CurrentUnitedHealthcarePolicy N/A

Tafamidis (Vyndaqel/Vyndamax) prior authorization for transthyretin cardiomyopathy

Criteria and authorization rules for coverage of tafamidis (Vyndaqel/Vyndamax) for adults with transthyretin-mediated cardiomyopathy (ATTR-CM) under UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerUnitedHealthcare

PolicyTafamidis (Vyndaqel/Vyndamax) prior authorization for transthyretin cardiomyopathy

Policy CodePolicy N/A

Change TypeRevised criteria and clarified excluded combination therapies

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization; approvals (initial and reauthorization) are issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Updated clinical criteria for diagnosis of ATTR cardiac amyloidosis and removed criteria allowing for temporary combination therapy.

Added examples of RNA-targeted therapies not to be used in combination with tafamidis (Amvuttra, Attruby, Onpattro, Tegsedi, Wainua).

12 monthsauthorization duration

Adultspopulation

Not allowedcombination therapy

Grade 2/3imaging requirement

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Coverage Criteria for Tafamidis (Vyndaqel/Vyndamax)

Initial Therapy

Covered when ALL of the following are met:

Overall initial criteria

Diagnosis of transthyretin (ATTR)-mediated amyloidosis with cardiomyopathy (ATTR-CM).
Diagnostic confirmation options
- Genetic confirmation: Documentation that the patient has a pathogenic TTR mutation.
- Histologic confirmation: Cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of ATTR amyloid deposits.
Supportive cardiac testing: Echocardiogram or cardiac MRI suggestive of amyloidosis AND radionuclide imaging (99mTc-DPD, 99mTc-PYP, or 99mTc-HMDP) showing cardiac uptake grade 2 or 3.
Clinical heart failure evidence: Either history of heart failure with at least one hospitalization for heart failure OR presence of clinical signs and symptoms of heart failure (e.g., dyspnea, edema).
Prescriber and therapy restrictions: Prescribed by or in consultation with a cardiologist AND patient is not receiving tafamidis (Vyndaqel/Vyndamax) in combination with an RNA-targeted therapy for ATTR amyloidosis (examples: Amvuttra [vutrisiran], Attruby [acoramadis], Onpattro [patisiran], Tegsedi [inotersen], Wainua [eplontersen]).

Reauthorization

Covered for reauthorization when ALL of the following are met:

Reauthorization criteria

Clinical response: Documentation that the patient has experienced a positive clinical response to tafamidis (e.g., improved symptoms, quality of life, slowing of disease progression, decreased hospitalizations).
Functional class: Patient continues to have New York Heart Association (NYHA) Functional Class I, II, or III heart failure.
Exclude light chain amyloidosis: Absence of light chain (AL) amyloidosis.
NT-proBNP and diagnosis confirmation: Physician attests that NT-proBNP level, when combined with signs and symptoms, is considered definitive for diagnosis of ATTR-CM.

Tafamidis (Vyndaqel/Vyndamax) must NOT be used in combination with RNA-targeted therapies for transthyretin (ATTR) amyloidosis. Examples of RNA-targeted agents that are prohibited for concurrent use with tafamidis include Amvuttra (vutrisiran), Attruby (acoramadis), Onpattro (patisiran), Tegsedi (inotersen), and Wainua (eplontersen).

Tafamidis is not indicated for patients with light chain (AL) amyloidosis. For reauthorization and ongoing coverage, the absence of light chain (AL) amyloidosis must be documented; if AL amyloidosis is present, tafamidis would be considered not medically necessary.

Authorization Duration and Imaging Requirements

Authorization duration

Authorization durationInitial and reauthorization approvals issued for 12 months.

Exceptions and notesState mandates, federal requirements, and member-specific benefit plans may affect coverage and duration.

Related programsOther UnitedHealthcare policies and utilization management programs may apply and require separate authorization or notification.

Radionuclide uptake requirement

Required imaging findingRadionuclide imaging (99mTc-DPD, 99mTc-PYP, or 99mTc-HMDP) must show cardiac uptake grade 2 or 3.

Acceptable radiotracers99mTc-DPD, 99mTc-PYP, or 99mTc-HMDP are the specified tracers for assessment.

Provider Requirements, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization required. Authorization will be issued for 12 months. State mandates, federal requirements, and member-specific benefit plans may affect coverage and additional UM programs may apply.

