How transparent is the VPAG?

Leela Barham takes a look at the transparency of the UK’s new pricing and access scheme, the 2024 VPAG, based on public sources. Whilst it’s early days, there is more in the public domain about VPAG than was known about VPAS, VPAG’s predecessor, at this point in the scheme’s implementation.

With numerous commitments made in VPAG, time will tell how transparent the government’s agencies and industry will be about progress and delivery, but there are reasons to be optimistic.

Key documents and a useful tool for calculating payments due

The 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG), is set out in a main document and annexes, on its own main website hosted by the UK government. There is a lot to read through; 97 pages for the scheme with 79 pages for the annexes (excluding Annex 5). As an aside, anyone who wants to understand the scheme does need to read it and should not rely on the interpretations of others; the devil really is in the details.

What’s different now in transparency terms versus predecessor VPAS is an open document for Annex 5 – which functions like an Excel spreadsheet – that presents scheme calculations. This allows companies, and anyone else who wants to, to input data and see what that means for payments that will become due from companies. This is bound to be a useful tool, avoiding the need for different people to generate their own tool to test out scenarios for the future.

The ABPI, the industry body that represents the research based industry and who negotiated the deal with the government, also provides resources to help companies understand the VPAG on their website. Anyone else can access these too and, with some raising the concern of a lack of knowledge of VPAG, these could help tackle the education gap for those who want to know more.

The ABPI has put together very useful slides on the scheme, but they weren’t found on their website (perhaps they were just missed in the desk research), but do turn up in other places, like this LinkedIn post.

The same is true of slides from the Department of Health and Social Care (DHSC), as well, spotted on this LinkedIn post. These slides likely come from emails or virtual meetings, but perhaps they would be better hosted on the VPAG websites of the DHSC and ABPI, so that everyone can easily find them.

Scheme members not yet known

Companies who wanted to join the voluntary, as opposed to the statutory scheme, had to let the DHSC know by 15th January 2024. In the past, membership has been published by the DHSC via a Kahootz site, but that has yet to be updated at the time of writing. Kahootz describes itself “as a secure collaboration in the cloud.”

With some high-profile leavers of the predecessor scheme VPAS – AbbVie and Eli Lilly – there will be interest in whether they’ve joined again. Presumably, an updated membership list will become available at some point.

Review meetings to be more inclusive

The VPAG sets out that there will be operational review meetings every six months. Under the previous scheme, meeting minutes were published, so it’s likely that this will happen again.

The first meeting will agree on “success factors and metrics”. VPAG also says that the success of the scheme will be measured against three objectives:

Promote better outcomes and a healthier population;
Support UK economic growth; and
Contribute to a financially sustainable NHS.

Metrics to assess delivery against these are likely to be hard to come by, but time will tell if DHSC and ABPI can manage it. The VPAG does give a hint at what’s likely to be featured in metrics as it commits to continuing the development of the Innovation Scorecard and Estimates Report and noting that this work will help monitor the implementation of VPAG. Metrics used under VPAS could well be the starting point this time around, too.

Unlike the situation in the previous scheme, the BGMA, who represent generic manufacturers, will be invited to operational review meetings. The BGMA had sought a role in negotiating the deal, but wasn’t successful. Their role will be as an observer only. The VPAG also suggests other industry representatives may be invited to observe, as well. There’s no mention of anyone representing patients, though.

Strategic engagement promised

VPAG says that the benefit of open and regular dialogue between the DHSC and pharmaceutical industry representatives is recognised. This will be via the Life Sciences Council (LSC) and sub-groups like the Patient Access to Medicines Partnership (PAMP). Yet, little is known about the LSC (their website just says “Life Sciences Council”; yes, really, that’s it). Details about LSC meetings have come out via social media in the past.

Future financial reporting

It’s too soon for the routine reporting of NHS spending on medicines and payments made by companies for VPAG because the first payments aren’t yet due. For VPAS, figures were published by the DHSC, who are responsible for the operation of the scheme, and that’s likely to continue.

