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”.

Under the new system, treatments for very rare conditions up to £100,000 per QALY will be automatically funded from routine commissioning budgets, but critics point out that NHS England is currently funding many rare disease therapies that cost more than £500,000 per QALY, and fear access to these would be interrupted.

The new procedures have the potential to cause significant delays for patients waiting for treatment for a range of conditions, including for cancer, heart disease and diabetes, and thus “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,” the ABPI said.

A new solution?

"​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,” added ABPI chief executive Mike Thompson. “We hope that the Government will reverse the changes and work with us to find a solution that works for everyone."

Baroness Delyth Morgan, chief executive at Breast Cancer Now, said the charity is also “extremely concerned” that the budget impact test could represent another “major additional hurdle” in getting access to modern breast cancer drugs.

“Thousands of women living with incurable breast cancer are relying on effective drugs to give them significant and precious extra time with their loved ones, and any further delays could sadly see patients lose their lives as they wait.”

She went on to say that, “from the outset, it was incredibly disappointing that, despite widespread opposition from those representing patients and a willingness to discuss alternative solutions, NICE and NHS England decided to implement this test,” and that the charity will now “closely monitor” the progress of the legal action “and hope that it will provide clarity on the issue of timely access to drugs in England.”