Discussion of reimbursement for Vyndamax is running in place

Schedule delay after passage of subcommittee

Virtually the only ATTR-CM treatment option

It seems that discussions on registration of transthyretin (TTR) amyloid cardiomyopathy drug 'Vindamax' for insurance benefits are at a standstill again.

 

As a result of the coverage, Pfizer Korea's ATTR-CM (ATTR amyloidosis with cardiomyopathy) treatment Vyndamax, (Tafamidis 61mg) passed the HIRA last year, but the schedule for presentation to the Pharmaceutical Reimbursement Evaluation Committee has not yet been set.

 

there is.

 

In fact, it is judged that the discussion has ceased.

 

The passage of the standard subcommittee itself was the result of only the fourth challenge, but it disproves that the gap between the government and pharmaceutical companies remains.

 

Vyndamax failed to designate an essential drug in its first reimbursement challenge in early 2021.

 

Afterward, an economic evaluation was conducted in the first half of the same year and a second challenge was reached through a Risk Sharing Agreement, but the results were the same.

 

And in April of last year, it failed to exceed the standard subcommittee again, but in the second half of last year, it barely made a step forward.

 

However, it is judged that there were still difficulties in finding a point of agreement in terms of financial sharing.

 

It remains to be seen whether Vyndamax will be able to supplement the data again and continue discussions on salary listing.

 

Meanwhile, Vyndamax is virtually the only ATTR-CM treatment option.

 

ATTR-CM has been regarded as a disease with poor treatment results because it is misdiagnosed as simple heart failure or has no treatment, even though it is fatal enough that the survival period is only 2 to 3.5 years if not treated appropriately.

 

In this situation, Vyndamax is a drug that has been shown to reduce the occurrence of cardiovascular events in CM patients through the phase 3 ATTR-ACT study and to improve the 6-minute walking test.

 

In the ATTR-ACT study, 441 patients have randomized to Tafamidis 80 mg, Tafamidis 20 mg, and placebo in a 2:1:2 ratio.

 

The main secondary endpoints of the study were the change in the 6-minute walk test from baseline to 30 months, the Kansas City Cardiomyopathy Questionnaire-Overall Summary, and the KCCQ-OS score, where higher scores mean better health.

 

As a result of the study, the Tafamidis-administered group showed a statistically significantly lower risk of all-cause death and cardiovascular-related hospitalization compared to the placebo-treated group.