NHS officials in England have made an improved two-year pricing deal to Vertex Pharmaceuticals in a bid to give patients access to cystic fibrosis (CF) medicines.
John Stewart, national director of specialised commissioning for NHS England outlined sketchy details of the new proposal to Dr Sarah Wollaston MP, chair of the influential Commons Health Committee.
The committee has been investigating the price of Orkambi and other CF drugs because of a three-year long pricing row sparked by NICE’s recommendation against NHS funding for the drug on cost-effectiveness grounds.
Since the committee heard from representatives of the NHS, NICE, and Vertex’s CEO Jeffrey Leiden in March, Stewart said there had been no new offers from the pharma company in five meetings.
The NHS has blinked first and improved the terms of a five-year deal that has been on the table since last year that aims to reimburse all of Vertex’s drugs, including those that have yet to be approved.
Most of the terms of the new offer are confidential – but it includes a two-year “managed access” deal that would give access to all eligible patients for Vertex’s Orkambi and Symkevi drugs.
The NHS will collect “real world” data on patient outcomes that could inform an appraisal of both products by NICE alongside any other evidence at the end of the two-year period.
NHS England has also “significantly increased” the annual price per patient for each medicine compared with a previous offer on July 18th last year, although details of the price on offer remain confidential.
The price could be increased or decreased depending on the outcome of NICE’s assessment at the end of the two-year period.
Vertex’s Kalydeco is already reimbursed by the NHS for some patients, but the NHS is offering to extend access to all licensed indications.
In line with a request from Leiden, negotiations over a triple therapy have been taken off the table.
Last week the NHS’ chief executive Simon Stevens seemed to take a swipe at Vertex for failing to sign a “smart deal” such as this.
Stevens made the comments as he announced a deal with Biogen for Spinraza (nusinersen) for spinal muscular atrophy, which NICE had also initially rejected.
Stewart backed this up and also referred to an an agreement with Roche over multiple sclerosis drug Ocrevus (ocrelizumab).
Stewart said: “This illustrates that where companies are willing to engage with NICE and price responsibly then deals can reached that are of benefit to patients, taxpayers and industry.
“We hope Vertex will now take a similarly responsible approach.”
Campaigner Christina Walker, whose son Luis has CF but cannot get Orkambi, said: “I’m delighted NHSE has made a new, improved offer and I urge Vertex to accept it. This has gone on long enough and patients have suffered considerably. My son Luis and thousands of other patients could be receiving Orkambi by the summer, if Vertex do the right thing now.”
More than 7,000 patients are thought to have CF in England, and more than 9,000 in all four UK countries, making it the second largest market for drugs to treat the disease in the world.
When approached by pharmaphorum for comment, Vertex referred to details of counter proposals on the health committee’s website.
Contrary to NHS England’s claim that no offers had been made Vertex said that it had made a number of proposals to break the impasse.
These included:
- significant discounts on both Orkambi and Symkevi and significant concessions on the already agreed upon pricing of Kalydeco,
- additional discounts that would improve its own 2018 offer, cutting ‘tens of thousands of pounds’ from the Orkambi’s £104,000 list price,
- an interim access deal to eligible patients to Orkambi, on terms similar to those accepted by the Scottish healthcare system,
- a commitment to submit Symkevi for NICE appraisal – which Vertex has not yet done
- continuing a compassionate use programme providing the sickest CF patients with free medicines, which has supported over 800 patients in England.
The differing accounts of negotiations indicate just hows bitter this row has become – and will be deeply frustrating for families affected by the disease who are desperate to get access to these medicines.
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