Sotatercept for Pulmonary Arterial Hypertension Patients

By Staff Writer

January 25, 2024

A New Ray of Hope

Pulmonary arterial hypertension (PAH) is a rare, progressive disease characterised by the thickening of pulmonary artery walls, causing increased resistance and pressure that makes it difficult for the heart to pump blood to the lungs. This leads to symptoms such as shortness of breath, fatigue, chest pain, and dizziness and can result in right ventricle dysfunction and premature death. This article explores the Final Evidence Report assessing the comparative clinical effectiveness and value of sotatercept from The Institute for Clinical and Economic Review (ICER).

Understanding PAH:

PAH significantly impacts patients financially, with costs exceeding $100,000 per person annually. The disease affects 50,000 to 100,000 people in the US, typically between the ages of 30 and 60, and is more common in women. PAH can be idiopathic, inherited, or associated with exposure to certain substances or conditions. The disease severely impacts the quality of life, particularly in physical function domains. One-fifth of PAH patients die within three years after diagnosis, significantly reducing lifespan. 

Current PAH Treatment Landscape:

Current treatment for PAH includes medications that promote vasodilation with the goals of improving functional status and survival. However, these treatments can be burdensome, and often have to be used in multiple combination therapies. Despite treatment many cases will inevitably be referred for lung or heart-lung transplantation.

Sotatercept for PAH treatment:

Sotatercept (Merck & Co., Inc) is a first-in-class activin signaling inhibitor and potentially disease-modifying drug. It is administered as a subcutaneous injection every three weeks and has been shown to improve pulmonary blood flow. The US Food and Drug Administration (FDA) has received a request for sotatercept, with a decision anticipated by March 26, 2024.

The STELLAR Trial:

The pivotal trial for sotatercept was STELLAR, a Phase III randomised, placebo-controlled trial based on 323 cases of PAH. The results showed that treatment with sotatercept added to background therapy can improve clinical outcomes for patients with PAH. The risk of clinical deterioration or death dropped 84%. Side effects of sotatercept included a considerable increase in telangiectasias, haemoglobin levels, and bleeding.

Economic impact:

The exact cost of sotatercept is still unknown. However, it is estimated that, if priced within the health benefit pricing benchmark (HBPB) range, all suitable patients could be treated with sotatercept over a five-year period without causing significant budget issues. ICER used a de novo decision analytic model to analyse the cost-effectiveness of adding sotatercept to background therapy in the health care sector. Sotatercept treatment led to increased symptom-free time at rest, quality-adjusted life years, and equal value life years. HBPB for sotatercept ranges from $17,900 to $35,400 annually as per the report.

Reference url

Recent Posts

NICE Endorses Breakthrough Bladder Cancer Treatment for Enhanced Survival

By Staff Writer

August 25, 2025

Bladder cancer treatment has recently advanced, offering new hope for adults with advanced urothelial cancer. If you’re wondering, “What is the most effective first-line bladder cancer treatment for advanced cases in the UK right now?”—the latest update is that the National Institute for Health a...
UK Pharmaceutical Pricing Analysis: Impasse in VPAG Review Undermines Patient Access and Market G...
The accelerated review of the UK's Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) concluded without agreement in August 2025. The review focused on soaring payment rates. These require companies to pay up to 35.6% of their revenue from NHS sales. Despite good faith effo...
TAVI Cost-Effectiveness in Brazil: Balancing Coverage Expansion and Economic Viability

By Staff Writer

August 21, 2025

The focus on TAVI cost-effectiveness Brazil has gained attention. The country is assessing the expansion of coverage for transcatheter aortic valve implantation (TAVI). This would include patients with severe aortic stenosis who are classified as low surgical risk (STS-PROM <4%) as a first-lin...