According to a statement by the NHS, a decision on whether Alexion's Soliris will be reimbursed in the UK for the treatment of atypical haemolytic uraemic syndrome (aHUS) will be delayed until the spring of 2014. This information contradicts recent assertions by Alexion that Soliris would soon be made available in the UK via an 'unprecedented' access programme. It now appears that management expects more immediate access to the drug to be facilitated by local/regional NHS trusts, although analysts note that such programmes are not new (although given its potential life-saving credentials in aHUS, Soliris is a perfect candidate for such a programme). See ViewPoints: Orphan drug developers take note - Alexion indicates that 'unprecedented' access programme will secure UK approval for Soliris in aHUS setting.
Insight, Analysis & Opinion
There are a number of factors at play here. One for example, is the role of the Advisory Group for National Specialised Services (AGNSS), which had previously granted a positive recommendation of reimbursement for Soliris in the aHUS indication. This recommendation was rejected by the Department of Health in January; dissolution of AGNSS means that responsibility now falls on the shoulders of the National Institute for Health and Clinical Excellence, which plans to begin assessment of Soliris this month. As such, the product may be viewed as something of a test case; it will be the first product to be assessed by the newly established Highly Specialised Technology Evaluation Committee.
The contradictory views emanating from the UK authorities and Alexion are not helped by how the reimbursement process is now being played out as a very public 'battle,' note analysts at Citi, as opposed to behind closed doors. In a note to investors, Citi's Yaron Werber added that such a scenario has facilitated "a lot of posturing on both sides."
The upshot – based on the NHS' latest statement – is that uncertainty surrounding the reimbursement of Soliris for aHUS is now poised to extend into next year. The key issue – if this timeline proves to be realistic – is that the NHS seems "intent on taking careful evaluations of expensive orphan drugs, regardless of how effective these drugs are" notes Werber, as previously discussed by FirstWord. See ViewPoints: Soliris and the orphan drug pricing conundrum – too effective for reimbursement in UK market?
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