Vyndaqel (tafamidis meglumine) — United Healthcare
Transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM)
Initial criteria
- Diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM)
- Patient is not receiving Vyndaqel/Vyndamax in combination with an RNA-targeted therapy for ATTR amyloidosis [i.e., Amvuttra (vutrisiran), Attruby (acoramadis), Onpattro (patisiran), Tegsedi (inotersen), or Wainua (eplontersen)]
Reauthorization criteria
- Documentation that the patient has experienced a positive clinical response to Vyndaqel/Vyndamax (e.g., improved symptoms, quality of life, slowing of disease progression, decreased hospitalizations, etc.)
- Patient is not receiving Vyndaqel/Vyndamax in combination with an RNA-targeted therapy for ATTR amyloidosis [i.e., Amvuttra (vutrisiran), Attruby (acoramadis), Onpattro (patisiran), Tegsedi (inotersen), or Wainua (eplontersen)]
Approval duration
12 months