How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    • Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Daratumumab in combination for untreated multiple myeloma when a stem cell transplant is suitable

Closed for comments This consultation ended on at   Request commenting lead permission

1 Recommendations

1.1 Daratumumab plus bortezomib, thalidomide and dexamethasone is not recommended, within its marketing authorisation, as induction and consolidation treatment for untreated multiple myeloma in adults, when an autologous stem cell transplant is suitable.

1.2 This recommendation is not intended to affect treatment with daratumumab plus bortezomib, thalidomide and dexamethasone that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Most people with untreated multiple myeloma who have an autologous stem cell transplant have bortezomib plus thalidomide and dexamethasone induction therapy before their transplant. As an alternative, daratumumab would be added (daratumumab in combination), but this treatment would also be continued for a short period after transplant (consolidation).

Clinical trial results show that, compared with bortezomib plus thalidomide and dexamethasone, adding daratumumab increases how long people live and extends the time before the condition gets worse.

But assumptions in the economic model around how long the effect of daratumumab lasts and how long people live are uncertain. Also, the model does not reflect what happens in the NHS in England.

The cost-effectiveness estimates are likely to be higher than what NICE considers acceptable. So, daratumumab plus bortezomib, thalidomide and dexamethasone cannot be recommended for use in the NHS.