G-BA updates Nipocalimab therapy costs for Myasthenia gravis

The Federal Joint Committee (G-BA) has newly determined the annual therapy costs for the active ingredient Nipocalimab for generalized myasthenia gravis. The amendment to the Pharmaceuticals Directive (AM-RL) in Annex XII was published as a notification from the Federal Ministry of Health in the Federal Gazette (Bundesanzeiger) on September 14, 2026. The decision dates from August 25, 2026, and comes into effect as of August 27, 2026.

Background of the Benefit Assessment

The basis is the benefit assessment of medicinal products with new active ingredients according to § 35a of the Fifth Book of the Social Code (SGB V). In its meeting on August 25, 2026, the G-BA’s Pharmaceuticals Subcommittee, in accordance with § 20 paragraph 4 of the rules of procedure, decided to amend the information on Nipocalimab in number 4 “Therapy Costs” of Annex XII.

Affected are patients aged 12 years and older with acetylcholine receptor antibody-positive (AChR+) as well as MuSK antibody-positive generalized myasthenia gravis. This updates the previous version of the decision from June 18, 2026 (BAnz AT 24.07.2026 B4).

Annual Therapy Costs for Adults

For adults with AChR-positive generalized myasthenia gravis who are eligible for add-on therapy to a standard therapy, the following annual therapy costs per patient apply:

• Nipocalimab: €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

The amounts are after deduction of legally required discounts, as of the Lauer-Taxe dated April 15, 2026.

Annual Therapy Costs for Adolescents

For adolescents with AChR-positive refractory generalized myasthenia gravis who are eligible for add-on therapy to a standard therapy, the G-BA sets the following costs:

• Nipocalimab: €395,602.14 – €523,093.85
• Eculizumab: €505,338.29 – €673,784.38

Here too, the amounts apply after deduction of legally required discounts, as of the Lauer-Taxe dated April 15, 2026.

Entry into Force and Significance

The decision comes into force with effect from the date of its publication on the G-BA website on August 27, 2026. The supporting reasons will be published at www.g-ba.de. The notification was signed in Berlin on August 25, 2026, by the Chairperson of the G-BA, Dr. Optendrenk.

The update is significant for reimbursement practice because Nipocalimab, at up to around 523,000 euros per year, is among the very expensive new antibody therapies. The information in Annex XII of the Pharmaceuticals Directive forms the basis for the assessment and reimbursement of therapy costs within the framework of statutory health insurance.

Source: Federal Gazette, issue of September 14, 2026, Official Section, pp. 1–2 (official reference: BAnz AT 14.09.2026 B3).