Lorviqua fails to receive reimb as first-line therapy

ALK+ NSCLC drug...fails pricing negotiations

Lorviqua conditionally passed DREC review in January but failed pricing negotiations

Demonstrated high survival rates as first-line therapy at ASCO…company plans to reattempt reimbursement listing

The reimbursement extension application for Lorviqua, a treatment for anaplastic lymphoma kinase (ALK)-positive non-small-cell cancer,  has failed to go beyond the negotiation stage with the National Health Insurance Service.

 

With the breakdown of the negotiations, the company will have to start over from the application stage for Lorviqua’s reimbursement According to industry sources, Pfizer Korea’s recent negotiations with the National Health Insurance Service for Lorviqua’s reimbursement(NHIS) fell through.

 

Lorviqua is a treatment for ALK (anaplastic lymphoma kinase) positive non-small cell lung cancer, that was listed for reimbursement in September 2022.

 

The drug is currently reimbursed to treat patients with  advanced or metastatic ALK-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib (brand name: Alecensa) or ceritinib (Zykadia) or Xalkori (crizotinib) as first-line ALK tyrosine kinase inhibitor (TKI) therapy, However, patients who received crizotinib (Xalkori) as a first-line ALK inhibitor may also have received alectinib, ceritinib, or brigatinib as a second-line ALK inhibitor and can use Lorviqua with reimbursement.

 

In other words, the drug is covered as second-line or later therapy in patients who have not responded to prior first-line or first- or second-line agents.

 

Lorviqua has become a blockbuster drug since its reimbursement, posting sales of KRW 11.7 billion last year, according to IQVIA.

 

Pfizer has been pushing to extend Lorviqua’s reimbursement to first-line based on clinical data.

 

In January, the Drug Reimbursement Review Committee deemed the drug's reimbursement extension adequate if the company is willing to accept a price lower than the assessed value.

 

Since then, Pfizer has been conducting drug pricing negotiations with the National Health Insurance Service, accepting the committee's opinion.

 

However, the negotiations fell through after the company and the government failed to reach an agreement on the terms of the risk-sharing agreement scheme, etc.

 

As a result, the company will have to start all over again from the reimbursement application stage.

 

At the 2024 American Society of Clinical Oncology Annual Meeting (ASCO 2024), which kicked off last month in Chicago, Pfizer unveiled the 5-year follow-up data on Lorviqua showing a progression-free survival rate of 60%, which is significantly higher than the 8% in the Xalkori arm.

 

The data showed Lorviqua’s advantage in the first-line treatment environment.

 

However, due to its failure to receive reimbursement extensions, existing first and second-line therapies will continue to dominate Korea’s ALK-positive targeted therapy market.

 

Pfizer is reportedly planning to reapply for reimbursement as soon as possible.