Transparency data

26 April 2022 minutes

Published 24 April 2023

Meeting details

The meeting was held on 26 April 2022 from 12:30pm to 4pm via Microsoft Teams and in Conference Room 1, 39 Victoria Street, London SW1H 0EU.

The chair was Neale Belson.

Minutes were taken by Michael Vidal.

Attendees

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

• Liz Woodeson
• Stephen Hennigan
• Will Olivier
• Richard Mattison
• Noah Kidron-Style
• Andina Ward
• Simon Roer
• Michael Vidal

From NHS England and Improvement (NHSEI):

• Claire Foreman
• Greg Manuel
• Mary Majiyagbe
• Hattie Simpole-Clarke

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):

• Neale Belson (GSK) (chair)
• Richard Erwin (Roche)
• Mike Ringe
• David Watson
• Kim Assender
• Paul Catchpole
• Ryan Hollingworth

From the devolved administrations (DAs):

• Cathy Harrison (Northern Ireland)

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

• Helen Knight

From the British Generic Manufacturers Association (BGMA):

• Mark Samuels

Introductory remarks

Neale Belson (NB) welcomed everyone to the meeting, especially Mark Samuels from the British Generic Manufacturers Association (BGMA) as an observer to the operational review.

While not part of the meeting agenda, ABPI wanted to note their correspondence with the Secretary of State (SofS) with regard to the 2023 VPAS payment percentage and industry concerns. ABPI welcomed the agreement on the 2022 payment percentage and hoped for a swift response from the SofS on this matter.

DHSC reassured ABPI that colleagues were working with ministers to expediate a response.

Minutes of last meeting

No comments on the minutes from last meeting held on 28 September 2021.

Operations update

DHSC presented their operations report, firstly highlighting the increase in scheme membership over the years of the scheme. This relates to companies moving from the statutory scheme into the 2019 voluntary scheme for branded medicines pricing and access (VPAS).

DHSC highlighted the devolved administrations’ acquirement 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 (PPRS) and is still considered the best available data to come up with that split.

Medium sized companies entitled to the exemption on sales up to £25 million has increased from 35 to 47 companies in total.

Great progress has been made working with companies to ensure they submit their presentation level report returns through the new portal in a timely way. A key system improvement incorporated is that companies can now upload to the portal using their existing spreadsheets. This has been welcomed by companies enabling them to save time on data input duplication.

There has been a marked improvement in the submission of 2019 presentation level reports following constructive liaison with DHSC business managers, with only a handful of returns still awaited. DHSC would be grateful if ABPI could kindly communicate with its members the importance of these returns being submitted.

Price increase applications granted have shown little fluctuation over the length of the scheme, with only a marked increase in 2020, but subsequently returning to 2019 levels.

Action

DHSC to investigate whether there are any common factors in the type of pricing applications received.

There have been no disputes under the current scheme. The department has been successful in recruiting a new chair, Jayne Salt, and panel member, Stephen Brown, for the Dispute Resolution Panel. Induction training is planned for mid-May, and DHSC would be most appreciative of any assistance ABPI could bring to the sessions.

Since the last operational review, there have been no further issues relating to the Northern Ireland Protocol, with the current system of reporting working well.

Scheme metrics update

DHSC presented the metrics data running from Q1 2021 to Q4 2021. DHSC noted that pre-meeting discussions with ABPI and NHSEI had highlighted a number of points. Price applications had seen a greater number of new active substance (NAS) applications in 2021 compared to 2020. ABPI noted the unequal rise in applications overall, suggesting fewer significant new indications applying for price applications. There has been an increase in published single technology appraisals (STAs) in 2021, compared to 2020, though this is still slightly lower than previous years.

COVID-19 continues to create uncertainty in sales profiles. It was noted that Q1 growth in both 2020 and 2021 was not representative of the full year growth in either years. ABPI felt overall growth continues to be highly volatile.

DHSC highlighted the breakdown of outcomes for the varying technology appraisals which revealed an increase in terminated appraisals in 2021. NICE confirmed that as a proportion of overall appraisals, the figures are broadly consistent with the levels witnessed in previous quarters and previous years.

DHSC noted the decline in the number of NAS STAs, linked to NICE’s key performance indicator (KPI) ‘received on time’. This fell from 50% in 2019 to 18% in 2021. NICE felt that there was some correlation in this area with the impacts of COVID-19. For example, companies requesting a delay to proceedings due to delays in clinical trials.

NICE mentioned that they are looking at including a KPI around license extensions. Agreement has been reached on the metric, that NICE will be looking to produce an appraisal consultation document (ACD) or final appraisal document (FAD) within 6 months of the product being licensed for that license extension.

DA update

Northern Ireland (NI) updated that the European legislative changes were now in place in relation to the Northern Ireland Protocol. NI are anticipating that industry will continue to make decisions which will be implemented over the coming months. NI will ensure this is monitored.

NHSEI update

NHSEI updated the committee, initially to reflect on the positive progress made in the context of the NHS continuing to respond to COVID-19. NHSEI highlighted positive collaborative work with industry to treat the most vulnerable patients with the latest COVID-19 treatments, while also focusing its attention on recovery. Substantial work has been undertaken, constructing recovery plans, to ensure the backlog is tackled around elective care, working with clinicians and patients to massively upscale diagnostic capacity by a quarter over the next 3 years.

