G-BA certifies no quantifiable added benefit for Sotatercept in severe pulmonary arterial hypertension

The Federal Joint Committee (G-BA) decided in its meeting on August 6, 2026, to supplement the Pharmaceuticals Directive for the active substance Sotatercept to include the area of application of pulmonary arterial hypertension WHO functional class IV. The announcement by the Federal Ministry of Health was published on Wednesday, September 16, 2026, in the Federal Gazette under the official reference BAnz AT 16.09.2026 B2. For the preparation Winrevair, the G-BA sees an indication of a non-quantifiable added benefit.

The basis is Section 35a of the Fifth Book of the Social Code (SGB V) and Annex XII of the Pharmaceuticals Directive (AM-RL) in the version of December 18, 2008/January 22, 2009 (BAnz. No. 49a of March 31, 2009), which was last amended by the decision of July 16, 2026 (BAnz AT 07.09.2026 B4). The new information will be added to the existing entries for Sotatercept from the decision of March 6, 2025, for pulmonary arterial hypertension after number 5.

The new area of application follows the authorization of January 19, 2026, according to which Winrevair in combination with other therapies against pulmonary arterial hypertension (PAH) is indicated for adult patients with WHO functional class II, III, and IV. The decision of August 6, 2026, refers exclusively to WHO functional class IV.

Non-quantifiable added benefit compared to triple therapy

The appropriate comparator therapy for Sotatercept in combination with other PAH therapies is considered to be an individualized therapy selected from the following triple therapies:

• parenteral PCA (Epoprostenol, Treprostinil) + ERA (Ambrisentan, Bosentan, Macitentan) + PDE5 inhibitor (Sildenafil, Tadalafil)
• parenteral PCA (Epoprostenol, Treprostinil) + ERA (Ambrisentan, Bosentan, Macitentan) + sGC stimulator (Riociguat)

The extent and probability of the added benefit compared to this comparator therapy are stated as an indication of a non-quantifiable added benefit.

ZENITH Study: Advantage in disease progression

The basis for the assessment is the randomized controlled ZENITH study (Sotatercept versus placebo, each in addition to a PAH background therapy, second data cut from June 6, 2025) with 20 evaluated patients in the intervention arm and 24 in the control arm. The results by endpoint category:

• Mortality: no difference relevant to the benefit assessment (HR 0.68 [95% CI 0.11; 4.19]; p = 0.679)
• Morbidity: advantage in the composite endpoint of disease progression (HR 0.25 [0.08; 0.78]; p = 0.017), median time to event 9.5 months under placebo versus not reached under Sotatercept
• Health-related quality of life: no data available
• Side effects: no relevant difference, serious adverse events in 60.0 versus 70.8 percent (HR 0.71 [0.34; 1.49]; p = 0.365)

The composite endpoint includes death from any cause (3 vs. 0), lung transplantation (1 vs. 0), and hospitalization for at least 24 hours due to PAH worsening (1 vs. 14). In the 6-minute walk test, the median change at week 24 was plus 91.5 meters compared to minus 5.0 meters (p = 0.059). The data are derived from the IQWiG dossier assessment (A26-12) and the addendum.

Around 35 to 130 patients and nearly 98,500 euros annual therapy

The decision specifies the number of patient groups eligible for treatment as approximately 35 to 130 patients. The annual therapy costs per patient after deduction of legally required discounts (as of Lauer-Taxe: June 1, 2026):

• Sotatercept: €98,428.67
• ERA: €16,818.84 to €19,118.34
• PDE5 inhibitor: €2,066.51 to €2,395.86
• sGC stimulator: €18,987.00 to €19,507.29
• parenteral PCA: varies by individual patient

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

Quality-assured application and entry into force

The specifications of the summary of product characteristics must be observed; the European Medicines Agency (EMA) provides the product information for Winrevair freely accessible. The initiation and monitoring of treatment with Sotatercept should only be carried out by specialist physicians experienced in the therapy of pulmonary arterial hypertension.

The decision entered into force with effect from the day of its publication on the G-BA website on August 6, 2026; the supporting reasons are published at www.g-ba.de. The announcement was signed in Berlin on August 6, 2026, by the Federal Joint Committee in accordance with § 91 SGB V, the Chair Dr. Optendrenk.

For lung centers and prescribing specialists, the supplement means that Sotatercept for the most severe form of PAH is now listed in the pharmaceutical guidelines with a recognized, although not quantified, added benefit. Since the assessment is based on a very small study population and no data on quality of life are available, prescribing practice remains characterized by individual case decisions and the specifications of the summary of product characteristics.

Source: Bundesanzeiger, BAnz AT 16.09.2026 B2, Announcement, pp. 1–4 (official reference: BAnz AT 16.09.2026 B2).