NICE estimates that this will affect one in five new medicines produced by the pharmaceutical industry each year and will impact most of the big drug manufacturers.

ABPI Chief Executive, Mike Thompson, said: “These new arrangements will delay access to cost-effective medicines and deny treatments to patients suffering from rare diseases.

“After many months of raising concerns with NICE, NHS England and the Department of Health and offering to work constructively on alternative proposals, we have applied to formally challenge these proposals in court.

“We believe this to be the right course of action due to the potential damage these changes will cause to NHS care and on our ability to research, develop and use new medicines here in the UK."