Transparency data

28 September 2021 minutes

Published 3 October 2022

Meeting details

The meeting was held on 28 September 2021 from 9am to 11am via Microsoft Teams.

The chair was Liz Woodeson.

Minutes were taken by Michael Vidal.

Attendees

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

• Liz Woodeson (chair)
• Stephen Hennigan
• Daniel Law
• Richard Mattison
• Noah Kidron-Style
• Andina Ward
• Will Olivier
• Michael Vidal

From NHS England and Improvement (NHSEI):

• Blake Dark
• Lauren Hughes
• Claire Foreman
• Matt Whitty
• John Stewart
• Amit Patel
• Greg Manuel

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)
• Neale Belson (GSK)
• Richard Torbett
• David Watson
• Santoke Naal
• Paul Catchpole
• Ryan Hollingworth

From the devolved administrations (DAs):

• Andrew Evans (Wales)
• Alison Strath (Scotland)
• Keith Willock (Scotland)
• Eimear Smyth (Scotland)
• Thea Kellock (Scotland)

From the Office for Life Sciences (OLS):

• Hannah Lom

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

• Meindert Boysen

Introductory remarks

Chair welcomed everyone to the meeting, highlighting that this would be an operational review of the 2019 voluntary scheme for branded medicines pricing and access (VPAS) as well as a ‘mid-scheme review’.

DHSC confirmed that the government viewed the voluntary scheme as being successful and an important part of the life sciences landscape in the UK.

Minutes of last meeting

No comments on the minutes from last meeting held on 20 January 2021.

Operations update

DHSC confirmed that the share of payments allocated to devolved nations would continue to be based on primary care data, and that the devolved nations were not however given a forecast of future payment share apart from broad scenarios.

Alison Strath noted there was an opportunity to utilise hospital prescribing data alongside primary care prescribing data in Scotland in the future to inform apportionments.

The total number of companies in the 2019 voluntary scheme had increased in 2020 over 2019.

DHSC confirmed that the new portal for scheme members to submit presentation level data was operating well, but 16% of scheme member reports for 2019 were still outstanding. The 2019 and 2020 data submissions deadlines were extended due to COVID. The ABPI offered to support any communication to scheme members to confirm reporting requirements.

Action

Richard Mattison to follow up with scheme members and ABPI on the importance of timely data submissions and communications.

DHSC confirmed the approach to ensure affiliates of UK companies (for example, based in Europe) selling medicines to Northern Ireland due to the Northern Ireland Protocol, would comply with scheme membership. These companies should apply to join the scheme as an affiliate of their UK business (if also in the scheme).

DHSC confirmed data on list price applications applied for and granted so far for this scheme versus the previous Pharmaceutical Price Regulation Scheme (PPRS) 2014.

DHSC shared an analysis on payment percentages, which concluded that the limitation of using incomplete data each year to Q3 had a greater impact than using subsequently audited data.

Similarly, DHSC analysis concluded that the initial growth forecast had little impact on eventual payments, since the model used an adjusted forecast which was more effective.

ABPI noted the reasons for agreeing a calculation that adjusted for actual growth and reminded DHSC that if that agreement hadn’t been reached industry would otherwise be asked to contribute to growth in the medicines bill without a clear link to sales growth.

Although the original scheme forecast was no longer required and was replaced by actual data in the calculation, all parties noted the ongoing importance of horizon scanning and forecasting so that all sides had a clear view of the likely challenges in the years ahead.

The need to review data on new active substance (NAS) availability was agreed, as well as the outcome of single technology appraisal (STA) decisions.

Action

ABPI and DHSC to work with NICE to reflect latest NAS timelines metrics and capture any further NICE data on rate of optimised decisions and terminated appraisals for new medicines.

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

Mid-scheme review

DHSC paper

DHSC noted that VPAS had driven faster access to clinically and cost-effective new medicines, referencing the NHSEI update paper on this point.

NICE had reduced assessment timelines for non-cancer medicines and aimed to publish draft guidance for new medicines (cancer and non-cancer) at the point of licence and final guidance within 3 months of marketing authorisation wherever possible.

DHSC also noted that the Medicines and Healthcare products Regulatory Agency (MHRA) supported innovative medicines and accelerate the time to market through the Innovative Licensing and Access Pathway (ILAP).

NHSEI noted the Commercial Framework, which had been introduced as a result of the scheme, that set out to simplify, streamline and improve access, uptake and pricing arrangements.

The VPAS caps the overall increase in sales of branded medicines at 2% per annum through the mechanism of payment from industry to the NHS calculated on the basis of aggregate growth above the cap.

DHSC noted that the payment percentages set would not have been notably different if set using the ABPI forecast at time of negotiation as opposed to the adjusted forecast. The forecast adjustment methodology seemed to be effective.

As part of lessons learned from the correction of the 2021 payment percentage calculation, DHSC will implement assurance of calculations which will be carried out by the Office for Life Sciences. DHSC will work with NHSEI and ABPI to improve the accuracy of spend growth forecasts, which should improve predictability of future payment percentages.

DHSC and industry will continue to work together to ensure ongoing successful operational delivery of the scheme. We note that the timely submission of audited sales reports is a possible area where performance could be improved.

In 2019 to 2020, Accelerated Access Collaborative (AAC) programmes helped over 2,500 innovators, including 477 health professionals, and supported over 2,500 innovations.

