No new news on reimb extension of Lorviqua for 4mths

When will the reimbursement extension procedures begin for Lorviqua?

No news heard on its progress since the company reapplied for reimbursement extensions in June

Had a rough start as a case where the drug’s reimbursement status was changed from RSA to general listing

No progress has been made on the discussions on the ALK inhibitor anticancer drug ‘Lorviqua,’ which the company had reapplied for first-line reimbursement benefits immediately upon failing to successfully conclude its first drug pricing negotiations.

 

According to industry sources, the health authorities have not decided at what stage they will initiate the process for Pfizer Korea’s ALK-positive NSCLC drug Lorviqua (lorlatinib), for which the company has now terminated the risk-sharing agreement (RSA) and applied to list it through the general reimbursement listing process.

 

It has already been more than 4 months since Pfizer submitted the application for the drug’s general reimbursement listing in June, shortly after negotiations with the National Health Insurance Service broke down over the drug's price.

 

At the time, the NHIS said that the drugmaker had expressed its intention to switch Lorviqua’s reimbursement listing status to general listing, which was listed through the pharmacoeconomic evaluations exemption system as an expenditure cap type RSA, but that the switching cannot be discussed as the company’s application falls under extending its reimbursed scope of use.

 

As a result, the negotiations broke down.

 

However, despite the company’s prompt reapplication thereafter, this delay in the simple initiation of the process itself has left patients waiting without reservation.

 

The issue is in the regulatory process.

 

Currently, RSA drugs can apply for reevaluation upon the expiry of their RSA term, or start their price-volume agreement negotiations from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee’s review stage.

 

However, for RSA drug’s reimbursement extensions, no such streamlined track is available.

 

Moreover, since Lorviqua was originally contracted as an expenditure-cap type RSA drug through the pharmacoeconomic evaluation exemption track but is seeking reimbursement through the general listing track, the government having more difficulty shaping the direction.

 

The problem is that the patients are left to wait without promise.

 

Regardless of whether the drug’s reimbursement will be extended or not, the government's flexible administration and the will of the pharmaceutical companies would be needed to achieve results.

 

Yool-Seo Cho, Director of the Korean Lung Cancer Patients' Association, who leads a community of more than 500 ALK-positive patients and caregivers, said, “It's frustrating for patients to have to wait and watch as Korea's reimbursement standards fail to keep up with treatment guidelines.

 

In ALK-positive NSCLC, access to treatment is a matter of life and death for the patients.” Cho added, “We request the government to actively work to improve patient access to treatment, including the swift review of the reimbursement extension for lorlatinib so that patients can receive the right treatment with less mental suffering and financial burden." Lorviqua was specifically designed and developed by Pfizer to penetrate the blood-brain barrier (BBB).

 

The drug’s high clinical value as a first-line treatment was recognized in the 5-year long-term follow-up results of the CROWN study that was presented at ASCO.

 

Results showed that Lorviqua reduced the risk of disease progression or death by 81% compared to crizotinib, with 60% of patients surviving without disease progression at 5 years.

 

The risk of brain metastasis progression was reduced in 94% of patients, with only 4 of 114 Lorviqua-treated patients without brain metastases developing brain metastases.