Freeman review interim report – Hit or miss for the pharmaceutical industry?

A chance to have your say on access to medicines

The interim report of the long-awaited Accelerated Access Review (AAR) has been published, setting out the Government’s plans to speed up access to innovative treatments and technologies.  When George Freeman announced the review in November 2014, no one could deny his ambition.  Not only would the review aim to stimulate jobs, growth and economic investment, it would seek to ‘ensure that the UK is the fastest place in the world for the design, development and widespread adoption of medical innovations.’  After the effective failure of Value Based Assessment (VBA) to allay stakeholders’ concerns about access to medicines, all eyes are on the Freeman review to solve the thorny issue of how medicines should be valued, and how to encourage valuable innovation for the future.

This report has been so eagerly anticipated primarily because it represents the first signs of emerging thinking on the needs, principles and priorities for increasing uptake and the spread of innovation in the NHS.  It is significant for the pharmaceutical industry for three key reasons:

  1. There is a strong emphasis placed on the need to explore flexible approaches to pricing and reimbursement, especially for the most promising products.  Companies boasting unique pipeline treatments, for example drugs with multiple indications or targeted treatments, should get ready to be involved at a much earlier stage in the development process.
  2. Although still in its early stages, the review will set the tone for the next round of pharmaceutical price regulation scheme (PPRS) negotiations in 2019.  There is a unique opportunity to optimise evaluation, funding and delivery methods for treatments, especially those with strong health outcomes data.  If companies don’t get involved in the process now, they could be left behind.
  3. The scope of the review goes beyond the UK, as it will seek to combine a continued drive to accelerate pathways at a European level.  This is especially relevant for medical technology companies who are concerned about the potential in future effects of European medical devices and IVD regulations.

Initial stakeholder reaction to the interim report has been positive.  Patient groups have welcomed the emphasis on putting the patient ‘centre-stage’, whilst the Association of the British Pharmaceutical Industry (ABPI) has applauded Freeman’s recognition of the need to ‘invest to save’.  The report’s vision of patients as partners in the innovation pathway is certainly commendable and aligns with the ‘no decision about me, without me’ mantra.  However the language used in the interim report is far from patient-friendly, and the authors will need to address this if they want the final report (due in April 2016) to resonate with a wide audience.

In terms of the importance of investment, Sir Hugh Taylor, is quick to point out the risks to the health system and wider economy if research budgets are threatened.  If we fail to invest in the change and innovation the NHS needs to deliver better care, then we will lose ground and fall even further behind other countries in providing patients with access to new medicines.  Whilst the report outlines a ‘radically new’ and proactive approach to accelerate access to the most promising emerging products, it falls short on practical detail.  Whilst Sir Taylor acknowledges that the report is deliberately high level, the true test will be in the months to come when stakeholders are invited to work together with the review to test the preliminary analyses and work up firm proposals that will form the backbone of the final report.

Another important recommendation is that the NHS should be incentivised and supported to adopt new products and systems quickly and effectively in order to become an active partner in promoting innovation.   The review quite rightly points out that the NHS has a reputation for being slow to adopt new products, and Sir Taylor’s team has clearly gathered a wealth of information on the key barriers the system faces, particularly when seeking to invest in innovations that have uncertain or long-term benefits.  One incentive suggested by the review is a new earmarked fund, with proposed models including social investment, match funding and re-purposing of existing funds.  Academic Health Science Networks (AHSNs) could play a key role in channeling funding, with the emphasis on using the fund as a source of true investment, with clear demands and expectations to return on investment.

The ideas in the interim report will now be used to frame the review’s next phase of engagement, where industry and other stakeholders can feedback and offer their views.  In a week that has seen what appears to be a U-turn by policy makers to re-instate Kadcyla on the Cancer Drugs Fund list, it is clear that the issue of access and availability of medicines is here to stay on the political and health agenda.  Whatever the final report concludes, a great deal of expectation is resting on Sir Taylor’s review and how far it can realise George Freeman’s high ambitions.  Industry and other stakeholders should waste no time engaging with the interim review and having their say in the debate on access to medicines.