Pricing negotiations complete for Pfizer’s Vyndamax

May be listed as soon as March…the only treatment for ATTR-CM

Pfizer has completed pricing negotiations with the National Health Insurance Service for its cardiomyopathy drug, Vyndamax Cap (tafamidis).

 

As a result, the drug is soon expected to be listed for reimbursement benefits in Korea.

 

Four and a half years after its approval in August 2020, the drug is finally being included in Korea’s health insurance system.

 

According to industry sources on the 7th, the National Health Insurance Service and Pfizer Korea recently agreed on the insurance price of Vyndamax Cap 61 mg, for which the pricing negotiations began in December last year.

 

The NHIS and Pfizer reportedly reached an agreement through a risk-sharing agreement.

 

Vyndamax has gained attention as the only treatment option for ATTR amyloidosis with cardiomyopathy (ATTR-CM).

 

ATTR-CM is a devastating disease with a median survival of 2 to 3.5 years without adequate treatment but has been poorly treated, either because it is mistaken for simple heart failure or because there are no other treatments available.

 

In this area with a dire need, Vyndamax has demonstrated its efficacy in reducing the incidence of cardiovascular events and improving the 6-minute walk test in CM patients through the Phase 3 ATTR-ACT study.

 

Although it is the only treatment for the disease, its approval process has not been smooth.

 

After receiving domestic approval in 2021, the company began to pursue reimbursement in earnest but was stuck in HIRA’s evaluation phase.

 

In April 2022, the drug failed to pass HIRA’s Drug Reimbursement Subcommittee in April 2022, and then was presented to the Drug Reimbursement Evaluation Committee (DREC) review in April 2023, the last stage of HIRA’s review, but was not deemed adequate for reimbursement.

 

However, in October of last year, it finally passed the DREC review and has been negotiating with the NHIS since early December by the Ministry of Health and Welfare's negotiation order.

 

By completing negotiations with the NHIS, the reimbursement listing process has now been virtually completed.

 

The only remaining procedures are the report to the Ministry of Health and Welfare’s Health Insurance Policy Deliberation Committee (HIPDC) and notification.

 

It is expected that the report will be presented to the HIPDC as early as this month and will be listed for reimbursement on March 1.

 

As the only treatment for ATTR-CM, Vyndamax’s reimbursement will provide patients with much better access to treatment.

 

As of 2021, there are 75 patients with ATTR-CM in Korea.