Published

May 11, 2025

Isatuximab [ISA1]

Isatuximab in combination with pomalidomide and dexamethasone for the 4th line treatment of adult patients with relapsed/refractory multiple myeloma where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with isatuximab in combination with pomalidomide and dexamethasone will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has a diagnosis of multiple myeloma.
  3. The patient has received 3 and only 3 prior lines of treatment and that the 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 (e.g. induction chemotherapy/chemotherapies if followed by stem cell transplantation then maintenance 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. 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. Note: the use of isatuximab in combination with pomalidomide and dexamethasone in patients who have had 3 and only 3 prior lines of therapy was primarily chosen by Sanofi in its NICE submission and thus provides the basis for NICE’s specific recommendation to the CDF. The use of isatuximab in combination with pomalidomide and dexamethasone in the 1- prior, 2-prior, 4-prior and >4-prior patient groups is not permitted within the CDF.
  4. The prescribing clinician understands that isatuximab in combination with pomalidomide and dexamethasone in this indication is not funded for amyloidosis patients (with the exception of patients who have a proven diagnosis of progressive myeloma and also have an associated diagnosis of amyloidosis) and that NHS funding for isatuximab in combination with pomalidomide and dexamethasone is only for the specific multiple myeloma indication recommended by NICE to the Cancer Drugs Fund. Please tick box below -this patient does not have a diagnosis of amyloidosis
  • this patient has a proven diagnosis of progressive myeloma and also an associated diagnosis of amyloidosis and isatuximab in combination with pomalidomide and dexamethasone is being prescribed for myeloma Note: For amyloidosis patients requiring systemic therapies, NHS England does fund those treatments in routine commissioning for myeloma. As this isatuximab with pomalidomide and dexamethasone combination is in the CDF and not routine commissioning, NHS England does not fund isatuximab in combination with pomalidomide and dexamethasone for patients with amyloidosis unless they have a proven diagnosis of progressive myeloma and also an associated diagnosis of amyloidosis.
  1. The patient has received prior treatment with at least 2 consecutive cycles of lenalidomide given alone or in combination and has failed treatment with lenalidomide on account of disease progression, refractory disease or intolerance.
  2. The patient has received prior treatment with at least 2 consecutive cycles of a proteasome inhibitor (e.g. bortezomib or carfilzomib or ixazomib) given alone or in combination and has failed treatment with a proteasome inhibitor on account of disease progression, refractory disease or intolerance.
  3. This patient has responded to at least one previous line of treatment i.e. the patient does not have primary refractory myeloma.
  4. The patient was refractory to the last line of therapy i.e. there was progression on or within 60 days of the end of the last line of active anti-myeloma systemic therapy.
  5. The patient either has had no previous therapy with any anti-CD38 antibody (e.g. daratumumab) or if there has been previous treatment with an anti-CD38 antibody, then the patient has received isatuximab via the EAMS scheme or the Sanofi early access scheme or did not progress whilst still receiving an anti-CD38 therapy other than isatuximab or did not progress within 60 days of the last infusion of an anti-CD38 treatment other than isatuximab. Please enter below as to which scenario applies to this patient:
  • no previous treatment with any anti-CD38 antibody or
  • previous treatment with isatuximab in the EAMS scheme or the Sanofi early access scheme
  • previous treatment with an anti-CD38 antibody other than isatuximab and the patient did not progress whilst still receiving the anti-CD38 therapy or did not progress within 60 days of the last infusion of the anti-CD38 treatment. Note: isatuximab is not permitted in patients who fulfil the definition of refractoriness to daratumumab/anti-CD38 treatment.
  1. The patient has not received any prior treatment with pomalidomide either as monotherapy or within combination therapy.
  2. Isatuximab is only to be used in combination with pomalidomide and dexamethasone and not with any other active systemic agents for myeloma.
  3. Isatuximab is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner.
  4. The patient has an ECOG performance status of 0 or 1 or 2.
  5. A formal medical review as to how isatuximab in combination with pomalidomide and dexamethasone is being tolerated and whether treatment with isatuximab in combination with pomalidomide and dexamethasone should continue or not will be scheduled to occur at least by the end of the second month of treatment.
  6. Where a treatment break of more than 6 weeks beyond the expected cycle length is needed, I will complete a treatment break approval form to restart treatment, including indicating as appropriate if the patient had an extended break because of COVID19.
  7. Isatuximab and pomalidomide will otherwise be used as set out in their respective Summary of Product Characteristics (SPCs).

CDF funded From: 15 October 2020

Form version:

CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

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.