NHS England said on Tuesday (June 30) that it has agreed a deal with Vertex Pharmaceuticals for its three-drug cystic fibrosis therapy Kaftrio.
The agreement allows Cystic Fibrosis (CF) patients in England to access Kaftrio when the European Medicines Agency (EMA) grants formal approval to the drug, said NHS England chief executive Sir Simon Stevens.
“The new expanded agreement includes reimbursed access to Vertex’s currently licensed medicines- Kalydeco (ivacaftor), Orkambi (lumacaftor/ivacaftor), and Symkevi (tezacaftor/ivacaftor), as well as the triple combination therapy if approved - and any future additional licensed indications for all of these medicines,” Vertex Pharmaceuticals said in a statement.
With the latest move, England will be the first country to access the drug in Europe. As many as 7,000 people, including 300 with rare mutations, which fall outside of the scope of EMA approvals.
Health Secretary Matt Hancock tweeted: “So delighted we have struck a deal with Vertex on Trikafta (to be called Kaftrio over here) - the next generation Cystic Fibrosis drug.
“This deal will save lives. Huge congratulations to the NHS team who landed the deal”.
CF community has welcomed the new deal as it had concerned that a prolonged negotiation over pricing could delay the drug’s availability in the UK.
As part of the agreement with NHS England, Vertex has agreed to submit Orkambi, Symkevi, and Kaftrio to the National Institute for Health and Care Excellence (NICE), allowing for a period of real-world data collection on the medicines.
Vertex will be working closely with the authorities in Northern Ireland, Wales and Scotland with the aim of securing an equivalent agreement in those countries as soon as possible.
Reshma Kewalramani, CEO and president at Vertex, said, “NHS England has recognized the value of Kaftrio, and that Vertex and NHS England have been able to work quickly, collaboratively and flexibly to expand the existing reimbursement agreement to include the triple combination therapy in advance of the medicine being licenced. This will ensure that eligible patients in England will be among the first in Europe to benefit from access to this innovative medicine upon approval.”
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recently adopted a positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with Kalydeco (ivacaftor) 150 mg to treat people with cystic fibrosis (CF) ages 12 and older with one F508del mutation and one minimal function mutation or two F508del mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Vertex’s CF medicines are reimbursed in more than 20 countries around the world including Australia, France, Germany, the Republic of Ireland, Italy, Switzerland, Spain, Denmark, the UK and the US.
Sukhi Basra