Vyndamax is reimbursed for ATTR-CM in Korea

For adults with transthyretin amyloid cardiomyopathy (ATTR-CM)

The first and only treatment option approved for ATTR-CM in Korea

Reimbursement applied when diagnosed with a hereditary type ATTR-CM or diagnosed as wild-type and meets certain conditions

Pic of Vyndamax

Pfizer Korea announced on the 5th that its Vyndamax (tafamidis), a treatment for wild-type or hereditary transthyretin amyloidosis cardiomyopathy (ATTR-CM), has been granted reimbursement by Korea’s National Health Insurance.

 

ATTR-CM is a progressive rare disease in which the naturally circulating transport protein in the blood, transthyretin (TTR), becomes unstable and separates into misfolded monomers, which accumulate in the heart and cause restrictive cardiomyopathy.

 

According to this announcement, Vyndamax may be prescribed with reimbursement in adult patients aged 18 or older who have been diagnosed with hereditary ATTR-CM.

 

Also, wild-type patients who satisfy all of the following conditions may receive the drug with reimbursement: those who ▲are Class I-III in the New York Heart Association (NYHA) heart failure severity classification for the last six months, ▲have received a diagnosis of heart failure and a history of one or more hospitalizations due to heart failure within the last six months, ▲has 600 pg/mL or higher level of pro-B-type natriuretic peptide (NT-proBNP, N-terminal pro-B-type natriuretic peptide level), and ▲have a left ventricular wall thickness at the end of diastole that is 12 mm or more.

 

Vyndamax, which is the first and only approved treatment for adult patients with ATTR-CM in Korea, has secured clinical evidence through the ATTR-ACT study and the ATTR-ACT LTE study.

 

In the ATTR-ACT study, which was conducted to compare the efficacy and safety of Vyndamax and placebo in 441 ATTR-CM patients, about 71% of patients in the tafamidis meglumine group were alive at the 30-month follow-up, showing improved survival compared to the placebo group (about 57%).

 

It also reduced the relative risk of heart-related hospitalizations (0.48/year) by 32% compared to placebo (0.70/year) (95% confidence interval, 0.56-0.81).

 

In addition, according to the results of the ATTR-CM LTE trial, which analyzed long-term survival rates of patients, the patient group that continued to receive tafamidis meglumine showed a reduction in all-cause mortality compared to the patient group that switched from placebo to tafamidis meglumine.

 

Ji-Eun Lee, Head of the Specialty Care Business Unit at Pfizer Korea, said, ” We are pleased to be able to improve the access to treatment for our ATTR-CM patients who have had difficulty using the treatment due to financial constraints despite the availability of this option rather than heart and liver transplantation.

 

We will continue to work to provide innovative treatments to patients with rare diseases, including ATTR-CM, and improve the treatment environment.”