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UK pharma launches legal challenge to NICE plans

Applies for judicial review of budget impact test

The ABPI is taking legal action to try and block NICE’s forthcoming additional access hurdle for high-cost medicines.

The budget impact test went live in April and allows NICE to delay access to drugs that it has already judged cost-effective, but which are likely to cost the NHS more than £20m in any of its first three years of use.

Based on NICE analysis this would hit around one in five new medicines, which would then be subject to an additional negotiation process - and if that is unsuccessful full access could be delayed by up to three years.

UK pharma trade body the ABPI has applied for a judicial review of those plans and of changes to the Highly Specialised Technology (HST) assessment process, the latter of which it says are “inappropriate and unworkable”.

Chief executive 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.

However, the ABPI’s action doesn’t appear to have unanimous industry backing, with GSK telling the Financial Times it was “not supportive of this action” and AZ telling the publication is had “reservations”.

Nevertheless, the ABPI said NICE’s changes could cause “significant delays” for patients suffering from conditions that include cancer, heart disease and diabetes.

The trade body said it is “important to challenge these new procedures before the first medicines get caught in the system”.

"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,” Thompson said. “We hope that the Government will reverse the changes and work with us to find a solution that works for everyone."

Article by
Dominic Tyer

11th July 2017

From: Regulatory

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