UK Early Access to Medicines Scheme - a new era for patient access | Deloitte UK has been saved
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In one of our previous blogs we discussed the US Food and Drug Administration’s (FDA’s) introduction of the ‘breakthrough’ designation concept as a way of improving earlier access to medicines for patients with high unmet medical need. In this blog we’re focussing on the Early Access to Medicines Scheme (EAMS), a similar scheme launched by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in April 2014. EAMS is a voluntary scheme that provides an accelerated route to market for drugs in the UK and aims to “give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have marketing authorisation”.[i]
Drugs under EAMS will be in phase III or, in exceptional circumstances (if data is compelling and there is a significant unmet need), late stage phase II trials. To gain marketing authorisation (MA) they will still need to go through the full clinical trials and drug licencing process, the MHRA highlight EAMS is not a replacement to the MA process and will only impact 5-10 drugs a year.
Three conditions must be met in sequential order for a drug to be accepted onto EAMS:
There are a number of potential benefits of this scheme which impact a wide range of stakeholders:
For EAMS to realise its potential, the engagement of drug companies is essential. Before deciding to engage, drug companies will need to consider a number of potential risks of EAMS inclusion, such as:
EAMS has so far been received positively by industry and patient groups but with caveats around funding, data clarity and how commissioning of the therapy by the NHS will work. A planned review of EAMS one or two years down the line may help to ensure these and any other concerns are addressed. Until then helping drug companies to better understand EAMS benefit on licencing and HTA opinions could increase interest in the scheme; engaging the National Institute for Health and Care Excellence (NICE) in the EAMS process could be one solution to provide reassurance of favourable HTA opinions. However, companies not considering the whole EAMS process may still apply for PIM status, costing just £4,027, a relatively small price to pay if it attracts potential acquirers or strengthens negotiating power when entering into in-licensing/ co-development agreements.
It is still early days for EAMS and as yet no formal applications have been made. Success will likely depend on the experience of the first few pioneering companies that ‘feel’ their way through the system and refine its evolution into something that can deliver on the goal of helping patients most in need.
Karen is the Research Director of the Centre for Health Solutions. She supports the Healthcare and Life Sciences practice by driving independent and objective business research and analysis into key industry challenges and associated solutions; generating evidence based insights and points of view on issues from pharmaceuticals and technology innovation to healthcare management and reform. Karen also produces a weekly blog on topical issues facing the healthcare and life science industries.