Published

May 11, 2025

Teclistamab, Teclistamab [TEC1, TEC1]

For the treatment of relapsed or refractory myeloma in adult patients who have relapsed or are refractory to their last anti-myeloma regimen AND have received at least 3 prior lines of systemic therapies which must have included at least one proteasome inhibitor, at least one immune-modulatory agent and at least one anti-CD38 antibody and where the following criteria have been met:, For the treatment of relapsed or refractory myeloma in adult patients who have relapsed or are refractory to their last anti-myeloma regimen AND have received at least 3 prior lines of systemic therapies which must have included at least one proteasome inhibitor, at least one immune-modulatory agent and at least one anti-CD38 antibody and where the following criteria have been met:

  1. This application for teclistamab monotherapy is both being made by and the first cycle of systemic anti-cancer therapy with teclistamab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient is an adult with a proven diagnosis of multiple myeloma. Note: patients with amyloidosis or POEMS syndrome are not eligible for teclistamab.
  3. The prescribing clinician understands that teclistamab is not funded for amyloidosis patients (with the exception of patients who have a proven diagnosis of myeloma with an associated diagnosis of amyloidosis) and that NHS funding for teclistamab is only for the relapsed or refractory myeloma indication in the specific indication recommended by NICE. Please tick the relevant box below:
  • this patient does not have a diagnosis of primary amyloidosis or
  • this patient has a proven diagnosis of progressive myeloma with an associated diagnosis of amyloidosis and teclistamab is being prescribed for the myeloma (and all other treatment criteria on this form apply)
  1. The patient patient has been previously treated with at least one proteasome inhibitor. Please confirm how many different proteasome inhibitors have been used to treat this patient’s myeloma:
  • 1 proteasome inhibitor or
  • 2 or more different proteasome inhibitors
  1. This patient has been previously treated with at least one immunomodulatory agent. Please confirm how many different immunomodulatory agents have been used to treat this patient’s myeloma:
  • 1 immunomodulatory agent or
  • 2 or more different immunomodulatory agents
  1. The patient has previously received a pomalidomide-containing regimen or not.
  • no, the patient has not been treated with a pomalidomide-containing regimen
  • yes, the patient has been treated with a pomalidomide-containing regimen
  1. The patient has been previously been treated with at least one anti-CD38 antibody. Please confirm how many anti-CD38 antibodies have been used to treat this patient’s myeloma:
  • 1 anti-CD38 antibody or
  • 2 or more different anti-CD38 antibodies
  1. The patient has received at least 3 lines of treatment according to the definition below and also set out below which line of myeloma therapy teclistamab is being used for. The prescribing clinician confirms that numbering of a line of treatment is in accordance with the International Myeloma Workshop Consensus recommendations for the uniform reporting of clinical trials (http://doi.org/10.1182/blood- 2010-10-299487). A line of therapy is defined as one or more cycles of a planned treatment program. This may consist of one or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner (ie induction chemotherapy/chemotherapies when followed by stem cell transplantation is considered to be 1 line of therapy). A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse or toxicity, the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. Please record at which line of therapy teclistamab is being given:
  • as 4th line of therapy or
  • as 5th line of therapy or
  • as 6th or subsequent line of therapy
  1. The has NOT been previously treated with any bispecific antibody targeting both BCMA and CD3 unless teclistamab needs to be continued following access to teclistamab via a company compassionate access scheme AND all treatment criteria on this form are fulfilled. Please confirm which situation applies to this patient:
  • this patient has not been previously treated with a bispecific antibody targeting both BCMA and CD3 or
  • this patient needs to continue teclistamab following access to teclistamab via a company compassionate access scheme AND all treatment criteria on this form are fulfilled. Note: patients previously treated with any bispecific antibody targeting BCMA and CD3 (e.g. elranatamab) are not eligible for teclistamab.
  1. The patient has ever been treated with a CAR-T therapy such as idecabtagene vicleucel or ciltacabtagene autoleucel. Please confirm which situation applies to this patient:
  • this patient has not been previously treated with a CAR-T therapy or
  • this patient has received prior CAR-T treatment (eg idecabtagene, ciltacabtagne). (continued on next page)
  1. The patient has been treated with a BCMA-targeted antibody drug conjugate (such as belantamab mafodotin). Please confirm which situation applies to this patient:
  • this patient has not been previously treated with a BCMA-targeted antibody drug conjugate or
  • this patient has been treated with a BCMA-targeted antibody drug conjugate.
  1. The patient has had progressive disease during or following the last received line of systemic anti-myeloma therapy.
  2. The patient has an ECOG performance status of 0 or 1. Please record below the ECOG performance status
  • PS 0 or
  • PS 1
  1. Teclistamab will be used as monotherapy only. Note: teclistamab is not to be used in combination with any other anti-myeloma agent.
  2. The prescribing clinician is aware of a) the 2 step up doses of teclistamab for the cycle 1 day 1 and cycle 1 day 3 treatments with teclistamab before the patient is then treated with the recommended full teclistamab dose on cycle 1 day 5 and from then on the maintenance weekly dosing schedule and b) the need for patients to switch to 2-weekly teclistamab dosing only if they have had a complete response or better for a minimum of 6 months.
  3. The treating hospital has facilities to manage severe reactions to teclistamab including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
  4. The prescribing clinician and the treating team are aware of the risks and grading of both cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, their monitoring and management as illustrated in Table 3 of section 4.2 and Table 4 of section 4.4 of the teclistamab Summary of Product Characteristics and both I and the treating team have all undergone training in these clinical issues.
  5. Clear arrangements have been made for the patient to be monitored for signs and symptoms of toxicities including CRS and ICANS for 48 hours after administration of the 2 step up doses and 1st maintenance full dose in week 1 of teclistamab treatment and the patient has been instructed to remain within close proximity of a healthcare facility for these 48 hour periods following treatment on all of the week 1 day 1, week 1 day 3 and week 1 day 5 treatments.
  6. 1 dose of tocilizumab is immediately available should tocilizumab be required for the treatment of cytokine release syndrome and access to an additional dose of tocilizumab within 8 hours of the previous tocilizumab dose must be ensured.
  7. The prescribing clinician is aware that serum immunoglobulin levels require monitoring and treatment with SC or IV immunoglobulin should be considered according to NHS England’s Clinical Commissioning Policy 2024 version 2.0.
  8. The prescribing clinician is aware of the risk of infections in patients treated with teclistamab and that prophylactic antimicrobials and antivirals should be administered according to local institutional guidelines, as stated in sections 4.2 and 4.4 of teclistamab’s Summary of Product Characteristics.
  9. The patient will be treated with teclistamab until loss of clinical benefit or the occurrence of excessive toxicity or the withdrawal of patient consent, whichever is the sooner. Note: once teclistamab is electively stopped (ie for reasons other than temporary toxicity), it cannot be re-started.
  10. A formal medical review as to how teclistamab is being tolerated and whether treatment with teclistamab should continue or not will be scheduled to occur at least by the end of the first 6 weeks of treatment.
  11. When a treatment break of more than 6 weeks beyond the expected weekly or 2-weekly cycle length (as appropriate) is needed, a treatment break approval form will be completed to restart treatment.
  12. Teclistamab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 11 February 2025

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA1015 (13 November 2024)

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.

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