Party lines on medicines pricing

The NHS has been a central battleground for the two major parties during the General Election campaign. Labour’s main attack line has focused on a potential future US-UK trade deal, in which the Party suggests the NHS would be ‘on the table’ in negotiations and ‘sold’ to private companies. Corbyn has continually sought to shift the narrative by focusing on this, what his advisers believe is one of his strongest lines. Given the spotlight on this issue, the Conservative Party manifesto treads lightly on detail but issues a clear denial: “When we are negotiating trade deals, the NHS will not be on the table. The price the NHS pays for drugs will not be on the table. The services the NHS provides will not be on the table.” However, despite this trepidation, the manifesto does not shy away from medicines policy entirely, making a significant commitment to the creation of an Innovative Medicines Fund. But what does this mean for industry and does it represent a significant change to medicines pricing?

A new and improved funding system for innovation?

It is timely that the Conservative Party Manifesto commits to expanding the Cancer Drugs Fund (CDF) to a £500 million Innovative Medicines Fund. A ring-fenced fund within the medicines budget, it would be used to support access to more ‘innovative’ medicines across a range of conditions, no longer limited to cancer drugs. While this is undoubtedly a good news story, this pledge will not be without its difficulties. While the fund represents an increase of nearly 50% on the CDF, the lack of detail around its permanence raises the question of how many patients would benefit. Given the political risks, it is reasonable – though not certain – to assume that any patient who receives a treatment during this period would remain on it thereafter. This may in turn raise questions about its cost and sustainability.

Indeed, the sustainability of the CDF in its original and revised configuration has been called into question since its announcement. The bill from the original CDF rose consistently until it reached an overspend of £126m, or 37% in its final year (2015/16), leading to its reform – morphing into an interim process to assess the effectiveness of new cancer medicines where there was not enough evidence for routine use. The widened scope of the new Innovative Medicines Fund – and lack of clarity – means there is a risk for this new fund to spiral into something similarly unsustainable.

Prioritising will therefore be key to its long-term success, selecting the most promising products that can use their time in the programme to build a solid evidence base to support long term commissioning on the NHS. Similarly, how the Government will define ‘innovative’ and ‘promising’ has not been defined and any political interference – or lack of clarity in the 12-month fund running time – risks challenging the orthodoxy by which the vast majority of medicines have been appraised since NICE’s establishment in 1999.

Funding fit for the future

NICE’s appraisal process is subject to change following the conclusion of the NICE methods review in 2020 but it is unclear how or whether the new fund be compatible. Will ‘innovative’ medicines be expected to enter the Early Access to Medicines Scheme and will the budget impact test still be relevant? These are questions that the Government will need to answer in the post-Election wash-up.

Clearly the fund could be used to help NHS England and the Government avoid damaging headlines. Cystic fibrosis treatment Orkambi could well be the kind of medicine that would benefit from the Innovative Medicines Fund, being made available on a temporary basis for patients while further data on efficacy was gathered. Indeed, the new fund is designed to offer a way forward for promising drugs for conditions such as Alzheimer’s, Huntington’s and motor neurone disease in addition to cancer. This begs the question as to how a wider range of drugs will compete for space on the programme – will it be all about manufacturers adhering to stringent data requirements to demonstrate value for money for the NHS? Or, will it come down to those that have the most patient and political support? For instance, while it is in rare diseases where the benefits of the fund could be most clearly felt, the temptation will be to channel funding towards areas where there is maximum public and political clamour – inevitably conditions with a higher patient population, in which data collection is less of a challenge. Without a clear plan that aligns with the existing regulatory process it is difficult to see how this new fund will operate as anything other than a short-term stopgap.

However, the fund does offer a more long-term opportunity. It affords the chance to use it as a pilot for some of the reforms being explored in the NICE methods review, precipitating a transition onto a more permanent footing. For example, the fund could incorporate a wider definition of value than the current QALY system, or introduce something similar to the Patient and Clinician Engagement (PACE) style meetings that are characteristic of the Scottish medicine appraisal system.

Given the number of changes to the appraisal and negotiating landscape in the last five years, with NHS England showing a desire to explore new ways of working with industry on more unique innovative pricing models, it is possible that the new fund – if implemented – will only be one aspect of a rapidly shifting political landscape for the life sciences.

What is clear, however, is that whoever wins the General Election will have a significant impact on medicines, access and pricing for years to come.