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Triple timeline announced by NICE

NICE announce planned timeline for assessing Vertex’s triple combination therapy (known as Trikafta in the US) and the EMA allow more time in their process to assess who the license would cover.

Yesterday, NICE announced its planned timelines for assessing the triple combination therapy, with 16 December 2020 the date they expect to publish their recommendation.

NICE is responsible for providing advice to the NHS in England on whether new treatments should be available for doctors to prescribe. Their advice is also generally followed by health authorities in Wales and Northern Ireland.

This important development comes as the European Medicines Agency (EMA) continues its assessment of the triple combination therapy. Earlier this month, the manufacturer, Vertex Pharmaceuticals, confirmed that they expect a licence to be awarded during the final three months of 2020. The triple combination therapy was initially being reviewed under so-called ‘Accelerated Assessment’ processes but we understand that, in order to address important questions relating to who the license would cover, the EMA and Vertex have allowed more time within the process.

The Cystic Fibrosis Trust is campaigning for the license to cover anybody with CF aged 12 or older with at least one copy of the F508del mutation, the most common CF-causing mutation in the world. Take a look at who this could benefit.

Earlier this month, we worked with CF Europe to raise the importance and urgency of the EMA process and our shared goal of rapid, broad access. You can read the letter here. Over the next few months we will continue this conversation with the EMA, and keep you updated on progress.

Nick Medhurst, Head of Policy and Public Affairs at the Cystic Fibrosis Trust, said:

“While it is encouraging that the EMA and NICE planned timelines are aligned, we must continue to engage with all stakeholders, including Vertex and the NHS, to ensure a rapid, positive outcome for everyone who can benefit.

“In Scotland, where different processes are followed to support NHS use of new medicines, this requires continuing our engagement with the Scottish Government, Scottish Medicines Consortium (SMC) and clinical teams.”

Over the coming months we will keep you updated with developments and let you know about opportunities to have your say on this vital issue. In the meantime, Nick Medhurst, Head of Policy and Public Affairs, answered the community's questions live on Facebook.

Watch the video