Policy and health profession must adapt to personalised medicine

Philippa Brice

26 June 2014

A new report claims that the number of personalised medicine products available in the US has jumped by 57% in three years.

The Personalized Medicine Coalition (PMC) is a US-based organisation that seeks to advance the understanding and adoption of personalised medicine ‘concepts and products’ for the benefit of patients and health systems. This involves work in scrutinising and influencing relevant areas of public policy. Leadership is primarily from the biopharmaceutical industry.

The rise in personalized medicine products

Their new report, The Case for Personalized Medicine, claims that examples of personalised drugs, treatments and diagnostics available on the market have risen from 72 in 2011 to 113 in 2014; the actual numbers are perhaps less striking than the percentage rise, but it does arguably signal that greater change is on the way.

In response, the PMC calls for ‘regulatory guidelines that adapt to and encourage the coupling of diagnostics and medicines that target genetically defined populations’, as well as corresponding  modernisation of health professional education and modification of health systems charges and insurance coverage.

The report also focuses on the limitations of most current therapeutics in terms of efficacy and safety, on the potential capacity of personalised medicine to ‘increase the efficiency of the health care system by improving quality, accessibility and affordability’, and on the increasing commitment of the pharmaceutical industry to the development in personalised therapeutics and diagnostics driven by the decreasing cost of DNA sequencing.

Issues in regulation and reimbursement

The increasing focus of the Food and Drug Agency (FDA) in regulatory oversight of personalized medicine in the US is noted as being signalled by the appointment of a dedicated Director and the release of their Paving the Way for Personalized Medicine report last year. Their reported plans to take a tiered approach to regulation of molecular diagnostics with greater scrutiny for those that involve the more serious forms of clinical decision-making are broadly approved. However, the PMC nevertheless call for a ‘defined path’ for regulatory approval of drugs and companion diagnostics to aid development.

Naturally, the report is also concerned with the evolution of payment for personalised medicines, suggesting that adaptations are needed to accommodate higher up-front costs for given diagnostics and medicines – but which should prove cost-effective in the longer term due to improved performance.

Striking a balance

Whilst it is certainly true that the PMC has a vested interest in the increasing adaptation of both regulatory and reimbursement systems towards personalised or ‘precision’ medicine, they are also correct that changes in both are needed – and this applies not only in the US, but also for health systems in other countries too. However, the difficulty may lie in striking an appropriate balance between the evidence of improved clinical outcomes and the new ways of paying for them; no one will (or should) pay more from limited resources for health care without evidence of benefit, but in some cases the full benefits may only become apparent as more patients receive personalised prevention and care. Assuming that genomics and biomedicine are indeed able to d eliver improved care as widely anticipated, a degree of flexibility from all stakeholders could be the key to shar ed success.

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