Lymphoma Action was among a number of clinical and patient organisations that objected to NHS England’s policy during an initial consultation period and we are very disappointed that it has not reconsidered its position.
We will continue to work with our clinical partners and other stakeholder groups to oppose the proposal. We hope this will result in a change of policy.
The consultation runs until 15 January 2019 and is open to anybody who has an interest - including people with lymphoma, carers, doctors, nurses, patient representative groups and others - so please let NHS England know your views.
You might find some of the questions in the consultation difficult to answer so we have drafted some responses below to help you.
NHS England’s Clinical Commissioning Policy Proposition: Bendamustine with rituximab for relapsed indolent (low-grade) non-Hodgkin’s lymphoma
You might find some of the questions in NHS England’s consultation difficult to answer. Below is a summary of Lymphoma Action’s responses, which you are free to copy or adapt.
Question 3: Has all the relevant evidence been taken into account?
Firstly, it is unreasonable to demand the same standards of trial evidence in rare subtypes of cancers as in more common cancers. In rarer indications, current clinical practice must be extensively relied on.
Secondly, there is ample indirect evidence of the efficacy of bendamustine plus rituximab in relapsed/refractory indolent NHL.
- Bendamustine plus rituximab compares favourably to R-CHOP or R-CVP in the frontline setting (Rummel et al, Lancet 2013;381:1203-10; Flinn IW et al, Blood 2014;123:2944-52).
- There are also numerous trials showing the benefit of adding rituximab to various chemotherapy regimens in the frontline and relapsed/refractory setting (Marcus R et al. J Clin Oncol 2008;26:4579–86; Van Oers MH et al. Blood 2006;108:3295-301; Hiddemann W et al. Blood 2005;106:3725–32; Forstpointner R et al. Blood 2004;104:3064–71; Herold M et al. J Clin Oncol 2007;25:1986–92; Salles G et al. Blood 2008;112:4824-31).
- Furthermore, bendamustine plus the CD20 antibody obinutuzumab is more effective than bendamustine alone in refractory indolent NHL (Sehn LH et al, Lancet Oncology 2016;17:1081-1093).
Bendamustine plus rituximab has not been directly compared with the policy’s ‘treatments of interest’ for relapsed/refractory indolent NHL for commercial reasons. As generic bendamustine is now available, there are unlikely to be industry-funded trials to further evaluate bendamustine’s efficacy.
However, based on the considerations above, it is entirely reasonable to assume that bendamustine plus rituximab is superior to bendamustine monotherapy and other rituximab-chemotherapy combinations in relapsed indolent NHL, and this is very much supported by everyday clinical experience.
Question 4: Does the impact assessment fairly reflect the likely activity, budget and service impact?
The stated cost per patient is based on R-CHOP. Many patients will have received R-CHOP as first-line therapy and will therefore require a different regimen for subsequent treatment.
It is not clear how the cost impact has been calculated or what the comparator regimen is.
Bendamustine is available as a generic drug, and rituximab biosimilars are available. Bendamustine plus rituximab is therefore a comparatively inexpensive regimen – and considerably lower cost than bendamustine plus obinutuzumab, which has received NICE approval.
In addition, since most regimens for indolent NHL include rituximab, the cost of the rituximab component should be disregarded, leaving only the cost of generic bendamustine to consider.
Question 5: Does the policy proposition accurately describe the current patient pathway that patients experience?
The policy proposition does not reflect the fact that bendamustine plus rituximab has been widely used on the NHS first-line or in the relapsed/refractory setting for several years, and is an important part of the treatment pathway for indolent NHL. It is essential to have a range of treatment options available for indolent NHL as it usually requires multiple treatment courses. Since it is not appropriate to give most drug regimens more than once, it is crucial to maintain flexibility regarding the deployment and sequencing of credible treatment options.
Bendamustine plus rituximab has been a recommended treatment option for relapsed or refractory disease in the BSH guidelines for the management of Waldenström’s macroglobulinaemia since 2014 (Owen RG et al. Br J Haematol 2014;165:316–33).
Removing bendamustine plus rituximab as an option for relapsed/refractory indolent NHL would cause a change in practice.
Question 6: Please provide any comments that you may have about the potential impact on equality and health inequalities which might arise as a result of the proposed changes that have been described.
Not funding bendamustine plus rituximab means that individual NHS Trusts will decide on whether to fund the treatment on a local basis. This is likely to lead to variations in availability from different trusts, with resulting ‘postcode prescribing’ issues.
Bendamustine plus rituximab is available in Scotland and Wales, causing disparity in access within the UK.
Question 7: Are there any changes or additions you think need to made to this document, and why?
Yes. The considerations listed above should be taken into account. Based on these considerations, it would seem entirely reasonable for the NHSE to fund this well-tolerated, effective and inexpensive drug regimen that is pivotal to treatment algorithms for indolent NHL across the globe.