A natural medicine called Stiren, developed from artemisia (mugwort) components, faces removal from the insurance coverage market. Voices in the pharmaceutical industry criticized the government, saying it encouraged development of natural new drugs only to abandon them now.
Health Insurance Review & Assessment Service (HIRA) said on the 7th that it concluded that Ai Ye (Artemisia leaf) extract is not appropriate for coverage for improvement of gastric mucosal lesions, bleeding and erythema in acute and chronic gastritis. It issued a preliminary decision to remove it from health insurance coverage. If a patient receives a prescription for the drug, health insurance will not apply and the patient must bear the full cost of treatment.
Ai Ye is the leaf of mugwort and is used as a medicinal ingredient in traditional Korean medicine. Dong-A ST is now under immediate pressure. The company developed the gastritis treatment Stiren from artemisia components native to Ganghwa Island and received approval as a natural new drug in 2002. Dong-A ST said on the 11th that it will appeal HIRA's Pharmaceutical Benefits Evaluation Committee decision and do its best to maintain coverage.
Stiren rose to blockbuster status as it was often prescribed together with other drugs that could burden the stomach. Originally released as a capsule, it was changed to a more convenient pill in 2005, and sales increased significantly. In 2011, annual sales of Stiren reached 88.1 billion won.
Stiren sales fell to the 20 billion won range after the patent expired in 2015 and generics emerged. Sales were dispersed to generic drugs from other pharmaceutical companies. But if HIRA makes a final decision to deny coverage for Stiren, generic manufacturers will also be hit. If it is removed from the health insurance benefit list, prescriptions will not be made because of patient cost sharing, and the product will inevitably be driven out of the market.
Not only Stiren but other herbal ingredient drugs also face the threat of removal. The Ministry of Food and Drug Safety said in December last year it will conduct bioequivalence re-evaluations for generics among prescription drugs containing Ai Ye extract, Pelargonium sidoides extract, and extracts of angelica, radish family, saposhnikovia, sargentodoxa, acanthopanax, achyranthes, wilfordii, cassia, cnidium, gastrodia and safflower. The target includes 212 items from 113 companies.
Bioequivalence re-evaluation is to prove that two formulations with the same active ingredient, content and dosage form have the same efficacy. Pharmaceutical companies argued that with herbal medicines the plant extract itself is a single active ingredient and contains various components, making it difficult to apply the same standards used for conventional chemically synthesized drugs, but the ministry did not accept that.
Because proving bioequivalence is difficult and the expense is not small, companies giving up on re-evaluation followed one after another. According to the industry, more than half of the 212 herbal formulation items subject to bioequivalence re-evaluation voluntarily withdrew their approvals and exited the market.
An industry official criticized, saying the Ministry of Food and Drug Safety and HIRA raised the bar for natural new drugs and are effectively cutting coverage, adding that until a few years ago they encouraged development of natural new drugs but now are dampening the will to develop new drugs.