Public Consultation on Including Technology Appraisal Guidance in NICE Guidelines:  ‘Incorporation’ versus ‘Integration’?

On the 5th February 2024, the National Institute for Health and Care Excellence (NICE) released a draft methods and processes document outlining their proposed approach for inclusion of technology appraisal recommendations in topic guidelines.1 The proposed changes aim to address feedback from NICE users around challenges accessing and synthesising all guidance for specific conditions. To simplify this process, and thereby increase the adoption of guidance in the UK health and care system, NICE have proposed changes to the way in which technology appraisal guidance is included in guideline topic areas.

We participated in the public consultation on the proposed process and methods updates and have highlighted several aspects of the proposed approach that we think would benefit from clarification by NICE, in addition to flagging several key concerns.

What changes have been proposed to the process for including technology appraisal recommendations in NICE guidelines?

NICE have proposed two distinct approaches for the inclusion of technology appraisal recommendations:


Technology appraisal recommendations within the scope of a guideline will be presented unchanged in the given guideline. No assessment will be performed comparing the intervention to alternative technologies; the recommendation and funding requirements will remain in place following incorporation.

Proposed benefits: NICE will be able to provide useful and more readily useable guidance in a timely and straightforward manner.


Comparative analyses of the costs and benefits for alternative technologies will be conducted. In light of the new analysis, guidance may be optimised (i.e., technologies may be recommended for expanded or narrower populations), or if a technology is no longer considered to be a good use of NHS resources, guidance may be withdrawn and a negative recommendation issued.

Proposed benefits: Integration will allow comprehensive and up-to-date guidance to be produced by NICE, setting up a clear clinical pathway in areas with multiple technologies available.

Criteria for integration: Technologies will be considered for integration if there are: 1) multiple treatment options, including at least one technology appraisal, within the decision space, 2) there is no clear or prespecified rationale for choosing one treatment option over another and 3) integration is not expected to happen sooner than three years from the publication of the NICE technology appraisal. If these minimum criteria are met, the NICE prioritisation board will consider whether integration is appropriate, based on factors such as known variation in clinical practice and system considerations.

NICE propose to pilot these approaches in selected updates of guideline topics, which will subsequently inform more detailed processes and methods for including technology appraisal recommendations in topic guidelines.

What are the key steps in the ‘integration’ process?

The consultation document outlined the following key steps in the ‘integration’ process:



  • Stakeholder organisations and consultees that participated in the NICE technology appraisal will be registered for the guideline, but the extent to which stakeholders can provide input on the scope is unclear.
  • The best available evidence will be used to inform integration decisions.
  • This may include specific calls for evidence and use of real-world data (RWD), as well as the economic model submitted as part of the NICE technology appraisal evaluation, but the extent to which stakeholders can provide input on the available evidence is unclear.
  • The application of quantitative decision modifiers will be considered in line with the NICE health technology evaluations manual.
  • In cases where decision modifiers used in the NICE technology appraisal guidance are no longer applicable, the guideline committee will be mindful of how this might influence decisions on cost-effectiveness, including whether health outcomes would be significantly reduced if a technology was withdrawn.
  • No stakeholder input is described.
  • Assessment of cost-effectiveness is described in line with the NICE health technology evaluations manual, and the influence of other factors on the decision to recommend a technology will be considered.
  • No stakeholder input is described.
  • The guideline committee may choose to make recommendations about preferred sequences or hierarchies.
  • Guidance may be optimised (i.e., technologies may be recommended for expanded or narrower populations), or if a technology is no longer considered to be a good use of NHS resources, guidance may be withdrawn and a negative recommendation issued.
  • The funding requirement will no longer apply if NICE technology appraisal guidance is withdrawn.
  • There will be an opportunity to revise an existing simple discount patient access scheme during/after stakeholder consultation or in response to the final draft recommendation.


  • Appeals will follow an amended NICE technology appraisal appeal process.
  • Only consultees are able to lodge an appeal.

Our thoughts on ‘integration’ of technology appraisal guidance into NICE guidelines

We appreciate the important role NICE plays in ensuring practitioners and commissioners are provided with up-to-date, clear and comprehensive guidance to ensure they can deliver high-quality, cost-effective health care for patients. We therefore welcome the proposed process of ‘incorporation’ to support the timely production of useful and relevant guidance.

We do see a potential place for comparative assessment of costs and benefits as part of NICE guidelines, in order to provide a clear and comprehensive overview of the relative benefits and limitations of treatments within a decision space to guide prioritisation and clinical decision-making. However, we see many risks and unanswered questions associated with the ‘integration’ process as outlined in the consultation document, particularly given the proposed potential consequences of the process for existing technology appraisal guidance (i.e. withdrawal of recommendations and associated mandated funding). Our concerns relate both to the feasibility of conducting fair, robust and consistent comparative analyses of costs and benefits with available evidence to be confident that the withdrawal of technologies will improve net population health, as well as long-term potential consequences for system-wide investment and incentives for manufacturers to launch products in the UK market given the already high upfront cost of engaging in the NICE technology appraisal process. Furthermore, the proposed guideline review process itself has the potential to be time- and resource-intensive at a time where NICE has committed to a more proportionate approach to decision-making in part due to concerns around capacity and its commitment to appraise all new medicines and significant licence extensions under the voluntary scheme for branded medicines pricing, access and growth (VPAG). As a result, in our view and pending further detail on how the outlined processes and methods would be applied, there is a real risk that the proposed approach could have adverse consequences for patient access to both existing and new innovative health technologies, as well as limiting patient choice, with potential to reduce net population health in the long run.

