BIA ‘disappointed’ by early access funding

pharmafile | March 14, 2014 | News story | Research and Development, Sales and Marketing BIA, NHS, bates, dams, early access 

The BioIndustry Association (BIA) is ‘disappointed’ that the government is not funding the much-anticipated Early Access to Medicines Scheme (EAMS).

The idea is that the scheme which is due to be launched by next month, enables access in the UK to unlicensed or off-label medicines in areas of unmet medical need – but BIA says that the lack of centrally-funded reimbursement is a problem.

Instead, pharma companies will foot the bill, “meaning patients will benefit from world-class breakthroughs at no cost to the NHS”, the Department of Health says.

“In return, the companies will be able to gain experience of their medicines being used in the NHS and work closely with regulators to look at the value of the drugs, gaining guidance and advice much earlier in the regulatory process,” it goes on.

This is cold comfort, BIA suggests. In an interview with Pharmafile, BIA chief executive Steve Bates said: “We’ve always argued that it needs a central reimbursement scheme and we’re concerned it might be under-utilised.”

By deciding not to fund the scheme the government is undermining its attractiveness to smaller UK firms “and to global corporations choosing the UK as a location for their clinical trials”, the organisation insists.   

Paul Catchpole, ABPI director of value and access, agrees that money is an issue. “This means companies have to bear the risk associated with the upfront investment that will be required to participate in the scheme,” he pointed out.

The ABPI has called for a review of the scheme after its first year in order that funding options can be reviewed.

The government says ‘innovative and promising’ drugs will be made available under the scheme as soon as UK regulator the Medicines and Healthcare Products Regulatory Agency (MHRA) deems that their benefits outweigh the risks ‘following an initial scientific assessment’.

Bates believes pharma needs more meat on the bones before it can properly assess the initiative’s potential impact, which is why BIA is holding an event to discuss the practicalities for companies in the UK on 28 April.

The outline of the scheme suggests that it will be complemented by the introduction of a new NICE technology appraisal and the government says NHS England will use ‘its specialised commissioning arrangements’.

“Companies are looking for understanding on what the commissioning process will be,” Bates continued. However, the BIA has broadly welcomed the EAMS, with Bates praising the ‘serious thought’ behind it.

And it does applaud the Promising Innovative Medicine (PIM) designation – a similar measure to the US Food and Drug Administration’s ‘breakthrough designation’ – which is to be introduced to give an early feel for whether a drug might be put forward for EAMS, using Phase II data for example. “This is significant and new,” Bates says.

The ABPI also highlights this as a highly positive move, with Catchpole saying it “should help make the UK more attractive for investment and growth”.

PIM designation will be issued after a MHRA scientific meeting and could occur several years before licensing, the government explains.

The risk/benefit ratio described in the scientific opinion will be based on the information submitted to the MHRA by an applicant – and it is this opinion which will enable doctors to make a decision with the patient on using the medicine, before it is approved.

Despite the BIA’s reservations about funding, Bates believes that simply having the blueprint for an early access scheme – whatever its shortcomings – is important because it will engender an ‘all hands on deck approach’ to making new therapies available.

Patient groups have also welcomed the announcement, with Harpal Kumar, chief executive of Cancer Research UK, saying the scheme “has at its heart the potential to bring promising new medicines to patients faster”.

Claire Halpin of Empower: Access to Medicine, called it a “significant step forward on the road to ensuring those patients in desperate need have the opportunity to access treatments they could not in the past”.

Adam Hill

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