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Orkambi row: government now considering Crown Use licensing

MPs call for radical solutions as deadlock remains


Vertex is under renewed pressure to reach agreement with NHS England on its cystic fibrosis drug Orkambi, with a government minister yesterday warning that it will consider ‘other options’ if no deal is agreed soon.

The row over access to the drug, which is potentially life-saving for some patients, has been going on for three years, with both sides still claiming that the other is making unreasonable demands.

Yesterday saw MPs in the House of Commons take part in a special debate on Orkambi, after it was triggered by 100,000 people signing an online petition urging members of Parliament to address the issue.

Last week it emerged that desperate parents have formed an Orkambi Buyers’ Club, which is circumventing Vertex’s UK patent on the drug, and paying privately to import supplies of a generic versions of Orkambi from Argentina.


Health minister Seema Kennedy at yesterday's parliamentary debate

Vertex’s UK list price for Orkambi is £104,000 ($136,000) for a year’s treatment, but NHS England's attempts to negotiate a much lower price have hit long-term refusal from the US pharma company.

Responding to impassioned pleas from MPs representing children with CF and their families in their constituencies, health minister Seema Kennedy was direct in her criticism of Vertex.

“It is no wonder that given that Vertex remains an extreme outlier in both pricing and behaviour, that patients and families are looking at alternative solutions to secure access to these drugs.”

She acknowledged pleas from MPs from across Parliament to consider endorsing similar workarounds if the negotiations showed no sign of progress.

These would include a compulsory licensing approach called Crown Use licensing or large scale clinical trials sponsored by the government. This is clear change in tone from the government, where minister had earlier this year more or less ruled out such a measure, which has only ever been undertaken once before.

The minister added: “Unless Vertex change their approach and behave responsibly, I have a moral obligation to look at these other options. Of course NHS England and NICE will carry on their negotiations because that is the desired option, but I have no other option but to look at these other options on the table.”

Despite momentum growing behind the call for compulsory licensing, campaigners know that the process would require legal clearance, and this would take an estimated two years to obtain – time that many CF patients do not have.

Seema Kennedy repeated NHS England’s claim that Vertex are “an extreme outlier in pricing and behaviour” and pointed out that England wasn’t the only country still struggling to reach a deal.

She pointed out that Spain was enduring a similarly long three year wait, and had proposed, like NHS England, a real world data collection element to allow rapid interim access.

“You need only look at Vertex’s rejection of the Spanish proposal,” said the minister. “This is based on the ongoing collection and interpretation of real world data. I would ask: why is this not acceptable for Vertex?”

As the row drags on, even the UK industry association the ABPI has sought to intervene in the row, albeit obliquely.

Writing in a blog last week, the ABPI’s Dr Richard Torbett said the two year ‘managed entry agreement’ now on offer from NHS England, which would allow prices to rise or fall once the trial period was over, was a reasonable offer.

“it is clear that the structure of the offer represents exactly the sort of flexibility industry has been calling for some time - and indeed responds to some of the observations made by the health select committee” he wrote, adding: “It feels like a helpful step in the right direction and we certainly welcome that.”

Vertex is, however, not a member of the ABPI, and won’t feel a great deal of pressure to fall in line with this point of view.

Clive Lewis, a frontbench Labour MP was among those to speak at the debate, and accused Vertex of being both ‘intransigent’ and ‘greedy’ and called on the government to consider Crown Use licensing.

“Surely this is an option that should be considered to send a message to that global pharma industry that are going to be greedy and put people’s lives at risk [while being given fair offers], then this could be used by our government.”

Vertex has responded to Westminster debate, saying it "shares the urgency" of the MPs to find a solution to access as soon as possible.

It confirmed that it had had another meeting with NHS England last Friday, and that "intensive work continues on a daily basis."

It also adds that in the absence of an access agreement, it will continue to provide free medicines to patients who are the most seriously ill, based on objective clinical criteria, through its compassionate use programme. Vertex says the programme has supported more than 800 of the sickest CF patients in England and over 1,000 patients across the UK.

Despite these measures, cystic fibrosis families and campaigners say they are appalled by the lack of progress, and the damage being done to the health of young CF sufferers, and have pledged to keep fighting for access.


Article by
Andrew McConaghie

20th June 2019

From: Healthcare



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