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    v1.0.28
    OpenPayerPolicy UpdatesCardiologyCareOregon tafamidis Prior Auth Coverage | OpenPay…
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    CurrentcareoregonPolicy N/A

    Vyndamax (tafamidis) prior authorization for ATTR-CM

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    Prior authorization criteria for coverage of Vyndamax (tafamidis) for treatment of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM); applies to prescribers seeking approval for initiation or continuation of therapy under the payer's guideline.

    Policy Summary
    Payercareoregon
    PolicyVyndamax (tafamidis) prior authorization for ATTR-CM
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateJul 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization for initiation or reauthorization; approvals are issued for 12 months.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 moapproval length per authorization
    NYHA I-IIIfunctional class eligible
    Initial & Reauththerapy stages covered
    2026-07-01effective date listed

    Coverage Criteria for Vyndamax (tafamidis)

    Initial/Reauthorization criteria

    Covered when ALL of the following are met:

    Main coverage criteria: Diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM).
    Evidence of TTR etiology: One of the following: (a) presence of a transthyretin (TTR) mutation detected by an FDA-approved or CLIA-approved test; OR (b) cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of TTR amyloid deposits; OR (c) both cardiac MRI or scintigraphy scan suggestive of amyloidosis AND absence of light-chain amyloidosis.
    Functional class: Patient has New York Heart Association (NYHA) Functional Class I, II, or III heart failure.
    Therapy combination restriction: Requested drug is not used in combination with a TTR silencer (e.g., Amvuttra) or a TTR stabilizer (e.g., Diflunisal).
    Policy Summary
    Payercareoregon
    PolicyVyndamax (tafamidis) prior authorization for ATTR-CM
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateJul 1, 2026
    Next Review DateN/A
    Key ActionSubmit prior authorization for initiation or reauthorization; approvals are issued for 12 months.
    SourceLink
    On This Page
    Coverage Criteria for Vyndamax (tafamidis)Provider Requirements and Authorization DetailsDefinitions and EligibilityBackgroundRevision History

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Prescriber requirement: Prescribed by or in consultation with a cardiologist.

    Please use expert/medical director review for high-cost products as needed.

    Use of tafamidis in combination with a transthyretin (TTR) silencer or an additional TTR stabilizer is excluded as a condition of approval. Specifically, requests that involve concurrent use with a TTR silencer (for example, Amvuttra) or with another TTR stabilizer (for example, Diflunisal) will not meet coverage criteria.

    Provider Requirements and Authorization Details

    Prior Authorization

    Prior authorization required; approvals valid 12 months

    Prior authorization is required for both initiation and reauthorization of Vyndamax (tafamidis). Approvals are issued for 12 months per authorization.

    Step Therapy

    No combination therapy with TTR silencers or stabilizers

    Tafamidis must not be prescribed or administered concurrently with a transthyretin (TTR) silencer (for example, Amvuttra) or a TTR stabilizer (for example, Diflunisal); use in combination is excluded as a condition of approval.

    Documentation Required

    Documentation required to support ATTR-CM diagnosis and eligibility

    Submit documentation that confirms ATTR-CM etiology and eligibility: evidence of a pathogenic TTR mutation, or tissue biopsy showing TTR amyloid deposits, or cardiac imaging suggestive of amyloidosis plus exclusion of light-chain amyloidosis; document NYHA functional class (I–III) and that the drug is prescribed by or in consultation with a cardiologist.

    • Genetic testing: presence of a transthyretin (TTR) mutation detected by an FDA-approved or CLIA-approved test (e.g., V122I), or
    • Pathology report: cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of TTR amyloid deposits, or
    • Imaging and lab exclusion: cardiac MRI or scintigraphy suggestive of amyloidosis plus documentation of absence of light-chain amyloidosis
    • Clinical status: documentation of NYHA Functional Class I, II, or III
    • Prescriber statement: prescribed by or in consultation with a cardiologist
    Denial Risk

    Common reasons a request may be denied

    Authorization may be denied if the request does not meet the ATTR-CM coverage criteria, including non-TTR diagnoses, NYHA class IV, use in combination with excluded TTR agents, or if not prescribed by/with consultation from a cardiologist.

    • Diagnosis is not transthyretin-mediated amyloidosis with cardiomyopathy
    • Patient has NYHA Functional Class IV heart failure
    • Requested tafamidis is to be used in combination with a TTR silencer (e.g., Amvuttra) or TTR stabilizer (e.g., Diflunisal)
    • Prescriber is not a cardiologist and no cardiology consultation is documented

    Definitions and Eligibility

    ATTR‑CM diagnostic criteria
    Accepted diagnostic pathwaysDiagnosis requires ATTR-CM PLUS one of: (a) pathogenic TTR mutation detected by FDA‑approved or CLIA‑approved test; (b) cardiac or noncardiac tissue biopsy with histologic confirmation of TTR amyloid; or (c) cardiac MRI or scintigraphy suggestive of amyloidosis plus documented absence of light‑chain (AL) amyloidosis.
    Genetic testing detailPresence of a transthyretin (TTR) mutation (e.g., V122I) detected by an FDA‑approved test or a CLIA‑approved laboratory.
    Biopsy confirmationCardiac or noncardiac tissue biopsy demonstrating histologic confirmation of TTR amyloid deposits.
    Imaging plus exclusion of AL amyloidCardiac MRI or scintigraphy suggestive of amyloidosis AND documented absence of light‑chain (AL) amyloidosis.
    Prescriber requirement (supporting requirement)Prescribed by or in consultation with a cardiologist (required for approval).
    NYHA class eligibility
    Eligible NYHA classesNew York Heart Association (NYHA) Functional Class I, II, or III heart failure are eligible for therapy under this guideline.
    Ineligible class noted in guidanceNYHA Class IV is not included among eligible functional classes and may lead to denial.
    Documentation requirementClinical documentation must support the patient’s NYHA functional class (I–III) as part of prior authorization submission.

    Background

    Transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM) is a progressive infiltrative cardiomyopathy caused by deposition of misfolded transthyretin. Tafamidis (Vyndamax) is indicated for treatment of ATTR-CM to reduce cardiovascular-related morbidity and mortality; appropriate use requires confirmation of TTR etiology (for example, a pathogenic TTR mutation, tissue biopsy confirming TTR amyloid, or cardiac imaging suggestive of amyloidosis with exclusion of light-chain disease) and that the patient has New York Heart Association (NYHA) Functional Class I, II, or III. Prior authorization is required for initiation and reauthorization, with approvals issued for 12 months.

    Revision History

    2026-07-01effective_dateLatest

    Policy effective date: 2026-07-01 for the Vyndamax (tafamidis) prior authorization guideline.

    approval_length_specified

    Approval length specified as 12 months for initial authorization and reauthorization of Vyndamax (tafamidis).

    therapy_stage_specified

    Therapy stages specified include Initial Authorization and Reauthorization for Vyndamax (tafamidis).