NHSEI noted that the success in meeting VPAS objectives was linked to partnerships with NICE, DHSC and industry, highlighting the collective work undertaken on key disease areas that feature as priorities within the long-term plan as well as collaborative work in response to COVID-19 treatments, vaccines and COVID-19 friendly cancer treatments.

NHSEI underlined the collective work with the Accelerated Access Collaborative (AAC) around horizon scanning. They also highlighted the continued growth in commercial activities, and our arrangements for reinvesting in new treatments, ensuring the NHS’s preparedness to make best use of competitive supply of medicines. This is happening within the context of changes and commitments around Life Sciences Vision, the Innovative Licensing and Access Pathway (ILAP), Project Orbis and the work collectively undertaken on the rare disease action plan.

NHSEI was encouraged by how issues were being tackled together, despite the challenges created by the pandemic, from treatments such as Zolgensma, right through to direct acting oral anticoagulants (DOACs). NHSEI also reminded colleagues about innovations, particularly in the rare diseases space such as CAR-T and spinal muscular atrophy (SMT).

NHSEI updated on the highest health gains. Asthma biologics has gained focus within the AAC as part of their rapid uptake product programme. Substantial work has been undertaken, particularly around optimising pathways for patients.

The UK is globally leading in terms of cystic fibrosis uptake with over 7000 patients benefiting. For hepatitis C, elimination strategies are on track for 2025, as well as a new service for children with hepatitis C launched last summer.

Smoking cessation did not reach expectations as a result of supply chain issues. While there is additional work in train on non-medical interventions, in supporting people to give up, there is hope that new suppliers will enter the market in the near future to rectify the issue. Hopefully NHSEI can collaborate with ABPI on this further.

NICE update

Helen Knight highlighted that the NICE methods review was published on 31 January 2022 with the changes following the review being applied to new topics from 1 February 2022. She noted that this new application would not apply to cancer drugs fund (CDF) reviews already in place before publication.

The key objectives for NICE over the next year was to embed the operation of the new methods and processes. A comprehensive training and implementation programme is currently being formulated, with engagement strategies in the pipeline with NICE committees, technical teams, industry and patient groups.

One area of industry interest was around NICE taking a modular approach to updating the methods. While NICE could not commit to undertaking a major overhaul of the system at this time, NICE was working towards the development of what the modular framework will look like, how NICE would prioritise the topics under consideration in such a modular approach and who NICE would engage with. There is also a commitment for NICE to undertake further research, particularly on severity.

NICE is formulating strategies for their work programme, and the challenges foreseen with a predicted increase in topics. A record number of 98 pieces of guidance was produced in the last business year. There was acknowledgement that 19 appraisals were terminated, though some topics were impacted by COVID-19 within that timeframe.

NICE is also looking to take a more proportionate approach to the way technology appraisals are conducted, which is currently a one size fits all strategy. Work will go into how NICE utilises the people involved in guidance development and what can be done differently, and whether NICE can take a more proportionate, risk-based approach to the different types of technologies appraised.

Action

NICE to update on ongoing work to prospectively collect evidence on the effects of discounting in evaluations.

ABPI update

ABPI thanked colleagues for the immense work undertaken over what has been a challenging time for all.

ABPI proposed an updated set of metrics to populate the horizon-scanning quadrant and the NHSEI commercial quadrant utilising information already collected elsewhere within the system.

Action

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

ABPI highlighted the investment in the continued collaborative work undertaken with NHSEI and the AAC on evolving horizon-scanning mechanisms to support demand signalling.

ABPI spoke of the positive engagement fostered with NHSEI with the formation of the Commercial Oversight Group (COG). This has helped facilitate broader discussions on new areas like net zero and sustainability.

On value assessment, ABPI suggested the possibility of undertaking joint work with NICE, DHSC and NHSEI to understand the numbers affected by delays to the marketing authorisation and NICE appraisal process, and how this subsequently effects the 36-month NAS exemption window. ABPI hoped this could lead to consideration for individual relief for companies where there had been a material disadvantage.

DHSC was happy to have conversations in this area going through the regular monthly meetings currently scheduled.

ABPI also wanted to gauge opinion on whether there was scope to discuss how commercial access agreements could be used to help promote uptake and drive adoption of medicines. NHSEI agreed that if ABPI could provide more detail in their thinking, this is a topic that could be tested within the context of COG.

Action

ABPI to put forward any proposed commercial arrangements for consideration at a future COG meeting.

ABPI reported on feedback received from companies who felt their inability to gain indication-based pricing commercial solutions was part of the reason for the increase in terminated appraisals. ABPI proposed that a joint piece of work ahead of the next negotiation to understand how this is working for all parties.

DHSC said they would be happy look into this and other such areas in more detail as part of the negotiation process later in 2021 and 2022.

ABPI lastly highlighted their work on finding an industry wide solution to combination pricing. ABPI have been engaged with Competition and Markets Authority (CMA) on future strategies and noted that they hoped to gain agreement very shortly to proceed with testing so that DHSC and NHSEI can provide feedback on ABPI’s proposed solution.

DHSC update

DHSC thanked colleagues on the work on setting the 2022 percentage, which through constructive discussion was set at 15% in January this year.

DHSC noted that the 6-week statutory scheme consultation closed today (26 April 2022), thanking colleagues for providing responses. The department will consider these responses with a view to publication in early June, with the coming into force of new legislation on 1 July 2022.