The Korean government’s drug insurance benefit and review system is so outdated that it fails to support the active development of locally made cell therapies, industry watchers said Monday.
Cell therapies have similar efficacy with conventional chemical medicines and biological drugs but go through different procedures in research and development.
Cell therapy makers said their products are facing disadvantages in the government’s assessment for insurance benefits and drug approval, calling for improvement.
A case in point is Tego Science’s burn injury treatment Kaloderm.
The drugmaker won approval for Kaloderm in early 2002. However, the cell therapy had to face limited insurance benefits after a similar product arrived on the market in 2015.
At that time, the Ministry of Health and Welfare changed the condition for insurance benefits of Tego Science’s drug, citing similar indications of the latecomer therapy Keraheal-Alo by another firm Bio Solutions.
The ministry allowed insurance benefits only to “a therapy mainly administered among the same type of treatments for a second-degree burn.”
The government gave benefits to Kaloderm at a maximum of 112 square centimeters, and Keraheal-Alo at a maximum of 100㎠ only. If the treatment area exceeded the limit, patients had to pay the rest of the drug cost.
If a patient used both treatments, he or she received insurance coverage for only one remedy.
Deciding that the system was unfair, Tego Science filed a suit against the government to cancel the change of the insurance coverage condition. Last year, the company won the case.
The health and welfare ministry revised some of the details in the insurance coverage condition, stating that patients receiving a combination therapy of Kaloderm and Keraheal-Alo will be allowed to enjoy insurance coverage of one drug which costs higher during the treatment period.
However, Tego Science said the revision was meaningless because the other drug is still out of insurance coverage. The amendment only changed the criteria from the total area to the drug cost, the company said.
For example, if a patient uses both a single sheet of Kaloderm 56㎠ and a bottle of Keraheal-Alo (44㎠), he or she will receive insurance benefit on Keraheal-Alo only. This is because the latter is more expensive.
After all, the revised system has not made any meaningful change, Tego Science said.
“Kaloderm is a completely different product from Keraheal-Alo. The two are different in shape and dosage. There is no comparative study, either,” said an official at Tego Science. “The government should apply each different criterion for each different drug by medicine type.”
Pharmicell is struggling to obtain approval for cell therapy.
Conducting research based on dendritic cells to develop next-generation anticancer treatment, Pharmicell plans to use a platform technology in working on the investigational drug.
With the platform technology, Pharmicell can develop multiple types of therapies by changing only antigens to dendritic cells.
A combination of dendritic cells with a breast cancer antigen can become a breast cancer treatment, and with a prostate cancer antigen, a prostate cancer treatment.
However, the Korean authorities do not offer a system to approve the platform technology.
The current system allows approval for drugs that went through all clinical trials from pre-stage to phase-3. This makes the company waste time and cost.
Aware of the criticism, the government is listening to the industry’s voices. The authorities are reportedly updating guidelines and the conditional approval system, sources said.
“There are many Korean cell therapies available in the global market. Analysts say the market is likely to see robust growth,” a pharmaceutical source said. “But the current regulatory system is based on chemicals and biological drugs, far from cell therapies. The government needs to set up a tool to directly communicate with industry officials and make a practical system to reflect the reality.”