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

prior authorization reforms
     

Streamlining Prior Authorization Reforms: Impacts and Insights for HEOR

🚀 Are prior authorizations stalling care delivery in the U.S. healthcare system?

The HHS has launched an ambitious collaboration with major insurers to reform prior authorization processes across Medicare Advantage, Medicaid, and commercial plans. With a goal to standardize submissions by 2027 and significantly reduce requirements by 2026, this initiative promises to accelerate care decisions and enhance transparency.

Dive into the details of these pivotal reforms and discover their potential to streamline healthcare and improve patient outcomes.

#SyenzaNews #HealthcareInnovation #healthcare #healthcarepolicy

private health funding
    

Private Health Funding Under South Africa’s National Health Insurance Act

🚀 Update on NHI in South Africa.

In their insightful article, Solanki et al. discuss the complexities of private health funding amidst the nation’s National Health Insurance Act. They discuss two key scenarios: a passive approach that risks the sustainability of the private sector and an active reform strategy that could ensure a smoother transition to universal coverage.

Curious about how these strategies could reshape healthcare access and costs in South Africa? Don’t miss out on this critical analysis!

#SyenzaNews #HealthEconomics #HealthcarePolicy

drug price transparency
     

Impending Net Drug Price Transparency Regulation in the U.S.

💡 Are you ready for a potential game-changer in drug pricing transparency?

CMS Administrator Mehmet Oz has hinted at a new rule aimed at enforcing stricter disclosures for drug prices, requiring healthcare companies to reveal actual transaction costs. This could reshape how price transparency is managed across the industry and challenge pharmacy benefit managers to rethink rebate practices.

Curious about how this will impact healthcare economics and what it means for drug affordability? Dive into the article for all the insights!

#SyenzaNews #healthcare #HealthEconomics

When you partner with Syenza, it’s like a Nuclear Fusion.

Our expertise are combined with yours, and we contribute clinical expertise and advanced degrees in health policy, health economics, systems analysis, public finance, business, and project management. You’ll also feel our high-impact global and local perspectives with cultural intelligence.

SPEAK WITH US

CORRESPONDENCE ADDRESS

1950 W. Corporate Way, Suite 95478
Anaheim, CA 92801, USA

© 2025 Syenza™. All rights reserved.