'Adempas' for pulmonary hypertension closer to obtain reimb

Reached the final agreement in drug price negotiation with the National Health Insurance Service (NHIS)

After 10 years since it was approved in South Korea, it will likely obtain reimbursement

Product photo of Adempas

A new reimbursable treatment option for pulmonary hypertension is anticipated to be introduced.

 

According to industry sources, Bayer Korea has finally reached an agreement with the National Health Insurance Service (NHIS) for its 'Adempas (riociguat).' Accordingly, after 10 years since it was approved in South Korea, Adempas will likely be included in the reimbursement list.

 

Adempas' negotiation was a dosage negotiation, rather than a ceiling price negotiation.

 

Bayer accepted the price 100% below the weighted average price (WAP) of a substitute drug and passed the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) in February.

 

Adempas was exempted from the drug pricing negotiations.

 

This drug obtained approval in South Korea as an orphan drug in June 2014.

 

Five products with different doses are available, and it has the efficacy and the effect in ▲patients with persistent/recurrent chronic-thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) after surgical treatment or inoperable CTEPH, to improve exercise capacity ▲adult patients with arterial pulmonary hypertension (PAH, WHO Group 1) who have WHO functional class 2-3, to improve exercise capacity.

 

Adempas has been known as the first novel drug to treat CTEPH.

 

CTEPH occurs in patients with chronic pulmonary embolism who progress to chronic obstructive pulmonary disease (COPD) and develop fibrotic stenosis and occlusion, leading to pathological vascular remodeling and increased resistance in the pulmonary arteries.

 

CTEPH is a chronic disease that causes progressive shortness of breath and right heart failure.

 

Symptoms include dyspnea, fatigue, chest pain, dizziness, peripheral edema, cough, and hemoptysis, significantly impacting quality of life.

 

Ultimately, it can progress to heart, kidney, and liver failure, potentially leading to death.

 

Meanwhile, Adempas is a stimulator of soluble guanylate cyclase (sGC), an enzyme found in cardiovascular organs.

 

The efficacy of the drug in patients with chronic thromboembolic pulmonary hypertension (CTEPH) was confirmed in Phase 2 and Phase 3 clinical trials.

 

The clinical trial results showed that Adempas improved the study's primary endpoint physical activity and demonstrated superior tolerability.

 

No unusual adverse reactions were reported.

 

In the CHEST-1 study, results from comparing the 6 Minute Walking Test (6MWT) at 16 weeks from baseline showed that the patient group treated with riociguat had statistically significant improvement compared to the placebo group.

 

In the PATENT-1 study, comparison of changes in 6MWT values at 12 weeks to the placebo group demonstrated statistically significant improvement, meeting the primary endpoint.