Yuhan Pharmaceutical’s Leclaza gains reimbursement suitability, alongside Bayer’s Kerendia.

Yuhan Pharmaceuticals' Leclaza and AstraZeneca's Tagrisso / Photo = Respective Companies
Yuhan Pharmaceuticals' Leclaza and AstraZeneca's Tagrisso / Photo = Respective Companies

Yuhan Pharmaceuticals' South Korean-developed Leclaza, featuring Lazertinib, has successfully navigated the drug reimbursement evaluation committee's proceedings to expand the eligibility criteria for first-line lung cancer treatment. Consequently, Leclaza is poised to join AstraZeneca's competing medication, Tagrisso, which contains Osimertinib, in price negotiation talks.

On October 12th, according to sources within the industry, the 11th drug reimbursement evaluation committee of 2023, organized by the Health Insurance Review and Assessment Service (HIRA), convened to appraise the suitability of Leclaza for reimbursement as a first-line treatment for lung cancer. The committee, after careful consideration, affirmed that the expansion of reimbursement criteria for Leclaza in the context of first-line lung cancer treatment is fitting. The next steps will involve the Ministry of Health and Welfare (MOHW) issuing negotiation directives. Subsequently, discussions between the National Health Insurance Service (NHIS), drug pricing, and the estimated claim amount will occur, with the Health Insurance Policy Deliberation Committee determining the final amount.

Of particular note is the concurrent progress of Tagrisso, a competitive drug for the same medical condition, which was cleared by the reimbursement committee the previous month and is currently in the midst of negotiation. As the negotiation phase spans 60 days, there is a substantial likelihood of overlapping negotiation periods for Leclaza and Tagrisso.

Should Yuhan Pharmaceuticals successfully adjust the pricing and estimated claim amounts for Leclaza and conclude negotiations expeditiously, it is plausible that the expansion of reimbursement criteria for both drugs will coincide. It is expected that the decision to expand reimbursement criteria for both medications will be reached within the current year.

Additionally, the drug reimbursement committee has also deemed Bayer Korea's "Kerendia Tablet," containing Finerenone, as suitable for reimbursement. Kerendia, a treatment for type 2 diabetic kidney disease, is a non-steroidal mineralocorticoid receptor antagonist (MRA). It effectively inhibits mineralocorticoid receptor overactivity, leading to reduced inflammation and fibrosis while preventing kidney damage. Kerendia has garnered attention in clinical practice for its potential synergy with existing SGLT-2 inhibitors for diabetes treatment, such as Forxiga and Jardiance.

Kolon Pharma's "Trimbow Inhaler," utilized in the treatment of asthma and chronic obstructive pulmonary disease (COPD), along with Takeda Pharmaceuticals' "Obizur," a therapy for hematological disorders, have also been acknowledged as candidates for reimbursement, considering they meet the evaluation price.

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