20 January 2021 minutes
Published 3 October 2022
Meeting details
The meeting was held on 20 January 2021 from 2pm to 4pm via Microsoft Teams.
The chair was Richard Erwin.
Minutes were taken by Michael Vidal.
Attendees
From the Department of Health and Social Care (DHSC):
- Liz Woodeson
- Stephen Hennigan
- Daniel Law
- Richard Mattison
- Michael Vidal
From NHS England and Improvement (NHSEI):
- Gareth Arthur
- Blake Dark
- Amit Patel
- Fatima Ahmed
- Lethwie Choga
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):
- Richard Erwin (Roche, chair)
- Richard Torbett
- David Watson
- Ryan Hollingsworth
- Paul Catchpole
- Ramya Logendra
- Mike Ringe
From the devolved administrations (DAs):
- Cathy Harrison (NI)
- Andrew Evans (Wales)
- Alison Strath (Scotland)
Introductory remarks
Chair welcomed everyone to the operational review meeting, especially extending ABPI and industry’s appreciation to the NHS for their hard work and dedication through the pandemic.
DHSC also thanked industry for rising to the challenge of finding a vaccine for COVID, alongside ensuring the continued development and supply of new medicines.
Minutes of last meeting
The minutes of the last meeting held on 15 July 2020 were agreed.
On actions arising from the previous meeting, NHSEI mentioned initial conversations had begun with NHS Digital to better understand data publication. NHSEI contributed to a recent consultation about some of the data. NHSEI agreed to pick this up with ABPI early next month to discuss the response to the consultation.
Action
NHSEI to liaise with ABPI in February 2021 to discuss any NHSEI response to NHS Digital’s consultation.
DHSC and ABPI agreed that scheme metrics should be published on a twice-yearly basis. ABPI suggested that further metrics might be developed for the second half of the scheme, including the possibility of NHSEI scheme metrics where appropriate.
NHSEI noted that there was limited progress against the action to discuss the ambition on data infrastructure from July’s operational review meeting with ABPI. ABPI highlighted the importance of this work in relation to real world evidence and supporting indication-specific prescribing.
Action
NHSEI to provide an update at July’s operational review.
There was agreement with the terms of reference of the operational review. ABPI drew attention to the review of brand equalisation in the middle of the scheme (paragraph 2.10 of The 2019 voluntary scheme for branded medicines pricing and access: chapters and glossary. It was agreed further discussion between DHSC and ABPI was needed on this issue before the next review meeting in July.
Action
DHSC to meet ABPI to review the potential impact on market dynamics of the discontinuation of brand equalisation to the voluntary scheme.
Operations update
DHSC updated on the operation matters of the scheme, highlighting Q3 2020 brought £2.5 billion of eligible sales which generated £147 million of scheme payments.
DHSC mentioned the development of a new portal for companies to submit their presentation level reports had gone live in late 2019. There had been good adoption from companies so far, but the department would continue to engage with all companies to ensure continued understanding and application of the new process.
ABPI welcomed this, underlining that the integrity of the voluntary scheme was paramount and would help ensure companies supply the correct sales information.
DHSC went on to highlight the department’s work in communicating with companies to clarify that there will be no change to reporting requirements under the voluntary scheme following the end of the EU Exit transition period. The department will also actively engage with companies to ensure they have a clear picture about the possible effect the Northern Ireland (NI) Protocol could have on their business model.
ABPI mentioned that work on the Northern Ireland Protocol was significant for the future medicines landscape. It was important that ABPI and DHSC work collaboratively to identify potential consequences and scenarios.
Action
ABPI will continue to assess its members’ issues on the supply and reporting of sales due to the NI Protocol and inform the DHSC.
DHSC stressed the importance of companies being open with the department and the NI health service about potential supply issues to NI and ensure continued dialogue with the department to mitigate such issues. To help facilitate this, the department’s portal for companies to report issues with supply is being modified to include a Northern Ireland-specific section.
