Published

May 11, 2025

Daratumumab (in combination with bortezomib and dexamethasone) [DAR2]

For treating relapsed multiple myeloma patients who have had only 1 line of therapy and are transplant ineligible where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with daratumumab in combination with bortezomib and dexamethasone will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has a diagnosis of multiple myeloma.
  3. The prescribing clinician understands that daratumumab in this indication is not funded for amyloidosis patients (with the exception of patients who have a proven diagnosis of myeloma with an associated diagnosis of amyloidosis) and that NHS funding for daratumumab is only for the specific multiple myeloma indication recommended by NICE. Please tick box below:
  • this patient does not have a diagnosis of primary amyloidosis.
  • this patient has a proven diagnosis of progressive myeloma with an associated diagnosis of amyloidosis and daratumumab is being prescribed for the myeloma Note: NHS England does not fund daratumumab in this indication for patients with amyloidosis unless they have a proven diagnosis of progressive myeloma with an associated diagnosis of amyloidosis.
  1. The patient has received 1 and no more than 1 prior line of treatment and that the numbering of a line of treatment is in accordance with the International Myeloma Workshop Consensus recommendations for the uniform reporting of clinical trials (http://doi.org/10.1182/blood-2010-10-299487). A line of therapy is defined as one or more cycles of a planned treatment program. This may consist of one or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner (ie induction chemotherapy/chemotherapies when followed by stem cell transplantation is considered to be 1 line of therapy). A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse or toxicity, the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. Patients who commenced on the Interim COVID option of ixazomib with lenalidomide and dexamethasone (Blueteq form code IXA2CV) as a second line therapy instead of daratumumab bortezomib and dexamethasone during the COVID19 pandemic to avoid hospital admissions can be granted an exception to the 1 prior line of therapy rule. Please tick box below:
  • this patient has received 1 and no more than 1 prior line of treatment or
  • this patient has received 2 lines of treatment the 2nd of which was the temporary COVID-related option of 2nd line ixazomib with lenalidomide and dexamethasone (Blueteq form code IXA2CV) Note: The use of daratumumab in combination with bortezomib and dexamethasone in the 1-prior treatment setting was the place in the treatment pathway chosen by Janssen for its submission to NICE for the appraisal of clinical and cost effectiveness of this daratumumab combination and thus is the basis of NICE’s recommendation.
  1. The patient responded to this 1-prior line of treatment (or if this patient received 2nd line ixazomib with lenalidomide and dexamethasone courtesy of Covid-related access IXA2CV, the patient must have responded to at least one of these 2 lines of therapy). Note: the need for patients to have responded to their 1 prior line of treatment is as a consequence of the 1-prior subgroup chosen by Janssen for its submission to NICE for the appraisal of clinical and cost effectiveness of this daratumumab combination.
  2. In relation to this 1-prior line of systemic therapy (or 2-prior in the case of patients accessing ixazomib with lenalidomide and dexamethasone via Covid-related access IXA2CV), the patient now has documented relapse of disease.
  3. With respect to previous consideration of treatment with lenalidomide as part of previous therapy: in - this patient was treated with 1st line lenalidomide (either as 1st line therapy for transplant ineligible patients or as maintenance therapy in patients treated with stem cell transplantation as part of 1st line treatment) or
  • the patient was treated with 2nd line ixazomib with lenalidomide and dexamethasone courtesy of the Covid-related access IXA2CV or
  • treatment with 1st line lenalidomide in the transplant ineligible setting was considered unsuitable for this patient at the time or
  • treatment with maintenance lenalidomide post stem cell transplantation was not available at the time of the transplant (i.e. before the NICE recommendation in January 2021) or was considered unsuitable for this patient
  1. The patient has not been previously treated with daratumumab or an anti-CD38 antibody unless they have been previously treated with daratumumab in which case the patient must have received the daratumumab as part of induction therapy pre-transplant and must have responded to that daratumumab-containing combination. The daratumumab-free period from previous therapy until now must be stated below. Please enter below as to which scenario applies to this patient:
  • no previous treatment with daratumumab or
  • previous treatment with daratumumab in the transplant-eligible setting and disease responded to this. Please record the time since the start of the last cycle of daratumumab to now
  1. With respect to current consideration of treatment with lenalidomide as part of 2nd line therapy:
  • the patient has already been treated with lenalidomide with 1st line lenalidomide (either as 1st line therapy for transplant ineligible patients or as maintenance therapy in patients treated with stem cell transplantation as part of 1st line treatment) or received 2nd line lenalidomide as part of the Covid-related access IXA2CV to ixazomib with lenalidomide and dexamethasone
  • the patient is lenalidomide-naïve but 2nd line treatment with lenalidomide is currently considered as unsuitable for this patient
  1. The patient has either not been treated with high dose chemotherapy and stem cell transplantation or has been previously treated with high dose chemotherapy and stem cell transplantation as part of 1st line therapy. Please fill in as appropriate below. Please enter below as to which scenario applies to this patient:
  • no previous treatment with high dose chemotherapy and stem cell transplantation or
  • previous treatment with high dose chemotherapy and stem cell transplantation
  1. the patient is of ECOG performance status 0 or 1 or 2. Please tick one of the boxes below:
  • performance status 0 or
  • performance status 1 or
  • performance status 2
  1. Daratumumab is only to be used in combination with bortezomib and dexamethasone and that it is not to be used in combination with any other agents.
  2. The dosage schedule of daratumumab will be for weekly treatment given in weeks 1-9 (a total of 9 doses), 3-weekly treatment in weeks 10 to 24 (a total of 5 doses) and 4-weekly treatment from week 25 onwards. NHS England recommends that the subcutaneous formulation of daratumumab is used.
  3. Daratumumab is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment.
  4. A formal medical review as to whether treatment with daratumumab in combination with bortezomib and dexamethasone continues or not will be scheduled to occur at least by the end of the first 6 weeks of treatment.
  5. When a treatment break of more than 6 weeks beyond the expected cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment.
  6. Daratumumab will be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 04 September 2023

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA897 (06 June 2023)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

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