Transparency data

15 July 2020 minutes

Published 3 October 2022

Meeting details

The meeting was held on 15 July 2020 from 11am to 1pm via Microsoft Teams.

The chair was Gareth Arthur.

Minutes were taken by Mike Ringe.

Attendees

From the Department of Health and Social Care (DHSC):

• Daniel Law
• Richard Mattison

From NHS England and Improvement (NHSEI):

• Gareth Arthur (chair)
• Amit Patel

Note: NHS England and NHS Improvement have worked together as a single organisation since 1 April 2019. NHS Improvement became part of NHS England in July 2022.

From the Association of the British Pharmaceutical Industry (ABPI):

• Ben Osborn (Pfizer)
• Neale Belson (GSK)
• Richard Erwin (Roche)
• Richard Torbett
• David Watson
• Paul Catchpole
• Mike Ringe

From the devolved administrations (DAs):

• Alison Strath (Scotland)
• Keith Wilcock (Scotland)

From the National Institute for Health and Care Excellence (NICE):

• Linda Landells

Introductory remarks, including on COVID-19

Gareth Arthur outlined the context that the system had recently been working in. He noted good cross organisational working both within and across health systems in the UK and with industry from which lessons could be learned for the future. COVID-19 had impacted the implementation of some of the 2019 voluntary scheme for branded medicines pricing and access (VPAS) ambitions but there had been progress, and the meeting was timely to review progress, particularly given the NHS ambition of achieving near-normal levels of non-COVID services.

Minutes of last meeting

The minutes of the last meeting held on 16 January 2020 were agreed.

On actions arising from the previous meeting, David Watson raised a number of points in relation to Action 1: calculation of medicines spend and associated communication. The action was in relation to the development by NHS Digital of a potential new publication on the ‘true’ (that is, not at list price) medicines expenditure. It was important for all parties to understand the new data sources (for example, RX Define), the proposed methodology and how any resulting reports and associated communication would be shared.

ABPI highlighted industry concerns that within England, spend and growth of medicines was often described using data based on list prices, which inflates the true picture. ABPI had shared a recent analysis of ‘net’ branded medicines spend with Blake Dark (Commercial Medicines Director for NHSEI).

ABPI said it believed NHSEI policy was to limit growth on medicines spend, partly by negotiating down prices, revisiting existing prices, having limited focus on improving uptake across the national institute for health and care excellence (NICE) recommended medicines. It said these policies were unwarranted given the voluntary scheme affordability mechanism. ABPI said industry perceived therefore the financial opportunities available under VPAS to improve uptake and allow pricing flexibility were not being fully utilised.

ABPI said industry’s concern was compounded by the lack of internal NHS transparency of how the industry payments flow into NHSEI and associated budgets, and therefore that the effect of the voluntary scheme rebate had no tangible effect on medicines management or policies.

Gareth Arthur noted that the NHS Digital work continued and agreed it would be timely for all parties to receive an update.

Gareth Arthur said that one of the objectives of the voluntary scheme was to deliver value for money for the NHS, as well as increasing certainty on overall medicines spend. The affordability mechanism does not obviate NHSEI’s responsibility to continue to deliver value for money for the NHS and that responsible pricing was in the interests of all parties.

NHSEI would continue to seek best value for the NHS from spending on medicines. Gareth Arthur said NHSEI were concerned about end of scheme risk, as well as future implications of higher prices.

ABPI argued that industry felt that NHSEI was seeking to ‘control growth’ and this undermined the fundamental design and aims of the scheme. ABPI contended that there was undue focus on affordability to the detriment of economy and innovation.

Gareth Arthur highlighted other elements of the scheme that supported innovation, including the commercial framework, the exemption for new active substances and the support for horizon scanning.

Ben Osborn noted that industry had been fully supportive of NHS activity in the COVID-19 response. However, he suggested that NHS had used ‘emergency legislation’ to introduce commercial arrangements to support access to direct oral anti-coagulants (DOACs), the terms of which increased the view in some global organisations that the English system did not value innovation. This, he thought, would have significant medium term impacts on both availability of new medicines and the wider economy in terms of global investment and clinical trials.

Gareth Arthur thanked members for expressing views, noting it was important that these messages are heard.

Action

DHSC and NHSEI to organise a meeting for all partners with NHS Digital to update on the potential publication of prescribing costs data that will better reflect the cost paid by the NHS for medicines.

Operations update

Richard Mattison briefly outlined the key points as set out in paper 2. The content was noted by all and there were no items raised for specific discussion.

