Pharmaceutical firms have little incentive to supply drugs while drug regulator sets prices too low
Korean patients and physicians still do not have access to a number of key pulmonary arterial hypertension (PAH) drugs that were approved in the U.S. and other countries almost 25 years ago, a local expert said.
"Multinational pharmaceutical companies (MNC) that develop pulmonary arterial hypertension drugs choose to 'skip' entering Korea with these drugs in a phenomenon called 'Korea Passing,'" Professor Chung Wook-jin from Gachon University Gil Medical Center, Department of Cardiology, said. "MNCs refuse to enter Korea because it is a small market with historically low drug costs."
"PAH treatments are used in other countries, including in China. However, in Korea, the Ministry of Food and Drug Safety (MFDS) requires too much of developers in the approval process. At the same time, the Health Insurance Review and Assessment Service (HIRA) set prices too low," Chung added.
Developed countries including Japan have been noted for treating PAH patients with government and social support. However, Chung pointed out that the level of patient care, support, and professional treatment in Korea is inadequate.
In particular, industry insiders note that PAH drugs, which have been used abroad for more than 20 years, are still not accessible in Korea because of reimbursement issues, among others.
GSK's epoprostenol (product name Flolan), Eli Lilly & Company's tadalafil (product name Cialis), and Bayer's riociguat (product name Adempas) are the three major drugs used to treat PAH.
Even though the U.S. Food and Drug Safety approved epoprostenol in 1995, the drug has yet to gain domestic approval.
According to Chung, epoprostenol developer GSK became aware of this issue in Korea and began to negotiate with HIRA for drug approval recently.
"GSK's Volibris team is currently working to bring epoprostenol into Korea within the next two to three years to help PAH patients,". a GSK official told the Medical Observer. "GSK is currently focusing on early PAH treatment with Volibris and raising awareness of the disease."
Despite GSK's recent efforts, Chung pointed out the grim reality for PAH patients in the country.
"The Korean Pulmonary Hypertension Society has tried to work with the MFDS for epoprostenol, but realistically, it would take about 10 years until drug approval considering the amount of data and material the drug regulators require and the length of the examination," Chung said.
Early treatment of pulmonary arterial hypertension is essential, which also makes using therapies early important. In this regard, a fast-track system is necessary to accelerate the entrance of these drugs into the domestic market.
"China has implemented a fast-track system because they understand that there's no need to drag out the approval process if the medication is absolutely necessary," Chung said. "The MFDS and HIRA should also approve the drugs quickly through the fast-track system so patients can receive early treatment."
In addition to epoprostenol, Lilly's tadalafil and Bayer's riociguat have either not been able to expand the drug's indications or are being prescribed without reimbursement, making it near impossible for patients to gain access.
Tadalafil, used to treat erectile dysfunction and benign prostatic hyperplasia, has also expanded its indications for pulmonary hypertension in countries such as the U.S.
Although the MFDS approved tadalafil as an erectile dysfunction treatment in Korea, it has no PAH indication approval.
Lilly Korea declined to comment.
For Bayer's riociguat, the MFDS approved the five dosages of the drug, ranging from 0.5mg to 2.5mg. Although riociguat is on the Korean market, its high cost hinders patient accessibilty. Despite this, Bayer said it would not file for reimbursement anytime soon.
"Riociguat is currently prescribed without reimbursement,," a Bayer official told the Medical Observer. "The company currently has no plans to apply for reimbursement."
PAH is a disease in which the blood pressure of the pulmonary artery, which supplies blood from the heart to the lungs, rises. The disease carries a poor prognosis and can be fatal, with most deaths attributed to sudden death or heart failure. Data show that there are about 5,000 PAH patients in Korea.
PAH, which displays symptoms of anemia, heart disease, and lung disease, among others, usually occurs in female patients in their late 40's. Despite its gravity, awareness of the disease remains low in the country.