Overview of NICE’s Elranatamab Managed Access Agreement
NICE recently recommended Elranatamab as an option for treating relapsed and refractory multiple myeloma in adults with a managed access agreement (MAA). The agreement outlines the terms for data collection and patient eligibility while the drug is being evaluated for routine use in the NHS. Here’s a breakdown of the key elements of the MAA:
Purpose
The MAA facilitates data collection to address uncertainties about Elranatamab’s long-term effectiveness and cost-effectiveness.
Data Collection
The primary data source is the ongoing MagnetisMM-3 clinical trial, which is expected to conclude in December 2025. Secondary data sources include the Systemic Anti-Cancer Therapy (SACT) dataset, NHSE’s Blueteq data, and the IG Database (MDSAS).
Data Analysis and Reporting
A final analysis of the MagnetisMM-3 trial will occur after the final overall survival event. The data will be available for a company submission to NICE in July 2026. NHSE will provide a final report with analyses of Blueteq and SACT data, to be shared with the company before the guidance update.
Patient Eligibility
Elranatamab will be available through the Cancer Drugs Fund to adult patients with multiple myeloma who meet specific criteria. These criteria include having received at least three prior lines of treatment, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody, and having experienced disease progression on their last treatment.
Areas of Clinical Uncertainty
Key areas of uncertainty include the long-term overall survival (OS) and progression-free survival (PFS) data for elranatamab, as well as long-term data on intravenous immunoglobulin (IVIg) use and duration. The data collected during managed access aims to resolve these uncertainties.
Guidance Update
Pfizer Ltd. is responsible for submitting an evidence submission to NICE for a guidance update by July 2026, incorporating data collected during the managed access period. NICE will schedule the guidance update into its work program to align with the estimated data collection completion.
Continued Access
The Cancer Drugs Fund will continue to make available elranatamab after the data collection period. They’ll also do so while the guidance is being reviewed, assuming the data collection concludes as planned.
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