Medicines and Medical Devices Bill — House of Lords, 2021-01-14
Topic: Health
Philip Alexander Hunt (Labour, Centre-left): My Lords, before I start, perhaps I may make the point to the clerks that the noble Baroness, Lady Thornton, needs to be unmuted every time the Deputy Speaker goes through the amendments so that she can move them or not. It is very frustrating; we can see it happening, and it is impossible for us to come in on this situation. That is why there is such a hiatus My Amendment 66 concerns NICE’s current view of its methods and processes as part of the agreement on the voluntary scheme for branded medicines pricing and access, happily known as VPAS. If NICE is to maintain its global relevance, it is critical that the methods review delivers tangible changes to ensure that it can fairly and effectively assess the true value of innovative medicines. The UK life sciences sector is at a crossroads. Without meaningful intervention from the Government, exiting the EU obviously presents significant threats to the attractiveness of the UK. We know that global boardrooms take a holistic approach when considering where to place their investment, including the attractiveness and speed of the commercial environment—we have debated these earlier in the Bill. The ability quickly to launch medicines and technologies into our market and to get medicines quickly to the patients who need them is one of the main factors that shape boardroom sentiment on future investment, alongside the quality of scientific research and the possibility of collaboration. It was the Labour Government who set up NICE to do that: to get innovative new medicines and devices to the NHS and implemented as quickly as possible But the UK risks missing out on a wave of breakthrough therapies, with the potential to transform outcomes, if the NICE review does not lead to meaningful change in the way it does its business. Not only do we risk losing our reputation as a leader at the cutting edge of medical science but, more importantly, patients will not be able to assess the most innovative treatments available elsewhere. So NICE’s approach to appraising value must take into account the strategic benefits of the NHS remaining at the forefront of medical innovation and demonstrate that the UK Government are committed to supporting a thriving, world-leading life science sector post Brexit In relation to my amendment, I would like to raise issues of barriers to new innovative technologies, such as gene therapy. Gene therapy is a prime example of a medical technology that the UK should embrace, and, indeed, the Government have rightfully lauded the UK’s efforts in this regard. But a procedure called the discount rate, used by NICE to adjust for future costs and health benefits when valuing treatments, discriminates against one-time therapies that offer potential long-term health benefits over many years, such as gene therapies. NICE almost always uses a 3.5% rate. It can apply a lower 1.5% rate for therapies that offer longer-term health benefits, but it has chosen to do this only on exceptionally rare occasions. I wonder whether the Minister will commit to working with NICE to review the circumstances in which the policy solution can be applied to unlock the potential of such innovations The VPAS was negotiated with the aim to secure a triple win for patients, government and industry. But NHS England’s current bespoke commercial agreements significantly undervalue innovation, and this is something global boardrooms look at for evidence in the NICE review—that speedy access to new medicines will be improved Why should the Government commit to doing an impact assessment of the changes? Well, warm words and promises from Ministers are not enough; we need a clear commitment from them that they will place the emphasis on NICE to ensure meaningful action. In Committee, the Minister argued that my amendment was not necessary, and that the issues I raised were already dealt with in existing legislation and were outside the remit of the Bill. She went on to say: "NICE, like the rest of the health system, is constantly keeping methods under review to ensure they are appropriate and support the speed of innovation in the life sciences sector," and she agreed about the need to get new innovations into the hands of patients quickly. In so doing, she referred to the methods and process manual produced by NICE "in consultation with a range of stakeholders, including industry and academics." She said: "NICE will publish a revised manual and related impact assessment when that process is completed."—[Official Report, 26/10/20; col. GC 52.] Is that sufficient The Ethical Medicines Industry Group has identified that medicines and medical devices often face challenges when being assessed by NICE, due the rigid focus on cost-effectiveness. Failing to consider other factors, such as the benefits of treatment in reducing health inequalities or the wider impacts on quality of life, often hinders patients’ ability to access innovative life-saving treatments. The EMIG argues that introducing a health inequalities modifier would be critical to demonstrate that NICE recognises the importance of reducing the high levels of unmet medical needs in the population and to benefit the most disadvantaged and underserved patient groups. There is strong support for the introduction of this modifier among experts involved in the development of the consultation, with a document noting that there is evidence that people are willing to generate less health overall if the health is generated in disadvantaged groups, particularly for socioeconomic disadvantage My amendment seeks to build on expert support to ensure equitable access to innovative treatments for conditions that are not adequately treated, to drive down health inequalities and benefit the most marginalised patients. I argue that NICE must also review its appraisal system for rare disease treatments to ensure that the system in place enables patient access. Inherently, rare disease treatments serve small patient populations, and generating sufficient data to meet NICE’s cost-effectiveness requirements is often challenging I have received a briefing from another organisation, Global Blood Therapeutics, on sickle cell disease. It argues that, in relation to the UK’s most prevalent genetic disorder, SCD treatments are currently limited to managing the condition rather than addressing the underlying causes. But there is hope that a new range of therapies may change this On occasion, NICE has also considered treatments which may not meet its traditional cost-effectiveness thresholds but which would have a significant impact on health inequalities. But consideration of health inequalities remains rare, and I think that this needs to be revisited. If NICE is truly committed to designing an appraisal process which reduces health inequalities and provides equitable access for the most disadvantaged patients, the introduction of a health inequalities modifier, as set out in my amendment, is vital The UK life science sector faces a great challenge. It is a huge asset. We have to ensure that organisations such as NICE play their part in making sure that the NHS and the UK are attractive for major investment in the future. In a nutshell, that is the crunch point of my amendment. We have as well to make sure that its methodology deals with health inequalities sufficiently. I beg to move.