NIHR and Novartis agree large scale clinical trial cardiovascular disease drug

A new deal will see the NHS involved in supporting a large scale trial of the drug, which it is hoped could treat large numbers of patients with cholesterol issues.

The agreement will see the National Institute of Health Research (NIHR), described as the ‘NHS’s research arm’, supporting the clinical trial in a large population of NHS patients. It is hoped that this trial can help accelerate uptake of inclisiran on the NHS, following an early clinical trial demonstrating success in preventing heart attacks and strokes.

As part of the agreement the NHS has said it hopes to routinely reimburse the product on the NHS following appraisal by the National Institute for Health and Care Excellence (NICE). It is hoped that 300,000 patients might be treated each year, with 55,000 heart attacks and strokes prevented, saving 30,000 lives over 10 years.

The Department of Health and Social Care (DHSC) has touted the potential for a ‘world-first’ ‘population-level’ deal in reimbursing the drug if the trial is successful. However it is unclear at present how this would differ from routine NICE recommendation across a licensed indication.

However the commitment of the Government to a NICE appraisal of inclisiran “at the earliest opportunity possible” suggests that timeline for this product could be accelerated in view of the potential public health impact.

Inclisiran is an PCSK9 inhibitor, using an siRNA-based approach to the same molecular target and indication as alirocumab and evolocumab which were adopted as part of the first round of the Accelerated Access Collaborative (AAC), indicating a general trend by the Government to smooth the regulatory and reimbursement process for drugs tackling major public health challenges.

In the Government’s press release, Health and Social Care Secretary Matt Hancock said:

“This partnership is fantastic news and is a huge stride forwards in helping to achieve this. This collaboration has the potential to save 30,000 lives over the next 10 years and is proof that the UK continues to be the world-leading destination for revolutionary healthcare.

“I will always help the NHS reach its full potential, and novel and innovative collaborations such as this put patients at the forefront of the most promising medical breakthroughs.”

Inclisiran is expected to be submitted for marketing authorisation in early 2020, with the aspiration of a commercial arrangement in early 2021.

Read the full Government press release on inclisiran here.

Tagged with

Published 14. January 2020 in Interesting Reads, News, News UK, Press Release