraisals and reduce costs to manufacturers:

  • Lower-risk cost-comparison cases could be further streamlined: It may be reasonable to accept greater uncertainty around cases of comparable efficacy when a decision is associated with low risk, for example, when the opportunity cost of marginal differences in treatment efficacy is likely to be very low, and an intervention is associated with considerable cost savings. Accordingly, the appraisal process for lower-risk appraisals could be aligned more closely to the corresponding ‘abbreviated submissions’ process at the Scottish Medicines Consortium (SMC).4 The SMC abbreviated submission process is stated to take 18 weeks from scheduling to publication. However, in our experience of submitting over 10 abbreviated submissions, the process often takes less than 12 weeks. Our research presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2023, revealed that 71% of appraisals proceeding via the FTA route at NICE also utilised the SMC abbreviated submission process, all of which received positive recommendations from both HTA bodies.5
  • Processes could be optimised for borderline, higher-risk cases, to ensure correct routing at the outset: The appraisal process could be further optimised for borderline, higher-risk cases, where there is uncertainty around whether an intervention satisfies the criteria for a cost comparison, e.g. where comparable efficacy versus recommended treatments is informed by an indirect treatment comparison (ITC). If the available evidence is associated with too much uncertainty to accept the case for comparable efficacy, the cost-comparison case may be rejected. The interim methods and process guide provides no clear guidance on the process and timelines associated with rejection, and our experience has not been consistent. In particular, the guidelines do not specify whether a new STA submission would be required, and if so, whether this appraisal would be re-scoped, which could result in substantial delays to reimbursement timelines. Further guidance on the evidence required to fulfil the eligibility criteria for cost-comparison appraisals, and additional clarity on the processes and timelines involved in cases of rejection, would encourage earlier routing of appraisals to the STA process where evidence is too uncertain to accept the criteria for a cost comparison.
  • Guidance and transparency surrounding cost comparison scoping could be improved: There is a lack of clarity around the definition of the decision problem for a cost comparison appraisal. The user guide for the FTA cost comparison company evidence submission published in February 2018 notes that it “is acceptable to make a cost-comparison case with only 1 of the comparators in the scope, provided that the selected comparator satisfies all of the following criteria: 1) it adequately represents the NICE-recommended treatments as a whole, both in terms of its cost and effects, 2) it has a significant market share and 3) it is recommended in published NICE technology appraisal guidance for the same indication.”6 No such wording is included in the user guide for STA cost comparison company evidence submission template published in January 2022. Our experience of recent cost-comparison appraisals is that selection of a single or subset of comparators from those listed within the NICE scope can still be accepted in certain circumstances, but this appears to be inconsistent across appraisals without clear rationale. For example, we have seen EAGs conclude that all treatments listed in the NICE scope should be included in the cost comparison if they represent relevant options in clinical practice, but in other cases EAGs have accepted restriction to a single comparator despite many treatments being available and used in practice.

Navigating the cost-comparison appraisal route

  • A lack of head-to-head evidence is a common and often unavoidable challenge facing manufacturers. Our research shows that indirect evidence informing the case for comparable efficacy can be sufficient, but the nature of evidence matters.7 Anchored ITC methods, such as network meta-analyses (NMAs) are often considered suitable to inform the case for comparable efficacy, but ITC methods that are subject to substantial uncertainty, such as unanchored, population-adjusted ITCs, are less likely to be considered sufficient.
  • To avoid potential rejection of a cost comparison and subsequent re-routing, we suggest transparently presenting the evidence available to inform the case for comparable efficacy at the scoping stage (as part of the decision problem meeting proforma) to inform NICE’s decision.
  • There are opportunities for streamlining appraisals within the STA process, if deemed appropriate (as discussed below); the fastest route to reimbursement for borderline cases may therefore be via the STA process initially. We suggest considering presenting cost-comparison scenarios for committee consideration alongside the necessary cost-utility analyses.
  • Our experience is that selection of a single comparator from those listed within the NICE scope for the purposes of a cost comparison can be accepted in certain circumstances, but acceptance is not a foregone conclusion given inconsistency in EAG feedback.


Other Proportionate Approaches

What other ‘streamlined approaches’ are available?

