Resource impact summary report | Tools and resources | Isatuximab in combination for untreated multiple myeloma when a stem cell transplant is unsuitable | Guidance

Recommendation

Isatuximab plus bortezomib, lenalidomide and dexamethasone can be used, within its marketing authorisation, as an option for untreated multiple myeloma in adults when an autologous stem cell transplant is unsuitable. It can only be used if the company provides it according to the commercial arrangement.

Eligible population for isatuximab

Table 1 shows the population eligible for isatuximab and the number of people expected to have isatuximab in each of the next 5 years, including forecast population growth.

**Table 1 Population expected to be eligible for and have isatuximab in England**
Eligible population and uptake	Number of people eligible for isatuximab	Uptake for isatuximab (%)	Number of people starting treatment each year	Number of people continuing treatment from previous year(s)	Number of people having isatuximab each year
Current practice without isatuximab	3,084	0	0	0	0
Year 1	3,111	10	311	0	311
Year 2	3,138	20	628	311	939
Year 3	3,166	30	950	939	1,889
Year 4	3,194	30	958	1,889	2,847
Year 5	3,222	30	967	2,536	3,502

The following assumptions have been used to calculate the eligible population:

the number of people who are diagnosed with multiple myeloma is around 5,750 each year in England (Cancer Registration Statistics, England 2022)
67% of people with multiple myeloma are ineligible for an autologous stem cell transplant (Company submission and NICE's technology appraisal guidance on daratumumab with lenalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is unsuitable [TA917])
80% people with multiple myeloma who are ineligible for an autologous stem cell transplant will have treatment (based on haematology consultant opinion).

The market share for isatuximab is based on haematology consultant opinion. It can be amended to reflect local practice in the resource impact template.

Treatment options for the eligible population

Usual treatment for untreated multiple myeloma when an autologous stem cell transplant is unsuitable is 1 of several combination treatments, most commonly daratumumab, lenalidomide and dexamethasone.

First-line treatment options for people with multiple myeloma depend on whether a stem cell transplant may be suitable. NICE recommends the following treatment options at first line when a stem cell transplant is not suitable:

thalidomide, cyclophosphamide and dexamethasone (see NICE's technology appraisal guidance on bortezomib and thalidomide for the first-line treatment of multiple myeloma [TA228])
bortezomib, cyclophosphamide and dexamethasone (see TA228)
bortezomib, melphalan and prednisone (see TA228)
lenalidomide and dexamethasone (see NICE's technology appraisal guidance on lenalidomide and dexamethasone for previously untreated multiple myeloma)
daratumumab, lenalidomide and dexamethasone (see TA917).

For more information about the treatments, such as dose and average treatment duration, see the resource impact template.

Financial resource impact (cash items)

Isatuximab plus bortezomib, lenalidomide and dexamethasone has not been directly compared in a clinical trial with daratumumab, lenalidomide and dexamethasone (most commonly used treatment combination). But the results of an indirect comparison suggest it may increase how long people live compared with them.

The company has a commercial arrangement (commercial access agreement). This makes isatuximab available to the NHS with a discount. The size of the discount is commercial in confidence.

Users can input the confidential price of isatuximab, and amend other variables, in the resource impact template.

The payment mechanism for the technology is determined by the responsible commissioner and depends on the technology being classified as high cost.

Daratumumab, lenalidomide and dexamethasone:

was recommended for untreated multiple myeloma when a stem cell transplant is unsuitable in October 2023 in TA917
has an estimated mean treatment duration of 4 years.

Because of this, the resource impact template will incorporate the financial impact of both this and isatuximab in combination for untreated multiple myeloma when a stem cell transplant is unsuitable.

For further analysis or to calculate the financial impact of cash items, see the resource impact template.

Capacity impact

Isatuximab is administered intravenously, whereas the main comparator is delivered subcutaneously. There will be more administration appointments needed for each treatment cycle with isatuximab and they will need longer nursing time to administer.

The resource impact template allows commissioners to assess the resource impact of any additional attendances needed at provider services.

The resource impact template includes the costs of treatment-related adverse events (grades 3 and 4).

The current and future uptake assumptions are based on estimates from consultant haematologists and internal communications from NHS England. They are shown in the resource impact template.

Table 2 shows the impact on administration capacity activity in each of the next 5 years. This will incorporate the capacity impact of both daratumumab, lenalidomide and dexamethasone and isatuximab in combination for untreated multiple myeloma when a stem cell transplant is unsuitable.

**Table 2 Capacity impact (activity) in England**
Capacity impact	Current practice	2024 to 2025	2025 to 2026	2026 to 2027	2027 to 2028	2028 to 20229
Number of administration appointments (oral)	8,018	8,053	8,124	8,195	8,267	8,340
Number of administration appointments (intravenous)	4,811	13,564	28,381	47,502	62,058	70,799
Number of administration appointments (subcutaneous)	95,722	128,664	157,855	151,153	140,242	133,280
Nursing administration – hours (intravenous)	401	6,937	18,022	32,334	43,222	49,749
Nursing administration – hours (subcutaneous)	7,977	15,699	23,197	27,792	27,017	26,571

For further analysis, or to calculate the financial capacity impact from a commissioner (national) and provider (local) perspective, see the resource impact template.

Key information

Table 3 Key information

Time from publication to routine commissioning funding	90 days
Programme budgeting category	02I cancer, Haematological
Commissioner	NHS England
Provider	Secondary care – acute
Pathway position	Untreated multiple myeloma when a stem cell transplant is unsuitable

About this resource impact summary report

This resource impact summary report accompanies the NICE guidance on Isatuximab in combination for untreated multiple myeloma when a stem cell transplant is unsuitable and should be read with it.

ISBN: 978-1-4731-7224-1