Time will tell if the DHSC will present aggregate VPAG payments or a breakdown according to the type of medicine. There is value in going into detail because it would provide stakeholders with an understanding of just how much comes from older and newer medicines.

Future reporting on other commitments

The VPAG includes several commitments, most for England, rather than the other parts of the UK. Some are supported by the new VPAG Investment Programme, expected to be worth £400 million, and funded by member companies paying a premium on top of usual VPAG payments. The commitments include:

Re-development of UK PharmaScan on a new technological platform by or before the end of 2026, funded by the VPAG Investment Programme.
Establishing a UK-wide cross-government working group with industry trade body representation to better coordinate activities across organisational boundaries, by or before the end of 2024.
A guide to the end-to-end pathway for routes to market due by the end of 2024.
An update to the NHS England Commercial Framework for New Medicines to include greater detail on enhanced commercial flexibilities and eligibility for indication-specific pricing mechanisms, consulted upon by June 2024, and other relevant policy documents (which aren’t specified). A further consultation on the NHSE Framework is also promised no later than June 2026 to align with updated regulatory and access pathways.
Further development of technology assessment methods and processes used by UK HTA agencies, funded by the VPAG Investment Programme.
Delivery of two innovative payment model pilots to explore practicalities of outcomes-based agreements for ATMPs.
Updating of the Budget Impact Threshold above its current rate of £40 million with a consultation to be launched by June 2024.
NICE doing more to ensure timely updates of clinical guidelines to incorporate technology appraisal guidance, funded by the VPAG Investment Programme.
Enhancement of NHS England and NICE adoption and support materials, funded by the VPAG Investment Programme.
Updating of national and regional clinical leadership job descriptions by NHS England, so that they embed their role in championing and advocating the use of NICE guidance and guidelines in clinical communities, as well as improving the clinical communication cascade.
Further development of uptake measurement tools, including the Innovation Scorecard and Estimates Reports, tracking variation in uptake of NICE-recommended medicines at Integrated Care Board (ICB) level. This will be supported by reviewing the terms of reference for the Strategic Metrics Group “as early as possible in 2024.” Desk research didn’t find any further details about the group.
A local formulary national minimum dataset to be developed by NHS England by, or before, June 2026. NHS England is also due to publish an annual report identifying unwarranted variation between national guidance and local formularies.
Working together, NHS England and companies who have joined VPAG will develop a new database of patient support programmes that companies fund and third parties deliver to the NHS by or before June 2026 and then it will be kept updated after that.
Boosting workforce capacity, resources, and infrastructure for commercial clinical trials, funded by the VPAG Investment Programme.
Improving the manufacturing innovation ecosystem delivered through co-developed challenge funding and collaborative R&D programmes via Innovate UK.

VPAG says that there will be an overarching UK-wide governance structure for the work funded by the VPAG Investment Programme. Workplans for each initiative within this should be available by the end of April 2024. Those in charge of the different initiatives will report to the Operational Review Group through a working level Programme subgroup.

The plan is for annual reporting on the progress of work funded by the VPAG Investment Programme, including metrics and the potential for a midpoint review in June 2026. However, it will be the DHSC that will be responsible for spending and accounting for the money, with the industry body the ABPI and their members having no say, at least up to the midpoint review. If there’s evidence of non-delivery, the ABPI can give a year’s notice to stop payments.

There are already calls for more clarity on the VPAG Investment Facility from the BGMA, they want “fair and equal access to […] support [on manufacturing].” Reporting should help with clarity, even if there may still be a debate about fair shares.

Transparency is key for accountability

The government has said that VPAG is a “landmark deal, which will boost the nation’s health and save NHS £14 billion.” Transparency is needed, so that those affected by the scheme – patients, companies, the NHS, and UK plc – can hold the government, its agencies, and the ABPI to account. The VPAG seems off to a good start.