PBAC results on Leclaza that was listed in 165 days show...

Used the approval-benefit appraisal linkage system… the nation’s 31st novel drug to be listed at an unprecedented speed

Academic societies “fully expect Leclaza to become an alternative for Tagrisso”

‘Leclaza tab.

 

(lazertinib mesylate monohydrate),' the 31st novel drug to be developed in Korea that received approval for insurance benefit in only 165 days after its approval, was reviewed as a 'new treatment alternative for non-small cell lung cancer patients' in the evaluation process for assessing the reasonableness of the medical care benefits for drugs.

 

The Health Insurance Review and Assessment Service (HIRA) had recently disclosed the results and minutes of the benefit evaluation that was conducted on Leclaza by the Pharmaceutical Benefit Assessment Committee on April 8th.

 

Leclaza was approved by the Ministry of Food and Drug Safety on January 18th as a ‘treatment for patients with EGFR T790M mutation-positive, locally advanced or metastatic NSCLC who were previously treated with an EGFR-TKI, then received reimbursement from July 1st after the notice was issued on the ‘amendment to the drug benefit list and the maximum ceiling price table’ on July 1st.

 

Yuhan Corp had applied for the insurance benefit listing of Leclaza on December 30th, 2020 with the ‘approval-benefit appraisal linkage system.’ Through the system, the drug received insurance benefits at an unprecedented pace - in only184 days from its listing application and 165 days since receiving the marketing authorization.

 

According to data disclosed by HIRA in 2017, it generally takes 1030 days for anticancer drugs, 475 days for rare disease drugs, 550 days for general drugs to receive notification for benefit listing since MFDS approval.

 

Compared to the average, Leclaza shortened the listing registration period by 30 months.

 

As a domestically developed novel drug that received its first approval this year, Leclaza’s approval status in the A7 countries, listing status in drug price reference books, and data on the clinical effectiveness in textbooks and clinical practice guidelines were not available for evaluation.

 

In the PBAC evaluation results disclosed, the committee members concluded that “it is difficult to see a difference between Leclaza, which was approved for the treatment of patients with EGFR T790M mutation-positive, locally advanced or metastatic NSCLC who were previously treated with an EGFR-TKI, and the alternative drug.” Despite the review, the reason why the domestic new drug was able to be listed for reimbursement in only 165 days since its approval was because its reasonableness of receiving medical care benefits was recognized from the cost-effectiveness aspect, as the drug ‘is therapeutically equivalent to Tagrisso (osimertinib) while being cheaper than Tagrisso when using the RSA scheme proposed by the pharmaceutical company.’ The comparator in the evaluation was Tagrisso (osimertinib), and PBAC emphasized that the “evaluation results and conditions of Tagrisso’s RSA scheme should be considered in Leclaza’s pricing negotiations.” Also, relevant academic societies including the Korean Cancer Study Group, Korean Society of Medical Oncology, Korean Association for Lung Cancer added their support, saying that, “Leclaza showed a similar effect to the already-approved Tagrisso, and demonstrated an acceptable safety profile and low cardiac toxicity.

 

We can fully expect Leclaza to become a viable substitute to Tagrisso” The societies requested reimbursement for Leclaza stating that “The drug can bring new opportunity to patients with EGFR T790M mutation-positive, locally advanced or metastatic NSCLC who had limited treatment options.” At the Cancer Disease Deliberation Committee meeting that was conducted on February 24th before the PBAC review, the committee had set the standard - ‘medical care benefit will be recognized for patients with Stage IIIA or higher NSCLC as second-line or later therapy that belong to one of the subject numbers (other than No.22,23,24)' for Leclaza.

 

After deliberation and decision by the PBAC and the negotiations with NHIS that followed from April 23rd to June 8th, Leclaza was applied the RSA refund-type and expenditure cap type and listed for medical care benefit at a ceiling price of ₩68,964 per tablet.