Vyndamax — Blue Cross Blue Shield of Kansas

Initial criteria

• Patient has ONE of the following: (A) ALL of the following: (1) Diagnosis of polyneuropathy of hereditary transthyretin-mediated amyloidosis confirmed by testing (e.g., genetic testing, biopsy) AND (2) Requested agent is FDA labeled for use in polyneuropathy of hereditary transthyretin-mediated amyloidosis AND (3) Patient has clinical manifestations of polyneuropathy (e.g., neuropathic pain, altered sensation, numbness, tingling, impaired balance, motor disability) OR (B) ALL of the following: (1) Diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis confirmed by testing (e.g., PYP scanning, monoclonal antibody studies, biopsy, scintigraphy, genetic testing [TTR genotyping]) AND (2) Requested agent is FDA labeled for use in cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis AND (3) Patient has New York Heart Association (NYHA) Functional Class I, II, or III Heart Failure AND (4) Patient has clinical manifestations of cardiomyopathy (e.g., dyspnea, fatigue, orthostatic hypotension, syncope, peripheral edema) OR (C) Patient has another FDA labeled indication for the requested agent and route of administration
• If patient has an FDA labeled indication, ONE of the following: (A) Patient’s age is within FDA labeling for the requested indication for the requested agent OR (B) There is support for using the requested agent for the patient’s age for the requested indication
• Patient has NOT received a liver transplant
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, geneticist, neurologist) or has consulted with a specialist
• Patient will NOT be using the requested agent in combination with another agent targeted in this program, Onpattro, OR Amvuttra, for the requested indication
• Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• Patient has had clinical benefit with the requested agent
• Patient has NOT received a liver transplant
• If the requested agent is Vyndamax, Vyndaqel, or Attruby, then patient has New York Heart Association (NYHA) Functional Class I, II, or III Heart Failure
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, geneticist, neurologist) or has consulted with a specialist
• Patient will NOT be using the requested agent in combination with another agent targeted in this program, Onpattro, OR Amvuttra, for the requested indication
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months