NICE issues two ‘Draft no’ decisions for the use of DVRD in newly diagnosed myeloma patients

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Updated 13 May 2026
NICE has maintained its draft recommendation not to recommend DVRD for newly diagnosed myeloma patients who are eligible for high-dose treatment and stem cell transplant.

The decision is not final. NICE has asked for more data on how DVRD works and will review its decision on 17 June 2026.

The National Institute for Health and Care Excellence (NICE) have published two draft guidance documents not recommending the use of daratumumab (Darzalex®) in combination with bortezomib (Velcade®), lenalidomide (Revlimid®) and dexamethasone (DVRD) in England and Wales.

DVRD for transplant-ineligible patients

The first draft guidance document, which was published on 9January 2026, saw NICE not recommend DVRD for newly diagnosed myeloma patients who are not eligible for a stem cell transplant.

If this use had been approved, DVRD would be the second quadruplet treatment for people ineligible for a stem cell transplant, and because daratumumab is given as an injection, it would have given patients access to a more convenient treatment option.

The evidence submitted included data from the Phase 3 CEPHEUS trial, which compared DVRD to the triplet combination of bortezomib, lenalidomide and dexamethasone (VRD), showed that 68% of people on DVRD were still in remission after four and a half years.

Although the NICE committee agreed that DVRD was safe and effective, members felt they could not confirm that the treatment was cost-effective for the NHS.

Key challenges for evaluating the cost-effectiveness of DVRD included the lack of trial data comparing DVRD to daratumumab, lenalidomide and dexamethasone (DRD) and the newly approved IsaVRD [(isatuximab (Sarclisa®) in combination with bortezomib, lenalidomide and dexamethasone)] as well as the immaturity of the data.

DVRD for transplant-eligible patients

The second draft guidance document, which was published on 14 January 2026, saw NICE not recommend DVRD for newly diagnosed myeloma patients who are eligible for a stem cell transplant.

If this use had been approved, DVRD would have been the first tailored treatment for newly-diagnosed patients due to the unique amendments to DVRD’s maintenance phase based on the patient’s minimal residual disease (MRD) status. 

It would also have allowed the much-anticipated switch from thalidomide to lenalidomide during induction and given stem cell transplant (SCT)-eligible patients access to doublet maintenance of daratumumab and lenalidomide for the first time. The Phase 3 PERSEUS trial data, submitted as part of the appraisal, showed that 84% of people in the DVRD arm of the trial were still in remission after four and a half years.

Although the NICE committee agreed that DVRD was safe and effective, members felt they could not confirm that the treatment was cost-effective for the NHS.

Key challenges for evaluating the cost-effectiveness of DVRD included the lack of trial data comparing DVRD to the standard treatment regimen (DVTD induction and consolidation) followed by lenalidomide maintenance and uncertainties around how the MRD stopping rule would be implemented in clinical practice.

What’s next?

While it is disappointing, NICE’s decisions are only draft recommendations at this stage, which means they are not final.

NICE is expected to review both decisions at a second committee meeting in March. Caroline Donoghue, Access Manager at Myeloma UK, said:

“This is really disappointing. We know how important it is for patients to get the most effective treatment at first line.

“These decisions are not final and we’ll keep submitting evidence and pushing for this treatment to be approved on the NHS.

“Until we have a cure, it is absolutely vital that people with myeloma get the treatment they need as soon as they’re diagnosed.”

Q&A

What is a draft no?

A draft recommendation is not a final decision from NICE. A draft no means that, after initial review, the new treatment was not deemed a cost-effective use of NHS resources. This could be because more evidence is needed or because the cost doesn’t reflect the benefit the treatment delivers. After a draft no is published there is a period of consultation where the pharmaceutical company, clinicians and patients can submit further evidence to inform the final decision. 

Why did NICE say no?

NICE recognised that DVRD is safe and effective for the treatment of newly-diagnosed myeloma patients. However, in both cases the committee said it needed further data to confirm how well DVRD works compared to available treatment options and, ultimately, whether DVRD is a cost-effective use of NHS resources. 

The price of drugs is a factor in NICE decisions, but it is important to bear in mind that the committee does not look at whether a drug is expensive. Rather, it looks at whether it is cost-effective compared to the current standard of treatment.

What happens next?

Myeloma UK and all other interested parties have three weeks to submit further evidence. A second committee meeting will then be held on 12 March. 

What is DVRD?

DVRD is a combination treatment used to treat myeloma. It contains four drugs: daratumumab, bortezomib, lenalidomide and dexamethasone.

All the drugs in the combination are already being used to treat myeloma but are used in different combinations. For example, the current induction treatment given to newly-diagnosed myeloma patients who can have a stem cell transplant is DVTD, a combination of daratumumab, bortezomib, thalidomide and dexamethasone.

NICE is currently assessing two uses of DVRD. One as a treatment for newly-diagnosed patients who can’t have a stem cell transplant (ineligible) and the other for newly-diagnosed patients who will have a stem cell transplant (eligible).

For transplant-ineligible patients, DVRD is given in two phases: induction and maintenance. In the induction phase, patients get all four drugs. In the maintenance phase, patients come off bortezomib and continue with DRD.

For transplant-eligible patients, DVRD is given in three phases: induction, consolidation and maintenance. In the induction and consolidation phases, patients get all four drugs. In the maintenance phase, patients come off bortezomib and dexamethasone and continue taking daratumumab and lenalidomide as maintenance. Patients who have been on maintenance for at least 24 months and have had no detectable myeloma cells in the blood or bone marrow for at least 12 months, can then come off daratumumab.

What about people living in Scotland and Northern Ireland?

In Scotland, the Scottish Medicines Consortium makes decisions about which treatments to fund through the NHS. The SMC has not started an appraisal of DVRD yet. We hope it will start later this year.

In Wales, decisions about which treatments to fund through the NHS are made by the All Wales Medicines Strategy Group (AWMSG) and NICE.

In Northern Ireland, the Department for Health makes decisions on which treatments to fund through the NHS. It can follow guidance issued by either NICE or the SMC, but usually follows the guidance issued by NICE.

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