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  • Question on Consultation

    a. Has all of the relevant evidence been taken into account?

  • Question on Consultation

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

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    d. 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?

  • Question on Consultation

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

Draft guidance consultation

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1 Recommendations

1.1

Ibrutinib with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R‑CHOP), alternating with rituximab, dexamethasone, cytarabine and cisplatin (R‑DHAP) or rituximab, dexamethasone, cytarabine and oxaliplatin (R‑DHAOx) without ibrutinib, followed by ibrutinib monotherapy, should not be used for untreated mantle cell lymphoma in adults when an autologous stem cell transplant (ASCT) is suitable.

1.2

This recommendation is not intended to affect treatment with ibrutinib with R‑CHOP 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.

What this means in practice

These are NICE's draft recommendations. If these recommendations become final, ibrutinib with R‑CHOP would not be required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because more evidence is needed to understand whether ibrutinib with R‑CHOP is value for money in this population.

Why the committee made these recommendations

Usual treatment for untreated mantle cell lymphoma depends on whether an autologous (using the person's own cells) stem cell transplant is suitable. If it is, people usually have chemotherapy, followed by an ASCT, and then maintenance treatment. Ibrutinib with R‑CHOP, alternating with R‑DHAP or R‑DHAOx without ibrutinib, then ibrutinib only, would be an alternative to an ASCT in this population.

Evidence from a clinical trial suggests that ibrutinib with R‑CHOP increases how long people have before their condition gets worse and how long people live compared with usual treatment. But by how long is uncertain because the trial is still ongoing.

There are uncertainties in the economic model. This is because of how it modelled:

  • the short-term risks and long-term benefits of usual treatment,

  • the benefits of ibrutinib with R‑CHOP, and

  • the cost of usual treatment.

Because of the uncertainties in the economic model, it is not possible to determine the most likely cost-effectiveness estimates for ibrutinib with R‑CHOP. So, ibrutinib with R‑CHOP should not be used.