Physicians have raised voice for importing new drugs to treat pulmonary arterial hypertension (PAH), which has a three-year survival rate of only 56 percent. Still, the health authorities have shown a lukewarm stance to speed up the process.
|GSK’s pulmonary arterial hypertension treatment Flolan|
Rep. Yoon Il-kyu of the ruling Democratic Party of Korea, a member of the National Assembly’s Health and Welfare Committee, recently asked the Ministry of Food and Drug Safety how the government was responding to the medical community’s demand to introduce PAH drugs and allow combination therapies using them.
In response, the ministry said, “Upon the request by various associations and groups, we will review introducing overseas drugs urgently.” The regulatory agency added that it would actively cooperate with the Ministry of Health and Welfare to decide whether to approve combination therapies based on the reimbursement and treatment guidelines.
Yoon first raised the issue at a session in July on the early detection and treatment of hard-to-treat PAH, organized by the Korean Pulmonary Hypertension Society.
At the forum, Jeong Wook-jin, director of general affairs at the society, said the survival rate of PAH was only 2.8 years after diagnosis in Korea. “Among the 10 treatments available around the world, only seven can be used in Korea. The most effective drug, epoprostenol (brand name: Flolan, manufacturer: GSK), has been in the market for nearly 20 years. Korea has yet to introduce it, however,” he said.
In contrast, Japan approved epoprostenol in 1999 and allowed combination therapies 10 years ago. With the Japanese government’s effort, PAH’s three-year survival rate in Japan went up by 50 percent in the past 20 years to 96 percent now, he added.
Jeong called on the government to designate advanced drugs, urgently needed for patients, and allow such medicines to win the nod easily with essential data (at the level of approval data submitted to regulators overseas).
“We need a fast-track approval system to introduce PAH drugs,” he emphasized.
GSK, the manufacturer of Flolan, said it was preparing to apply for the designation of the medicine as an orphan drug in Korea.