Bundesanzeiger · 14 Sep 2026 · 6 vistas
G-BA updates Nipocalimab therapy costs for Myasthenia gravis
Por FactBox Admin
The Federal Joint Committee (G-BA) has newly determined the annual therapy costs of the active substance Nipocalimab for myasthenia gravis. The amendment to the Pharmaceuticals Directive (AM-RL) in Annex XII was decided on August 25, 2026, and announced in the Federal Gazette (Bundesanzeiger) on September 14, 2026, under the official reference BAnz AT 14.09.2026 B3. The decision comes into effect as of August 27, 2026.
Background of the Benefit Assessment
The announcement originates from the Federal Ministry of Health and concerns the benefit assessment of medicinal products with new active substances according to § 35a of the Fifth Book of the Social Code (SGB V). It amends the information regarding Nipocalimab (myasthenia gravis, AChR-antibody+, MuSK-antibody+, ≥ 12 years) in number 4 “Therapy Costs” of Annex XII, which were last determined by the decision of June 18, 2026 (BAnz AT 24.07.2026 B4).
The new values apply to two patient groups and are stated after the deduction of legally required rebates, as of the Lauer-Taxe: April 15, 2026.
Annual Therapy Costs for Adults
For adults with acetylcholine receptor antibody-positive generalized myasthenia gravis who are eligible for add-on therapy to a standard therapy, the following annual therapy costs per patient apply:
- Nipocalimab (medicinal product to be assessed): €523,093.85
- Eculizumab: €505,338.29 – €673,784.38
- Efgartigimod alfa: €55,887.92 – €413,570.61
- Ravulizumab: €301,859.03
- Rozanolixizumab: €262,781.17 – €506,097.07
- Zilucoplan: €281,966.02
Annual Therapy Costs for Adolescents
For adolescents with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis who are eligible for add-on therapy to a standard therapy, the decision establishes the following values:
- Nipocalimab (medicinal product to be assessed): €395,602.14 – €523,093.85
- Eculizumab (appropriate comparator therapy): €505,338.29 – €673,784.38
Significance for Care
The updated therapy costs are of immediate importance for patients, physicians, and health insurance funds in the care of the rare disease myasthenia gravis. They serve as the basis for reimbursement and the economic evaluation of treatment with Nipocalimab compared to approved alternatives. The primary reasons for the decision are published on the G-BA website at www.g-ba.de; the decision is signed by the Chairperson of the G-BA, Dr. Optendrenk.
Source: Federal Gazette, BAnz AT 14.09.2026 B3, published on September 14, 2026, section Announcements of the Federal Ministry of Health (official reference: BAnz AT 14.09.2026 B3).