Attruby — Blue Cross Blue Shield of Texas

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) 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., stannous pyrophosphate [PYP] scanning, monoclonal antibody studies, biopsy, scintigraphy, genetic testing [TTR genotyping]) 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 AND
• 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 AND
• 3. The patient has NOT received a liver transplant AND
• 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 AND
• 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 AND
• 6. The patient does NOT have any FDA labeled contraindications to the requested agent
• Additional approval path (Ohio Fully Insured or HIM Shop plans):
• 1. Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND BOTH of the following:
• A. The patient does NOT have any FDA labeled contraindications to the requested agent AND
• B. ONE of the following: another FDA labeled indication; indication supported in compendia; or TWO peer-reviewed journal articles supporting proposed use with acceptable study design.

Reauthorization criteria

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

Approval duration

12 months