British pharmaceutical companies are taking the National Institute for Health and Care Excellence (NICE) to court over the watchdog’s policy of capping funding at £20 million.
Under NICE’s policy, funding could be delayed or restricted for any drug that costs the NHS more than £20 million per year in its first three years. The new ruling was put in place in April 2017.
NICE analysis suggests that the move would affect one in five new medicines.
In response to the policy, the Association of the British Pharmaceutical Industry (ABPI) is seeking a Judicial Review, saying that NICE’s stance “contravenes the fundamental right to access to cost-effective medicines”.
In a press statement, the ABPI said the changes to assessment of drugs for rare diseases were “inappropriate and unworkable”’, adding that they believe “it is important to challenge these new procedures before the first medicines get caught in the system, creating uncertainty for patients about whether they will be able to receive them”.
Chief Executive of ABPI, 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. We hope that the Government will reverse the changes and work with us to find a solution that works for everyone.”
NICE have declined to comment at this time.