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NICE has today issued it’s final appraisal determination (FAD) in relation to the appraisal of brentuximab vedotin (ID 722) for the treatment of CD30 positive Hodgkin lymphoma. Brentuximab vedotin is manufactured by Takeda and also known as Adcetris®.
Brentuximab vedotin has been recommended for the treatment of CD30 positive Hodgkin lymphoma in adults if:
· “they have relapsed or refractory disease after autologous stem cell transplant”
Interim access is maintained through the Cancer Drugs Fund (CDF) for the treatment of patients with:
· “relapsed or refractory disease after at least 2 previous therapies and they cannot have autologous stem cell transplant or multi-agent chemotherapy”
Brentuximab vedotin has not been recommended for the treatment of Hodgkin lymphoma where there is an “increased risk of disease relapse or progression after autologous stem cell transplant”.
Unless appealed, this will be upheld in their final guidance, which is expected in May 2017. This guidance does not affect people who are already receiving brentuximab vedotin, who will be able to continue to do so until their clinician considers it appropriate to stop.
Overall, this decision means that the current access is maintained in line with the previous availability through the Cancer Drugs Fund (CDF), where it has been available for several years. This decision is consistent with previous guidance in Scotland and Wales, so access remains consistent throughout the UK.
Whilst this decision maintains access for patients, it raises wider issues with the current NICE methodology, which often struggles to cope with assessing drugs for rarer cancers and the small patient populations associated with this. NICE particularly struggle with assessing the most innovative medicines, as these are usually licensed on limited evidence due to the lack of alternative treatment options and high unmet need.
In particular, long-term access in the ‘CDF indication’ remains uncertain, with a final decision expected in early 2018. Whilst NICE are still unable to provide guidance, it has been routinely approved in Scotland since October 2014. In the interim, the CDF will continue to provide access for patients. However, the uncertainty of access provided through the CDF can be a source of worry for patients, particularly those for whom brentuximab vedotin may be a future treatment option. As such, it is imperative that NICE reach a final decision on the ‘CDF indication’ as soon as possible to safeguard long-term access.
It is important to remember the reasons behind the creation of the CDF in the first place. It was created as an interim measure to provide access to innovative treatments, whilst a system was designed to replace NICE. However, at present, there is no public work ongoing to design a replacement for this broken system.
Zack Pemberton-Whiteley, Head of Campaigns and Advocacy at Leukaemia CARE commented:
“Overall, this decision represents a modest victory for patients. We are extremely pleased that a negative preliminary recommendation (ACD) has been overturned in the final guidance, which means that access will be maintained for patients, in line with the current availability.”
“However, this appraisal also highlights systemic issues with the NICE process, which often does not work appropriately for rarer cancers, with small patient populations and limited data. It is imperative that NICE learn from this appraisal and the system is appropriately reformed so that other drugs do not experience years of delay.”
For further information, please contact our Campaigns and Advocacy team. They are available Monday to Friday from 9:00am – 5:30pm. If you would like to contact them, you can:
· Call our office line on 01905 755977
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