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  • What now for Vyndamax failing essential drug designation?
  • by Eo, Yun-Ho | translator Byun Kyung A | Feb 8, 2021 06:08am
PE exemption highly unlikely to work, the government and pharmaceutical company should come together for solution
A Phase III trial confirms efficacy of lowering risk of death by all causes and cardiovascular related hospitalization
A transthyretin amyloid cardiomyopathy (ATTR-CM) new drug Vyndamax (tafamidis) seems to be struggling to receive National Health Insurance (NHI) reimbursement in South Korea.

A pharmaceutical industry source reported Pfizer¡¯s new drug treating patients with ATTR-CM Vyndamax (tafamidis 61 mg) has failed to get a treatment-purpose essential drug designation.

But as Vyndamax has comparatively normal patient size, it would be unlikely to get listed for reimbursement with the pharmacoeconomic evaluation (PE) exemption.

Approved in South Korea to treat patients with transthyretin amyloidosis with polyneuropathy (ATTR-PN) in October 2018, Vyndaqel (tafamidis 20 mg) has highly limited patient size for the heredi
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