Vyndaqel (tafamidis meglumine) — Blue Cross Blue Shield of New Mexico

Initial criteria

• The 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) [medical records required] 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 scan, monoclonal antibody studies, biopsy, scintigraphy, genetic testing [TTR genotyping]) [medical records required] 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
• AND
• If the patient has an FDA labeled indication, then ONE of the following:
• A. Patient’s age is within FDA labeling for the requested indication for the requested agent OR
• B. Support exists for using the requested agent for the patient's age for the requested indication
• AND
• Patient has NOT received a liver transplant AND
• Prescriber is a specialist in the area of the diagnosis (e.g., cardiologist, geneticist, neurologist) or has consulted with a specialist AND
• Patient will NOT be using the requested agent in combination with another agent targeted in this program, Onpattro, or Amvuttra, for the requested indication AND
• Patient has NO FDA labeled contraindications to the requested agent
• For Ohio members (Fully Insured or HIM Shop (SG)): ALL of the following:
• 1. Patient has no FDA labeled contraindications to the requested agent AND
• 2. ONE of the following:
• a. Patient has another FDA labeled indication for the requested agent and route of administration OR
• b. Patient has another indication that is supported in compendia for the requested agent and route of administration OR
• c. Prescriber has submitted TWO articles from major peer-reviewed professional medical journals (e.g., JAMA, NEJM, Lancet) supporting the proposed use as generally safe and effective

Reauthorization criteria

• Patient has been previously approved for the requested agent through the plan’s prior authorization process AND
• Patient has had clinical benefit with the requested agent AND
• Patient has NOT received a liver transplant AND
• If requested agent is Vyndamax, Vyndaqel, or Attruby, patient has NYHA Functional Class I, II, or III Heart Failure AND
• Prescriber is a specialist (cardiologist, geneticist, neurologist) or has consulted with a specialist AND
• Patient will NOT be using the requested agent in combination with another agent targeted in this program, Onpattro (patisiran), or Amvuttra (vutrisiran) for the requested indication AND
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months