pharmafileNovember 12, 2018
Tag: Top Story , Orkambi , Kalydeco
The UK House of Commons' Health and Social Care Committee on Friday said that it requested documents from Vertex Pharmaceuticals, NHS England and the National Institute for Health and Care Excellence (NICE) regarding ongoing talks about the availability of the cystic fibrosis treatment Orkambi (lumacaftor/ivacaftor) on the NHS. Negotiations between the parties have been under way since NICE declined to recommendthe drug in 2016, determining that its benefits do not justify its annual cost of 104 000 pounds ($148 755) per patient.
Meanwhile, earlier this year, Vertex said it has "made the best offer in the world to NHS England" regarding Orkambi, which was approved in Europe in 2015, and another cystic fibrosis treatment Kalydeco (ivacaftor). Although details of Vertex's specific reimbursement offer remain confidential, it includes Kalydeco and Orkambi, as well as cystic fibrosis compounds still in development.
However, the Health and Social Care Committee said Friday that it would publish the documents it receives from the parties, including offers made by Vertex to NICE and NHS England, unless they reach a deal by a deadline of November 30. The committee has also requested NHS England's formal response to Vertex's original offer, and any subsequent proposals, as well as NICE's unredacted assessment of the clinical and cost effectiveness of the drugs.
The Health and Social Care Committee added that if no agreement is reached by the deadline, it will consider further how to proceed.
In response to the news, Vertex confirmed the Health and Social Care Committee's request, adding it "welcomes the committee's interest in access to cystic fibrosis medicines in England and we look forward to supporting its inquiry into this important issue."
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