Why is the ABPI attempting to overturn new rules for medicines?
A trade association representing pharmaceutical manufacturers is challenging new drug price negotiation rules introduced in April.
The Association of the British Pharmaceutical Industry (ABPI) has confirmed it has applied for a judicial review of both the budget impact test and the system for assessing therapies for rare conditions. The measures came into effect from April.
The ABPI, patient groups and health charities argue the changes will lead to some patients having to wait longer to receive treatment. The trade association has also predicted the new rules will affect clinical research.
The budget impact test leads to price negotiations for any drug that is assessed as cost effective but will cost the NHS more than £20m in its first three years of use. The ABPI says this will affect one in five new medicines.
Where an agreement cannot be reached, NHS England asks NICE for permission to phase in the treatment over three years. Previously, all treatments approved by NICE had to be made available by the NHS within 90 days.
Under the rare conditions rule, treatments, devices and diagnostics are funded if they can provide a quality adjusted life year (QALY) for £100,000.
Drugs with a higher cost per QALY (up to the maximum threshold of £300,000) are evaluated against a sliding scale that looks for more benefits to offset higher prices.
ABPI chief executive Mike Thompson said the organisation was going to court because the potential damage the changes will cause to NHS care.
The National Institute for Health and Care Excellence has said the fast-track system for rare conditions will mean that patients can access cost-effective new technologies more quickly.