Vyndaqel — Blue Cross Blue Shield of Montana

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) 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) 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 patient has an FDA labeled indication, ONE of the following:
• A. Patient’s age is within FDA labeling for the requested indication OR
• B. There is support 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 patient’s diagnosis (e.g., cardiologist, geneticist, neurologist) or has consulted with a specialist AND
• Patient will NOT use the requested agent in combination with another agent targeted in this program, Onpattro, OR Amvuttra, for the requested indication AND
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Length of Approval: 12 months
• Additional approval for Ohio members if ALL apply: member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND patient has no contraindications AND ONE of:
• 1. Patient has another FDA labeled indication for the requested agent and route of administration OR
• 2. Indication supported in compendia OR
• 3. Prescriber submitted two supporting peer-reviewed journal articles (e.g., JAMA, NEJM, Lancet) showing safety and efficacy per accepted trials.

Reauthorization criteria

• Patient previously approved through 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 in area of patient’s diagnosis or has consulted with such specialist AND
• Patient will NOT use requested agent in combination with another agent targeted in this program, Onpattro, OR Amvuttra, for the requested indication AND
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Length of Approval: 12 months

Approval duration

12 months