Amgen Korea said Thursday its “first and only” biologic treatment for osteoporosis Prolia (ingredient: denosumab) will gain insurance benefits from next month.
Prolia is a monoclonal antibody injection that targets Receptor Activator of Nuclear factor Kappa-B Ligand (RANKL) proteins in osteoporosis patients. The drug, administered once every six months, became a U.S. blockbuster by recording $1.05 billion in sales last year.
|Sang K. Noh, general manager of Amgen Korea, opens the Prolia press conference Thursday in downtown Seoul.|
“Prolia gained approval [in Korea] last November as the first biologic treatment for osteoporosis,” said Sang K. Noh, general manager of Amgen Korea at a news conference Thursday. “Korea is becoming a super-aged society wherein the rate of osteoporosis occurrence will increase. We are pleased to provide a new treatment option now covered by insurance, decreasing the patient’s burden.”
The drug had previously gained approval as the first-line treatment for postmenopausal women with osteoporosis and to increase bone density in men with the disease.
The insurance coverage, however, is applied to the drug as a second-line treatment.
Reimbursement will apply to people who developed osteoporotic fractures despite more than a year of bisphosphonate treatment, or those who have a lower T-score lower after one year of treatment, and those who gained resistance to bisphosphonate treatment such as kidney failure and hypersensitivity reactions.
The drug’s listing price of 215,678 won ($188) per shot which translates to roughly 129,407 won on the patient’s end is notably lower than competitor Lilly Korea’s Forsteo priced at 326,500 won per 2.4 mL.
Those who have a T-score of -2.5 or less or osteoporotic fractures during a follow-up study may be eligible for coverage up to an additional two years, extending the total coverage period to three years, the company said.