Scheme metrics
DHSC presented the scheme metrics which centred around product launches, scheme membership and growth.
DHSC noted that after a slowdown in the early part of 2020, there had been a subsequent increase in the new product launches.
DHSC also highlighted the positive outcome that all new active substances (NASs) over the last 18 months had gained a positive National Institute for Health and Care Excellence (NICE) appraisal, as well as an overall increase in NICE single technology appraisals (STAs). This is coupled with the speed of NICE appraisals which continues to improve, with oncology appraisals especially, close to achieving their 3-month target.
ABPI pointed out a significant proportion of NICE’s recommendations are ‘optimised’ whereby the patient population benefiting from the positive recommendation is smaller than the license population. DHSC noted that the 2010 Office of Health Economics (OHE) report showed how this had improved in recent years. All parties welcomed further information sharing to understand evidence in this area.
Note: a copy the metrics slide pack is available on request from dh.brandedmedicines@dhsc.gov.uk.
Action
ABPI to share with DHSC, NHSEI and NICE analysis of the latest information and evidence on levels of optimised recommendations and patient coverage.
DSHC mentioned that growth in measured sales have fluctuated over the last year. This is something all parties would continue to collaboratively engage on to bring together the various data sources to understand and evaluate the reasons for this trend. ABPI agreed and suggested that the next operational review would be a good opportunity to consider any further additions to scheme metrics.
Action
ABPI to present scheme metrics proposal to DHSC and NHSEI ahead of next operational review meeting.
Access, uptake and outcome ambitions
NHSEI updated on NHSEI’s continued work on access, uptake and commercial arrangements and highlighted the achievements made in relation to the voluntary scheme objectives and the access, uptake and outcomes ambitions.
NHSEI highlighted the progress made on horizon scanning, with the reformation of the horizon scanning steering group, notably looking at gene therapy and the challenge of how to systematise this better.
NHSEI noted that while the commercial framework will be published imminently, NHSEI have continued commercial engagement with companies to ensure the ambitions and objectives for the framework.
The highest health gain categories were announced at the Life Sciences Council meeting in November. Work is now underway on the development, measurement and metrics for these categories, using a blend of both international comparisons as well as the innovation scorecard. NHSEI noted the uptake support that is in place for each category.
ABPI noted that improved engagement and enhanced flexibilities were being mentioned by some of its members and was positive about the intent of the commercial framework. ABPI was concerned though that for some, including smaller companies, the delay in publication had hindered awareness and understanding of what might be appropriate.
ABPI recognised progress was being made with horizon scanning, which is now clearly laid out and structured, with better dialogue about what specifically is coming through the pipeline. The ABPI suggested that there is a need to ensure that investment is not made in horizon scanning structures which do not benefit the UK.
ABPI stressed that despite these positives, there was a sustained view from companies that the scheme was not doing enough to meet the ambition on uptake at scale. ABPI said that in their view, initiatives on uptake were narrow and didn’t benefit all medicines. NHSEI mentioned there were numerous activities currently in progress to support the uptake in line with ambitions of the voluntary scheme.
Action
NHSEI to highlight these other activities which demonstrate the progress on uptake at the July operational review meeting.
Scope of a mid-scheme review
ABPI, DHSC and NHSEI agreed that a mid-scheme review would be an opportunity to positively reflect and openly discuss how the operation of the scheme was supporting the high-level ambitions and principles set out in the 2019 voluntary scheme for branded medicines pricing and access (VPAS).
It would be a chance to analyse where improvements to the delivery of the scheme can be achieved on all sides and be an important forum to discuss issues that had not been addressed so far, such as stability and predictability.
DHSC agreed that it was important to put together a shared position of expectations from the review. All agreed that the outcome of the review would not be published to provide a greater degree of open discussion of the issues.
Action
DHSC, NHSEI and ABPI would jointly agree a mid-scheme review paper to establish what is in and out of scope for discussion, agenda items, and what analysis each party would bring to the review and attendees.