Tego Science is seeking to obtain insurance coverage for Kaloderm, a biological wound dressing for diabetic foot ulcers, after failing it four times.

Pharmaceutical sources said the company recently submitted a request to the Health Insurance Review and Assessment Service (HIRA) to expand reimbursement conditions for the cell therapy.

Kaloderm, a wound dressing for diabetic foot ulcer, by Tego Science

Kaloderm is Tego Science’s flagship product, approved as the nation’s second cell treatment.

The wound dressing has two indications -- promoting re-epithelization of deep, second-degree burn, and facilitating healing of wounds from diabetic foot ulcers with smooth blood supply and no infection.

A diabetic foot ulcer is a serious disease. If a patient misses the timing of treatment or neglects the disease, he or she may have to sever the foot.

Tego Science said the seriousness of the disease made the company keep seeking reimbursement for Kaloderm, even though the treatment was mostly used for burns.

Kaloderm is more effective than its rival product, which already benefits from insurance coverage, the company said. Besides, Kaloderm is cheaper, which will help the treatment win reimbursement this time, the company added.

In a clinical study, the company applied Kaloderm to patients six weeks after the onset of the 3.57±4.07 ㎠diabetic foot ulcers on average. After using the dressing once every week for eight weeks, the cure rate reached 100 percent at the 12th week, the company said.

Although the company had planned a 12-week study, it took only five weeks (35 days) to cure, Tego Science said.

Kaloderm’s rival product showed a 73.2 percent cure rate with the average cure time of eight weeks (56 days) at the 12th week. Patients used the comparison treatment four weeks after the onset of the disease whose ulcers were 2.08±3.72㎠ on average. They applied the therapy twice a day for 12 weeks.

Tego Science emphasized that Kaloderm had a competitive edge in price, too.

Kaloderm costs 30,041 won ($26.5) per 1㎠ for products with 56 ㎠ units. The minimum unit purchase price is set at 91,102 won for one sheet of 90 ㎠. A five-week use costs about 450,000 won.

On the other hand, the product in competition is 291,000 won per 10ml bottle, which is sprayed twice a day, and requires eight weeks to cure.

Kaloderm also received better evaluation than the rival product from the academic circles.

The Korean Society for Diabetic Food gave Kaloderm “Medium” grade in the recommendation in the 2014 treatment guidelines while giving the rival product “Low” grade.

“Diabetic foot ulcer is a chronic disease that must be treated continuously for a complete cure. Patients mostly come from low-income households, and they sometimes miss the proper treatment due to drug costs,” said an official at Tego Science. "The results of the clinical study showed that Kaloderm cost less than the comparison drug and had better efficacy.”

He went on to say that Kaloderm did not need additional cost for the HIRA and required a shorter treatment time, which would benefit the HIRA’s finance as well. “The treatment suits well for the government’s policy to expand reimbursement for non-reimbursed drugs,” he added.

Tego Science applied for reimbursement of Kaloderm for the treatment of diabetic foot ulcer in July 2010, May 2011, October 2011, and May 2013.

sjh@docdocdoc.co.kr

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