It is estimated that, on average, development of a new medicine takes over a decade and the cost of research and development is around £1 billion. A recent report, published by the UK Department of Business, Innovation and Skills has highlighted the slow uptake in the UK of new medicines approved by NICE compared to other countries such as the USA, Germany, France and Japan.
The UK Government has recently initiated a review, supported by the Wellcome Trust, which will endeavour to accelerate access to innovative medicines through the UK National Health Service ("NHS") and to reduce both time to market and cost of drug development.
UK Accelerated Access Review
In November 2014, George Freeman, the Life Sciences Minister of the UK Government, announced a major initiative called the "The Innovative Medicines and Medical Technology Review", now renamed as the "Accelerated Access Review".
The Accelerated Access Review is being led by Sir Hugh Taylor, Chair of Guy's and St. Thomas' NHS Foundation Trust. He will be supported by an expert advisory group headed by Professor Sir John Bell, Regius Professor of Medicine at Oxford University.
In summary, the review will include the following:
- a full review of the current pathways for development, assessment and adoption of medicines, devices and diagnostics. It is intended that the review will map the current landscape with a view to:
- producing practical improvements to the NHS;
- creating a better alignment of existing assets and initiatives;
- identifying key strategic and operational priorities to enable the speeding up of patient access to cost-effective and innovative medicines;
- reducing the time it takes for innovative medicines to get from clinical trial to market.
- encouragement of the continued development and use of stratified medicines and new therapeutic technologies. This will include giving consideration to existing funding structures and looking at current ways of working, to assess how best to support medical and technological innovations.
- greater consideration will be given to the benefits of new and emerging technologies. There will be greater encouragement of more widespread use of such technologies which have, traditionally, suffered from slow take up in the medical sphere. For example:
- the promotion of greater use of digital devices, medical apps and other digital technologies in the medical world, both for use by patients and medical practitioners;
- better and more effective use of medical data. This will be effected by first identifying the data governance and privacy requirements that need to be put in place and then dealing with any issues surrounding the use of real-time data and monitoring systems in the medical world;
- better utilisation of data analytics, data measurements and big data for evidence-based technological developments. Data gathering and analysis will assist with assessment and commissioning of effective innovative medicines, devices and diagnostics;
- better adoption, diffusion and tracking of innovative products, using innovative technologies and tracking patient responses throughout the NHS, in line with whatever relevant data protection and regulatory requirements may apply.
Accelerated Access Review and Impact on Existing Schemes
The Accelerated Access Review will take into account and seek to strengthen other schemes already in existence, such as the Early Access to Medicines Scheme; the Adaptive Pathways Pilot; the National Institute for Health Care and Excellence (NICE) Technology Appraisal; the NICE Implementation Collaborative; and the Evaluation through Commissioning scheme.
Accelerated Access Review and Investors
The Accelerated Access Review seeks to encourage investors to work jointly with the NHS. For example:
- to ensure greater numbers of clinical trials are undertaken using NHS patient groupings;
- to consider how the NHS can collaborate with relevant partners to provide real life evidence of utility and cost effectiveness (both domestically and at an international level);
- to jointly promote innovative drugs, devices and diagnostics.
It is envisaged that the review may lead to fast track regulation which could make innovative medicines more readily available and this should result in the cost of new medicines being reduced. To that end, the Accelerated Access Review encourages investors who have funds, resources and know-how to work within and with an integrated system, eventually creating a reformed health care system that benefits from greater private sector input.
Potential Reform of Reimbursement Models for Medicines
The Accelerated Access Review will look at potential reforms to existing reimbursement models. It will consider how systems of economic assessment can be adapted to reflect technological advances in genomics, precision medicines and informatics. The review will consider changes to the traditional research and development model so that innovative products can be better integrated and funded as inexpensively as possible and thereby become more accessible to patients.
The particular nature of the NHS, being a fully publicly funded healthcare system with access to vast amounts of patient information, means the UK is perhaps uniquely placed to effect such changes.
Response of Stakeholders to the Accelerated Access Review
It is not surprising that proposals to improve and ensure both access to, and uptake of, new medicines have been widely welcomed by pharmaceutical industry bodies.
The Association of British Pharmaceutical Industry's (ABPI) project director for manufacturing, James Christie, has said:
"the stronger the medicines manufacturing sector in the UK, the more effective we will be in bringing innovative therapies and treatments to patients… by looking across the board at issues such as supply chain innovation, developments in technology, changes to the fiscal environment and access to sustainable funding, we hope to create a user-friendly blueprint for success in UK medicines manufacturing."
The BioIndustry Association (BIA) has commented:
"Continued government focus and commitment to the life science sector is crucial to the success of the UK life science ecosystem."
The Accelerated Access Review will also be welcomed by patients and pharmaceutical companies alike, frustrated by the fact that innovative drugs have been removed from the lists of treatments available recently.
The Accelerated Access Review has the potential to bring the UK to the forefront of the global life sciences arena, alongside cities such as Boston, San Francisco and Singapore. The proposed reforms under the Accelerated Access Review have been welcomed by a range of key stakeholders involved in the provision and delivery of healthcare in the UK. We will be monitoring developments and reporting on the different elements of UK Accelerated Access Review as it progresses over the ensuing months.