What happens after a draft ‘no’ from NICE?

8th September 2020 // Daniel Cairns

This week the National Institute for Healthcare Excellence (NICE) issued a draft ‘no’ for the use of lenalidomide maintenance to treat newly diagnosed myeloma patients following high-dose therapy and stem cell transplantation (HDT-SCT).

The report issued by NICE (known as an Appraisal Consultation Document or ACD) highlights the clinical benefits of lenalidomide maintenance but also states that there were uncertainties around cost-effectiveness.

Myeloma UK are deeply disappointed in this recommendation and are doing everything possible to advocate for this draft ‘no’ to turn into ‘yes’ to secure approval for use of lenalidomide maintenance on the NHS in England, Wales, and Northern Ireland.

But what happens next?

First, NICE shares the ACD with all the key stakeholders for consultation. This document summarises the evidence presented as part of the appraisal and outlines the rationale for the draft ‘no’.

Stakeholders, including Myeloma UK, have until the 29 September to submit comments on the ACD.

During this time, Myeloma UK will be in discussions with NICE, NHS England and the pharmaceutical company, Celgene/BMS, to identify and address specific points and issues raised in the ACD.

Once the consultation ends there is another appraisal meeting. This meeting is normally a discussion between NICE and the pharmaceutical company Celgene/BMS. However, Myeloma UK can request to attend this meeting and we will seek to do so on behalf of patients.

In this meeting the appraisal committee considers the comments received on the ACD, then makes its final recommendation on whether the treatment will be approved for use on the NHS in England, Wales, and Northern Ireland.

NICE then issues the Final Appraisal Document (FAD) to the stakeholders, including Myeloma UK. This document summarises the evidence and provides details of the final recommendation.

If NICE still does not recommend the treatment, the stakeholders do have a further opportunity to appeal the decision. However, this would be based on the content of the FAD.

The whole process should take around nine weeks to complete. However, this could change depending on negotiations between NICE, NHS England and Celgene/BMS.

It should be noted that a NICE draft ‘no’ was given in three of the most recent appraisals for myeloma. These treatments are now recommended for use on the NHS through the Cancer Drugs Fund (CDF). These were daratumumab (Darzalex®), bortezomib (Velcade®) and dexamethasone; daratumumab monotherapy; and ixazomib (Ninlaro®), lenalidomide and dexamethasone.

The CDF is primarily used for funding novel cancer treatments when there is uncertainty around the clinical and cost-effectiveness, and there is a need for more data collection.

Unfortunately, as lenalidomide is a well-established cancer treatment and there is a large data set from Myeloma XI it is not eligible for funding through the CDF.

Myeloma UK will be doing everything possible to ensure that this treatment is approved.

Further information

If you have any questions or comments on the recommendation please email or call the Myeloma Infoline on 0800 980 3332 during office hours, Monday to Friday.