Yuhan’s Leclaza reimb. held back by companion diagnostics

MOHW decides to temporally suspend public notice of Leclaza following the objection filed against the drug

Lacks in-vitro diagnostics device approved by MFDS to prescribe Leclaza

Reimbursement of the novel domestic drug ‘Leclaza’ that was due today (July 1st) was postponed.

 

The listing process of Yuhan Corporation’s new drug which had been progressing at an unprecedented pace came to a full stop due to ‘companion diagnostics.’ Dailypharm found that the Ministry of Health and Welfare had pulled a temporary stop on the enforcement of the notice related to Leclaza (lazertinib).

 

Leclaza was supposed to be listed from July after passing the Health Insurance Policy Deliberative Committee’s review on the 25th of last month.

 

The brakes were pulled by an objection that was registered during the pre-announcement of administration period regarding the lack of a companion diagnostics device Delayed listing of a drug that has already passed the HIPDC deliberations is rare.

 

Since 2018, the Ministry of Food and Drug Safety had regularized a sort of ‘customized use’ of in-vitro companion diagnostics devices through the ‘Guideline on the Review & Approval of companion diagnostic medical devices,’ under which a drug and the companion diagnostics device used as the basis for medications and prescriptions are reflected together in the license.

 

The measure was implemented to precisely screen patients eligible for each prescribed drug target.

 

The problem was that no MFDS-approved diagnostic device existed for the purpose of prescribing Leclaza even though the drug already passed the HIPDC review.

 

Under the current regulations, 3rd generation EGFR TKIs like ‘Tagrisso (Osimertinib)’ and Leclaza may only be prescribed to ‘patients whose EGFR T790M mutation status has been confirmed with an in-vitro diagnostic medical device approved by MFDS.’ In-vitro diagnostic medical devices that are approved and used to identify the EGFR T790M mutation status in Korea include the blood-based ‘Cobas EGFR Mutation Test,’ and ‘PANAMutyper EGFR Kit,’ among others.

 

However, these devices are only approved to be used to screen patients for Tagrisso.

 

In other words, the objection was that Leclaza prescriptions, if made, are all off-label prescriptions, and therefore unfit for reimbursement.

 

As the health authorities have been limiting reimbursement of anticancer therapies with targets such as Tagrisso, the immunotherapy ‘Keytruda (pembrolizumab).’ ‘Tecentriq (atezolizumab),’ the ALK-inhibitor ‘Xalkori (crizotinib), and 'Alubrig (brigatinib)' to those that have used approved diagnostic devices to prescribe the therapies, it was difficult for the government to overlook the objections made regarding this matter.

 

Accordingly, the MFDS had requested the Ministry of Food and Drug Safety to deliberate on whether the in-vitro diagnostic device needed for the prescription of Leclaza should be regarded as a 'companion diagnostics device.' To add an in-vitro companion diagnostic device to a drug's license, additional data that demonstrates that the diagnostic device used in the clinical trial and the device the company wishes to register is equivalent in identifying EGFR T790M mutations need to be submitted.

 

Generally, it takes around 3 to 4 months for the tests to be conducted and the MFDS license to be updated.