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 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 age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Draft guidance consultation

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

1 Recommendations

1.1

Elranatamab is recommended with managed access as an option for treating relapsed and refractory multiple myeloma in adults after 3 or more lines of treatment (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody) when the myeloma has progressed on the last treatment. It is only recommended if:

  • pomalidomide plus dexamethasone would otherwise be offered, and

  • the conditions in the managed access agreement for elranatamab are followed.

1.2

This recommendation is not intended to affect treatment with elranatamab 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 healthcare professional consider it appropriate to stop.

Why the committee made these recommendations:

The treatment most commonly used for relapsed and refractory multiple myeloma after 3 lines of treatment (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody) is pomalidomide plus dexamethasone. For this evaluation, the company asked for elranatamab to only be considered as an alternative to pomalidomide plus dexamethasone. This does not include everyone who it is licensed for.

Evidence from a clinical trial for elranatamab is promising, but it was not compared with other treatments and the trial is still ongoing. So, the effectiveness of elranatamab and its long-term benefits are uncertain. The results from this trial were used for an indirect comparison with pomalidomide plus dexamethasone. It suggests that elranatamab could increase how long people have before their condition gets worse and how long they live compared with pomalidomide plus dexamethasone. But the results are uncertain because it was based on the uncertain elranatamab trial data.

Because of the uncertainty in the long-term benefits of elranatamab, and in the long-term use of intravenous immunoglobulin in people having elranatamab, the cost-effectiveness estimates are also highly uncertain. So, it cannot be recommended for routine use in the NHS.

Elranatamab could be cost effective if further evidence shows that people live longer with treatment. Longer-term evidence from the trial and NHS practice could help address the remaining uncertainties. So, elranatamab is recommended for use with managed access if it is used only as an alternative to pomalidomide plus dexamethasone.