Overview of NICE’s Elranatamab Managed Access Agreement

By João L. Carapinha

October 29, 2024

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.
Reference url

Recent Posts

Evolving Burden of Obesity in the US: Key Insights on Obesity Prevention Strategies

By HEOR Staff Writer

October 10, 2025

What are the most effective obesity prevention strategies for reducing long-term healthcare and societal costs in the United States? Recent advanced population models reveal that focusing on early, targeted obesity prevention strategies offers far greater value to health systems and society than ...
Simponi Pediatric Approval: FDA Grants First Pediatric Indication for Ulcerative Colitis Treatment

By HEOR Staff Writer

October 9, 2025

The U.S. Food and Drug Administration has granted Simponi pediatric approval for Johnson & Johnson's Simponi (golimumab), which is intended for children with moderately to severely active ulcerative colitis who weigh at least 15 kg. This historic approval is backed by data from the PURSUIT pr...
Paving the Way for Digital Health Technologies: NICE’s Bold New Strategy for the NHS
The National Institute for Health and Care Excellence (NICE) is expanding its technology appraisals programme, and starting April 2026, this will include digital health technologies that are placed on an equal legal footing with medicines in the NHS. This initiative forms part of the NHS 10-year ...