Drug pricing nego start in earnest for Tagrisso·Leclaza

Application of initial treatment refund type RSA remains a variable

Leclaza, which is being supplied for free through the EAP, is not applied the initial treatment refund type RSA

Negotiations over the RSA refund rate remain key… equity between the two treatments also requires consideration

With drug pricing negotiations ongoing for the reimbursement of Tagrisso (AZ, osimertinib) and Leclaza (Yuhan, lasertinib) as a first-line treatment for non-small cell lung cancer, whether the two drugs will be applied the initial treatment refund-type RSA (risk-sharing agreement system) remains a variable.

 

Leclaza, which is being supplied for free through the early access program (EAP), is not applied to the initial treatment refund type RSA and the National Health Insurance Service is conducting negotiations in consideration of this.

 

According to industry sources on the 8th, Leclaza began drug pricing negotiations with the National Health Insurance Service at the end of last month.

 

Leclaza was previously recognized as adequate for reimbursement in the first line at the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting that was held on the 12th.

 

Tagrisso had been conducting negotiations with the corporation since the end of September.

 

Given that drug price negotiations are carried out within a 60-day deadline, Tagrisso and Leclaza are expected to complete negotiations in December at the earliest receive reimbursement listing in January.

 

However, a tense tug-of-war between the government and companies is expected over the RSA refund rate.

 

In particular, in the case of Leclaza, as the initial treatment refund type is not included in its RSA, the government is expected to adjust the other refund rates while taking this into account.

 

The initial treatment reimbursement type RSA takes into account uncertainties in effect among others for the initial treatment period.

 

The initial treatment reimbursement type RSA was not applied for Leclaza because the full amount is being supported without limit to patients until its reimbursement listing through the Early Access Program (EAP).

 

However, from the NHIS’s perspective, the authorities would need to adjust the other refund rates as it has no choice but to consider treatment uncertainty and the required finances.

 

Moreover, they also must consider equity with Tagrisso, which is also under negotiation.

 

Due to high interest in the reimbursement of the two drugs, including the National Assembly, the NHIS is expected to speed up negotiations.

 

However, it remains to be seen whether both drugs will succeed in receiving reimbursement together or whether only one drug will be listed for reimbursement.

 

An industry official said, “Their reimbursement depends on how much the pharmaceutical company is willing to give up on the RSA refund rate.

 

Since the government and pharmaceutical companies are all willing to reimburse both drugs, it is highly likely that negotiations will be concluded at an appropriate level.”