Vertex agrees to new talks with NICE, NHS as sides seek to break impasse over cystic fibrosis drug Orkambi

Vertex Pharmaceuticals has agreed to new talks with the National Institute for Health and Care Excellence and NHS England as the parties look to break a deadlock regarding funding of the drugmaker's cystic fibrosis treatment Orkambi (lumacaftor/ivacaftor). A spokesman for the UK Department of Health said "they have agreed to meet again soon to identify ways of breaking the current impasse."  

NICE issued draft guidance in 2016 recommending against NHS coverage of Orkambi, which was authorised in the EU a year earlier, on the grounds of cost-effectiveness. The agency formalised its negative decision later in 2016, with Vertex subsequently exiting negotiations last year after declining an NHS offer valued at 500 million pounds ($655 million) over five years for access to Orkambi and its other cystic fibrosis drugs.

UK Health Secretary Matt Hancock remarked "I am delighted finally Vertex has agreed to participate in [discussions]," adding "the parties have committed to providing the data needed for an objective assessment of the drugs and I look forward to those discussions proceeding effectively."  

However, the news comes as Vertex disclosed that in 2018, 7880 packs of Orkambi were destroyed after exceeding their expiry date. The company noted that the packs, which contained a 28-day supply of the drug, were manufactured in 2015 and 2016 for the purposes of supplying 13 countries, including the UK. Vertex revealed the number of packs destroyed after CEO Jeff Leiden pledged to provide the figure in a recent UK government hearing.

In the same hearing, Vertex's chief commercial officer Stuart Arbuckle said "I do not believe we have had any stock go out of date and be destroyed…we do not package it up until we are due to be selling it." The drugmaker added that it maintains "significant inventory reserves of Orkambi" that will allow it to supply the product to every patient in the UK within four weeks of a successful resolution of negotiations with NICE and NHS England.  

For related analysis, see ViewPoints: Vertex hits its marks in CF, but with reimbursement overhang.

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