The government granted health insurance benefits for Bausch Health Korea’s glaucoma treatment Vyzulta Eye Drops 0.024% (ingredient: latanoprostene bunod), and Kolon Pharma’s psoriasis treatment Skilarence Enteric Coated Tab. 120mg (dimethyl fumarate) from February.
Also, the government expanded the reimbursement scope for Pfizer’s Besponsa Inj. (inotuzumab ozogamicin), treatment for acute lymphoblastic leukemia. The benefit will cover not only Philadelphia chromosome-negative acute lymphoblastic leukemia remission induction therapy but Philadelphia chromosome-positive acute lymphoblastic leukemia remission induction and positive/negative acute lymphoblastic leukemia remission consolidation therapy.
The broader insurance coverage for Besponsa also starts from Feb. 1.
The Ministry of Health and Welfare’s health insurance policy review committee made the decisions at a meeting to decide the maximum reimbursement rates on certain medicines on Thursday.
The government set the final cap of the reimbursement rate for Vyzulta at 14,095 won ($11.7) per 2.5ml and 21,143 won per 5ml.
Vyzulta eye drop is a prostaglandin derivative that reduces intraocular pressure. It is used as a first-line treatment for open-angle glaucoma or ocular hypertension. Vyzulta proved clinical usefulness by demonstrating non-inferiority to alternative drugs such as prostaglandin derivatives -- bimatoprost, latanoprost, tafluprost, and travoprost -- in clinical trials.
The government said even though Vyzulta was clinically useful compared to alternative medicines, its reimbursement would be eligible at 90 percent of the weighted average price of alternative drugs (15,662 won per 2.5ml, 23,493 won per 5ml).
After the government and Bausch Health Korea reflected on Vyzulta’s clinical usefulness and expected market share, they agreed that the estimated reimbursement billing amount would be 2.1 billion won.
Skilarence is an oral, systemic treatment for psoriasis. It is recommended as second-line therapy for long-term use or when other systemic therapy fails.
Skilarence obtained the marketing approval in May 2020. It proved non-inferiority to alternative drugs such as Cipol-N Soft Cap., Methotrexate Tab., and Neotigason Cap. 10mg.
Skilarence is eligible for health insurance benefits if the drug price is set at 90 percent of the weighted average price of alternative drugs (448 won per 30mg, 1,120 won per 120mg), the government said.
Given the market size, an estimated market share reflecting clinical usefulness, the estimated total reimbursement for Skilarence would be 2.8 billion won.
Besponsa is a treatment for acute lymphoblastic leukemia that obtained the permit in January 2019 and reimbursement in October 2019. At the time, the maximum benefit rate was 11.82 million won per bottle.
This year, Besponsa’s indication was expanded to Philadelphia chromosome-positive acute lymphoblastic leukemia remission induction and positive/negative acute lymphoblastic leukemia remission consolidation therapy.
The broader indication for Besponsa was based on the U.S. National Comprehensive Cancer Network (NCCN) treatment guidelines. Clinical trials also found that the treatment demonstrated clinical improvement compared to the standard of care FLAG therapy (fludarabine, cytarabine, and G-CSF).
If Pfizer accepts Besponsa’s price to be lower than the weighted average price of Blincyto Inj. (11.74 million won/1 mg/bottle), the drug price would be cost-effective, the government said. The Korean Society of Hematology also suggested that Besponsa’s efficacy was similar to alternative drugs, including Blincyto Inj.
Pfizer Korea and the government signed a risk-sharing agreement (RSA) in expenditure cap type for Besponsa.
In the expenditure cap type of RSA, if the actual amount of reimbursement billing exceeds the expected amount, the government retrieves the excess amount from the pharmaceutical company.
The government set the reimbursement rate at 11.44 million won, 3.2 percent lower than the current 11.82 million won.
The government expected that the broader reimbursement for Besponsa would raise the reimbursement amount by 1 billion won per year additionally.
It is also expected to save health insurance costs as the drug price was set below the weighted average price of alternative drugs.