| Status: Supported for use via the One Wales Medicines process | |
Bendamustine in combination with rituximab can be made available within NHS Wales for the treatment of previously untreated and relapsed mantle cell lymphoma in patients currently deemed unsuitable for anthracycline-based therapy or other health technology appraisal-approved regimens. The risks and benefits of the off-label use of bendamustine plus rituximab for this indication should be clearly stated and discussed with the patient to allow informed consent. At the latest review of this recommendation in February 2024, the decision by the One Wales Medicines Assessment Group was to retain the current advice with no changes required. This advice will be reviewed after two years or earlier if new evidence becomes available. |
Darllen yn Gymraeg / Read in English
Beth benderfynodd Grŵp Asesu Meddyginiaethau Cymru’n Un?
Gellir rhoi bendamustine a rituximab i drin lymffoma celloedd mantle (math prin o ganser y gwaed), pan nad yw triniaethau trwyddedig yn addas. Gellir rhoi bendamustine a rituximab fel triniaeth gyntaf, neu pan nad yw triniaethau eraill wedi gweithio.
Bydd bendamustine a rituximab ar gael i gleifion cymwys sydd wedi cofrestru gyda phractis meddyg teulu yng Nghymru, hyd yn oed os oes angen iddynt dderbyn eu triniaeth y tu allan i Gymru.
Nid yw bendamustine a rituximab wedi'u trwyddedu i drin lymffoma celloedd mantle, felly os cânt eu defnyddio i drin lymffoma celloedd mantle fe’i gelwir yn ddefnydd “all-drwydded”. Pan gaiff meddyginiaeth ei defnyddio yn “all-drwydded”, rhaid i'ch meddyg esbonio'n glir i chi y risgiau a'r manteision o gymryd y feddyginiaeth. Dylai eich meddyg roi gwybodaeth glir i chi, siarad â chi am eich opsiynau a gwrando'n ofalus ar eich barn a'ch pryderon. Darllenwch ein taflen wybodaeth i gleifion am ddefnydd di-drwydded ac all-drwydded o feddyginiaethau.
Mae Grŵp Asesu Meddyginiaethau Cymru'n Un ac AWTTC yn adolygu'r penderfyniad hwn yn rheolaidd i weld a oes unrhyw dystiolaeth newydd a allai effeithio ar y penderfyniad hwn.
Am ragor o wybodaeth, ewch i: Lymphoma Action
What did the One Wales Medicines Assessment Group decide?
Bendamustine and rituximab can be given to treat mantle cell lymphoma (a rare type of blood cancer), when licensed treatments are not suitable. Bendamustine and rituximab can be given as a first treatment, or when other treatments have not worked.
Bendamustine and rituximab will be available to eligible patients who are registered with a GP practice in Wales, even if they need to receive their treatment outside Wales.
Bendamustine and rituximab are not licensed to treat mantle cell lymphoma, so using them to treat it is called “off-label” use. When a medicine is used “off-label”, your doctor must clearly explain to you the risks and benefits of taking the medicine. Your doctor should give you clear information, talk with you about your options and listen carefully to your views and concerns. Read our patient information leaflet about unlicensed and off-label use of medicines.
The One Wales Medicines Assessment Group and AWTTC review this decision regularly to see if there is any new evidence that may affect this decision.
For more information on these types of blood cancer visit: Lymphoma Action
Health boards will take responsibility for implementing One Wales Medicines Assessment Group decisions and ensuring that a process is in place for monitoring clinical outcomes.
Background: Bendamustine with rituximab is available in NHS England through clinical commissioning for the treatment of previously untreated and relapsed and refractory mantle cell lymphoma. Although rituximab is not licensed for treating mantle cell lymphoma, the National Institute for Health and Care Excellence (NICE) mantle cell lymphoma treatment pathway recommends it in combination with chemotherapy as first-line treatment of advanced-stage mantle cell lymphoma. A cohort of patients, identified through data from individual patient funding request panels, and clinicians in Wales, confirmed there to be an unmet need within the service. This cohort included people with untreated and relapsed mantle cell lymphoma for whom anthracycline-based therapy is unsuitable. Based on this unmet need, this medicine combination was considered suitable for assessment via the One Wales process. Clinical experts consulted for this review supported the ongoing need for the option for use in NHS Wales for this cohort of patients
Current One Wales decision: Supported with restrictions
Licence status: Off-label use for this licensed medicine combination.
