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Myeloma UK welcomes NICE approval for the first maintenance treatment for myeloma

Other News // 27th January 2021

Myeloma UK welcomes NICE approval for the first maintenance treatment for myeloma

The National Institute for Health and Care Excellence (NICE) has recommended the use of lenalidomide as a maintenance treatment for newly diagnosed myeloma patients in England and Wales who are eligible for high-dose therapy and stem cell transplantation (HDT-SCT).

This is the first maintenance treatment for myeloma to be made available through the NHS and is currently considered the global gold standard for HDT-SCT eligible patients.

Lenalidomide maintenance has been studied in several clinical trials including Myeloma XI the largest trial conducted in myeloma with over 4000 participants. Results showed that lenalidomide maintenance following HDT-SCT increased remission time and improved overall survival.

This approval follows the draft ‘no’ recommendation issued by NICE in September 2020. Since then, Myeloma UK has been working with patients, clinicians, and the pharmaceutical company Celgene BMS to change this draft ‘no’ recommendation into a ‘yes’.

Laura Kerby, Chief Executive of Myeloma UK said:

“We are delighted with this outcome. The scale of benefit that this approval can deliver to patients at the start of the myeloma treatment pathway is a hugely significant moment in our history. This decision is a real breakthrough for the future of myeloma treatment.

“Myeloma UK has been a key part of the effort to deliver this treatment for newly diagnosed patients from the start, including supporting the Myeloma XI trial, led by Professor Graham Jackson.

“We have consistently made the case for approval to NICE at meetings and in written evidence and have worked behind the scenes with other key partners.

“We were able to present clear evidence of patient support thanks to the more than 460 patients who completed our patient survey, where 98% of respondents supported approval and 90% of those who had received lenalidomide maintenance rated their experience as very positive or positive.

“We want to thank all those patients who took part in the clinical trial and the survey. Their support has helped us deliver this approval, meeting a significant need and helping patients now and in the future live longer and with a better quality of life.”

Steve Billcliffe, Patient Expert:

“Lenalidomide maintenance treatment has given me six years of remission from Myeloma and an enhanced quality of life.

“Despite an initial gloomy prognosis I have gone on to enjoy my retirement. Family holidays at the seaside, attending my sister’s wedding; receiving a Master’s degree, being active in the garden, and celebrating the arrival of a new granddaughter have all been enjoyably possible.

“I am very grateful to have been able to take part in the Myeloma XI Trial and am delighted that newly diagnosed Myeloma patients will have the chance to benefit from the same treatment in the future.”

Professor Graham Jackson, Myeloma XI Chief Investigator said:

“Everyone involved in the care of myeloma patients will be delighted with this news.

“Lenalidomide maintenance is a vital part of the treatment of myeloma patients who have had a stem cell transplant. This treatment prolongs remissions by over two years and is one of the most effective interventions in the treatment of this disease.

“Tribute to everyone at Myeloma UK, all the investigators and patients who took part in the Myeloma XI trial which was pivotal to this decision. This is a fantastic, welcome and brilliant development and takes us a massive step forwards in myeloma care.”

What does this mean for patients?

Newly diagnosed myeloma patients in England and Wales who are eligible for HDT-SCT can now receive lenalidomide maintenance after their stem cell transplant.

Lenalidomide maintenance will only be available to newly diagnosed (first line) patients after recovery from HDT-SCT. It will not be available to patients who received HDT-SCT a considerable time ago and have completed their first line of treatment. This is because clinical trial data is only available for this group of patients.

Evidence from clinical trials, including Myeloma XI, shows that lenalidomide maintenance increases remission time and overall survival.

What about patients in Scotland and Northern Ireland?

Lenalidomide maintenance was approved by the Scottish Medicines Consortium (SMC) for patients through NHS Scotland in October 2020. You can read more about this decision from our webstory.

In Northern Ireland, the Department for Health decides which treatments to fund through Health and Social Care Northern Ireland. These decisions follow guidance issued by NICE and lenalidomide maintenance will also be made available to patients in Northern Ireland.

Further information

If you have any questions or comments on the decision please email policy@myeloma.org.uk or call the Myeloma Infoline on 0800 980 3332 (UK) or 1800 937 773 (Ireland) during office hours, Monday to Friday.