Ibrutinib [IBR5]

For the treatment of relapsed/ refractory mantle cell lymphoma in patients who have either only received 1 prior line of systemic therapy or been treated with prior lines if 2nd line therapy was initiated before NICE’s recommendation in January 2018 where all the following criteria are met:

1. This application has been made by and the first cycle of systemic anti-cancer therapy is to be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has a confirmed histopathological diagnosis of mantle cell lymphoma
3. The patient has previously been treated with one and only one prior line of rituximab-containing chemotherapy. Note: Patients treated with more than 1 line of prior therapy are not eligible for treatment with ibrutinib.
4. The presence of relapsed/refractory mantle cell lymphoma with documented progression of disease during or following rituximab-containing 1st line systemic therapy.
5. The patient has never received any prior therapy with a BTK inhibitor (ibrutinib or zanubrutinib or another BTK inhibitor) unless the patient has suffered unacceptable toxicity on therapy with zanubrutinib without any evidence of disease progression and is transferring to treatment with ibrutinib. Please enter below which of these scenarios applies to this patient: ≥2

• the patient is treatment-naïve to a BTK inhibitor or
• the patient has been receiving therapy with zanubrutinib but has suffered unacceptable toxicity without any evidence of disease progression and is transferring to treatment with ibrutinib

6. Ibrutinib is to be used as a single agent
7. Ibrutinib is to be continued until disease progression, unacceptable toxicity or the patient’s choice to stop treatment.
8. The patient’s performance status is 0 or 1 or 2
9. The patient is not on concurrent therapy with warfarin.
10. The rescribing clinician is aware that ibrutinib has clinically significant interactions with cytochrome P450 enzyme 3A4 (CYP3A4) inhibitors and inducers as described in ibrutinib’s Summary of Product Characteristics.
11. When a treatment break of more than 6 weeks beyond the expected cycle length occurs, the prescribing clinician will complete a treatment break approval form to restart treatment.
12. Ibrutinib will be otherwise used as set out in its Summary of Product Characteristics

NHS funded From: 01 May 2018

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA502 (31 January 2018)

Current Form Version

Note

The data on this page was produced using version 1.367 of the CDF list, downloaded from NHS England’s website on 27 June 2025 at 18:00.

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.

Older Form Versions

There are previous versions of this form. These may not all be available on this site.

• IBR5_prior_to_cdf_1.361
• IBR5_prior_to_cdf_1.367