Fiblast, a cell therapy product to treat burn injuries, will make its fourth attempt to receive health care benefits in July. If the medicine fails in what is regarded as the final challenge, it will highly likely withdraw from the Korean market.
Fiblast is a burn injury therapy developed by Japan’s Kaken Pharmaceutical, the world’s first medicine based on basic fibroblast growth factor (BFGF). This medicine facilitates the regeneration of cell tissues, by helping to proliferate fibroblast that creates collagen and to create new blood vessels.
|Burn injury cell therapy ‘Fiblast spray’|
As a result of clinical trials in Japan, 98.7 percent (81 out of 82) of burned and 76.9 percent (80 out of 104) bedsore patients experienced improvement in skin regeneration while only 1.51 percent (11 out of 729) saw adverse effects occur.
Fiblast is a spray suitable for treating burns in a particular area and was released on the market in 2009. Daewoong Pharmaceutical has the right to sell the product in the domestic market.
The burn injury therapies in the domestic market include Fiblast, Tego Science’s Kaloderm, and Biosolution’s KeraHeal-Allo. Kaloderm is receiving full benefits, and KeraHeal-Allo is getting partial benefits starting in 2016. But Daewoong Pharmaceutical’s Fiblast remains a non-benefit item.
Daewoong made three attempts to get benefits but to no avail thus far. In its first attempt in 2010, the company passed the Pharmaceutical Benefits Committee of Health Insurance Review & Assessment Agency test, but could not come to an agreement with National Health Insurance Services (NHIS). At the time, the NHIS proposal was to release the product at 30 percent of the price Daewoong had offered. The company immediately complemented the data and made the second attempt in 2011 but the negotiations with NHIS broke down.
Daewoong made its third attempt last year. That was because the company could skip bargaining with NHIS if it accepts the 90-100 percent of the average price of alternative therapies. Daewoong Pharmaceuticals made renewed challenge by lowering the prices of Fiblast. It also offered the drug price 30 percent lower than the existing products, but couldn’t pass even the Pharmaceutical Benefits Committee, from which it had won the approval in 2010.
According to Health Insurance Review & Assessment Service (HIRA), the committee has made the non-benefit decision because of its high uncertainty in clinical usefulness and unclear cost-benefit effects, considering major assessment indexes, such as the difference between the drug and its alternative therapies and the degree of burns suffered by test subjects.
Daewoong is planning to receive assessments by adding a report of an indirect comparison of re-epithelization periods of burned parts in the run-up to the reexamination by the committee this month.
The Korean Burn Society has also set about to provide its support. The society has recently recognized the need for its insurance coverage in a letter it recently submitted to HIRA.
“There is no set standardized treatment for burn therapies. If the injury is severe, surgery is the solution. But for others, the treatment is done through the dressing. The key point is how well the dressing process is done,” said Moon Duck-Joo, head of Bestian Medical Center specializing in burn injuries. “The objective of dressing treatment is to treat the burn without creating infection and not to leave a scar while making the patient comfortable. But there seem to be differences in this part between the government and the clinical fields.”
Moon explained that especially with burns if the treatment period becomes too long, it will leave a scar. The period of leaving a scar or not is less than two weeks, and as the treatment period becomes longer, bigger scars remain.
“Burns by their nature are hard to conduct clinical treatments. Even though the same 2nd-degree burns can differ from one another by their severity – deep, shallow and medium. Burns themselves are extremely diverse, resulting in treatment effects of infinite varieties. Nor are comparative clinical treatments for these reasons.
Because of the characteristics of burns in which burned areas can be wide or narrow with their depth varying, various treatment options are needed, according to Moon.
“Fiblast has been on the market for about 10 years. If there had been no positive effects, it would not have survived, let alone be used in clinical situations. Also, because it is in a spray form, it could be easily applied to areas that are difficult to reach, such as joints, and it is suitable for applying to small areas,” he said. “It is not that expensive, either, compared with other products. If it receives health benefits, Fiblast will be a great option for doctors and patients.”
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