CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tafamidis (Vyndaqel, Vyndamax) — Coverage Criteria for Transthyretin-Mediated Cardiomyopathy

Covers use of tafamidis (Vyndaqel, Vyndamax) for treatment of transthyretin-mediated cardiomyopathy (wild-type or hereditary ATTR-CM) in adults when approval criteria are met; applies to members under the Medicaid scope noted in the document.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTafamidis (Vyndaqel, Vyndamax) coverage criteria for ATTR-CM

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2020

Next Review DateMay 1, 2025

Key ActionObtain prior authorization for tafamidis; a 6-month authorization may be granted when all approval criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization duration

4 caps/dayVyndaqel limit

1 cap/dayVyndamax limit

NYHA I-IIIeligible symptom class

NYHA IVcontinuation exclusion

Coverage Criteria for Tafamidis (Vyndaqel, Vyndamax)

Initial Therapy

Covered when ALL of the following are met

Prescriber: Tafamidis (Vyndaqel or Vyndamax) is prescribed by, or in consultation with, a cardiologist.

Authorization of 6 months may be granted.

Symptoms: Documentation that the member exhibits clinical symptoms of cardiomyopathy and heart failure (e.g., dyspnea, fatigue, orthostatic hypotension, syncope, peripheral edema) classified as New York Heart Association (NYHA) class I, II, or III.NYHA I–III

Cardiac involvement confirmation: Diagnosis confirmed by echocardiography or cardiac magnetic resonance imaging (e.g., end-diastolic interventricular wall thickness exceeding 12 mm).end-diastolic interventricular wall thickness >12 mm

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTafamidis (Vyndaqel, Vyndamax) coverage criteria for ATTR-CM

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2020

Next Review DateMay 1, 2025

Key ActionObtain prior authorization for tafamidis; a 6-month authorization may be granted when all approval criteria are met.

SourceLink

On This Page

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Continuation of Therapy

Covered when ALL of the following are met

Initial criteria maintained: Documentation that the member continues to meet all initial authorization criteria.

Authorization of 6 months may be granted.

NYHA exclusion: Documentation that the member has not progressed to New York Heart Association (NYHA) class IV disease.exclude NYHA IV

Demonstrated benefit: Medical records document a beneficial response to tafamidis, demonstrated by measures such as distance walked on the 6-minute walk test, KCCQ-OS score, cardiovascular-related hospitalizations, left ventricular stroke volume, or NT-proBNP level.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for tafamidis (Vyndaqel/Vyndamax) for treatment of transthyretin-mediated cardiomyopathy (ATTR-CM). Authorization of up to 6 months may be granted when criteria are met.

Authorization duration: up to 6 months when initial or continuation criteria are satisfied
Prescriber requirement: prescribed by or in consultation with a cardiologist

Documentation Required

Combination Therapy Requirement

Requests for tafamidis to be used in combination with a TTR-silencer/reducer (e.g., patisiran/Onpattro, eplontersen/Wainua, vutrisiran/Amvuttra) for members with overlapping ATTR-CM and ATTR-PN require clear justification. Combination therapy will only be considered when documentation shows inadequate response, intolerance, or contraindication to appropriate monotherapy and when a specialist (cardiologist and neurologist as applicable) is involved in care.

Combination therapy prohibited in routine use; must document one of: inadequate response, intolerance, or contraindication to monotherapy
When combination is requested, include documentation of specialist involvement (cardiology and neurology as applicable)
Examples of TTR-silencer/reducers: patisiran (Onpattro), eplontersen (Wainua), vutrisiran (Amvuttra)
Concomitant use with acoramidis (Attruby) is not allowed

Documentation Required

Required Documentation for Initial Authorization

For initial authorization, include documentation confirming cardiac involvement and diagnostic evidence, plus clinical symptom classification and specialist involvement.

Document clinical symptoms of cardiomyopathy/heart failure (e.g., dyspnea, fatigue, orthostatic hypotension, syncope, peripheral edema) and NYHA class I–III
Confirmation of diagnosis by echocardiography or cardiac MRI (e.g., end-diastolic interventricular wall thickness > 12 mm)
Evidence of transthyretin amyloid deposits from cardiac or noncardiac biopsy or positive technetium-labeled bone scintigraphy
For hereditary/variant ATTR-CM, documentation of a pathogenic TTR gene mutation
Rule out systemic light chain (AL) amyloidosis with tests showing absence of monoclonal proteins (serum kappa/lambda free light chain ratio, serum and/or urine immunofixation)
Prescriber: ordered by or in consultation with a cardiologist

Denial Risk

Denial Triggers

Applications may be denied if required documentation or clinical criteria are not met.

No documented cardiac involvement (no supportive echocardiogram or cardiac MRI findings)
Absence of required diagnostic evidence (no biopsy confirmation or positive technetium bone scintigraphy, and AL amyloidosis not adequately ruled out)
NYHA class IV heart failure
Requested use in combination with disallowed agents without required justification or specialist documentation
Member is a liver transplant recipient (exclusion)

Background

Transthyretin‑mediated amyloid cardiomyopathy (ATTR‑CM) is a restrictive cardiomyopathy that results from deposition of transthyretin amyloid in the myocardium and leads to progressive heart failure symptoms. Tafamidis is a transthyretin stabilizer indicated to reduce cardiovascular mortality and cardiovascular‑related hospitalizations in adults with ATTR‑CM. Diagnosis and treatment decisions typically require documentation of clinical cardiomyopathy symptoms (NYHA class I–III), objective evidence of cardiac involvement by echocardiography or cardiac MRI (for example, end‑diastolic interventricular wall thickness >12 mm), confirmation of transthyretin amyloid or precursor proteins by tissue analysis or positive technetium‑labeled bone scintigraphy, and exclusion of light‑chain (AL) amyloidosis.

Definitions

ATTR-CM and role of tafamidis

DefinitionTransthyretin-mediated amyloid cardiomyopathy (ATTR-CM) — cardiomyopathy caused by deposition of transthyretin amyloid in the myocardium (wild-type or hereditary).

Indication for tafamidisTafamidis (Vyndaqel, Vyndamax) is indicated to reduce cardiovascular mortality and cardiovascular-related hospitalizations in adults with ATTR-CM; authorization may be granted for 6 months when criteria are met.

Diagnostic confirmationRequires demonstration of cardiac involvement (imaging or biopsy) and confirmation of transthyretin amyloid or precursor proteins; technetium-labeled bone scintigraphy may be used.

Combination restrictionsTafamidis will not be used in combination with acoramidis, patisiran, eplontersen, or vutrisiran except as allowed by specific combination rules for overlapping disease.

NYHA functional class requirement

NYHA classes includedNew York Heart Association functional classes I, II, or III (mild to moderate limitation from heart failure symptoms) are required for initiation/authorization.

Clinical symptomsExamples include dyspnea, fatigue, orthostatic hypotension, syncope, and peripheral edema as evidence of cardiomyopathy/heart failure symptoms.

Continuation requirementFor continuation of therapy, member must not have progressed to NYHA class IV disease.

DocumentationNYHA class must be documented in medical records as part of initial authorization and continuation assessments.

OpenPayer

Tafamidis (Vyndaqel, Vyndamax) — Coverage Criteria for Transthyretin-Mediated Cardiomyopathy

Coverage Criteria for Tafamidis (Vyndaqel, Vyndamax)

Diagnostic / Measurement Criteria

Provider Actions and Authorization Requirements

Background

Definitions