Published

May 11, 2025

Axicabtagene ciloleucel [AXI01b]

Axicabtagene ciloleucel for treating relapsed/refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL) to DLBCL in patients aged 18 years and over where the following criteria are met: This second part of the form is to document the date of infusion of CAR-T cell therapy and for registration of this infusion with NHS England so that the treating Trust is reimbursed for the cost of axicabtagene ciloleucel. There is a first part of the form for the approval of leucapheresis and manufacture of CAR-T cells which has already been completed (AXI01a). This second part of the form (AXI01b) should only be completed as continuation form once the date of CAR-T cell infusion is known.

  1. This application for continuation is being made by and treatment with axicabtagene ciloleucel-modified CAR-T cells will be initiated by a consultant haematologist/medical oncologist specifically trained and accredited in the use of systemic anti-cancer therapy and working in an accredited CAR-T cell treatment centre and who is a member of the National CAR-T Clinical Panel for DLBCL, PMBCL and TFL and a member of the treating Trust’s DLBCL, PMBCL and TFL and CAR-T cell multidisciplinary teams.
  2. The patient has an ECOG performance score of 0 or 1 or 2. Please tick one of the boxes below as to the patient’s current ECOG performance status (PS): The ECOG performance status scale is as follows: PS 0 The patient is fully active and able to carry on all pre-disease performance without restriction B PS 1 The patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature eg light house work, office work PS 2 The patient is ambulatory and capable of all selfcare but unable to carry out any work activities and is up and about more than 50% of waking hours PS 3 The patient is capable of only limited selfcare and is confined to bed or chair more than 50% of waking hours PS 4 The patient is completely disabled, cannot carry out any selfcare and is totally confined to bed or chair The patient currently has a performance status of:
  • ECOG PS 0 or
  • ECOG PS 1 or
  • ECOG PS 2
  1. If the patient has required bridging therapy in between leucapheresis and CAR-T cell infusion, please indicate what type(s) of bridging therapy have been required by ticking the most appropriate option below:
  • no bridging therapy at all or
  • corticosteroids only or
  • chemo(immuno)therapy only or
  • radiotherapy only or
  • corticosteroids and chemo(immuno)therapy or
  • corticosteroids and radiotherapy or a - chemo(immuno)therapy and radiotherapy ± corticosteroids
  1. The patient has sufficient end organ function to tolerate treatment with CAR-T cell therapy.
  2. Prior to infusion 2 doses of tocilizumab are available for use in this patient in the event of the development of cytokine release syndrome.
  3. Axicabtagene ciloleucel-modified CAR-T cell therapy will otherwise be used as set out in its Summary of Product Characteristics (SPC).
  4. Following national approval for use of axicabtagene ciloleucel there has been local CAR-T cell multidisciplinary team agreement that this patient continues to have the necessary fitness for infusion and fulfils all of the treatment criteria listed here.

NHS funded From: 29 May 2023

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA872 (28 February 2023)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

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.