Joint statement: NICE and SMC/HIS collaboration on MTA for cystic fibrosis

NICE and SMC/HIS collaboration on health technology appraisal of ivacaftor-tezacaftor-elexacaftor (Kaftrio), tezacaftor-ivacaftor (Symkevi) and lumacaftor-ivacaftor (Orkambi) for treating cystic fibrosis.

NHS England has an interim access agreement with Vertex Pharmaceuticals for Orkambi, Symkevi and Kaftrio, which includes collecting further data through an interim data collection agreement. This comes to an end in 2023/4. Scottish Government and Vertex Pharmaceuticals arranged a pricing agreement for the supply of Orkambi, Symkevi and Kaftrio for NHS Scotland, which also includes data collection. This comes to an end in 2024. Both data collection exercises are through the UK Cystic Fibrosis registry.

NICE has commenced a multiple technology appraisal (MTA) of ivacaftor-tezacaftor-elexacaftor, tezacaftor-ivacaftor and lumacaftor-ivacaftor for treating cystic fibrosis. Given similar circumstances regarding access arrangements and data collection to date, NICE and SMC have agreed to collaborate on the MTA, which will ensure alignment of guidance on these therapies across England and Scotland.

The SMC will input directly into the MTA so that the MTA guidance will also be relevant to the NHS in Scotland. Both NICE and the SMC will produce separate guidance and advice documents, but the recommendations will be aligned. The usual obligations for complying with technology appraisal recommendations will apply to healthcare commissioners in England. In Scotland, the MTA advice will have the same status for health board consideration as other SMC advice on new medicines.

While the MTA is underway and until NICE final guidance and SMC advice is issued the existing arrangements in England and Scotland for access to these medicines will continue.

NICE and the SMC will continue to work together on any updates to this MTA guidance after publication.