Scheme metrics

Daniel Law introduced the scheme metrics slide deck, noting that since the last meeting DHSC had worked with partners to develop or refine a number of the DHSC metric charts. He therefore focused his presentation on highlighting these changes.

With regard to slides 5, 6 and 7 NICE single technology appraisals (STAs), Daniel Law noted that through working with NICE, these charts now presented a detailed view of NICE STAs and in particular greater granularity of outcome in terms of STAs terminated, recommended, optimised or not recommended and by oncology and non- oncology products.

Paul Catchpole welcomed the added granularity but suggested the need to better understand the number of terminations and non submissions. He suggested this was partly due to some companies withdrawing from the NICE process where they believed their product could not ‘get through’ under the current NICE decision making framework. Paul Catchpole suggested this highlighted the need for an ‘ambitious’ approach to the current NICE methods and process review.

The data showed an increase in the percentage of optimised decisions. ABPI noted their internal information that within these decisions, the size of the patient cohorts recommended for treatment were also decreasing. ABPI felt it would be important for the NICE review to ensure future methods were better able to reflect, and manage, uncertainty on a more pragmatic basis so that more NHS patients could access new treatments.

Linda Landells noted that as a proportion of all STAs, the number of company non- submissions or withdrawals remained much the same. She questioned whether the increasing number of optimised recommendations reflected regulators accepting an indication as safe and effective for a larger population, but which was not backed up by sufficient evidence on clinical and cost-effectiveness for the NICE committees to subsequently support.

Paul Catchpole noted the need to better manage uncertainty in the NICE methods review. Paul Catchpole stated that as more products receive conditional support under the cancer drugs fund (CDF), while in the short term this is positive, it is reflecting the need for ambitious change and in particular the need to align the perspectives of risk of the Medicines and Healthcare products Regulatory Agency (MHRA) as a regulator, NICE as a technology assessment body and NHSEI as the payer.

Gareth Arthur noted the issue, and that alignment is important and welcomed further dialogue to ensure understanding, if not agreement of the issues. Ben Osborn noted that innovation is increasingly focused on smaller populations with inevitably more uncertain evidence bases but that there is a real ambition across government to evolve the regulatory system to become both quicker and develop more appropriate methods and process.

Richard Torbett highlighted the need for precise language, noting there had been incorrect inferences in public discussions that the MHRA may in future move its focus away from assessing efficacy and more towards safety which would not be acceptable.

Linda Landells commented that while the number of technology appraisals (TAs) is increasing, the strength of the supporting evidence base for each is reducing, as shown by decreasing numbers of Phase III trial evidence and increasing numbers of single arm trials. Therefore, an aligned view of managing uncertainty across regulators, assessment and health bodies was critical. Neale Belson stated there was an increasing reluctance to enter the NICE appraisal process given the growing perception that any resulting commercial deal was unlikely to achieve what was deemed an appropriate revenue for the innovation.

AS highlighted the merit of discussing this issue on a UK basis. Richard Torbett agreed, noting there were current opportunities to do this either at the patient access to medicines partnership (PAMP) or under the new office for life sciences (OLS) project looking into the future of regulation and already including MHRA and NICE.

Action

ABPI to follow up with MHRA and NICE in the appropriate forums and to pick up with OLS in their upcoming workshop discussions.

Daniel Law moved on to the STA speed by product metric. These showed decreases in the time to decision for cancer products and a similar trend for non-oncology products. ABPI welcomed the trend, noting NICE had worked hard to achieve these improvements. Linda Landells thanked colleagues for their comments, noting that some delays, such as those caused by the regulator or ongoing commercial discussions between the company and NHSEI were outside the control of NICE.

Daniel Law noted the growth gross of payment chart had also been revised, providing quarterly data and a rolling 12 month average. Quarter 1 2020 data showed an 8.8% growth, but it would be important to recognise that impacts from COVID-19 are likely temporary. This has been discussed with ABPI and while all parties expected a fall in quarter 2 it was unclear how and if growth would settle down or continue to fluctuate in the light of a return of all non-COVID NHS services, a second wave of COVID-19 or EU exit.

David Watson noted it was important that all parties continued to monitor and discuss growth impacts. He highlighted the importance of joint work on understanding growth and seeking to align forecasting approaches. While it may not be possible to agree a single joint forecast, closer working was vital so all parties understood perspectives of underlying growth drivers. Work is already underway via a PAMP action seeking to align on this point. Gareth Arthur highlighted the importance of horizon scanning, which NHSEI was actively supporting. DHSC, ABPI, and NHSEI had committed to meet quarterly to review latest data.

