G-BA extends benefit assessment of the contrast agent gadopiclenol to toddlers

The Federal Joint Committee (G-BA) decided in its meeting on August 20, 2026, to extend the benefit assessment of the contrast agent gadopiclenol to children from birth up to under two years of age. The decision to amend the Pharmaceuticals Directive (Annex XII) was announced in the Federal Gazette (Bundesanzeiger) on September 15, 2026, under the official reference BAnz AT 15.09.2026 B3. No added benefit has been proven for the new area of application.

Legal Basis and Procedure

The basis for the decision is the benefit assessment of pharmaceuticals with new active ingredients according to Section 35a of the Fifth Book of the Social Code (SGB V). The amendment concerns Annex XII of the Pharmaceuticals Directive, which was last amended by the decision of August 6, 2026 (BAnz AT 02.09.2026 B3). The announcement was issued by the Federal Ministry of Health; the supporting reasons are published by the G-BA on its website.

The new area of application is based on the authorization dated January 22, 2026. According to this, gadopiclenol is used in adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to make pathologies with a disruption of the blood-brain barrier and/or anomalies of the vessels more recognizable.

Added Benefit Not Proven

For children from birth up to under two years of age for whom a contrast-enhanced MRI is indicated, the added benefit of gadopiclenol was examined compared to the appropriate comparator therapy. Three active ingredients are considered as comparator therapies:

• Gadoteric acid
• Gadobutrol
• Gadoteridol

The result: An added benefit is not proven. There are no evaluable data compared to the appropriate comparator therapy; there are no evaluable data for mortality, morbidity, and side effects, and no data are available regarding health-related quality of life. The information is based on the dossier assessment of the IQWiG (A26-13).

Number of Patients and Therapy Costs

The affected patient group includes children from birth up to under two years of age with an indicated contrast-enhanced MRI. The G-BA estimates the number of eligible patients to be approximately 20,600 to 22,200. After deducting legally required discounts (as of Lauer-Taxe: June 15, 2026), the annual therapy costs per patient amount to:

• Gadopiclenol: €135.20
• Gadobutrol: €113.02
• Gadoteridol: €110.36
• Gadoteric acid: €75.76

Costs for additional necessary SHI (GKV) services are not applicable.

Quality-Assured Application

The application of gadopiclenol may only be carried out by trained medical professionals with technical experience in performing contrast-enhanced MRIs with gadolinium. The specifications of the Summary of Product Characteristics (SmPC) must be observed; the European Medicines Agency (EMA) provides the contents of the SmPC for Elucirem (active substance: gadopiclenol) via open access. The decision shall enter into force on the date of its publication on the G-BA website on August 20, 2026.

For statutory health insurance, the decision means that the reimbursement of gadopiclenol in toddlers is now based on a formal benefit assessment, without a proven added benefit compared to the established comparator active substances. This is practically relevant primarily for cost coverage in pediatric MRI diagnostics.

Source: Bundesanzeiger, BAnz AT 15.09.2026 B3, September 15, 2026, Announcements section, pp. 1–3 (official reference: BAnz AT 15.09.2026 B3).