The German legislature has excluded weight loss drugs from the benefits provided by statutory health insurance since 2004, categorizing them as so-called lifestyle drugs according to § 34 Abs. 1 Satz 7 SGB V. This regulatory exclusion also applies to the prescription drug Wegovy® containing the active ingredient Semaglutide, which is approved for weight reduction.
The Federal Joint Committee (G-BA) has formally confirmed this exclusion from insurance coverage today by listing Wegovy®, also known as the “weight loss injection,” under the Medicinal Products Directive (Annex II – Lifestyle Drugs). However, this regulatory exclusion was already in effect before this formal decision. Medications containing Semaglutide that are not approved for weight management and are used for other indications, such as Type 2 Diabetes Mellitus, are not subject to this exclusion.
During the statement procedure on the draft decision, the G-BA extensively debated requests to make exceptions for Wegovy® at least for patients with severe obesity (with a BMI over 30) due to the increased risk of associated and subsequent diseases in these cases. However, the G-BA saw no room for discretion due to the general legal exclusion from prescription.
Weight Loss Drug Wegovy® Faces Insurance Exclusion, Despite Semaglutide’s Broad Application in Germany
The pharmaceutical company markets the active ingredient Semaglutide for different indications and under different product names: Wegovy®, Rybelsus®, and Ozempic®.
Wegovy® is approved for weight management in obese or significantly overweight patients, in addition to a calorie-reduced diet and increased physical activity. Due to its indication for “weight management,” it is subject to legal prescription exclusion. Therefore, Wegovy® cannot be considered in the recently decided DMP (Disease Management Program) for Obesity by the G-BA – the G-BA has no discretion in this matter.
Rybelsus®/Ozempic® are approved for the treatment of Type 2 Diabetes Mellitus: Prescriptions are possible within this approved indication since their market launch in Germany – statutory health insurance covers the costs.
The decision will take effect after review by the Federal Ministry of Health and publication in the Federal Gazette.
Resource: Gemeinsamer Bundesausschuss, March 21, 2024