Daniel Law noted that the current scheme mechanics would revise any payment rates based on actuals, so this work was more in preparation for a future scheme rather than an intention to change the current scheme.

David Watson welcomed the development of the scheme metrics but noted ABPI was keen to see these published alongside the operational review minutes to support scheme member awareness. This was agreed in principle, although it was noted that some detailed information (for example internal unpublished NICE data) should be redacted from the metrics.

Action

DHSC, ABPI and NHSEI to discuss approach to publishing voluntary scheme metrics alongside the review minutes.

Note: a copy of the metrics slide pack is available on request from [email protected].

Access update and outcome ambitions

NHSEI paper and update

Gareth Arthur introduced the NHSEI paper on access, update and outcomes and drew attention to the 6 ambitions of the voluntary scheme set out on slide 1 (horizon scanning, engagement, commercial arrangements, transparency, NICE value assessment and uptake support). He also highlighted the collaborative approach embraced through the Rapid COVID-19 research partnership (NHSEI, MHRA, NICE, national institute for health and care research (NIHR)) under which all parties openly and urgently collaborated to identify new treatments identified through research and made them rapidly available to patients. This work and approach continues under the UK wide DHSC Therapeutics Taskforce.

NHSEI commercial framework

Gareth Arthur noted that while the framework had yet to be published it was clear that NHSEI’s commercial medicines directorate had developed strong working relationships with companies, which enabled rapid dialogue and commercial agreements to be met. Gareth Arthur believed this showed that the underlying ethos set out in the commercial framework was already in operation and companies are now benefiting from significantly enhanced commercial flexibilities.

Horizon scanning

Gareth Arthur noted considerable work was underway within NHSEI to support horizon scanning, with additional resource being seconded to the team. Additionally, a new internal team had been created to support the adoption and commissioning of new technologies such as advanced therapeutic medicinal products (ATMPs), in the recognition that such products might require significant service change. He acknowledged that the horizon scanning steering group had to be restarted post-COVID.

Gareth Arthur invited comments on overall progress as set out in slide 1.

ABPI agreed with the positive change in relationships between companies and commercial medicines directorate (CMD), which were generally working well, enabling both formal and informal dialogue. However, it remains important that this engagement is made available to all companies including smaller companies, and the level of engagement should be kept under review.

ABPI asked for more information on the innovative treatment oversight group. Gareth Arthur noted this was a new internal NHSEI group bringing together commissioners and was focused on the NHS service, commissioning implications of high-impact products.

RE returned to the objectives of the voluntary scheme, stating that they are intended to enable a balanced approach to financial sustainability, innovation and wider economic growth, but that there is the perception that the overriding driver of the NHSEI’s commercial approach was to drive down short-term costs, despite the voluntary scheme affordability mechanism. Gareth Arthur similarly reiterated his view that this was not an either – or situation and did not agree that value for money is irrelevant due to the affordability mechanism.

Richard Torbett recognised both the strong partnership working across COVID-19 and the improving company engagement with CMD. However, he highlighted that the voluntary scheme affordability mechanism was not the only mechanism in place to maintain affordability. While recognising the need for balance, he stated that it is the overwhelming view of companies that industry and NHSEI are at opposite ends of the ‘dial’, particularly given that industry colleagues are not clear if and how voluntary scheme payments influence NHS commercial activity. What appears to be the apparent view was that the financial cap or payments were not entirely relevant to NHSEI commercial activities, and that the industry perspective was that the procurement focus was out of balance with the objectives on uptake in the voluntary scheme.

He also highlighted that the views held about ‘end of scheme’ risk appear to stifle any real policy debate on this issue. Specifically, in relation to the ‘end of scheme risk’ he maintained that industry has always covered this moving into subsequent schemes. Similarly, Richard Torbett emphasised that it is important to keep to the fore the broader ambitions of the government, the health system and industry that underpin and shape the voluntary scheme which must be recognised, as must the impact of the actions of individual partners in the achievement or otherwise of those ambitions.

Gareth Arthur thanked colleagues for clearly iterating their views, noting the comments on end of scheme risk.

David Watson proposed that given next year represents the midpoint of the voluntary scheme, it would be appropriate to review how the implementation of the scheme is meeting its overarching objectives for patients, affordability and the economy and innovation.

