Vertex is coming under increased pressure to sign a deal with the NHS covering its Orkambi cystic fibrosis (CF) drug, with a government minister suggesting she would consider implementing laws allowing the NHS to use generic alternatives.
It’s more than three years since NICE said that Orkambi (lumacaftor+ivacaftor) is too expensive for the England’s NHS, sparking an increasingly bitter stand-off between health service officials, patients and the company.
Despite an improved offer from NHS England covering Orkambi last month, there has been no sign of the deadlock being broken.
Last week families of children with CF said they created a “buyers club” to import generic Orkambi from a manufacturer in Argentina.
In a debate in Parliament yesterday, MPs expressed outrage at this latest development, and junior health minister Seema Kennedy said the government has a “moral obligation” to explore all options to bring Orkambi to the UK market.
This includes a previously discussed move to implement a “Crown use” law that would allow the government to use a generic version of the drug at a vastly reduced price.
Continued negotiations between NHS England, NICE and Vertex is the “desired option” according to Kennedy.
“It is possible to go through the NICE appraisal process and reach an agreement with NHS England,” said Kennedy.
But in the absence of any progress Kennedy said she would explore other alternatives including Crown use, although MPs heard that putting these arrangements into place could take more than two years.
Sharon Hodgson, Labour MP for Washington and Sunderland West, said an agreement between Vertex, NICE, and the NHS would provide an “immediate outcome” that would get families their cystic fibrosis drugs.
Crown use remains an alternative only if negotiations continue to stall as it would take such a long time to implement, she said.
“Although that would be an option to look at if nothing else can be found, it would not give the families the drugs as quickly as we would like.”
In a separate development, the Association of the British Pharmaceutical Industry (ABPI) took the unusual step of praising NHS England for the flexibility it has shown during the negotiations.
In a blog post last week, the ABPI’s executive director for commercial policy, Richard Torbett, noted that Vertex is not a member of the trade body, and added that there is no information about the prices that are being discussed in the negotiations.
These are being kept secret for commercial reasons – but what is in the public domain is the structure of the deal NHS England has offered.
This would allow for a two-year managed entry period during which time the NHS would gather information about how Orkambi works in the real world.
If the drug performs well there is scope for a price increase, while if outcomes are below expectations its price could drop.
Torbett said: “It is clear that the structure of the offer represents exactly the sort of flexibility industry has been calling for some time.”
The ABPI has struck a new five-year pricing deal with the government for branded drugs that caps the overall spend each year, and rebates any excess back to the NHS.
A spokesperson for Vertex said the company welcomed the debate and “shared the urgency” of the speakers who wished to bring the drug to patients in England.
The spokesperson added: “We remain highly committed to the negotiations with NHS England and can confirm that a further meeting took place between Vertex and NHS England on Friday, 7th June. Our intensive work continues on a daily basis.
“In the absence of an access agreement, Vertex will continue to provide free medicines to patients who are the most seriously ill, based on objective clinical criteria, through our compassionate use programme.”
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