Transparency data

26 September 2022 minutes

Published 24 April 2023

Meeting details

The meeting was held on 26 September 2022 from 10am to midday via Microsoft Teams and in Conference Room 7, 39 Victoria Street, London SW1H 0EU.

The chair was Liz Woodeson.

Minutes were taken by David Watson.

Attendees

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

• Liz Woodeson (chair)
• Stephen Hennigan
• Will Olivier
• Lisa Holloway
• Noah Kidron-Style
• Eleanor Johnson
• Jessica Hill
• Kenny Mok
• Michael Vidal

From NHS England (NHSE):

• Claire Foreman
• Mary Majiyagbe

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

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

From the devolved administrations (DAs):

• Alison Strath (Scotland)
• Andrew Evans (Wales)

From the Office for Life Sciences (OLS):

• Hannah Lom

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

• Helen Knight

From the British Generic Manufacturers Association (BGMA):

• Robert Russell-Pavier (observer)

Introductory remarks

Liz Woodeson, the chair, welcomed everyone to the meeting, noting the attendance of Robert Russell-Pavier from the British Generic Manufacturers Association (BGMA) as an observer to the operational review.

Liz Woodeson noted we were in somewhat turbulent times, both globally and in the UK, and with a new DHSC ministerial team coming into post. She noted though that from an operational perspective the voluntary scheme for branded medicines pricing and access (VPAS) continued to run smoothly and gave her thanks to member companies and wanted that thanks to the industry to be recorded.

Minutes of last meeting

Stephen Hennigan introduced the minutes of the last meeting, held on 26 April 2022.

There were no comments on the accuracy of minutes, which were accepted as an accurate record. There were 4 actions arising.

Action

DHSC to investigate whether there were any common factors in the types of pricing applications received.

Stephen Hennigan noted this has been further discussed with ABPI and at the previous metrics meeting held immediately before the review meeting. It was noted there had been an increase in the number of applications, although a significant proportion were related to issues within a particular therapeutic area. ABPI and DHSC would continue to monitor the situation in their regular meetings.

Action

DHSC and NHSE to consider ABPI proposed metrics for the next operational review. DHSC to also include metrics discussions as part of the DHSC and ABPI monthly meeting schedule.

Claire Foreman was unsure of the latest NHSE position regarding this action. She agreed to raise internally and report back at the next review if not sooner.

Action

ABPI to put forward any proposed commercial arrangements for consideration at a future Commercial Oversight Group (COG) meeting.

Paul Catchpole noted ABPI was following up with partners to further explore the case for novel payment mechanisms for advanced therapy medicinal products (ATMPs) following an Accelerated Access Collaborative (AAC) board action. A workshop was planned for later in the year.

Discussions had taken place at Patient Access to Medicines Partnership (PAMP) regarding the current policy of companies having to provide new medicines free of charge under the Innovative Licensing and Access Pathway (ILAP), Project Orbis and similar initiatives. A paper would be presented at the next PAMP. Paul Catchpole iterated the importance of setting this in the context of what other countries are doing to provider earlier access to new medicines.

Action

NICE to update on work to prospectively collect evidence on the impact of different discount rates in health technology assessment (HTA) evaluations.

Helen Knight covered this in the NICE update section of the agenda.

General comment on the minutes

David Watson noted that the overall tone of the minutes, and of previous meetings, conveyed the message that the uptake of new medicines was positive. While NHSE is right to celebrate their successes, there was frustration from industry at perceived lower uptake in other areas. David Watson noted that a lack of a shared view might make practical discussions on this issue difficult to progress, especially given it was positioned as a key objective of the current VPAS scheme.

Paul Catchpole noted the desire to move away from broad generalisations, recognising that uptake in some areas is good, but less so in others. We need to, collectively, hold more targeted policy discussions to explore variations in uptake, outcomes, and inequalities.

Liz Woodeson stressed the importance of finding solutions to shift industry narrative away from the current perception of uptake and access as this colours the whole scheme and the work all parties have been undertaking to improve this area.

Operations update

Lisa Holloway noted there had been limited changes in overall terms since the last operational metrics presented in April 2022.

Lisa Holloway noted progress in working with companies to ensure they submit their presentation level report returns through the recently introduced single portal in a timely way. There continues to be improvement in company submissions. 4% of companies continue to have outstanding 2019 presentation level report submissions, and 16% of companies continue to have outstanding 2020 submissions. The deadline for the 2021 presentation level report was 31 March 2022 of which 30% remain outstanding. However, DHSC reported the situation was in hand.

DHSC had assessed audited 2019 and 2020 historic cash payment (HCP) submissions. 50% of audited 2020 submissions have been received and outstanding submissions are being chased.

There have been 28 price increase applications received for branded products (relating to 93 different presentations) in 2022 as of 26 September, which is an increase from the equivalent period in 2021. Stephen Hennigan noted this had been discussed at the previous Metrics Group meeting. Blood products made up the largest proportion of applications granted, and most applications related to raw material issues including higher costs of active pharmaceutical ingredients (API), though companies also cited increased VPAS rates. It was noted that only a couple had been turned down, suggesting companies have a good understanding of the circumstances in which price increases are justified.

David Watson noted that while DHSC may approve a price increase, most products were subject to prices set within NHS tender frameworks and asked if there was any indication that NHSE was accepting DHSC approved price increases in their contracts. Lisa Holloway noted companies were in discussion with NHSE but could not provide firm information.