  • NICE have expanded the streamlined approaches already used for cost-comparison appraisals to include a wider group of medicines. Potential streamlining approaches for appraisals not satisfying the cost-comparison criteria include:
    • Streamlined decision-making: Reimbursement decisions made outside of a full committee meeting (sub-committee sign-off)
    • Optional technical engagement: Removal of the 4-week technical engagement step
    • Paired appraisals: Joint committee meetings for appraisals in the same disease area following similar regulatory timelines
  • Unlike the cost-comparison route (where a routing decision is made at scoping), the interim methods and process guide specifies that appraisals may only be re-routed down the streamlined route following full review of the evidence package by the EAG.2

What impact have we seen?

Current timelines for appraisals proceeding via the standard STA route are lengthy, taking a minimum of 44 weeks. We therefore welcome that NICE are investigating ways to streamline the decision-making process for all medicines, not just those satisfying the cost-comparison criteria. Overall, our experience of proportionate approaches outside of the cost-comparison route has been positive, with a reduction in the time to reimbursement versus the standard STA process. In particular, removal of the 4-week technical engagement step has the potential to make the post-submission process less resource-intensive for both manufacturers and NICE, and reduce the time to reimbursement accordingly.

What challenges and opportunities have we faced?

  • Criteria for other streamlined approaches are not well defined: The criteria appraisals must satisfy to be eligible for the changes to topic progression under the proportionate approach remain unclear. In particular, as part of the consultation on the interim methods and process guide, we requested that further clarity be provided on which appraisals may satisfy the requirements for ‘streamlined’ decision-making. Our experience of the cost-comparison process suggests that providing clear requirements with an accompanying incentive of faster routes to access may encourage manufacturers to offer price flexibility to mitigate uncertainty. Manufacturers may opt to present a cost comparison even in cases where available evidence suggests the intervention has additional benefits over existing treatments, but where such benefits are uncertain or difficult to quantify and thus where a price premium would likely require comprehensive evaluation. Similarly, manufacturers may be willing to accept more conservative assumptions around intervention benefit to gain faster access through ‘streamlined’ decision-making.
  • Paired appraisals may be at risk of key issue ‘creep’: Consultees raised concerns around the impact of the paired appraisal process, highlighting that scheduling of two appraisals to align may cause delays to individual appraisal timelines. To this extent, in response to public consultation, NICE have updated the manual to be clear that no topic would ever be delayed, or timelines shifted, to allow alignment to take place. However, beyond timelines, there remains a risk of bias, in which key issues identified may not be common across appraisals, and which may hinder efficient and productive discussion about individual technologies.


  1. NICE. Public commitee slides [GID-TA11158]. Treatments for renal cell carcinoma – cabozantinib with nivolumab. Technology appraisal committee B [1 February 2024]. 2024. Available here. Last accessed: April 2024.
  2. NICE. Health technology evaluations: interim methods and process guide for the proportionate approach to technology appraisals. Available here. Last Accessed: August 2023.
  3. NICE. A proportionate approach to technology appraisals: March update. Available here. Last accessed: August 2023.
  4. SMC. Guidance to submitting companies on abbreviated submissions. Available here. Last accessed: August 2023.
  5. HTA30. The NICE vs SMC Cost Comparison Pathways – How Similar are They? ISPOR 2023. Available here. Last accessed: August 2023.
  6. NICE. User guide for fast track appraisal company evidence submission template. February 2018. Available here. Last accessed: April 2024.
  7. HTA34. Demonstrating Similar or Greater Health Benefits Based on Indirect Evidence: A Review of NICE Evaluations that Included a Cost-Comparison Approach. ISPOR 2023. Available here. Last accessed: January 2023.

If you would like any further information on the themes presented above, please do not hesitate to contact Alex Porteous, Senior Consultant – HTA and Health Economics (LinkedIn). Alex Porteous is a member of the HTA division and an employee at Costello Medical. The views/opinions expressed are their own and do not necessarily reflect those of Costello Medical’s clients/affiliated partners. For more information on our services, please explore What We Do. For more information about HTA at Costello Medical, please contact Rose Wickstead (LinkedIn).