The Early Access to Medicines Scheme (EAMS) offers treatments for rare, debilitating conditions a fast track from trials to prescription – but whether many meds will actually make it to patients is up for debate.
The scheme, launched this month, means “promising” drugs for serious conditions that have no other treatments, or where those that are available are unsatisfactory, could be given to patients on the basis of phase two trial results.
Unlike the National Cancer Drugs Fund before it, though, EAMS is not backed by the Government’s coffers. Instead, it works on the assumption the pharmaceutical industry will offer medicines for free until they are licensed.
According to the Department of Health, the scheme will help companies attract funding by showing the drug “has traction” in the NHS market, but some in the industry say it simply means it runs the risk of being underutilised.
The initiative will be overseen by Medicines and Healthcare Products Regulatory Agency (MHRA). It will grant Promising Innovative Medicine (PIM) designation to a product backed up by a “scientific opinion” outlining the risks and benefits to help patients and doctors make an informed decision.
Once clinicians have prescribed an EAMS drug, they will have to follow-up and monitor the patients using it. This could potentially create real-world clinical trials on a scale not seen before, which may very well prove popular to the industry.
Whether pharma will be happy to give up the fruits of its labour for free, or whether taking the drugs to real-world testing years before previously expected will balance out the loss, remains to be seen – the proof will be the pudding.
Published on: April 4, 2014