The High Court has refused ABPI's application for a judicial review of NICE's new "budget impact"' tests for assessing high cost medicines.
The Association of the British Pharmaceutical Industry’s (ABPI) application for judicial review of new procedures for assessing high cost medicines - so called "budget impact" tests - has been rejected by the High Court.
ABPI’s application concerned policy changes that came into effect in April which enabled NHS England (NHSE) and the National Institute for Health Care and Excellence (NICE) to limit funding of medicines predicted to cost over £20m in any year during the first three years following approval. The new budget impact test is one of several mechanisms applied to the pricing and reimbursement of prescription medicines; another mechanism being the voluntary Pharmaceutical Price Regulation Scheme (PPRS) under which it has been reported that pharmaceutical companies had paid over £1bn in 2014.
The new policy means that from 01 April 2017 access to NICE-approved drugs falling within the new criteria can be "phased and delayed" whilst further pricing negotiations are conducted between NHSE and the pharmaceutical company concerned. More information on the budget impact tests can be found on NICE’s website here. NICE has estimated that one in five new medicines would be impacted by the new procedures. It is understood that the impact of the application of the new procedures will be reviewed by NICE and NHSE in 2020.
In its press release of 10 July 2017 announcing its application for judicial review, the ABPI explained that it was concerned that the new procedures have the potential to cause significant delays for patients waiting for treatments for a range of conditions, including cancer, heart disease and diabetes. The ABPI brought its application after initially raising concerns with NICE and offering to work on alternative proposals. The ABPI’s concerns were that the new policy should be reviewed before any new medicines had been subjected to the new assessment procedures, in order to bring reassurance to patients. It is also understood that the ABPI’s application sought to reverse changes to the assessment of medicines for very rare diseases, or "ultra-orphans".
The ABPI has issued a second statement to state that whilst it is disappointed by the High Court’s decision, its Board has unanimously agreed to accept the decision and will not appeal. The ABPI states that it has maintained positive and constructive dialogue with NICE, the NHS and the Government throughout the action and is encouraged that the issues are now better understood. An ABPI spokesperson commented that “working in partnership with industry, Government and the NHS we must now focus on finding real, workable solutions to help NHS patients get fast access to the medicines they need.” The ABPI’s statement of 05 October 2017 can be read here
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