Bioregnum, Pricing

Vertex’s fight club rule: Block new treatments to cystic fibrosis patients until Orkambi is reimbursed properly

The bare-knuckle brawl between Vertex’s executive crew and NICE has now extended to its new cystic fibrosis combo Symkevi — matching tezacaftor and ivacaftor. 

Late last week the British drug price regulator put out word that it was halting its appraisal of Symkevi — sold in the US as Symdeko — because Vertex “has not provided an evidence submission for this appraisal.”

A meeting planned for November 8, as a result, has been cancelled.

Vertex $VRTX, for its part, turned around to slap NICE , saying its “single technology appraisal has not kept pace with changes in medicine and has significant limitations in how it captures and values the full benefits of precision medicines such as tezacaftor/ivacaftor.”

Vertex says it will happily re-engage “in the context of an appropriate appraisal process, which takes into account the structure of an innovative framework contract for all of Vertex’s cystic fibrosis medicines, on which we are currently negotiating with NHS England.”

While Vertex has been scoring steadily rising revenue from its market-leading cystic fibrosis drug Orkambi in the US, where manufacturers have considerably more power in unilaterally setting prices, the big biotech has been duking it out with a slate of single European payers not anxious to cover a drug they consider far too weak for the price the company wants.

That’s led to some interesting donnybrooks. 

In France, the biotech told patients groups they wouldn’t be running clinical trials of their new combos because the country’s regulatory obstacles made the process “unpredictable” and conducting the trials “would raise false hope.”And in the UK CEO Jeff Leiden followed up by accusing British Prime Minister Theresa May and her government of putting “a lower value on the life of a CF patient than other countries around the world.”

The back-and-forth has included calls on Vertex to reveal the price it’s demanding, which so far hasn’t happened. In an email message Monday morning, a Vertex spokesperson noted:

Our CEO reached out to both the head of the NHS, Simon Stevens and the Secretary of State for Health and Social Care, Matt Hancock, weeks ago to meet and continue discussions to find a solution that would secure access to our current and future medicines for all CF patients in England, but we have heard nothing since that outreach.

For now, it seems, talking is over. If British patients want their drugs, says Vertex, NICE is going to have to bend first. Patients, however, will remain caught between two opposing forces.


Image: Vertex HQ.Vertex


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Molecular Templates Austin, TX
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Koneksa Health New York, NY

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