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UK gets its own 'breakthrough' status for early medicines access

But concerns remain over funding
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The UK Government plans to fast-track patient access to certain new medicines for serious life-threatening conditions in a move that was backed by both the country's pharma and biotech industry.

From April, the Early Access to Medicines scheme will allow pharma companies to have innovative treatments used in an NHS population once UK regulator the Medicines and Healthcare Products Regulatory Agency (MHRA) has determined the benefits outweigh the risks.

This bypasses the usual route for new drugs for NHS use, which includes approval from the European Commission and then a cost effectiveness review by the National Institute for Health and Care Excellence (NICE) or the Scottish Medicines Consortium (SMC).

Investigational drugs considered for the scheme will receive a Promising Innovative Medicines (PIM) designation. This has been likened to the US FDA's 'breakthrough' designation, which is accelerating the review process for new drugs for serious conditions in the US.

Health secretary Jeremy Hunt explained that the scheme had benefits for both patients and industry in the UK, which has been criticised in the past for poor access to the new treatments and has been hit by a number of companies reducing R&D operations.

“This ground-breaking scheme will provide cutting edge medicines earlier, give hope to patients and their families and save lives,” said Hunt. “And as part of our Strategy for Life Sciences it will create more jobs and opportunities for people, helping secure a better future for our country."

Industry response
This view was broadly backed by trade bodies the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA), although concerns were raised about the way the scheme is funded by pharma companies who produce the medicines rather than through national reimbursement.

The line of thought behind its funding is that companies will benefit from the experience of their drugs being used in a real-world NHS setting and can work closely with regulators, greatly speeding up the process to gain a full licence.

Although this is good news for the NHS, for which it comes at no cost, the BIA's CEO Steve Bates explained that the scheme “runs the risk of being under-utilised” by companies who cannot afford to take part.

There also needs to be a greater understanding of how the scheme will work in practice, including further discussion on the funding process.

“Most companies are keen to understand a little more of the detail and are keen to ask questions of the scheme,” Bates told PMLiVE. “The challenge as to whether the scheme and the goodwill that you get and the 'all hands on deck' approach is enough for companies to switch decisions as to where they are doing trial will be key."

He added: “We will continue to argue that companies need to be reimbursed at an earlier stage to make this something that is globally competitive.”

Pharma body the ABPI also welcomed the scheme and its director of value and access, Paul Catchpole, said “the scheme will benefit patients, the NHS and the UK clinical research community”.

Catchpole also raised concerns about the funding, stating that, as part of the consultation process, the ABPI has called for a one-year-on joint review of the scheme to appraise its first year and potentially review funding options.

Article by
Thomas Meek

14th March 2014

From: Research, Sales, Regulatory, Healthcare

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