Transparency data

13 February 2023 minutes

Published 30 June 2023

Meeting details

The meeting was held on 13 February 2023 from 11am to 12:20pm on Microsoft Teams.

The chair was Stephen Hennigan.

Minutes were taken by Michael Vidal.

Attendees

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

• Stephen Hennigan (chair)
• Bilal Evans
• Richard Mattison
• Noah Kidron-Style
• Will Olivier
• Simon Roer
• Michael Vidal

From NHS England (NHSE):

• Claire Foreman
• Alexander Williams
• Mary Majiyagbe

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

• David Watson
• Kim Assender
• Paul Catchpole
• Mike Ringe

From devolved administrations (DAs):

• Alison Strath (Scotland)

From the Office for Life Sciences (OLS):

• Hannah Lom

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

• Ian Watson

From the British Generic Manufacturers Association (BGMA):

• Mark Samuels (observer)

Introductory remarks

Stephen Hennigan welcomed everyone to the meeting and extended his apologies from Liz Woodeson who was unable to attend.

Stephen Hennigan highlighted that as we lead up to negotiations on a successor to the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), it was important that these meetings maintained their independence from the negotiating process and should continue to solely focus on the operation of the current scheme.

This is to ensure that lines of communication are not blurred to ensure proper governance of negotiations are maintained. All attendees agreed.

Minutes of last meeting

Stephen Hennigan apologised for the minutes of the last meeting held on 26 September 2022 which had not yet been agreed. Stephen Hennigan noted the importance of continued dialogue between DHSC and the Association of the British Pharmaceutical Industry (ABPI) to ensure sign-off was achieved as quickly as possible for the minutes of both this meeting (13 February) and the September 2022 meeting.

ABPI noted that the publication of the operational review minutes was now on the GOV.UK website but that some scheme members nonetheless struggled to find them. They also queried why the VPAS scheme metrics were not published on GOV.UK.

Action

DHSC agreed to consider options for improving the visibility of operational review minutes and metrics.

Operations update

DHSC presented the operations report which incorporates the latest published sales data up to Q3 2022, highlighting that the increased payment percentages over the last few years have been linked to increased year on year sales.

DHSC noted the devolved administrations (DA) apportionment of their share of VPAS quarterly income, based on primary care data spend on branded medicines for each quarter which is consistent across the UK. This system has been in place since the previous 2014 Pharmaceutical Pricing Regulation Scheme and is still considered the best available data to make the apportionment.

It was noted that medium-sized companies entitled to the exemption on sales up to £25 million has increased during the life of the scheme from 35 to 57 companies in total.

Price increase applications have increased in 2022 to the highest level since the start of the scheme. These tend to be products where there is cost inflation of the active pharmaceutical ingredient (API) or global supply constraint, although the increase in the payment percentage in 2022 was also cited as a contributing factor.

ABPI asked if DHSC could share data about the number of unsuccessful price increase applications.

Action

DHSC to share data with ABPI on the number of unsuccessful price increase applications.

There have so far been no disputes during the life of the current scheme.

ABPI enquired whether the Q4 2022 sales data publication would include an update on what 2022 growth would have been and in turn have an updated forecast of 2023 growth. ABPI mentioned that this information is important to companies in terms of end scheme reconciliation.

Action

DHSC to investigate whether detailed information on end scheme reconciliation can be provided as part of the Q4 2022 sales data publication.

Scheme metrics update

DHSC presented updated metrics with data running to Q3 2022. DHSC noted that pre-meeting discussions with ABPI and the National Institute for Health and Care Excellence (NICE) had highlighted a number of points. ABPI noted the recent decrease in pricing applications, which was largely in line with their expectations from discussions with industry.

On discussion of the NICE single technology appraisals (STAs) ABPI expressed their interest in better understanding the trends behind the speed of these STAs and the reasoning behind the number of terminated appraisals.

DHSC highlighted the breakdown of outcomes for the varying technology appraisals which revealed an increase in published appraisals from the previous quarter, but also an increase the number of terminated appraisals in the same period.

Positive STA appraisals in the previous 12 months were 94%, while STAs involving a new active substance (NAS) were 90%.

DHSC noted that the actual sales of companies receiving a medium-sized company exemption had steadily grown since 2021. Analytical colleagues plan on investigating this further to understand more fully the reasoning behind this trend.

ABPI update

ABPI iterated that they had proposed draft scheme metrics on commercial flexibilities and horizon-scanning over a year ago, but these had not been agreed. ABPI awaited a response from NHSE, DHSC and NICE on including pharma-scan data and NICE patient access scheme (PAS), commercial access agreement (CAA) data in the scheme metrics. ABPI noted that including this data would have helped them more fully articulate to members and the wider community about how the deal is working over the course of the scheme.

NHSE noted that whilst proposals around timeliness could be helpful, other proposals were potentially duplicative, would potentially breach commercial confidentiality or could be misinterpreted. NHSE agreed the importance of concluding the conversations on ABPI’s proposals and are happy for a separate meeting to be set up to address this issue.

Action

NHSE to arrange a dedicated meeting to discuss ABPI proposals for commercial framework and horizon-scanning data for the VPAS dashboard.

NHSE update

There was no NHSE update.

DA update

Scotland updated on the current backlog with the Scottish Medicines Consortium (SMC) in terms of dealing with submissions and the work being undertaken to find additional resources to help alleviate this. There have also been discussions within SMC about new ways of working with an aim of improving work processes and output.

On horizon-scanning, the Scottish Government are keen to do more work to support the service implications around some of the new medicines currently coming through the system, using better horizon-scanning to work with health boards including to ensure appropriate companion diagnostics are in place when they are needed and are able to work through any service delivery issues.

Scotland mentioned that they are having some significant challenges with a company who have been reluctant to agree a commercial agreement for an SMC submission, stating that they would charge a higher price in comparation to England and Wales for their medicines. This highlights the issue around the transparency clauses in the voluntary scheme. Scotland felt that it was important that any successor scheme has better clarity and wording to properly define what expectations are about these 2 clauses to ensure this is clearer in the future.

DHSC update

DHSC noted the publication of the 2023 payment percentage. They acknowledged the concerns of industry representatives about the high payment percentage but reiterated that it was in line with forecasts made when the scheme was agreed. They noted that they would be keen to hear company feedback on the impact of the payment percentage.

The statutory scheme consultation concluded on 26 January. DHSC noted that they were in the process of analysing the responses and aimed to publish a consultation response in early March.

NICE update

Ian Watson updated on the key areas of work in implementing their methods and process review, which was published in 2022, and proportionate approaches now being introduced. NICE were pleased to announce that over the last 3 months, over 20 topics using the new methods had a committee discussion, with about half of those achieving positive guidance.

NICE are now looking to undertake work on quantitative and qualitative monitoring of the uptake of the new methods and hope to present initial findings from that work in the coming months. Early analysis is positive, especially around the severity modifier, which has been applied at its highest level on 2 occasions.

In terms of the proportional approaches to technology appraisals (TAs), NICE have been making rapid progress, with current indications showing that they are on course to increase their capacity by the projected 20% in line with predicted demand.

A number of pilots had completed. Three streamlined cost comparisons have produced either draft or final guidance. Further streamlined cost utility analysis has also been completed around 8 weeks faster. There are also pilots underway for a paired appraisals and pathways which may involve more longer-term work.

NICE wanted to also highlight that the proportionate approach project would also include work around the key performance indicators (KPIs).

NICE finally noted that their next steps would be working towards finalising this round of the proportionate approaches and rolling these out as interim methods and processes from April with a view to making them into final methods through modular updates.

AOB

None.