Authorization duration: 12 months
State and plan-level mandates may affect coverage

Documentation Required

Diagnostic Documentation Required

Documented diagnosis of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy is required. Diagnostic evidence should include one of the following: cardiac or noncardiac tissue biopsy demonstrating histologic confirmation of ATTR amyloid deposits OR noninvasive imaging supportive of ATTR-CM (echocardiogram or cardiac MRI suggestive of amyloidosis). Radionuclide imaging (99mTc-DPD, 99mTc-PYP, or 99mTc-HMDP) must show cardiac uptake grade 2 or 3.

Acceptable biopsy evidence: cardiac or noncardiac tissue with ATTR amyloid deposits

Background on Tafamidis and Indication

Tafamidis (Vyndaqel/Vyndamax) are transthyretin stabilizers indicated for transthyretin-mediated cardiomyopathy (ATTR-CM). They act by stabilizing the transthyretin tetramer to reduce disease progression, with demonstrated benefit in reducing cardiovascular mortality and cardiovascular-related hospitalizations in adults with wild-type or hereditary ATTR cardiomyopathy.

Key Definitions Used in This Policy

ATTR-CM (definition)

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

Indication contextTafamidis (Vyndaqel/Vyndamax) is indicated for treatment of cardiomyopathy due to wild-type or hereditary ATTR in adults.

Diagnostic basisDiagnosis may be established by pathogenic TTR mutation or tissue biopsy demonstrating ATTR deposits, supported by cardiac imaging and clinical heart failure evidence.

Grade 2/3 cardiac uptake (definition)

Grade 2 cardiac uptakeMyocardial uptake equal to bone uptake (Perugini visual score 2) — interpreted as consistent with ATTR cardiac amyloidosis when seen on 99mTc-DPD, 99mTc-PYP, or 99mTc-HMDP imaging.

Grade 3 cardiac uptake

Policy Summary

PayerUnitedHealthcare

PolicyTafamidis (Vyndaqel/Vyndamax) prior authorization for transthyretin cardiomyopathy

Policy CodePolicy N/A

Change TypeRevised criteria and clarified excluded combination therapies

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization; approvals (initial and reauthorization) are issued for 12 months.

SourceLink

On This Page

Prescriber and therapy restrictions (reauth): Prescribed by or in consultation with a cardiologist AND patient is not receiving tafamidis (Vyndaqel/Vyndamax) in combination with an RNA-targeted therapy for ATTR amyloidosis (examples: Amvuttra [vutrisiran], Attruby [acoramadis], Onpattro [patisiran], Tegsedi [inotersen], Wainua [eplontersen]).

Clinical roleGrade 2 or 3 uptake is required as supportive evidence of ATTR cardiac amyloidosis for coverage decisions.

Imaging: echocardiogram or cardiac MRI consistent with amyloidosis

Radionuclide imaging uptake: grade 2 or 3 (99mTc-DPD, 99mTc-PYP, or 99mTc-HMDP)

Documentation Required

Prescriber and Clinical Status Documentation

Prescriber must be a cardiologist or the prescription must be made in consultation with a cardiologist. Clinical documentation must record presence or history of heart failure (e.g., prior heart failure hospitalization OR current signs/symptoms such as dyspnea or edema) and confirm New York Heart Association (NYHA) Functional Class I, II, or III. For reauthorization, document positive clinical response and include recent NT-proBNP and other assessments as applicable.

Prescriber requirement: cardiology specialty or documented cardiology consult
Heart failure evidence: prior hospitalization for heart failure OR current signs/symptoms (dyspnea, edema)
NYHA class required: I, II, or III
Reauthorization documentation: evidence of positive clinical response and recent NT-proBNP

Note

Program Automation and Supply Limits

UnitedHealthcare may use automated approval and re-approval processes based on prior claim/medication history, diagnosis codes (ICD-10), and claim logic. Supply limits may apply.

Automated approvals/re-approvals may be used depending on program
Supply limits may be in place

Myocardial uptake greater than bone uptake (Perugini visual score 3) — interpreted as consistent with ATTR cardiac amyloidosis on specified radionuclide imaging.

Imaging requirementRadionuclide imaging demonstrating grade 2 or 3 uptake is required as supportive cardiac testing for coverage consideration.