French EGPA patients and their doctors received disappointing news recently when the French health authority (HAS) decided not to reimburse Fasenra (benralizumab) for treating EGPA. This decision has created significant concern within the EGPA community, as it limits access to what could be an important alternative treatment option.

What is Fasenra?

Fasenra is a targeted therapy that blocks certain immune system signals involved in EGPA. Originally approved for severe eosinophilic asthma, it received European approval in late 2024 as an additional treatment for patients with relapsing or hard-to-treat EGPA. The medication works similarly to mepolizumab, another IL-5 pathway drug already used in EGPA care.

Why Was Reimbursement Denied?

The French health authority based their decision on concerns about the design of the MANDARA trial, which compared Fasenra directly to mepolizumab. HAS felt the study’s design allowed for too much uncertainty about whether Fasenra was truly as effective as mepolizumab. In the trial, Fasenra could have been up to 25% less effective than mepolizumab and still be considered successful – a margin HAS considered too wide.

Doctors Disagree with the Decision

Many EGPA specialists are frustrated with this ruling. In the actual trial results, Fasenra performed just as well as mepolizumab. For doctors treating this rare and serious condition, having treatment options that work “just as well” is extremely valuable, especially when patients have so few alternatives available.

Fasenra also offers a practical advantage: patients only need injections every 8 weeks instead of every 4 weeks with mepolizumab. This less frequent dosing schedule can significantly improve quality of life for patients managing a chronic condition.

What This Means for Patients

Without reimbursement, French EGPA patients cannot access Fasenra through their public health system. This is particularly concerning for patients who may not respond well to mepolizumab or experience side effects. For these patients, Fasenra could have provided a crucial alternative, but the lack of reimbursement effectively closes this door.

Patients in France will continue to rely on existing treatments: corticosteroids, traditional immunosuppressants, or mepolizumab. While these can be effective, having fewer options limits doctors’ ability to personalize treatment when patients don’t respond well to current therapies.

The Bigger Picture

This decision highlights the ongoing challenge in rare disease treatment: balancing the need for scientific certainty with the practical realities of caring for patients with limited treatment options. While health authorities focus on cost-effectiveness and statistical precision, doctors and patients often value having additional tools available, even when the benefits might be modest.

For the EGPA community, this ruling serves as a reminder of the importance of continued advocacy for patient access to promising treatments, especially in rare diseases where every therapeutic option can make a meaningful difference in someone’s life.