There have been no disputes under the current scheme.

In terms of the Northern Ireland Protocol, it was noted that where companies are supplying Northern Ireland directly from a European country, DHSC had worked with those companies to ensure those sales are reported appropriately as a ‘subsidiary’ company.

Scheme metrics update

There had been a fall in Q2 of the number of single technology appraisals (STAs) and new active substances (NASs), and the positive technology appraisal (TA) subset, and an associated fall in the rolling 12 month trend.

There had been a rise in Q1 of ‘not recommended’ decisions, and a slight rise in the number of terminated NAS technology appraisals in Q2.

There had been an increase in time to first output for STA appraisals since Q2 2021. As noted in the metrics pre-meet this is based on a sample of 29% of all NAS STAs.

There was an increasing percentage of companies eligible for the mid-size company exemption. ABPI asked for a breakdown of company profiles to gain a better understanding of the company membership and spread.

ABPI questioned whether price increase application data should be published as part of the metrics pack. DHSC noted that price increase applications are highly context dependent and often concentrated in particular market segments and so they preferred this data was not published in this form.

DA update

Both Alison Strath (Scotland) and Andrew Evans (Wales) noted there were no issues of note from their perspectives.

NHSE update

Claire Foreman emphasised that NHSE was a key partner in the Life Sciences Vision and continues to drive this through maximising its ability to offer a single national market and to leverage that position wherever possible.

Claire Foreman noted the progress of the hepatitis C elimination initiative. The UK is the first European country to commission some ATMPs, of which 5 are now routinely available. Claire Foreman also highlighted the success of the NHS national approaches to cystic fibrosis and stroke prevention. Claire Foreman welcomed the introduction of the Innovative Medicines Fund (IMF), and congratulated colleagues as the Cancer Drugs Fund (CDF) has recently seen its 100th medicine approved.

ABPI noted that rates of availability in the UK were comparatively good but proposed that uptake often needed more work.

Paul Catchpole asked whether there was an update on the expected timeline for when a first medicine might enter the IMF. Helen Knight noted the processes were now all in place, she will provide an update on early triaging, but NICE has not had a medicine triggered in the IMF to date. Liz Woodeson noted that in a way it would be preferable that products went straight to routine commissioning, but the IMF provides a positive alternative if necessary. Paul Catchpole noted that the IMF also provides early access from draft guidance, and this was an important opportunity which provides benefits to patients.

DHSC update

Stephen Hennigan noted positive and regular dialogue with the ABPI. Since the last meeting Q2 data had been published and the department has sent out information on how both the VPAS and the statutory schemes work to support any company considering moving from one scheme to the other.

Stephen Hennigan also noted this included reassurance to existing VPAS members that they would not be asked to pay a disproportionate share of net historic underpayments if they remained in the scheme in 2023.

NICE update

Helen Knight updated the group on new NICE processes and methods, as set out in the revised NICE manual. These were now being utlilised by appraisal committees. There had been extensive training on the new methods with committee chairs, and patient groups.

The development of proportionate approaches to TA was ongoing and a critical NICE business plan priority, with the ambition of achieving up to a 20% increase in overall efficiency to accommodate increasing numbers of appraisals. This work was seeking new ways to streamline processes, take pathway approaches or pair appraisals. Helen Knight noted this work was underway while maintaining business as usual. ABPI and NHSE colleagues are closely involved in these developments.

David Watson asked whether there were more insights into the apparent increase in the number of terminated TAs. Helen Knight noted that while there had been a slight increase, actual numbers fluctuate, and each medicine or termination is usually down to specific company decision. It was sometimes difficult to be clear of the true reason behind termination.

Helen Knight noted the success of the NICE internal employee initiatives - the first cohort of the Master’s program was now in place with analysts starting.

Liz Woodeson noted ABPI and NICE were working together to help develop the ‘proportionate approach’.

Paul Catchpole noted that the NICE metrics on the VPAS dashboard were helpful but only portrayed part of the picture with only 20% to 30% of NICE workload being reported through these metrics. Paul Catchpole noted work was underway on potential evolution to the current metrics set, which would be a topic of discussion at the forthcoming NICE Industry Council.

ABPI update

David Watson noted the operational review meetings were helpful to bring us back to the objectives of the scheme. There was significant concern across industry on the financial implications of the scheme in 2022 to 2023. In the wake of the pandemic, the voluntary and statutory scheme payments had placed an unsustainable financial burden on industry. The 2022 payment rate far exceeds those elsewhere and rendered the UK internationally uncompetitive. The 2023 payment rate is the number one issue UK general managers are having to face, which is in part why no general managers were in attendance at the meeting.

David Watson thanked DHSC colleagues for their ongoing engagement, and for developing the ‘assurance’ position in relation to companies considering leaving VPAS for the statutory scheme, which was welcomed. He noted that this was the best available technical solution in the circumstances, while reiterating the industry concern that payment rates in 2023 are too high in general.

Liz Woodeson thanked David Watson for his candidness and noted that DHSC has heard the message, but that the previous 2 secretaries of state had been clear that rates equivalent to those expected in 2022 and 2023 were projected when the scheme was agreed with industry, and that recent increases reflect the scheme working as intended to adjust for increased sales of branded medicines to the NHS.

Robert Russell-Pavier reiterated that the BGMA had the same, significant concerns as the ABPI.

Stephen Hennigan noted the importance of maintaining a strong dialogue over the coming weeks, given the 30 September 2022 deadline.