China study ranks PAH treatments for safety, costs, benefits
Volibris achieves highest score under decision framework for ERAs
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In China, Volibris (ambrisentan, sold as Letairis and generics in the U.S.) may have advantages over similar medications for pulmonary arterial hypertension (PAH) when considering factors including safety, efficacy, and economic value.
That’s according to a study in which a team of experts developed a multi-criteria decision analysis (MCDA) framework to compare medication features. In addition to Volibris, they examined Tracleer (bosentan) and Opsumit (macitentan), both PAH medications approved and available as generics in the U.S.
“Overall, within the present MCDA framework, [Volibris] achieved the highest overall score across efficacy, safety, cost-effectiveness, and suitability, suggesting that it may represent a favorable option when multiple clinical and practical factors are considered,” the researchers wrote. “However, treatment decisions should remain individualized based on patient characteristics, comorbidities [co-existing conditions], and treatment preferences.”
A similar approach could be used in other settings to help guide complex decisions in healthcare, they said.
The study, “Comparative clinical evaluation of endothelin receptor antagonists in pulmonary arterial hypertension using a multi-criteria decision analysis framework,” was published in the International Journal of Clinical Pharmacy.
Comparing similar medications
PAH is a type of pulmonary hypertension, or high blood pressure in pulmonary arteries, the vessels that supply the lungs. In PAH, this occurs because the vessels narrow, altering how blood moves through them (hemodynamics). This can put stress on the heart, leading to PH symptoms such as a reduced capacity for exercise.
One PAH treatment class is endothelin receptor antagonists, or ERAs. People with PAH have high levels of a protein called endothelin, which contributes to blood vessel narrowing. ERAs block endothelin activity, which can help ease symptoms for many people.
Three ERAs are approved in the U.S., China, and other regions: Volibris/Letairis, Tracleer, and Opsumit. “However, despite similar mechanisms of action, ERA differ in safety profiles, monitoring requirements, drug–drug interactions (DDIs) potential, dosing convenience, and cost, all of which influence their use in routine clinical practice,” the team wrote.
To better compare these PAH-approved ERAs, a group of experts created an MCDA framework with six categories: safety, efficacy, economic value, suitability, accessibility, and innovation. They used measurable indicators in each category, weighted by importance, to rate the medications.
In terms of safety, Volibris had fewer clinically relevant interactions with other medications than Tracleer and Opsumit. Volibris also had a slightly lower risk of side effects in its clinical trials. Both Volibris and Tracleer are contraindicated in pregnancy, and Tracleer and Opsumit require ongoing safety monitoring of the kidneys or liver.
“From a clinical pharmacy perspective, these differences are highly relevant, as adverse events and drug interactions directly influence medication review, patient counseling, and ongoing therapy management,” the researchers wrote. They concluded that Volibris tended to have a reliable and acceptable safety profile.
For efficacy, the team evaluated two main metrics. Participants in Volibris and Tracleer trials showed significant increases in six-minute walk distance, a standard metric of exercise capacity. On the other hand, Tracleer and Opsumit had more impact on mean pulmonary artery pressure, a hemodynamic measure.
“These findings suggest that while all ERA[s] provide clinical benefit, differences in efficacy may influence drug selection depending on treatment goals, such as exercise capacity improvement versus hemodynamic control,” the team wrote.
They assessed economic value within the context of the Chinese market. On average, the annual costs were ¥24,600 ($154,82) for Volibris, ¥17,820 ($112,14) for Tracleer, and ¥57,240 ($360,22) for Opsumit. Opsumit had the highest cost‑to‑income ratio, suggesting it may be more difficult for patients to access even though the Chinese national insurance system reimburses all three therapies.
Based on this, the team concluded that Volibris and Tracleer provide better economic value and greater accessibility than Opsumit.
Suitability metrics assessed other potential burdens to patients. Tracleer performed worse using these, as it required more frequent dosing (twice daily instead of once daily, as for the other two medications) and more intensive safety monitoring.
The researchers also considered innovation. Tracleer, as the first developed ERA, had the highest score in the first-in-class or novel mechanism domain, while Opsumit scored higher in the fulfillment of unmet clinical needs and target selectivity domains.
After weighing the indicators based on the expert consensus, Volibris scored highest, followed closely by Tracleer. Opsumit came third.
“These findings suggest that [Volibris] may represent a favorable option when multiple decision dimensions are considered simultaneously,” the researchers wrote.
They noted several caveats and limitations of their analysis, including that it was specific to China and may not generalize to other markets. And efficacy and safety comparisons were indirect, using data from separate clinical trials for each medication.
The researchers also emphasized that individual patients’ needs should guide personalized clinical decision-making.
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