Vyndamax & Vyndaqel– NC Standard

Restricted Product(s)

• Vyndamax™ (tafamidis) 
• Vyndaqel® (tafamidis meglumine)

FDA Approved Use

• Indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.

Criteria for Approval of Restricted Product(s)

1. The patient is 18 years of age or older; AND 
2. The patient has a diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) as confirmed by radionuclide bone scintigraphy with technetium-labeled bisphosphonates or cardiac biopsy (medical record documentation required); AND 
3. The patient has clinical manifestations of cardiomyopathy (e.g., dyspnea, fatigue, orthostatic hypotension, syncope, peripheral edema) (medical record documentation required); AND 
4. The patient will NOT use Vyndamax and Vyndaqel concurrently with each other; AND 
5. The patient will NOT be using Vyndamax or Vyndaqel in combination with Onpattro or Amvuttra; AND 
6. The patient does not have NYHA functional class IV heart failure; AND 
7. The patient has an estimated glomerular filtration rate ≥ 25 mL/min/1.73m2 (medical record documentation required); AND 
8. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
9. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., geneticist, cardiologist); AND 
10. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. (medical records and references / evidence must be provided); AND 
11. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
    
    Duration of Approval: 365 days (1 year)

Continuation Criteria

1. The patient has been previously approved with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND 
2. The prescribed dose and quantity are appropriate based on intended use and FDA labeling; AND 
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., geneticist, cardiologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND 
4. The patient has shown a clinical benefit with the requested agent (i.e. decrease in cardiac-related hospitalizations, improvement in cardiac symptoms, improvement in 6-Minute Walk Test (6MWT) (medical record documentation required); AND 
5. Vyndamax and Vyndaqel will continue to NOT be used concurrently with each other; AND 
6. Vyndamax or Vyndaqel will continue to NOT be used in combination with Onpattro or Amvuttra.

Duration of approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
2. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
3. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
   
   Duration of Approval: 365 Days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

July 2022 v2: Criteria change: Added requested medication cannot be used in combination with Amvuttra to initial and continuation criteria.
July 2022: Criteria change: Updated initial criteria to include heart failure classification, glomerular filtration rate and cardiomyopathy symptoms. Updated medications which cannot be used in combination with Vyndamax or Vyndaqel. Added prescriber is a specialist or consulted a specialist. Added dose and quantity are appropriate based on FDA labeling. Added continuation criteria.
Dec 2021: Criteria update: Annual criteria review: No changes to policy.
Sept 2019: Original utilization management criteria issued.