All parties agree that overall operational performance of VPAS has been good thanks to effective engagement between DHSC, NHSEI and industry. No disputes have been raised demonstrating good relations. An independent internal audit of the scheme confirmed that it operates effectively, and that appropriate processes and controls are in place.

NHSEI paper

NHSEI set out progress on each of the objectives of the voluntary scheme and progress on specific ambitions noting the context of the COVID-19 pandemic.

In addition, NHSEI highlighted relevant government developments including ILAP, the new Life Science Vision and the development of the Innovative Medicines Fund.

Uptake

NHSEI reiterated the range of implementation and support available through the AAC, including the expansion of the Rapid Uptake Products (RUP) programme.

NHSEI reported that on uptake, the updated Innovation Scorecard showed that in 4 out of 5 of the highest health gain categories (5HHG), the NHS was meeting or exceeding the level of uptake projected by NICE and that uptake of the products continues to increase.

NHSEI noted that they had commissioned a comparative analysis of uptake of the categories against other European countries. This showed that for hepatitis C and cystic fibrosis England fell within the upper quartile whereas it had not been possible to ‘rank’ England for direct-acting oral anticoagulants (DOACs) or asthma biologics.

NHSEI noted that in line with the NICE estimate, England was not within the upper quartile for use of smoking cessation pharmacotherapies. NHSEI noted the impact of COVID-19 on the rollout of a programme on smoking prevention in hospitals which is expected to improve uptake of this category.

NHSEI reiterated their commitment to VPAS and to its continued success across the second half of the scheme.

ABPI paper

ABPI thanked NHSEI and DHSC for their presentations and highlighted progress on horizon scanning, engagement and commercial arrangements, but noted their concerns on uptake and the affordability mechanism.

Uptake

ABPI noted the considerable success of new uptake arrangements for COVID therapeutics and applauded the success of the NHS. However, more generally they stated that scheme ambitions on the uptake of the most clinically and cost-effective medicines (paragraphs 3.50, 3.51 and 3.52 of ‘The 2019 voluntary scheme for branded medicines pricing and access: chapters and glossary’) had not met the expectations of scheme members and asked for further activity to support this ambition. NHSEI reiterated the range of implementation and uptake support available to the most clinically and cost-effective medicines and reiterated the invitation for the ABPI to highlight technologies that might benefit from further support.

ABPI said industry perceived progress on the 5 highest health gain categories to have been slow and that they understood from the Logex report that 2 out of 4 of the 5 highest health gains were in the upper quartile of comparator countries. NHSEI noted that for 4 out of 5 categories the NHS was meeting or exceeding the level of uptake expected by NICE but acknowledged that some programmes of work to support the uptake of the categories had been impacted by COVID-19 and committed to continue to update on progress.

Action

NHSEI to update on uptake of the 5 highest health gain categories at the next VPAS Operational Review meeting.

Affordability mechanism

ABPI reported that they felt that industry payments under the VPAS affordability mechanism were not clearly informing medicines policy as well as their concern about the NHS Digital prescribing costs statistics. They noted their concern that within the NHS some organisations are not aware of the scheme and therefore it does not inform their financial planning.

Given this, ABPI proposed further work on the reporting of medicines expenditure and accounting treatment of scheme payments. They suggested this could be used to communicate the effect of the cap. DHSC emphasised that they would not support changing the financial operation of the scheme but invited ABPI to share any proposals with them for further considerations.

Action

DHSC and ABPI to discuss issues around relevance and expenditure at upcoming regular discussions. ABPI to put forward proposals on these issues for consideration by DHSC.

Data and infrastructure

ABPI noted that they had developed a proposal for data infrastructure for health delivery to support commercial access agreements.

Action

ABPI to share paper on data and infrastructure with OLS, DHSC and NHSEI.

ABPI said that in their view the NHS overall has not taken full advantage of the financial security provided by the cap mechanism to improve uptake. ABPI stated that they had heard NHSEI leaders similarly highlight opportunities for enhancement. ABPI stated that it is important that the scheme can be demonstrated to be ‘relevant’ to NHSEI medicines policy in the next 2 years.

Tendering

ABPI stated that industry had not anticipated the use of tendering during the scheme and reiterated that they saw this as a significant change to the UK operating environment.

NICE methods review

ABPI welcomed the consultation on NICE methods review and noted that they wanted NICE to be able to make ‘ambitious’ changes. ABPI reiterated that they had believed changes could be managed through the VPAS affordability mechanism.

ABPI commended NICE for the effort and resources committed to progressing a thorough review of methods and processes during challenging times. Industry and other stakeholders broadly supported the proposals, although industry described how they wanted NICE to be permitted to make the ambitious changes they believed are needed. ABPI reminded DHSC and NHSEI that it had proposed this could be done in a managed way given the scheme cap.

ABPI noted that industry had expected the scheme to be the overarching agreement on how affordability and financial sustainability were supported, in line with the stated purpose of the scheme. A predictable commercial environment had been expected, in return for the financial contribution made by industry through the affordability mechanism. Industry did not anticipate the further use of competitive tendering on classes of medicines after the scheme came into effect and saw this trend as representing a very significant long-term change to the UK operating environment. NHSEI noted that the use of tendering is covered in the 2019 VPAS and was similarly covered in the 2014 pharmaceutical pricing regulation scheme.

Industry noted medicines expenditure data published by NHS Digital. This data relies on public list prices and does not take account of VAT, wholesaler and distributor margins as well as commercial discounts and other central rebates and as such it is not fully reflective of prices paid by the NHS or NHS medicines expenditure.