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Double approval from NICE increases NHS treatment options in England and Wales

The National Institute of Health and Care Excellence (NICE) has today approved the myeloma treatment lenalidomide (Revlimid®) and dexamethasone for use in treating newly diagnosed patients and patients at first relapse.

Patient advocacy news // 17th May 2019

The National Institute of Health and Care Excellence (NICE) has today approved the myeloma treatment lenalidomide (Revlimid®) and dexamethasone for use in treating newly diagnosed patients and patients at first relapse.
The decision means that lenalidomide and dexamethasone will now be available on the NHS to patients in England and Wales who are not eligible for a stem cell transplant and who are:

• Newly diagnosed and not able to receive thalidomide
• At first relapse (second line) and have been treated with bortezomib (Velcade®)

Patients in Wales were already able to access lenalidomide and dexamethasone when newly diagnosed; this approval extends access to patients at first relapse. Patients in Scotland are already able to access the treatment at these points in the pathway. Northern Ireland reviews NICE decisions once they are published.
These approvals follow a period where NICE suspended its consideration while the manufacturer, Celgene, and NHS England agreed a new discount scheme for lenalidomide.

Myeloma UK Head of Patient Advocacy, Shelagh McKinlay said:

“This double approval from NICE is a significant step forward in building the best possible treatment pathway for patients in England and Wales.
“In their decision NICE confirm that unmet need was a key factor for them. This follows many years of work by Myeloma UK in raising awareness of the unmet need which exists for these patient groups.
“We have also long argued that individual treatment decisions must not be seen in isolation but as part of a treatment pathway that makes the best clinical sense for patients. In both decisions, particularly for patients at first relapse, NICE have taken the changing treatment pathway into account. We very much welcome the flexibility they have shown and their commitment to finding a solution that delivers for patients.
“While these decisions are great news for patients and their families, they have taken too long. Work to gain approval for lenalidomide and dexamethasone at first relapse has been ongoing for several years and discussions to agree a new commercial deal took a year to conclude.
“Everyone involved must keep patients and their families and carers at the forefront of their minds and move as swiftly as possible to resolve the complex challenges involved in approving new treatments.”

FAQs

When will these treatments become available?

Both treatments will be available immediately through interim funding provided via the Cancer Drugs Fund.

Does this decision apply to all patients in the UK?

The decision affects myeloma patients living in England and Wales, although newly diagnosed patients in Wales were already able to receive lenalidomide and dexamethasone.
Patients in Scotland are already able to access lenalidomide and dexamethasone when newly diagnosed and at first relapse, with the same restrictions.
In Northern Ireland, the Department of Health makes a decision on whether to fund a new treatment following publication of the final NICE and SMC decisions.

Why are there restrictions on who can access this treatment?

NICE consider not just whether a treatment is clinically effective but also whether it is cost effective. This means asking whether it is a good use of NHS resources compared to the treatments already available.
For newly diagnosed patients NICE found that lenalidomide and dexamethasone was not cost effective compared to thalidomide and it therefore is only available to patients who cannot receive thalidomide. Your doctor would discuss with you whether you are able to receive thalidomide.
For patients at first relapse, NICE were uncertain whether lenalidomide and dexamethasone is cost effective. However, they recognised that patients who have had bortezomib when newly diagnosed, would value access to lenalidomide and dexamethasone as a second line of treatment.

What kind of treatment is lenalidomide?

Lenalidomide, also known as Revlimid, is an immunomodulatory drug which works by affecting the body’s immune system. It helps to kill myeloma cells in a number of different ways. It is an oral treatment (taken by mouth). You can learn more about lenalidomide in our Treatment Guide.
Further information

If you have any questions or comments on the NICE decision please email policy@myeloma.org.uk. If you have questions about lenalidomide as a treatment call the Myeloma Infoline on 0800 980 3332 during office hours, Monday to Friday.