Guidelines: No updates to guidelines since last review.
Licensed alternative medicines or Health Technology Assessment advice for alternative medicines:
NICE ID3975: pirtobrutinib for treating relapsed or refractory mantle cell lymphoma. Currently in scoping, publication TBC.
NICE ID6155: acalabrutinib with bendamustine and rituximab for untreated mantle cell lymphoma. Currently in scoping, publication TBC.
NICE ID3879: venetoclax with ibrutinib for treating relapsed mantle cell lymphoma. Currently in scoping, publication TBC.
Effectiveness: A repeat literature search conducted by AWTTC identified one study relevant to the indicated recommendation.
The Swedish mantle cell lymphoma (MCL) project (Jerkeman et al 2023) is a nationwide assessment of treatment strategies and outcomes in MCL. Patients diagnosed with MCL between 2006–2018 (n = 1367) were followed up to August 2021. Bendamustine/rituximab (BR) was the most common first (n = 368) and second-line (n = 185) treatment regimen used. Median progression free survival (PFS) from treatment initiation for BR, Nordic MCL2 regimen (n = 342), and rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP; n = 165) was 2.7 (95% CI: 2.1–3.2), 5.1 (95% CI: 4.2–6.1) and 1.5 (95% CI: 1.1–2.0) years respectively. Median overall survival (OS) for the same treatments was 4.1 (95% CI: 3.5–5.0), 11.7 (95% CI: 7.8–not reached) and 2.9 (95% CI: 2.2–4.1) years respectively. When considering disease progression (by first relapse within 24 months or after 24 months), treatment with first line BR resulted in similar rates of OS and PFS, whereas such an effect following treatment with Nordic MCL2 and R-CHOP was less apparent (with first relapse within 24 months trending towards poorer OS and PFS rates). Median PFS from initiation of second-line BR was 1.2 years (95% CI, 0.9–1.4), and median OS was 2.2 years (95% CI: 1.6–3.0); this effect was seen across all regimens.
Safety: No relevant safety analyses identified in the repeat literature search.
Cost-effectiveness: No relevant cost-effectiveness analyses were identified in the repeat literature search.
Budget impact: No information on patient numbers has been provided.
Impact on health and social care services: Minimal.
Patient outcome data: No patient outcome data have been received.
Evaluation of evidence: The clinical evidence presented supports the current use of bendamustine with rituximab as a treatment option in line with the current One Wales decision. Bendamustine in combination with rituximab for the treatment of mantle cell lymphoma should only be used in circumstances where other licensed and health technology appraisal-approved regimens are unsuitable.
Next review date: In 2 years
References: a full reference list is available on request.
Disclaimer: This document includes evidence published since the last review or full assessment of this medicine for the indication under consideration. It does not replace the original full evidence status report. Any previous reviews and the original full evidence status report are available from this webpage in the document history section.
Care has been taken to ensure the information is accurate and complete at the time of publication. However, the All Wales Therapeutics and Toxicology Centre (AWTTC) do not make any guarantees to that effect. The information in this document is subject to review and may be updated or withdrawn at any time. AWTTC accept no liability in association with the use of its content. An Equality and Health Impact Assessment (EHIA) has been completed in relation to the One Wales policy and this found there to be a positive impact. Key actions have been identified and these can be found in the One Wales Policy EHIA document.
Information presented in this document can be reproduced using the following citation: All Wales Therapeutics & Toxicology Centre. Bendamustine in combination with rituximab for the treatment of previously untreated and relapsed mantle cell lymphoma (OW09) February 2024
Copyright AWTTC 2024. All rights reserved.
Medicine details |
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| Medicine name | bendamustine and rituximab |
| One Wales decision status | Supported for use via the One Wales Medicines process |
| Reference number | OW09 |
| Decision issue date | March 2017 |
| Date of last review | February 2024 |
| Review schedule | Every 2 years |