Vertex spars with UK's May over Orkambi pricing
- Vertex is reaching high in its attempt to get U.K. reimbursement for its cystic fibrosis medications by writing to request "urgent intervention" from Prime Minister Theresa May, citing it as "a test case for the Government’s delivery of accelerated access to innovative medicines in the U.K."
- The letter contends Vertex made what the company describes as "the most innovative and best offer in the world to NHS England," but that the NHS did not accept the offer.
- Vertex has its international HQ in London and an R&D site near Oxford. The letter suggests Vertex's future in the U.K. could be in question, referring to the company "questioning this ecosystem" and that "any future biotech investment in the U.K. is at significant risk."
Vertex's cystic fibrosis sales are climbing, with the franchise up 33% year-on-year in the first quarter of 2018. Still there are concerns that the price for Orkambi (lumacaftor and ivacaftor) is too high. In the U.S., the price tag for Orkambi is about $272,000 a year, and a May 2017 report from the Institute for Clinical and Economic Review said that would have to come down more than 70% to be affordable. Vertex shot back a letter to the ICER, accusing the review process of being a "sham" and the body being reliant on "flawed scientific methodology."
Orkambi was approved in Europe in November 2015. However, in July 2016, the National Institute for Health and Care Excellence stated that Orkambi was "not recommended, within its marketing authorisation, for treating cystic fibrosis in people 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene."
Vertex and the NHS have been in discussions over the subsequent two years to work out a pricing scheme that will cover Orkambi and Vertex's other two CF therapeutics, Kalydeco (ivacaftor), and tezacaftor/ivacaftor, as well as other future medicines still in development, and use of the medicines in children. In the House of Commons on May 16, May said she wanted to see a quick resolution to the negotiations.
There is a petition ongoing in the U.K., asking the government "to call for a resolution to ongoing negotiations between Vertex Pharmaceuticals, NHS England and NICE as a matter of the utmost urgency."
The company met with the NHS last Wednesday, but the two sides failed to reach agreement and each issued combative statements.
Vertex accused NHS England of "placing a lower value on the life of a CF patient than other countries around the world," and called on to the government to intervene.
The NHS response to the meeting, which had an equally battling tone, supported NICE's decision: "NICE has been clear that Vertex’s pricing is unsupportable. If Vertex really believe they are offering a reasonable deal they should waive their confidentiality clause and let patients and taxpayers judge whether it is fair."
The next step was Vertex's letter from CEO Jeff Leiden to May requesting her urgent intervention.
"We are confident our proposal to NHS England would achieve rapid patient access, budget certainty for the NHS, and fair reward for innovation… We respectfully request, therefore, that you urge NHS England to properly value and realise the potential of our portfolio of cystic fibrosis medicines. It would be disappointing in the extreme that, as the NHS turns 70, it is found to be shutting the door to a new era of precision medicines that stand to revolutionize healthcare."
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