We appreciate that the consultation documents are not designed to present the full or final detail of how the guideline integration process would be implemented, but as part of the consultation we provided comments on specific areas where we have identified risks and challenges to help inform the future development of more detailed process and methods documentation.

A summary of our overarching concerns with the proposed integration process is provided below:

The integration process may limit patient choice

Each technology in a given decision space offers unique benefits to patients, in terms of differing efficacy on a patient-by-patient basis, differing contraindications, differing mechanisms of action and differing modes of administration. Withdrawing or restricting recommendations and associated funding mandates will therefore restrict patient choice, with fewer alternative technologies available to patients who may be unsuitable for the technology deemed most cost effective during the integration process. There may also be geographical restrictions to specific technologies, in particular for highly specialised technologies, and thus withdrawing guidance could impact geographical equity of access.

It may be challenging to appraise technologies in a fair and consistent manner

A fair and consistent comparative analysis of the costs and benefits of each technology in a given decision space may be challenging, and the methods and processes outlined in the consultation document leave open a number of important questions that would influence the robustness of such analyses. For example:

  • Criteria for integration – The criteria for technologies being eligible for integration are not clear, with no definition of “decision space” provided and a lack of clarity on whether technologies available under managed access agreements would be within the scope of these assessments. Furthermore, no rationale was provided for the selection of a three-year timeframe for technology appraisal guidance to be considered for the integration process; this timeframe is unlikely to result in substantial additional evidence generation in rare disease spaces or for diseases with a long disease course.
  • Stakeholder input – It is unclear how stakeholders, including manufacturers, will have the opportunity to input on the integration process, for example, responding to the proposed decision problem and providing additional evidence collected on the new technology. Stakeholder input is key to ensure the process is informed by the most appropriate and up-to-date evidence available.
  • Methods for comparative analysis of costs and benefits:
  • It is unclear how these analyses account for the potential for differences in committee preferences across previous technology appraisals for therapies in the same decision space.
  • We note that NICE piloted a ‘pathways approach’ using a central economic model under the proportionate approach to technology appraisal, but based on concerns relating to complexity and transparency, NICE have since revised their approach to make use of ‘reference models’ that can be implemented within the current single technology appraisal (STA) framework.2 This guideline integration process is likely to be subject to similar challenges if a central model would be required for guideline integration assessments.
  • It is also unclear how NICE would account for the impact of experience using technologies accumulated over years of use in clinical practice, which may not be reflected in the evidence submitted during technology appraisals informing initial recommendations.
  • On the one hand, RWD accrued through use in practice can provide valuable new evidence. However, its usefulness may be limited given typically shorter follow-up and the potential for known and unknown sources of bias.
  • In particular, consideration would need to be given to potential bias associated with the availability of multiple interventions in a decision space. Whilst multiple technologies may receive an NICE recommendation for use in the same patient population, in practice there can be optimisation of technologies to different patient subpopulations. For example, in a recent managed access review appraisal of tisagenlecleucel for treating children with acute lymphoblastic leukaemia, it was acknowledged that the introduction of the tisagenlecleucel changed the way in which the comparator, blinatumomab, was used in the NHS, restricting its use to a population more likely to achieve a complete response and thus be eligible for curative stem cell transplant. As a result, despite the availability of more recent trial and registry data for blinatumomab, the evidence source used to inform the original appraisal was deemed most appropriate on the basis that it was the only evidence reflecting a world without tisagenlecleucel.3
  • Use of decision modifiers – It is currently unclear how decision modifiers will be considered for multiple technologies, and in particular how ‘established NHS practice’ would be defined to inform the calculation of the quality-adjusted life year (QALY) shortfall for each technology, given these technologies would already be available in NHS practice at the time of guideline integration. Furthermore, there may be challenges applying fair and consistent decision-making criteria and cost-effectiveness thresholds if technologies were originally assessed under different technology appraisal frameworks (STA vs cost comparison vs highly specialised technology [HST] appraisal).

The integration of recommendations may be time- and resource-intensive and may duplicate existing NICE processes

Evaluating the clinical and cost-effectiveness of each technology in a given decision space in a fair and robust manner is likely to be a time- and resource-intensive process, which may further stretch NICE’s limited capacity to provide guidance. It’s currently unclear whether this process would require time from external assessment groups, for example. The integration process could have knock-on impacts on NICE’s ability to produce guidance and guidelines on novel topics and interventions due to resource constraints; equally, upscaling of NICE resource to meet the additional evaluation burden could in theory translate to further or increased manufacturer submission fees unless there are other external sources of funding.

The integration process may disincentivise UK product launches

NICE technology appraisals are already associated with high upfront costs – submission to NICE alone costs upwards of £100,000 to the manufacturer.4 The integration process risks withdrawal of recommendations just three years after the initial recommendation. Therefore, manufacturers may deprioritise or avoid applying for reimbursement of their product in the UK. This process therefore risks preventing patient access to new and effective technologies.


  1. NICE. Methods and processes for including NICE technology appraisal recommendations in guidelines. In development [GID-PMG10002]. Available here. Last accessed: April 2024.
  2. 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.
  3. NICE. Tisagenlecleucel for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged up to 25 years (MA review of TA554) [ID6290]. Available here. Last accessed: April 2024.
  4. NICE. Costs: Charging for technology appraisals and highly specialised technologies. Available here. Last accessed: April 2024.

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).