1st drug to win 2nd concurrent approval·pricing program

Fast reimbursement review process anticipated

The Ministry of Food and Drug Safety has granted marketing authorization for MSD's 'Winrevair'

Demonstrated to improve the 6-minute walk distance, based on the STELLAR study

As the first drug has been approved under the 2nd concurrent approval·drug pricing program, the process for insurance reimbursement is garnering attention.

 

MSD Korea's 'Winrevair (sotatercept),' a new drug for pulmonary arterial hypertension (PAH), recently obtained final approval from the Ministry of Food and Drug Safety.

 

As it has been selected for the concurrent approval-evaluation-negotiation pilot program, Winrevair will soon be subjected to reimbursement review.

 

The Ministry of Health and Welfare has been running the 'Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations' since 2023 to improve treatment access for life-threatening severe and rare diseases.

 

The project conducts approval, reimbursement evaluation, and drug price negotiations concurrently, aiming to shorten the time required for new drugs to be included in the National Health Insurance list.

 

The first pilot project is in its final stage, showing accomplishments.

 

The Ministry of Health and Welfare recently completed selecting items, and three drugs were chosen.

 

Three drugs chosen for the second pilot project are 'Winrevair (sotatercept),' a pulmonary hypertension treatment from MSD Korea; 'Fintepla (fenfluramine),' a Dravet syndrome treatment from UCB Pharma Korea; and 'Limcato,' a large B-cell lymphoma treatment from the Korean company Curocell.

 

Winrevair is a first-in-class innovative new drug with a novel mechanism of action, emerging 20 years after 'Sildenafil,' which targeted the NO-sGC-cGMP pathway in 2005.

 

As of 2023, the number of pulmonary hypertension patients in Korea was approximately 3,600.

 

The average age of these patients is in their 40s, a demographic that plays a crucial role in society and families.

 

Although the 5-year survival rate has significantly improved compared to the past, 3 out of 10 Korean pulmonary hypertension patients still die within 5 years.

 

Furthermore, most patients experience significant difficulties performing daily activities such as housework, childcare, and light outings.

 

Pulmonary hypertension is a rare, intractable, and progressive disease, delaying the worsening of the condition directly impacts patients' quality of life and survival.

 

To date, no cure through drug treatment has been discovered, and the mechanism of existing drugs primarily aims to alleviate symptoms by relaxing thickened pulmonary arteries.

 

It remains to be seen how quickly drugs undergoing the concurrent approval-evaluation process, including Winrevair, will be included to the list.

 

Meanwhile, the approval of Winrevair was based on the 'STELLAR' clinical study.

 

This study evaluated the efficacy and safety of Winrevair in 323 adult patients with pulmonary hypertension (WHO-FC II or III).

 

During the 24-week study period, patients received either Winrevair or a placebo in combination with their existing therapy, administered once every three weeks.

 

As a result, Winrevair increased the 6-minute walk distance by 40.8m (Hodges–Lehmann estimate) compared to placebo at the 24-week mark and reduced the risk of clinical worsening or death by 84%.

 

Additionally, significant improvements were confirmed compared to the placebo in eight secondary efficacy endpoints, including the WHO-FC, pulmonary vascular resistance (PVR), and NT-proBNP levels, a biomarker for heart failure.

 

Wook-Jin Chung, President of the Korean Society of Pulmonary Hypertension (Professor of Cardiology at Gachon University Gil Hospital), stated, "Winrevair is a new mechanism treatment that normalizes modified pulmonary vascular structures.

 

It's also presented as a combination therapy option for use in early treatment stages, as outlined in updated global clinical guidelines, based on the latest evidence.

 

This approval has widened the range of treatment options for pulmonary hypertension patients in Korea."