Lorviqua, Tevimbra, Pemazyre enter NHIS negotiations

NHIS announces news of their negotiations…whether Lorviqua’s RSA will be terminated gains attention

Pfizer

Three items, including Lorviqua (lorlatinib, Pfizer Korea), Tevimbra Inj 100 mg (tislelizumab, BeiGene Korea), and Pemazyre (pemigatinib, Handok), are currently under negotiations with the National Health Insurance Service.

 

These drugs were deliberated by the Health Insurance Review and Assessment Service Drug Reimbursement Evaluation Committee (DREC) on January 9 and were deemed adequate for reimbursement.

 

According to industry sources on the 17th, the National Health Insurance Service updated the website with information on drug price negotiations for 3 items.

 

The National Health Insurance Service discloses information on the progress of negotiations for new drugs, drugs exempt from drug price negotiations, and drugs with expanded indications on its website.

 

Upon the Ministry of Health and Welfare's negotiation order, the NHIS begins drug price negotiations with individual pharmaceutical companies.

 

However, drugs for which the company has accepted the assessed amount to receive drug price negotiation exemptions will only be subject to negotiations on the expected claim amount.

 

Among the 3 items currently under negotiations, Tevimbra and Pemazyre are expected to have entered into negotiations with the NHIS as expected, as they were recognized by the DREC as adequate for reimbursement without conditions.

 

However, Lorviqua Tab, which is applying for the reimbursement extension as a first-line treatment for anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer, was judged by DREC to be “appropriate for reimbursement extensions if the company accepts a price less than the evaluated amount,” so NHIS negotiations for the drug was only possible after the pharmaceutical company accepted the condition.

 

Pfizer is expected to accept the 'below the evaluation price' proposed by DREC and will again try to win the bid through negotiations with the National Health Insurance Service, as it did last year.

 

Last year, the drug price negotiations broke down due to disagreements over the adjustment of the expenditure cap under the Expenditure Cap type of Risk Sharing Agreement (RSA).

 

The Expenditure Cap type is a system in which the pharmaceutical company refunds the excess amount of the claim to the National Health Insurance Service if it exceeds the set total amount (cap).

 

For this reason, in the case of Lorviqua, the profit earned by the pharmaceutical company also changes depending on how the total amount is set when expanding reimbursement.

 

Pfizer has applied to terminate the RSA contract with NHIS and wants to expand the reimbursement without an expenditure cap.

 

Therefore, it is expected that the termination of the RSA contract and the financial sharing plan will be the key to reaching an agreement during negotiations.

 

Meanwhile, Tevimbra is a treatment for esophageal squamous cell carcinoma from the Chinese pharmaceutical company BeiGene Korea, and Pemazyre, which is imported by Handok, is a treatment for FGFR2 fusion or rearrangement cholangiocarcinoma.

 

If these products reach an agreement with the NHIS, they will be added to the drug reimbursement list after reporting to the Ministry of Health and Welfare's Health Insurance Policy Review Committee.