With exciting NICE approvals of Teclistamab and Eranatamab, we want to ensure patients with Myeloma across the UK have fair access to these treatments. However, there are challenges to delivery. We are a group of NHS haematology healthcare professionals across the UK that are working to support hospitals to deliver this new therapy to patients.
This website contains resources to support the development of services to provide bispecific antibodies to patients with Multiple Myeloma. This project is ongoing and resources will be added as they are developed. We aim to develop and provide:
- Guidance on service development
- Templates for referrals
- Educational resources
Updates
Improved Access to Immunoglobulin (IG) for Multiple Myeloma Patients receiving Bispecific Antibodies
This month, the NHS updated its clinical commissioning policy in England for immunoglobulin (IG) use, making it easier and quicker for patients with multiple myeloma receiving bispecific antibodies to access IG. This is a welcome change that will help reduce infection risks for this vulnerable group and brings us in line with many other countries and international guidelines.
Previously, under the Secondary Antibody Deficiency – Long-Term Use category, patients needed to meet all the following criteria:
· Underlying cause of Hypogammaglobulinaemia cannot be reversed, or reversal is contraindicated, OR
· Hypogammaglobulinaemia associated with drugs including emerging bispecifics
AND
a. Recurrent or severe bacterial infection despite continuous oral antibiotic therapy for 6 months
b. IgG <4g/L excluding paraprotein
c. Documented failure of serum antibody response to unconjugated pneumococcal or other polysaccharide vaccine challenge (may be omitted if IgG <3g/L)
Following a review, NHS commissioners in England now acknowledges that not all of these criteria must be met. The policy has been expanded to allow IG use at the start of bispecific antibody treatment for patients with myeloma as well as B-cell lymphoma. Acknowledging that many of these patients already have low serum IgG levels due to prior chemo-immunotherapy, including CD20- and CD38-targeting agents. Now, prophylactic IVIG can be considered for those with serum IgG < 4 g/L at the time of bispecific antibody initiation.
As part of the EMMBRAce Bispecific Antibody Implementation Group, we made the case to the Immunoglobulin Expert Working Group that prophylactic Ig was essential to reduce severe infections in patients receiving these treatments. We submitted evidence from clinical trials as well as real world data showing the impact of this therapy on reducing infection risk. This is in accordance with the International Myeloma Working Group Bispecific Guidelines.
This update represents an important step in improving infection prevention and access to supportive care for myeloma patients.[HT6] [DB7] We are continuing our work to improve the use of bispecific antibodies in myeloma patients and will now be focusing on the impact of the increased use of IVIG on hospital capacity, improving access to subcutaneous Ig and writing guidelines in collaboration with Immunology experts to ensure Ig is used optimally.
About us
This project is being led and overseen by a steering group involving a multidisciplinary team of NHS doctors, nurses and pharmacists from across the UK alongside charity and industry partners.
Project Background
Find out why this project is needed.
Bispecific T cell antibodies have recently been funded in the NHS for treatment of relapsed/refractory multiple myeloma (RRMM). A survey by Leeds Clinical Trials Unit showed that of 62 hospitals that participated (31 transplant and 31 non-transplant centres), 47% had some experience with bispecific antibodies, but only 29% had used them for multiple myeloma. Of those with experience, 86% were transplant centres.
To ensure equitable access to these therapies, it will be important for non-transplant centres to be able to provide bispecific antibody therapy to reduce the distances patients need to travel for treatment.
The survey also identified the need for staff training, Standard Operating Procedures (SOPs) for managing adverse events, and logistical support for hospitalisation and pharmacy storage. It also highlighted concerns about restricted access to Intravenous Immunoglobulin (IVIg) therapy.
Who will benefit from the project
Initially patients who can access bispecifics will have had four prior lines of treatment and are triple-class exposed (PI, IMiD, and CD38 Mab). However, this project will set up structures to deliver bispecifics for a wider range of indications, as these treatments move to earlier lines and combination therapies. It will also improve access to clinical trials for bispecifics.
There is concern that patients in under-served groups cannot access treatments that are NICE approved promptly. Data shows that this may be particularly an issue with patients from non-white communities (Black and Asian), and those from low socio-economic backgrounds. Patients from a more deprived background or minority group are unlikely to travel for treatment. There is also concern that older patients who may be suitable may be hesitant to try bispecific treatments. Through our interventions, we will enable many hospitals to allow access to their local patients, reducing inequalities.
