Bayer Korea's hemophilia treatment, 'Jivi,' and Roche's macular degeneration treatment, 'Vabysmo,' both previously considered non-reimbursable, have now been included in the reimbursement system, having agreed to pricing terms below the evaluation threshold.

On September 25th, the Ministry of Health and Welfare's Health Insurance Policy Deliberation Committee made crucial decisions regarding health insurance reimbursement and maximum pricing for new pharmaceuticals.

For Jivi, the upper limit has been established at $0.51. Jivi, which applied for insurance coverage a year after receiving approval from the Ministry of Food and Drug Safety (MFDS) in July 2022, is now eligible for reimbursement.

The Pharmaceutical Benefit Evaluation Committee assessed Jivi as a replacement therapy for "Hemophilia A (congenital deficiency of clotting factor VIII) in adult and adolescent patients for the management of bleeding episodes, prophylaxis, and perioperative management of bleeding, and routine prevention of bleeding episodes." They found it suitable for reimbursement if it accepted pricing below the evaluation threshold, provided its efficacy was similar to that of existing replacement therapies and if it was cost-effective.

As a result, Bayer agreed to a price below the evaluation threshold for Jivi, bypassing the drug price negotiation process. The negotiation exemption criteria for biopharmaceuticals like Jivi was set at 100% of the weighted average price of alternative drugs.

The annual per capita cost for Jivi is approximately $62,000 for adults, resulting in a patient's out-of-pocket expense of around $3,000 when a 5% co-payment is applied.

In the realm of macular degeneration treatment, options have expanded. The upper limit for Vabysmo has been set at $514.58, rendering it eligible for reimbursement starting in October.

Vabysmo is a medication approved for the treatment of neovascular (wet) age-related macular degeneration and vision impairment caused by diabetic macular edema. The Pharmaceutical Benefit Evaluation Committee determined that its effectiveness was on par with alternative drugs but at a higher cost, making its cost-effectiveness unclear.

However, Roche agreed to pricing below the weighted average cost of alternative drugs, leading to its inclusion in the reimbursement program. Roche skipped the drug price negotiation process and only engaged in negotiations regarding the expected reimbursement amount. The annual per capita cost is approximately $2,054, but with a 30% co-payment, the patient bears $613.48.

Furthermore, risk-sharing contracts for Pfizer's leukemia treatment, 'Besponsa,' and Takeda Pharmaceuticals' ovarian cancer treatment, 'Zejula Capsules,' which had previously expired, have been renewed.

Besponsa was deemed cost-effective, and the renewal negotiations factored in aspects like the application of the risk-sharing agreement (RSA) as a subsequent drug, allowing for the omission of economic evaluation data submission. In the case of Zejula, its lower medication cost compared to alternative drugs and its status as a first-line treatment, combined with the continuation of a risk-sharing contract, led to the decision to renew the contract.