Vertex’s cystic fibrosis drugs become publicly available in Denmark

Vertex Pharmaceuticals has signed an access agreement with Denmark’s pharmaceutical procurement agency Amgros for public hospital use of all current and future drugs for mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Vertex international commercial operations senior vice-president Ludovic Fenaux said: "We’re delighted to have collaborated with Amgros to finalize this pioneering contract.

"Our medicines have fundamentally changed the way CF is treated and we share the community’s sense of urgency for rapid access. This contract also allows Danes with CF to be among the first in the world to access our future CFTR modulator medicines."

Amgros CEO Flemming Sonne said: "I would like to thank Vertex for its will and engagement to make this deal. Most of all, I’m happy that we have made it possible to offer a group of patients the newest treatments.

"And naturally, I’m also enthusiastic that this new kind of contract gives the Danish hospitals and their owners in the regions much more predictable budgets – at times of rising costs of hospital medicines."

Vertex’s agreement with Amgros includes CF drugs such as Orkambi (ivacaftor /lumacaftor), Symkevi (tezacaftor/ivacaftor) and Kalydeco (ivacaftor). It follows a similar agreement with Austrian health authorities to provide access to Orkambi.

Vertex has been engaged in negotiations with the UK’s pricing regulator the National Institute of Health and Care Excellence (NICE) for two years over the price of these three drugs. Vertex is seeking a deal with the UK’s National Health Service that is similar to the all-encompassing agreement with Denmark that includes both its existing and future CF pipeline.

Two years after rejecting Orkambi on cost-grounds, NHS England and Vertex returned to the negotiating table. However, the talks reached an impasse in Julythis year.

Despite repeated calls from the UK government and patient groups, Vertex has repeated refused to reveal the price it offered the NHS, saying it cannot under a non-disclosure agreement.

In addition, one month later, NICE suspended its review of Symkevi. NICE wrote in its appraisal overview: "Vertex Pharmaceuticals has not provided an evidence submission for this appraisal. Therefore, we are suspending the appraisal whilst we consider the next steps. Consequently the discussion of this appraisal at the committee meeting on the 8 November 2018 has been cancelled."

The pricing regulator, however, re-opened negotiations with Vertex over Orkambi last week. A spokesperson for Vertex told pharmaphorum on 2 October: "Yesterday [Thursday, 27 September 2018], we met with representatives from NHS England and NICE. It was a productive meeting and discussions will continue."

At the time of writing, no agreement between the two parties has been made public.

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