Gareth Arthur agreed, noting that it was important for all partners to understand, if not agree with, the respective positions. Daniel Law also supported such an approach, noting he recognised RT’s comments that, while the department was mindful of ‘end scheme’ risk, this should not be a barrier to exploring productive policy conversations.

Action

ABPI, DHSC and NHSEI to agree the scope of a review of how the voluntary scheme is meeting the objectives set out in the voluntary scheme before the end of 2020

5 highest health gain categories – proposed

Gareth Arthur noted that the development and agreement of the 5HHG categories had been a difficult task. He outlined the 5 proposed categories noting NHSEI had aimed to achieve a balance between categories of larger population but smaller health gain, and those providing significant health gain for smaller populations. These were presented for comment, but NHSEI expected to publish these in August or September 2020.

ABPI recognised the link to the long-term plan (LTP) but felt the selection overall did not reflect the most innovative classes, with some products involved coming to the end of their patent life. Ben Osborn noted, however, that the proposed categories were largely balanced across disease areas and primary care and secondary care settings.

Gareth Arthur noted that NHSEI was keen to ensure the balance between increased uptake reflected in any commercial agreements.

ABPI voiced concern on the point regarding any future commercial arrangements to support uptake and access and noted their view that commercial arrangements should not be applied to inappropriately restrict access to NICE recommended treatments.

ABPI said it was concerned on the progress of some commercial arrangements, whereby having received a NICE recommendation as cost effective, companies might nevertheless need to lower their prices in the following years before generic competitors entered the market. ABPI noted this emerging approach of multiple price discussions at different phases was leading companies to see the UK as unattractive, which industry considered would limit the ambition of the UK as a life science hub.

NICE update

Linda Landells noted much of her update had been reflected in the previous metrics discussion and highlighted that NICE had published the formal methods review consultation timelines.

Gareth Arthur noted the previous discussion about uncertainty. Paul Catchpole reinforced the need for further discussions between NICE, ABPI, DHSC and NHSEI prior to the formal launch of the consultation to ensure the opportunities provided by the voluntary scheme were to be realised through the methods review.

Richard Torbett noted that this discussion was important as he understood that maintaining affordability and the issue of ‘end of scheme’ risk had been highlighted as a potential barrier to potential changes. In his view, it would be inappropriate if this issue were to limit the opportunity that the review offers.

Action

ABPI, DHSC and NHSEI to engage in further joint dialogues with NICE via appropriate forums.

Any other business (AOB)

Innovative Medicines Fund

Gareth Arthur provided an update on the Innovative Medicines Fund (IMF). Work is underway with NICE to map out the relationship between the IMF and the CDF, particularly exploring entry and exit criteria. The intention is to hold a joint NHSEI and NICE consultation in the autumn, with the intention the new fund will go live in April 2021.

ABPI noted it would be timely for all parties to meet collectively to discuss the proposals and that this is currently being arranged by NHSEI and NICE.

Action

Progress update to be presented at the next operational review meeting.

Scheme agreement in relation to data infrastructure

David Watson noted that while there had been some brief discussions with DHSC and NHSEI on progressing joint activity on the voluntary scheme ambitions on NHS data infrastructure, in his view progress had been very limited.

Action

NHSEI to confirm with ABPI and DHSC their lead on the voluntary scheme data infrastructure ambition and discuss potential activities for discussion at the next operational review January 2021.

Operational review meeting terms of reference

Daniel Law noted given the importance of the operational review meetings it would be helpful to agree a clear terms of reference. A draft had been circulated for comment but given limited time it was agreed that all members should respond by email with comments. Daniel Law proposed this could be agreed electronically by email between meetings.

Action

All members to review and comment on the proposed terms of reference by the end of July. Daniel Law to revise and circulate final draft for agreement in September.

NHSEI perception of the success of the voluntary scheme

In closing Neale Belson noted that, notwithstanding the progress that industry acknowledged had been made on NICE timeliness, commercial engagement and the overall scheme operation, the industry had used the meeting as a sounding board for its frustration at how some elements of the voluntary scheme were being implemented in practice. To provide an opportunity for balance, he asked Gareth Arthur to share his NHSEI’s perception of the scheme.

Gareth Arthur noted that overall good progress had been made, particularly in terms of commercial engagement, on more flexible commercial arrangements, on the speed of NICE appraisals, and encouraging developments in horizon scanning. However, he noted that overall growth in sales has been low, and it would be good to get a better understanding of the reasons for this lower growth and, recognising the previous comments, it is important to come to a shared understanding of the balance between the objectives of the scheme.

Date of next meeting

The next operational review will be held on 20 January 2021.