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The Disraeli Room

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Accessing the Future of Healthcare: Why the commissioning of new medicines must be a priority for the next government

22nd April 2015

The Coalition Government should be commended for its efforts to drive the life sciences agenda. After setting down an early statement of intent with the Strategy for UK life sciences, last year’s re-launch of the Office for Life Sciences, operating across the departments of business and health, signalled a clear intention to harness the potential of modern technology to create a health service fit for the 21st century.

As Minister for Life Sciences, George Freeman’s task has been two-fold: to promote investment in the UK, and champion the adoption of innovation in the NHS. There is a clear need to address both elements in tandem. In a competitive global environment, the appeal of the UK as a destination for investment will largely depend on the NHS’ success as a hub for pioneering medical technologies – including advances in genomics and stratified medicine that hold the potential to revolutionise patient outcomes in a range of genetic diseases.

Yet this is the challenge that Freeman has been confronted with during his first year in office. While the last five years have seen the emergence of groundbreaking drugs for a host of rare diseases, patients have been repeatedly let down by the absence of a coherent system for getting these treatments to patients.

The UK’s poor record of utilising new medicines is illustrated in a recent comparative study by the Office for Life Sciences. Prepared at the request of the ABPI, the report shows that the uptake of newly-licensed medicines in the UK is only 11% of the average of other developed countries after one year, less than a third of the average after two years, and only half of the average after four years. This is an alarming performance which threatens to jeopardise Britain’s long-term vision for the life sciences, and underscores the urgent need for reform in the next parliament.

As traditional mechanisms have struggled to keep pace with rapid advances in medical technology, the appraisal landscape has become increasingly complex and fragmented. A report by Genetic Alliance UK has highlighted no fewer than seven routes through which new medicines can now be approved in England, following a string of policy interventions that have resulted in growing uncertainty over where responsibility lies for any given drug.

The National Institute for Health and Care Excellence (NICE) has been slow to adapt to its responsibility for specialist treatments. Its programme for highly specialised technologies intended to treat so-called ‘ultra-rare’ diseases has been hindered by long delays and limited capacity, with only one evaluation completed to date. Meanwhile, Andrew Dillon (Chief Executive of NICE) has acknowledged that the current structures are not fit for purpose, calling for a national debate on how to approach the assessment of high-cost low-volume medicines.

At NHS England, the ethical implications of the confusion have been brought into sharp focus. The Clinical Priorities Advisory Group (CPAG) is facing a backlog of more than 80 treatments awaiting a decision after its scorecard was suspended following the threat of a legal challenge, amid concerns that the evaluation criteria could disadvantage patients with rare diseases. This has culminated in a patient protest outside Parliament, and a letter to Downing Street demanding immediate funding for the treatments they need.

The blame cannot be laid solely at the door of the Coalition Government, but it must take responsibility for the delay in addressing an increasingly disjointed system that has long shown signs of considerable strain. The premature decision to abolish the Advisory Group for National Specialised Services was also a key failing, prompting one backbench MP to declare in January that ministers have “a moral and potentially a legal responsibility” to step in and ensure that people with rare diseases have access to the drugs they need.

The next Minister for Life Sciences will need to display decisive leadership and set a clear direction for reform. George Freeman’s ongoing review of access to innovative medicines, led by Sir Hugh Taylor, raises the prospect of wide-ranging changes to assessment and reimbursement systems to reflect technological developments including the advent of genomic medicine.

Exactly what this will entail should become clearer once the initial report is published in the summer, but its recommendations must deliver on three main fronts: a clearly-defined relationship between NHS England and NICE; a health economic assessment model that reflects a contemporary interpretation of value; and a stronger voice for patient representatives and clinical experts.

There is no miracle cure for the fractures in the current system, and the proliferating cost of new treatments remains a stumbling block. However, a 21st century health service, in which patients are able to experience the benefits of the emerging revolution in biotechnology, is within reach. Creative collaboration between the NHS and industry, and no small dose of political courage, will be the key to unlocking this potential.

 


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