The cardiomyopathy drug 'Vyndamax' is reimbursed

A new treatment option becomes available

Attempted to get listed for the past 4 years since 2021

Demonstrated improvement in a 6 minute walk test

'Vyndamax,' a new drug for the treatment of transthyretin amyloid cardiomyopathy, has recently been added to the insurance reimbursement list after five attempts.

 

Three years have passed since the company initially applied for the listing.

 

Product photo of Vyndamax

Consequently, the prescription of Pfizer Korea's Vyndamax (tafamidis 61 mg) is now covered with reimbursement for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM).

 

Vyndamax was approved in August 2020 in South Korea.

 

It has finally been added to the reimbursement listing after multiple rounds of challenges.

 

At its first attempt at reimbursement in early 2021, Vyndamax failed to receive designation as an essential medicine.

 

After that, the economic evaluation was conducted in the first half of the same year, and a second attempt was made through the Risk Sharing Agreement (RSA) program.

 

However, it received the same result.

 

In April 2022, the drug had not passed the reimbursement criteria committee of the Health Insurance Review and Assessment Service (HIRA).

 

It passed the committee review in July of the same year.

 

However, after 9 months, it received a non-reimbursement decision from the Drug Reimbursement Evaluation Committee (DREC) review.

 

An agreement had not been reached between the government and the pharmaceutical company regarding the RSA.

 

After that, Pfizer re-applied for the reimbursement process in June 2024.

 

It passed the DREC review in October of the same year and reached an agreement with the National Health Insurance Service (NHIS) last month.

 

Vyndamax's ceiling price has been set as KRW 100,000.

 

Vyndamax is a product that received approval after adjusting a dosage of tafamidis, the same active ingredient in Vyndaqel, a treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP).

 

Some view that the company strategized this to aim at differential drug pricing.

 

Reimbursement news is regarded as favorable since the company finally gained listing after five attempts over 4 years.

 

Patients now only have to pay 10% of the drug price with the special exemption coverage.

 

Meanwhile, the efficacy of Vyndamax was demonstrated through the Phase ATTR-ACT study, which showed Vyndamax reduced the occurrence of cardiovascular-related events and improved 6 minutes walking test in CM patients.

 

In the ATTR-ACT study, 441 patients were randomly assigned at a 2:1:2 ratio to the tafamidis 80 mg treatment group, the tafamidis 20 mg treatment group, and the placebo group.

 

The primary endpoint was hierarchical evaluation of all-cause mortality and cardiovascular-related hospitalizations.

 

The study's secondary endpoints were changes in the 6 minute walk test and the 'Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS)' score, which indicates better health conditions with a higher score from the baseline up to 30 months after treatment.

 

The study results showed that the tafamidis treatment groups had statistically lower all-cause mortality or cardiovascular-related hospitalizations compared to the placebo group.