ATTR Amyloid Cardiomyopathy Prior Authorization Drug List A
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Defines prior authorization criteria and approval durations for tafamidis (Vyndaqel, Vyndamax) and acoramidis (Attruby) when used to treat transthyretin (ATTR) amyloid cardiomyopathy for members of Curative Health Plan.
No material clinical or coverage changes in this revision.
Coverage Criteria for TTR-directed Therapies
Initial Therapy — Covered when ALL of the following are met:
Covered when ALL of the following are met:
Initial Therapy Criteria
- Chart notes document ATTR amyloid cardiomyopathy (also known as ATTR cardiac amyloidosis) within the past 90 days.
- If the request is for Vyndaqel or Vyndamax, there is documented failure to Attruby.
- Diagnosis of ATTRwt-CM or ATTRv-CM is confirmed by one of: monoclonal antibody studies with scintigraphy using a technetium radiopharmaceutical, tissue biopsy, or TTR gene sequencing.
- Patient has clinical manifestations of cardiomyopathy (for example: dyspnea, fatigue, orthostatic hypotension, syncope, peripheral edema).
- Patient has NYHA functional class I, II, or III.
- Patient has not received a liver transplant.
- Prescriber is a specialist or has consulted with a specialist in the area of the patient's diagnosis (e.g., cardiologist, geneticist, neurologist).
- Chart notes and/or prescriber do not document concurrent use of the requested agent with another TTR-directed therapy (e.g., Amvuttra, Attruby, Onpattro, Vyndaqel, Vyndamax, or Wainua).
Continued Therapy — Covered when ALL of the following are met:
Covered when ALL of the following are met:
Continued Therapy Criteria
- Chart notes document amyloid cardiomyopathy within the past 12 months.
- Patient was previously approved for the requested agent through the plan's prior authorization process or meets the initial therapy criteria.
- There is documented clinical benefit since starting the requested agent (for example: improvement or stabilization in 6-minute walk distance or other heart failure-related signs/symptoms, or a reduction in cardiovascular-related hospitalizations).
- Patient has not received a liver transplant.
- Prescriber is a specialist or has consulted with a specialist in the area of the patient's diagnosis (e.g., cardiologist, geneticist, neurologist).
- Chart notes and/or prescriber do not document concurrent use of the requested agent with another TTR-directed therapy (e.g., Amvuttra, Attruby, Onpattro, Vyndaqel, Vyndamax, or Wainua).
Concurrent use of the requested agent with another transthyretin (TTR)‑directed therapy is not allowed. Chart notes and/or the prescriber must not document use of the requested agent in combination with another TTR‑directed therapy (for example, Amvuttra, Attruby, Onpattro, Vyndaqel, Vyndamax, or Wainua). Requests that indicate combination therapy will not meet the coverage criteria and may be denied.
For requests for Vyndaqel or Vyndamax, the policy requires documented failure to Attruby as part of the initial therapy criteria. A request for Vyndaqel or Vyndamax without prior documented failure to Attruby does not meet initial therapy criteria and is not medically necessary under this policy.
Key Coding and Clinical Labels
Provider Actions, Documentation, and Prior Auth Requirements
Prior authorization required for FDA‑approved indication
Prior authorization is required; approvals are granted when the requested medication is being used for an FDA‑approved indication and all specified initial or continued therapy criteria are met.
Step therapy — failure to Attruby required for Vyndaqel/Vyndamax
For requests for Vyndaqel or Vyndamax, the request must include documentation of prior failure to Attruby before the plan will approve Vyndaqel or Vyndamax.
- If request is for Vyndaqel or Vyndamax, must have documented failure to Attruby.
Required documentation and recency
Provide chart notes demonstrating ATTR amyloid cardiomyopathy and supporting diagnostic information within the required recency: within 90 days for initial therapy and within 12 months for continued therapy.
- Initial therapy: chart notes indicating ATTR cardiac amyloidosis within past 90 days.
- Continued therapy: chart notes indicating amyloid cardiomyopathy within past 12 months.
- Diagnostic confirmation: scintigraphy with technetium radiopharmaceutical, tissue biopsy, or TTR gene sequencing.
- Include NYHA functional class, clinical manifestations, prior authorization history, and documentation of clinical benefit for continuation.
Denial risks for missing documentation or requirements
Requests risk denial if chart notes do not document ATTR cardiac amyloidosis within the required timeframe, if diagnosis is not confirmed by the required testing, if the patient has received a liver transplant, if the prescriber is not a specialist (or has not consulted one), if the agent is used concurrently with another TTR‑directed therapy, or (for Vyndaqel/Vyndamax) if there is no documented failure to Attruby.
- Denial risk when initial-chart-note recency (90 days) or continued recency (12 months) not met.
- Denial risk if diagnostic confirmation (scintigraphy, tissue biopsy, or TTR gene sequencing) is absent.
- Denial risk if patient has received a liver transplant.
- Denial risk if prescriber is not a specialist and no specialist consultation is documented.
- Denial risk if requested agent is used concurrently with another TTR-directed therapy (e.g., Amvuttra, Attruby, Onpattro, Vyndaqel, Vyndamax, Wainua).
- For Vyndaqel/Vyndamax, denial risk if no documented failure to Attruby.
Background
Transthyretin (ATTR) amyloid cardiomyopathy (also referred to as ATTR cardiac amyloidosis) is a disease caused by deposition of misfolded transthyretin in the myocardium leading to cardiomyopathy. Clinical manifestations commonly include dyspnea, fatigue, orthostatic hypotension, syncope, and peripheral edema. Diagnostic confirmation may be established by radionuclide scintigraphy with a technetium‑labeled radiopharmaceutical, tissue biopsy, or genetic testing (TTR gene sequencing) to distinguish wild‑type (ATTRwt‑CM) from variant (ATTRv‑CM) forms. Disease‑modifying, TTR‑directed therapies (e.g., tafamidis formulations and transgene‑targeting agents) are subject to prior authorization and the specific initial and continued therapy criteria described in this policy.
Definitions
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