Vyndaqel — Blue Cross Blue Shield of Oklahoma

Initial criteria

• 1. The patient has ONE of the following: A. ALL of the following: 1. A diagnosis of polyneuropathy of hereditary transthyretin-mediated amyloidosis confirmed by testing (e.g., genetic testing, biopsy) [medical records including chart notes, lab results are required] AND 2. The requested agent is FDA labeled for use in polyneuropathy of hereditary transthyretin-mediated amyloidosis AND 3. The 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. A 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]) [medical records including chart notes, lab results are required] AND 2. The requested agent is FDA labeled for use in cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis AND 3. The patient has New York Heart Association (NYHA) Functional Class I, II, or III Heart Failure AND 4. The patient has clinical manifestations of cardiomyopathy (e.g., dyspnea, fatigue, orthostatic hypotension, syncope, peripheral edema) OR C. The patient has another FDA labeled indication for the requested agent and route of administration
• 2. If the patient has an FDA labeled indication, then ONE of the following: A. The 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
• 3. The patient has NOT received a liver transplant
• 4. 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
• 5. 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
• 6. The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• 2. The patient has had clinical benefit with the requested agent
• 3. The patient has NOT received a liver transplant
• 4. If the requested agent is Vyndamax, Vyndaqel or Attruby, then the patient has NYHA Functional Class I, II, or III Heart Failure
• 5. 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
• 6. The 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
• 7. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months