Will 'Lorviqua' secure a deal on drug price negotiations?

Reimbursement expansion has been passed as a first-line treatment by the DREC, under the condition

Lorviqua's company applied to terminate the RSA…mentioned in last year's parliamentary audit

Product photo of Lorviqua

The reimbursement expansion case for Lorviqua (lorlatinib, Pfizer), which was stalled during the drug price negotiation last year, has passed the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) under a conditional term.

 

It draws attention to whether it will succeed this round.

 

Pfizer wants the termination of the Risk Sharing Agreement (RSA) and the reimbursement expansion for this drug, so the focus is on whether the company will reach an agreement with the insurance authority.

 

The DREC meeting on January 9 ruled that Lorviqua would be appropriate for expanded reimbursement scope if the company accepted the drug price below the evaluated amount.

 

Consequently, if Pfizer agrees with the drug price below the evaluated amount, it will proceed with the negotiation phase with the NHIS.

 

Lorviqua is under consideration for reimbursement expansion as a first-line treatment for patients with anaplastic Lymphoma Kinase (ALK)-positive and metastatic non-small cell lung cancer.

 

The drug passed the DREC last year, but it failed after negotiating with the National Health Insurance Service (NHIS).

 

It has been reported that the company differed in opinion regarding adjusting the cap for reimbursement ceiling type during the negotiation process.

 

Pfizer wanted to terminate the RSA and switch to general medicine reimbursement.

 

When it was initially approved for reimbursement, Lorviqua was categorized as a reimbursement ceiling type under the cost-effectiveness evaluation waiver system.

 

However, it was approved for being cost-effective after receiving the economic evaluation by the HIRA.

 

However, the company failed to reach an agreement at the drug pricing negotiation because RSA was not terminated.

 

Following the announcement of failed negotiations, doctors and patients called for immediate reimbursement listings.

 

During the parliamentary audit held in October, Rep.

 

Han Ji-ah, a member of the People Power Party, stressed the importance of reimbursement expansion while introducing a male patient's case.

 

Regarding this, Lee Joongkyu, Director of the National Health Policy at the Ministry of Health and Welfare (MOHW), said, "We will help patients receive benefits by quickly reaching an agreement as soon as possible." The NHIS recently revised the RSA guidelines regarding the termination clause.

 

Cost-effectiveness-evaluated drugs like Lorviqua that have demonstrated cost-effectiveness through the DREC review, companies and NHIS can renegotiate to adjust reimbursement ceilings, reset expected claim amounts, or modify·terminate total expenditure-capped RSAs.

 

This opens the possibility of terminating total expenditure-capped RSAs through the renewal of the agreement.

 

Drugs categorized as a basic refund type RSA can be terminated early when a pharmaceutical company wishes to terminate.

 

In the case of Lorviqua, the company applied for RSA termination before the revision, early termination may be possible, even if it is not for renewing contract negotiations.

 

Prior to the revision, drugs were not categorized into specific types that could be terminated early.

 

Consequently, when the company begins negotiation with the NHIS, there will be a discussion about RSA termination and reimbursement expansion.

 

The remaining issue is whether both parties could agree on the drug price without financial burden while allowing RSA termination.

 

In the CROWN trial, Lorviqua reduced the disease progression and death risk by 81% compared to crizotinib, and 60% of treated patients were alive without disease progression after five years.

 

The results indicate that reimbursement of the drug is necessary.

 

The industry draws attention to whether the discussion for expanding Lorviqua's reimbursement, which previously failed in drug pricing negotiations, will lead to an agreement this year.