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NHS England and Vertex both claim to have made major new concessions to break the stalemate over the Orkambi cystic fibrosis drug – but an agreement remains out of reach.
For more than three years, Vertex has been stuck for more than three years in monitoring profitability by NICE and the NHS's drug budget specialist in England. Today, both sides unveiled the details of their ongoing negotiations.
NHS England revealed that it wanted to use some kind of money back guarantee via a two year managed access program – but Vertex seems to be waiting for an unconditional agreement.
Responding to a request for an update from the House of Commons Health Selection Committee, both parties confirmed that they have met five times since their appearance at a special parliamentary hearing held in March with the goal of reviving the talks.
A year ago, NHS England publicly announced a "final offer" of £ 500 million over five years for Orkambi and Kalydeco (Symkevi, then about to be approved soon), so wait for NICE ratings .
Vertex rejected this offer, saying she was grossly underestimating her medication and presented her own confidential offer, which she said was the best offer for her drugs in the world.
Now, both sides say they have made new concessions.
According to Vertex, its offering, further improved, represents "significant reductions of several tens of thousands of pounds sterling" compared to Orkambi's UK catalog price of £ 104,000 per year for Orkambi.
He also indicates that he has proposed a temporary access agreement to provide immediate access to eligible Orkambi patients on terms similar to those accepted in Scotland where an agreement was reached.
The pharmaceutical company also claims to have provided NICE with "substantial new evidence" about Kalydeco, Orkambi and Symkevi, reflecting the latest clinical studies.
However, it is clear that this differs considerably from what NHS England wishes to see happen.
He proposed a two year managed access agreement for Orkambi and Symekvi. This would involve collecting real-world data to supplement clinical trial evidence and help influence a final reimbursement decision.
NHS England states that it has proposed a "significant increase" in price per patient per year for each drug compared to its July 2018 offer.
However, it also proposes that at the end of this two-year managed access period, the Orkambi price "can then be adjusted upwards or downwards, depending on the NICE Commission's findings".
He added: "In order to protect taxpayers' interests, if NICE decided that the interim price had been set too high, the NHS would receive a discount corresponding to the difference."
This money back guarantee approach is thought to be similar to some recent agreements with other pharmaceutical companies – the difference here is that the offer has been made public.
Vertex has been resisting for some time already any payment link based on the results and also seems to oppose the latter offer.
The updates provided in their letters to Dr. Sarah Wollaston, Chair of the Select Committee on Health, also illustrate how the two sides continue to struggle, even on the merits of their negotiations.
John Stewart, Head of Special Orders at NHS England, said in his letter that Vertex had not submitted any new official offers since the March parliamentary hearing and that Dr. Jeff Leiden, CEO of the company, decided to withdraw Symkevi from the negotiating table to simplify the negotiations.
At the same time, in his letter, Simon Lem, the head of Vertex for Northern Europe, responded to this claim, saying "disappointed with the way the NHSE has qualified our participation in the negotiations". He says NHS England misrepresented Dr Leiden's offer and said Symkevi's exit from the negotiations reflected the health service's budget constraints.
He also challenged NHS England's badertion that it had improved its offer of July 2018, claiming that it equated to the same value.
Patient advocates quickly expressed frustration at the continuing lack of progress on social media.
In this context of permanent mistrust of the negotiations, it is difficult to see how the two sides can reach an agreement – although the pressure for an agreement may eventually lead to some kind of compromise. .
NHS England pointed out that, in recent weeks, it had signed new market access agreements with Roche and Biogen, and had also called on Vertex to be equally "willing to engage with NICE and pay responsibly "in order to reach an agreement.
Vertex revealed that she had planned a phone call with the NHS England today and at a face-to-face meeting next week.
In addition to having acceptable financial conditions, both parties will have to be able to claim victory after a deadly public battle. This means that the transaction will have to remain confidential, contrary to the offer of NHS England last summer, for Vertex to accept it.
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