18 April 2016
Statistics show the US spends more than any other country on health. In fact, the health share of US GDP is projected to rise from 17.4% in 2013 to 19.6% in 2024.
One reason for such exceptional resources may be President Obama’s enthusiastic support for personalised (or precision medicine), or as he puts it: “a new era of medicine – one that delivers the right treatment at the right time”. In contrast, the UK spent the much lower 8.5% of GDP on health in 2013, which dropped to 7.3% in 2014/15 and is expected to fall to 6.6% by 2020/21. This is despite Prime Minister David Cameron’s interest in making the life sciences “the jewel in the crown of the economy”. Additional funding may facilitate research and development but money is not a cure-all. The US continues to grapple with common and also unique barriers to implementing personalised medicine.
“Personalised medicine…gives us one of the greatest opportunities for new medical breakthroughs that we have ever seen”. By reiterating its importance in both words and deeds, president Obama’s wholehearted support for personalised medicine has been crucial to propelling the agenda forward. Most importantly, following the success of the Human Genome Project, a total investment of about $4 billion that has spurred on an estimated $956 billion in economic growth in the US alone, the president launched the Precision Medicine Initiative (PMI) in 2015.
Designed to “enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualised care”, the PMI involves collaborations with various institutions including the National Cancer Institute and the Food and Drug Administration (FDA). The Privacy and Trust Principles for the PMI also include provisions for ‘empowering patients through access to information,’ ‘ensuring responsible data sharing, access and use’, and ‘trust and accountability through transparency’. Under the president’s leadership, bipartisan legislation secured more than $200 million for this project in 2015 and the most recent budget saw an additional $1 billion allocated specifically ’to accelerate the development of new cancer detection and treatments’.
There are too many individual projects associated with the PMI to list here. But beyond crucial research awards, data sharing platforms and accessible electronic records, there are a few flagship projects worth highlighting. For example, the Million Veteran Program, one of the world’s largest medical databases, already comprises the genetic data of over 450,000 volunteer veterans and is being used to study how genes affect health. With an ultimate target of sequencing one million genomes, this project is expected to cost about $1 billion.
The FDA has developed precisionFDA: a cloud-based platform that ’encourages the genomics community to advance quality standards and achieve more consistent and accurate DNA test results‘. With access to a range of tools including reference genomes and previously validated results, this new platform also facilitates communication between groups including patients, researchers, healthcare providers and government agencies.
Finally, a Bill to Provide for the Implementation of a Precision Medicine Initiative was introduced on 17th March 2016 and, unlike 75% of all Bills, it has since passed the Committee stage. The Bill propels ’efforts to address disease prevention, diagnosis, and treatment‘ via measures including a network of scientists, applying genomic technologies to provide data and developing new approaches for addressing scientific, medical and public health issues.
American producers and consumers actually face many of the same barriers to adoption of the diagnostic tests essential for personalised medicine that currently plague the UK, for example delivering the quality and accuracy of tests; ensuring test availability and access; and achieving suitable awareness and buy-in from clinicians. Public and patient concerns over loss of privacy and the potential misuse of genomic data have predictably garnered attention as well.
However, privatisation of the American healthcare system –which operates via an insurance-based reimbursement system - also results in unique barriers to realising the benefits of personalised medicine for patients. For example, many advanced medications, including personalised treatments already on the market, have been placed on a special tier that requires additional payments on top of traditional co-payment amounts. Where patients must pay a percentage of the drug cost, frequently stretching into the thousands for a single treatment, personalised treatment is often rendered inaccessible for all but the richest. This is in additional to ’clinical pathway programs in which payers are incentivising doctors to prescribe treatments based on a small pre-determined list that is not likely to include one of the many options suggested by a genomic profile‘. Thus the exceptional growth of the personalised medicine market (and the profits made) do have their cost, both to the consumer and to the pace of implementation.
As recently as 2013, the White House admitted that ’the advances in genomics have yet to impact the lives of most American citizens through…personalised medicine‘. In fact, despite impressive funding levels and initiatives, a 2014 survey of 1,024 adults found most consumers still do not know what personalised medicine is; 62% of respondents hadn’t even heard the term ‘personalised medicine’ and only 11% said their doctor had discussed or recommended it to them. Thus money and motivation are only elements of a more complex solution to the problem of how to make personalised medicine accessible to all.