Why personalised medicine needs incentives to match ‘value’

By European Alliance of Personalised Medicine (EAPM) Executive Director Denis Horgan

Personalised medicine is on the rise, there’s no doubt.

Mainly through the use of advancing developments in genetics, it has the ability to give the right treatment to the right patient at the right time, often work in a preventative way, improve quality of life for those already being treated, empower patients in decision-making processes and keep them out of expensive hospitals as much as possible, and even contribute to the amount of hours they spend in the workplace – mainly through a reduction in sick days.

Taken as a whole, there is no doubt that a healthier Europe is a wealthier Europe and personalised medicine is already being, and can be much more so in the future, a great contributor.

And it’s not just in Europe where personalised treatments are making the news. In the US, President Obama recently proposed an investment of $215 million in a Precision Medicine Initiative, aimed at furthering research into patient genetics and customized treatments.

However, these are testing fiscal times. And with an aging population of 500 million potential patients across the EU’s 28 member states, ‘value’ is always going to be at the top of the agenda.

Health care in the EU has never been more expensive. People are living longer and will, in most cases, be treated for not just one but several ailments – ‘co-morbidity’ - during their lifetime. It’s a dilemma, and it won’t go away.

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So what do we mean by ‘value’? How do we define it? How do we measure a human life – or quality of life –against the cost of a treatment?

Patients, when they understand their options, will have their own views on what constitutes value, depending on their circumstances  – “Will I get better? Will I live longer? Will my quality of life improve? What are the side effects?”.

And what about cost and value of, say, in vitro diagnostics? According to a recent survey by the Brussels-based European Alliance for Personalised Medicine (EAPM) 96% of patient respondents stated that they would be ‘interested’ or ‘very interested’ in having a companion diagnostic available for them. So it is clear that patients place significant value on having the facts.

Of course payers, not surprisingly, when they weigh the benefits against cost and other considerations, may take a different approach.

Meanwhile, manufacturers and innovators are obliged to operate within limits of ‘value’ that are as yet unclear in this exciting new age of personalised medicine.

But there is a solid argument that value should always be defined in respect of the customer. Value in health care depends on results and outcomes – vital to the patient –regardless of the volume of services delivered, yet the value is always going to be seen as relative to cost.

The World Health Organization tells us that 350,000 people die each year from the 150 million chronically infected with the virus, and these new direct-acting anti-virals could halt the global spread of infection. So, if health-care systems pay to supply the drugs, to save up to 350 million lives, every year, is that value?

Meanwhile, up-to-the-minute cancer treatments can now treat some of the most severe or rarest diseases known on this planet. Over the past two-and-a-half decades, patient life expectancy has risen by some three years, with four-fifths of that figure directly down to new treatments and medicines.

Yet these drugs and treatments are expensive. But, given these huge improvements, are they worth it?

And, lest we forget, the full promise of personalised medicine means much more than treatment for patients who are already ill – it has the ability to identify those with a high risk of developing a disease which, in turn, allows targeted prevention.

There are societal benefits here, as well obvious personal ones.

One way of looking at value is a method called ‘DALYs’. This stands for ‘disability-adjusted life years’, and is a unit measure of personal, public and global health.

DALYs are calculated by measuring how many potential years of life are lost when a person dies. They then incorporate total years lived with disability —based on international estimates of how much each non-fatal condition detracts from perfect health.

In terms of death, lung cancer kills many more people than road injuries annually. Yet measured by DALYs, road injuries are almost two-and-a-half times worse. This is because most patients dying of lung cancer are in their 60s-80s, while those most likely to die on the roads are in their 20s and 30s — the latter cause almost 40 times more disabilities. So, should we invest in road-accident prevention or anti-tobacco campaigns as a priority? An interesting question…

Prevention is clearly of high societal value, yet where are the real fiscal incentives? Current reimbursement systems, with short-term budget pressures, work in favour of treatments that might generate less value overall - a worse DALY score, perhaps - yet provide greater short-term returns.

Meanwhile, estimates of the value of health generated from 2012-2060 by personalised medicine innovations that reduce incidence in a key disease by just 10% show a value of billions of euro in the form of longer, healthier lives. In the case of a 50% reduction in, say, heart disease incidence, this would generate more than 500bn euro in improved health over 50 years.

Therapeutics, generally speaking, are well reimbursed. Diagnostics are much less so. Reimbursement based on ‘value’, rather than cost, would create an environment for diagnostics to get to market much faster.

EAPM believes that health policymakers with responsibility for spending decisions need to seriously take into account how much investment and incentivisation now can save a fortune in, for example, areas such as cancers (including rare versions), hepatitis, diabetes and heart disease – all major killers.

’Value’ needs to be quantified taking into account all of its meanings – and soon.

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