Federal Joint Committee denies additional benefit of Tirzepatide in children and adolescents

The Federal Ministry of Health has published in the Federal Gazette (Bundesanzeiger) the announcement of a resolution by the Federal Joint Committee (G-BA), whereby the Pharmaceuticals Directive (AM-RL) for the active ingredient Tirzepatide is amended for the new area of application: type 2 diabetes in children and adolescents. The resolution dated August 20, 2026, states that an added benefit for the preparation Mounjaro in this patient group has not been proven. The announcement appears on Wednesday, October 14, 2026, under the official reference BAnz AT 14.10.2026 B2.

The resolution was issued on the basis of the benefit assessment of pharmaceuticals with new active ingredients according to Section 35a of the Fifth Book of the Social Code (SGB V) and amends Annex XII of the AM-RL. The G-BA acts in accordance with Section 91 SGB V. The directive applies in the version dated December 18, 2008/January 22, 2009 (BAnz. No. 49a of March 31, 2009) and was last amended by the announcement of the resolution dated September 3, 2026 (BAnz AT 05.10.2026 B2).

The resolution comes into force with effect from the date of its publication on the G-BA website on August 20, 2026. The supporting reasons will be published on the G-BA website at www.g-ba.de. The announcement was signed in Berlin on August 20, 2026, by the Chairperson Dr. Optendrenk.

New area of application since January 2026

The European authorization dated January 22, 2026, indicates Mounjaro for the treatment of adults, adolescents, and children from 10 years of age with inadequately controlled type 2 diabetes mellitus as a supplement to diet and exercise. It is intended for use as monotherapy when the intake of Metformin is not indicated due to intolerances or contraindications, as well as in addition to other pharmaceuticals for the treatment of diabetes mellitus.

The area of application of the resolution dated August 20, 2026, includes adolescents and children from 10 years of age. Children and adolescents aged 10 to under 18 years with type 2 diabetes mellitus who have not achieved sufficient blood glucose control with their previous drug therapy in addition to diet and exercise were assessed.

Added benefit not proven

As the appropriate comparator therapy, the G-BA specifies an individualized therapy selected from:

• Metformin + basal insulin
• Metformin + Liraglutide or Dulaglutide
• Metformin + Dapagliflozin or Empagliflozin
• Basal insulin + Metformin + Liraglutide or Dulaglutide
• Basal insulin + Metformin + Dapagliflozin or Empagliflozin
• Escalation of insulin therapy: conventional therapy (CT) or intensified insulin therapy (ICT), each in combination with Metformin and Liraglutide or Dulaglutide or Dapagliflozin or Empagliflozin

Extent and probability of the added benefit of Tirzepatide compared to this comparator therapy: An added benefit has not been proven. Regarding the study results by endpoint, it is stated that no suitable data are available; no data are reported for mortality and health-related quality of life, and morbidity and side effects are not assessable. Unless otherwise indicated, the information is based on the dossier assessment by IQWiG (A26-14).

Around 300 to 390 affected persons and annual therapy costs

The G-BA states that the number of patients eligible for treatment is approximately 300 to 390. The annual therapy costs per patient are:

• Tirzepatide: €3,308.22 – €4,614.89
• Metformin: €29.08 – €67.81
• Empagliflozin: €649.92 – €808.37
• Dapagliflozin: €874.03
• Tirzepatide + Metformin + Dapagliflozin: Total €3,337.30 – €4,682.70
• Tirzepatide + Metformin + Empagliflozin: Total €4,211.33 – €5,556.73
• Basal insulin in combination with Metformin: Total €3,987.22 – €5,491.07
• Human insulin (NPH insulin) + Tirzepatide: Total €3,413.93 – €5,707.97
• Insulin degludec + Tirzepatide: Total €3,401.21 – €5,576.39
• Insulin glargine: cannot be quantified

The costs were determined after deducting legally required discounts based on the Lauer-Taxe as of June 15, 2026. For additional necessary SHI (statutory health insurance) services, the announcement mentions, among others, single-use needles at €10.94, blood glucose test strips at €131.04 – €393.11, and lancets at €7.67 – €23.00.

Requirements for quality-assured application

The specifications of the Summary of Product Characteristics (SmPC) must be observed. The European regulatory authority, the European Medicines Agency (EMA), provides the contents of the SmPC for Mounjaro (active ingredient: Tirzepatide) via open access; the last access was June 15, 2026.

The use of GLP-1 receptor agonists, including Tirzepatide, has been associated with a risk of developing acute pancreatitis. Patients should be informed about the characteristic symptoms of acute pancreatitis, and the therapy should be changed if necessary.

With the publication in the Bundesanzeiger (Federal Gazette), the benefit assessment for the new area of application is officially completed: For children and adolescents with type 2 diabetes, Tirzepatide remains a prescribable option, but one for which no added benefit compared to the appropriate comparator therapy has been demonstrated. For physicians and payers, this means that the prescription must be justified on a case-by-case basis, while annual therapy costs of up to €5,775.77 in combination therapies affect the efficiency audit of the statutory health insurance.

Source: Federal Gazette, BAnz AT 14.10.2026 B2, October 14, 2026, Announcement (official reference: BAnz AT 14.10.2026 B2).