NICE

The focus of responses was different across stakeholders from different sectors.

Stakeholders from NHS and ICB organisations commented that integration could lead to increased patient access to clinically and cost-effective treatments. This group of respondents also stated that there was a need to review the funding requirement, and that technology appraisals with significant changes in their clinical effectiveness and/ or their costs should be prioritised. They also noted that there was a need to include consideration of biosimilars and generics. This group of stakeholders also said we should include other types of NICE guidance in the project.

Professional, clinical and academic groups commented that there is a need to withdraw guidance on technologies if they are no longer cost-effective. They commented that continuing to recommend the use of technologies that are no longer cost-effective leads to inefficient use of NHS resources that reduces the net population health.

Comments from patient groups and charities noted that integration of technology appraisals into guidelines has the potential to reduce the appeal of the UK as a launch market for new medicines, which could reduce access to medicines for patients. Some stakeholders in this group commented that integration offered the potential for increased implementation, reduced costs and improved care; noting that there would be clear pathways of care based on clinical and cost-effectiveness.

Responses from industry were strongly opposed to integration, stating that the proposal undermines the VPAG agreement and that there was no need for additional cost control given the appraisal process that all technologies have been through. Respondents also commented that the proposals reduce the appeal of the UK as a launch market and destabilise the life sciences sector.

All stakeholders commented on access to medicines. Some stakeholders approved of using cost-effectiveness to ensure efficient allocation of resources, whereas others were concerned about risk of restricted choice of medicines and the potential impact of this on patient outcomes.

NHS and ICB respondents commented that integration would allow for the efficient allocation of NHS resources, and again there was mention of the need to include biosimilars and generics in integration, in this theme of responses. This group also noted the need for consideration of sequencing and hierarchies of treatments. This group of stakeholders also commented on the need for opportunities for price negotiations to maintain access to medicines.

Professional, clinical and academic groups shared similar comments to the NHS and ICB respondents. In addition, they also noted that the displaced health impacts of integration decisions need to be considered.

Patient groups and charities commented that integration of technology appraisals creates uncertainty of continued access to a range of treatments and could reduce choice of medicines for patients; they commented that this in turn could lead to worse patient outcomes and could also deepen health inequalities.

Industry respondents commented that the proposals could lead to less individualised treatment and worse patient outcomes if options were removed based on cost-effectiveness. It was also noted in responses that integration could undermine local commissioning decisions, that the proposal prioritises cost-effectiveness over clinical efficacy and that it could widen inequalities across devolved nations.

All stakeholders requested clarity and justification for the 3-year time-period between publication of a technology appraisal guidance and publication of the guideline into which it would be integrated.

NHS and ICB respondents commented that it was unclear what the rationale was for the 3-year time period, with some commenting that there should not be any time-limit for integration of technology appraisals. Some respondents noted that more rapid integration is needed when prices change and cheaper comparators become available. There was a high volume of comments that integration proposals would lead to an increased workload for local ICBs.

Similar to comments from NHS and ICB respondents, professional, clinical and academic groups also commented that more rapid integration is needed when prices change and cheaper comparators become available.

Patient group respondents had no specific concerns regarding the methodology, but concerns were expressed around the potential change in access to medicines.

Comments from industry stated that the proposals for integration were anti-innovation and were not supportive of the life sciences industry. They also commented that the proposed process was resource intensive and duplicated the work completed for the original technology appraisal. Further comments suggested that medicines which have been found to be clinically and cost-effective for the technology appraisal should not be reassessed, and that this process undermines the decisions made by the appraisals committee.

The responses from stakeholders on this theme were polarised, with opposing views from industry compared with NHS bodies and academia.

NHS and ICB respondents noted the need for comparative analysis of all treatment options in a decision space, and put forward the view that assessment of cost-effectiveness is key to efficient use of NHS resources. They also commented on the need for treatments to be sequenced or put into a hierarchy as part of integration. The role of the budget impact test, with respect to effect on NHS and personal social services resources and any likely resource constraints, was also noted here.

Patient groups and VCS organisations raised concerns about the potential removal of severity modifiers and the impact of the proposals on rare diseases. They also noted that integration methods would need to ensure that outcomes for patients were improved.

Industry respondents commented that the proposals for integration reduced the robustness, rigour and transparency of NICE's methods. Respondents also commented that there was a lack of consistency in decision-making processes between technology appraisal committees and guideline committees and that these proposals devalued the technology appraisal process. Concerns were also raised about sequencing of treatments.

Concerns were raised by all respondents around the status of technology appraisal recommendations if they are integrated into guidelines. There were clearly differing views between industry and professional, clinical and academic groups.

NHS bodies and ICBs commented that there were implications for how mandatory funding applies if the populations were to be narrowed or widened as part of integration. This group of respondents also raised concerns about having multiple pieces of conflicting NICE guidance if mandatory funding was narrowed or widened.

Professional, clinical and academic groups raised concerns over technology appraisals having a funding requirement with no end-date; they noted that NICE should recommend options that it is confident represents value for money in the present-day environment.

Patient groups and VCS respondents commented that it is important that the legal status of a technology appraisal remains.

Respondents from industry commented that the funding requirement must remain in place and be unchanged. They also raised concerns that the proposals for integration would make guidelines mandatory (rather than their current advisory status). Respondents noted that the scope for the proposed integration methods and processes was wider than that of a technology appraisal; given the inclusion of sequences and extended populations. Lastly, they commented that there is already a multiple technology assessment (MTA) process and technology appraisal review process in place, and therefore these mechanisms should be used rather than creating a new process.

In stakeholder comments there was an overall perception that commercial options would be highly complex to implement as part of integration.

NHS and ICB respondents commented that price changes of interventions should be a key trigger for integration of technology appraisal guidance into guidelines. Stakeholders from this group also noted that integration could be an opportunity to renegotiate simple Patient Access Schemes (PAS), and that commercial engagement should include ICBs and CMUs. Comments were also received saying that there is a need to reflect the pricing of procurement and commissioning arrangements.

Professional, clinical and academic groups also commented that price changes should be a key trigger for integration of technology appraisals into guidelines. They also noted the complexities of price negotiation when looking at multiple comparators.

Some patient groups and VCS organisations raised concerns around confidential pricing. Some respondents suggested that commercial pricing would be undermined by the proposals for the integration of technology appraisals into guidelines, and questioned how it may affect access to medicines.

Respondents from industry commented that spending is protected by VPAG., which sets a limit for NHS expenditure on branded medicines, beyond which pharmaceutical companies pay rebates back to the NHS. They also noted that commercial negotiations would be complex with multiple options available; operational concerns were raised in the event that multiple companies are involved, or if the treatment has more than 1 indication reliant on PAS discounts.