Vertex has reached an agreement with NHS England to reimburse its triple combination therapy Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with Kalydeco (ivacaftor), should the medicine win European approval.
The new expanded agreement includes reimbursed access to Vertex’ 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.
The move follows recent backing for Kaftrio in combination with Kalydeco from the European Medicines Agency’s human medicines committee (CHMP), which issued a green light for its use to treat people with CF ages 12 and older with one F508del mutation and one minimal function mutation (F/MF) or two F508del mutations (F/F) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
As part of the deal with NHS England, Vertex has committed to submit Orkambi, Symkevi and Kaftrio to the National Institute for Health and Care Excellence (NICE) within an agreed upon timetable, allowing for a period of real-world data collection on the medicines, it said.
If approved, three in five patients with the deadly genetic condition could benefit from the ‘triple combination’ treatment, and nine in ten CF patients – more than 7,000 people – will now benefit from a therapy which tackles the underlying causes of the disease.
“The triple therapy is the latest improvement in care which will help thousands of people with CF lead longer, healthier lives and shows once again that where drug companies are prepared to work flexibly with the NHS we can deliver life-changing medicines,” noted NHS chief executive Simon Stevens.
“I’m pleased that NHS England has recognised 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,” said Vertex' chief executive and president Reshma Kewalramani.
“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.”
Commercial terms of the agreement are confidential, but NHS England noted that the approach achieved is consistent with its other managed access agreements reached with the pharmaceutical industry.