NHS England and Vertex are both claiming to have made significant new concessions in order to break the deadlock over cystic fibrosis drug Orkambi – but a deal remains out of reach.
Vertex has been locked in a row with England’s cost effectiveness watchdog NICE and specialist medicines budget holder NHS England for more than three years, and today both sides disclosed details of their continuing negotiations.
NHS England has revealed that it wants to use a kind of money back guarantee via a two year managed access programme – but Vertex looks to be holding out for a no strings attached deal.
Responding to a request for an update from the House of Commons health select committee, both sides confirmed that they have met five times since appearing at a special parliamentary hearing in March designed to revive the stalled talks.
A year ago, NHS England went public with a ‘final offer’ of £500m over five years for Orkambi and Kalydeco, (the then soon-to-be- approved) Symkevi and a triple therapy in late-stage testing, without having to wait for NICE appraisals.
Vertex rejected this offer out of hand, saying it undervalued its medicines hugely, and made its own confidential offer, which it says was the best deal on its drugs anywhere in the world.
Now both sides say they have made new concessions.
Vertex says its yet-again improved offer represents ‘significant discounts of tens of thousands of pounds’ below Orkambi’s UK list price of £104,000 per year for Orkambi.
It also says it has offered an interim access deal to provide immediate access to eligible patients to Orkambi, on terms similar to those accepted in Scotland, where a deal has been agreed.
The pharma firm says it has also provided NICE with “substantial new evidence” on Kalydeco, Orkambi and Symkevi, reflecting the most recent clinical studies.
However it is clear that this differs significantly from what NHS England want to see happen.
It has proposed a two-year managed access arrangement for Orkambi and Symekvi. This would involve the collection of real-world data to supplement clinical trial evidence and help influence a final reimbursement decision.
NHS England says it has proposed a “significant increase” in the per patient per year price for each medicine compared to its July 2018 offer.
However it is also proposing that at the end of this two year managed access period, the price of Orkambi “could then either be adjusted upwards further or downwards depending on the NICE Committee’s conclusions.”
It adds: “In order to safeguard taxpayers’ interests, should NICE conclude that the interim price had been set too high then the NHS would receive a rebate for the difference.”
This money back guarantee approach is thought to resemble some recent deals struck with other pharma companies – the difference here, though, is that the offer has been made public.
Vertex has been resisting any outcomes-based link to payment for some time, and looks to be opposed to this latest offer as well.
The updates provided in their letters to chair of the health select committee, Dr Sarah Wollaston, also illustrate how the two sides continue to struggle to see eye to eye, even on the substance of their negotiations.
NHS England’s head of specialised commissioning John Stewart says in his letter that Vertex has not submitted any formal new offer since the parliamentary hearing in March, and that CEO Dr Jeff Leiden had wanted to take Symkevi ‘off the table’ to simplify negotiations.
Meanwhile in his letter, Vertex’s head of northern Europe Simon Lem has responded to this claim, saying it is “disappointed with NHSE’s characterisation of our participation in the negotiations”. He says NHS England has misrepresented Dr Leiden’s offer, and said Symkevi’s removal from negotiations reflected the health service’s budget constraints.
It has also challenged NHS England’s claim that it has improved on its July 2018 offer, saying that it amounts to the same value.
Patients advocates have been swift to express their frustration at the continued lack of progress on social media.
Against this background of continuing distrust in the talks, it is difficult to see how the two sides can reach agreement – though the pressure for a deal is likely to eventually bring about some sort of compromise.
NHS England has pointed out that just in the last few weeks it has signed novel market access deals with Roche and Biogen, and called on Vertex to be similarly “willing to engage with NICE and price responsibly” in order to reach agreement.
Vertex revealed that it has a planned telephone call with NHS England today and in a face-to-face meeting next week.
As well as having acceptable financial terms, both sides will need to be able to claim victory after a bruising public row. This means the deal will have to remain confidential, unlike NHS England’s offer last summer, for Vertex to accept it.