Vyndaqel — Blue Cross Blue Shield of Alabama

Initial criteria

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

Reauthorization criteria

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

Approval duration

12 months