The Association of the British Pharmaceutical Industry is seeking to challenge in court new rules on appraising medicines for NHS use, insisting that the changes will hinder patient access to the latest medical innovations.

The trade body has confirmed that it has applied for a Judicial Review over the introduction by the National Institute for Health and Care Excellence and NHS England of a budget impact test and a new system for assessing therapies for very rare conditions.

Under the new budget impact test, any medicine deemed cost effective but likely to cost the NHS more than £20 million in any of the first three years of its use will have to undergo a separate negotiation process to agree commercial arrangements to help better manage their introduction and subsequent drag on funds.

The ABPI argues that this is both “heavy-handed and unrealistic”, and will create further delays in accessing medicines for a large number of NHS patients. It also highlights evidence from NICE’s own analysis that around one in five new medicines will be impacted by the new rule.

The Association is also seeking to reverse changes to the assessment of medicines for very rare diseases, which it believes are “inappropriate and unworkable”.