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Red tape and pricing hindering progress on personalised medicines

Patients and the UK plc missing out, says Academy of Medical Sciences

Caroline White

Friday, 12 July 2013

Existing regulation and pricing systems are hindering progress on the adoption of personalised medicines, claims a report from the Academy of Medical Sciences

“Stratified” medicine assesses patients’ biological make-up to tailor treatment based on an individual’s risk of disease or their response to a particular medicine.

But despite rapid advances in research and technology, existing systems for clinical development, regulation, pricing and reimbursement are preventing the widespread development and adoption of stratified medicine, says the report.

Examples of the approach include the development of a genetic test for HIV positive patients to check their compatibility with the drug Ziagen, which causes extremely severe reactions in up to 10% of those with a particular genetic profile; and Xalkori (crizotinib), a drug used to treat a particular type of lung cancer, which can boost the response to chemotherapy from 10% to 55% of those treated with it.

“Fast and efficient progress in the stratification – and ultimately personalisation - of medicine will rely on the collection, storage and analysis of significant amounts of data regarding the molecular and genetic basis of disease,” commented Professor Sir John Bell, who chairs the Academy of Medical Sciences group.

“This data driven approach to medicine requires the development of appropriate infrastructure and working practices to provide the high quality data needed to personalise medicines,” he added.  

The report emphasises the need to harmonise and link databases and biobanks, both nationally and internationally, to maximise the potential of collected data.

The current pricing system, in which the cost of a drug remains the same or falls after it has entered the market, removes any incentive to stratify existing products, because patient numbers for personalised medicines may be smaller, so lowering the financial return, it says. Changing the system to allow prices to go both up and down to reflect the changing value of a product would provide the necessary incentive, says the report.

Personalised medicines additionally depend on reliable and accurate diagnostic tests, but these are not protected by patent, so there are insufficient incentives in the system to build up the evidence on which ones work best, says the report.

The report concludes that influencing clinical practice and collaboration will be critical for stratified – and increasingly personalised - medicines to become part of routine healthcare, and it calls for an overarching body to oversee this.

Professor Bell said: “Stratified medicine offers promising advances to patients across the UK and worldwide. Embracing this technology, and empowering researchers in the field will help the UK remain at the forefront of this pioneering approach.”

The Academy’s previous report on the subject, which was published in 2007, highlighted many of the same obstacles identified in the latest report. We must “ensure we are not in the same position five years from now,” he said.

Realising the potential of stratified medicine

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