CurrentAvMedPolicy N/A

Transthyretin (TTR) stabilizer prior authorization (Attruby, Vyndamax, Vyndaqel)

This form and policy govern prior authorization and step-edit requests for transthyretin (TTR) stabilizer drugs (acoramidis, tafamidis formulations) for AvMed members; it applies to prescribers requesting coverage and specialty pharmacy fulfillment.

Policy Summary

PayerAvMed

PolicyTransthyretin (TTR) stabilizer prior authorization (Attruby, Vyndamax, Vyndaqel)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign and print name on the prior authorization request and submit required clinical documentation (labs, imaging, chart notes) by fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsApproval duration

18+Minimum age

4/dayAttruby limit

1/dayVyndamax limit

4/dayVyndaqel limit

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Authorization Criteria

Covered when ALL of the following are met

Age and prescriber: Member is 18 years of age or older AND prescribed by or in consultation with a cardiologist

Evidence of cardiac amyloidosis with heart failure: Member has echocardiogram or cardiac magnetic resonance imaging suggestive of amyloidosis (left ventricular wall thickness >= 12 mm) AND a medical history of heart failure with at least ONE of: prior hospitalization for heart failure, signs/symptoms of volume overload or requires treatment with diuretics, OR New York Heart Association (NYHA) class I, II, or III (submit chart notes)

Submit documentation including imaging and chart notes

Rule out AL (light-chain) amyloidosis: Light chain (AL) amyloidosis has been ruled out via serum free light chain assay and serum and urine protein immunofixation electrophoresis (sFLC, SIFE, UIFE)

Submit documentation

Confirm ATTR-CM diagnosis: Diagnosis of wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM) confirmed by ONE of: cardiac tissue biopsy demonstrating TTR amyloid deposits, nuclear scintigraphy (e.g., Tc-PYP) showing grade 2 or 3 uptake, OR genetic testing confirming a pathogenic TTR mutation (e.g., Val122Ile)

Submit documentation

Baseline assessments: At least ONE baseline assessment of disease status provided: Kansas City Cardiomyopathy Questionnaire score, 6-minute walk distance, frequency of cardiovascular hospitalizations, OR cardiac biomarkers (e.g., NT-proBNP)

Submit documentation

Combination therapy and transplant exclusions: Requested medication will NOT be used in combination with another therapy targeting transthyretin AND member has NOT received a liver or heart transplant

Reauthorization Criteria

Reauthorization covered when ALL of the following are met

Functional status: Member continues to have NYHA Functional Class I, II, or III heart failure

Submit chart notes

No combination therapy: Requested medication will NOT be used in combination with another therapy targeting transthyretin

Clinical response: Member has been observed to have a positive clinical response since therapy initiation as evidenced by disease stability or only mild progression in Kansas City Cardiomyopathy Questionnaire score, 6-minute walk distance, frequency of cardiovascular hospitalizations, OR cardiac biomarkers (e.g., NT-proBNP)

Submit documentation and clinical notes

The requested medication will not be approved if it is being used in combination with another therapy targeting transthyretin (examples listed in the form include Attruby™, Vyndamax™, Vyndaqel®, Amvuttra™, Onpattro®, Wainua™). In addition, the member must not have received a liver or heart transplant. These exclusions apply to both initial authorization and reauthorization determinations and must be confirmed in the submitted documentation.

Use of manufacturer or office samples to initiate therapy does not meet step edit/preauthorization criteria. Prior therapies will be verified through pharmacy paid claims or submitted chart notes; therefore samples alone are insufficient evidence of prior therapy and cannot be used to satisfy step requirements for approval.

Coding and Diagnostic Criteria

Diagnosis codes (form field)ICD-10

ICD code if applicable

Requested on form; no specific ICD-10 codes listed

Left ventricular wall thickness

Left ventricular wall thickness threshold>= 12 mm

Context for thresholdEchocardiogram or cardiac MRI suggestive of amyloidosis (used with clinical heart failure criteria)

Measurement usePart of initial authorization criteria to support evidence of cardiac involvement

Provider Actions and Submission Requirements

Prior Authorization

Form Completion and Submission

PHARMACY PRIOR AUTHORIZATION/STEP-EDIT REQUEST: The prescribing physician must sign and clearly print their name (preprinted stamps not valid) on the request. All other information may be filled in by office staff and faxed to 1-305-671-0200. No additional phone calls will be necessary if all information (including phone and fax numbers) on this form is correct. If the information provided is not complete, correct, or legible, the authorization process can be delayed.

Prescriber signature must be handwritten; preprinted stamps are not valid
Include complete member and prescriber information (name, AvMed #, DOB, prescriber name, signature, NPI, office contact, phone, fax)
Fax completed form to 1-305-671-0200

Denial Risk

Samples and Prior Therapy Verification

Use of samples to initiate therapy does not meet step edit/preauthorization criteria. Prior therapies will be verified through pharmacy paid claims or submitted chart notes; ensure prior therapy documentation is included with the request when applicable.

Samples cannot be used to satisfy initiation or step-therapy requirements
Provide documentation of prior therapies via pharmacy claims or chart notes when required

Documentation Required

Required Supporting Documentation

To support each clinical criterion checked, provide all required supporting documentation. This includes but is not limited to lab results, diagnostic reports, imaging (e.g., echocardiogram, cardiac MRI, Tc‑PYP nuclear scintigraphy), biopsy reports, genetic testing results, and clinical chart notes (e.g., NYHA class, KCCQ score, 6-minute walk distance, NT-proBNP, hospitalizations). Requests may be denied if supporting documentation is not provided.

Echocardiogram or cardiac MRI showing LV wall thickness ≥ 12 mm (submit report)
Cardiac tissue biopsy or nuclear scintigraphy (Tc‑PYP) results when used to confirm ATTR-CM (submit images/reports)
Serum free light chain assay and serum/urine immunofixation electrophoresis to rule out AL amyloidosis (submit results)
Genetic testing results if claiming hereditary ATTR-CM (submit report)
Baseline and follow-up assessments (KCCQ, 6‑minute walk, hospitalizations, NT‑proBNP) documented in chart notes

Denial Risk

Incomplete or Missing Documentation

Incomplete, incorrect, or illegible information (including missing prescriber signature, missing member or prescriber identifiers, absent or unclear drug/dose/diagnosis fields, or absent supporting documentation) can delay processing or result in denial of the authorization request.

Ensure prescriber handwritten signature and date are present
Complete member identifiers (AvMed #, DOB) and prescriber contact info (NPI, phone, fax)
Complete drug name/form/strength, dosing schedule, length of therapy, diagnosis, ICD code, weight (if applicable) and date obtained
Attach all requested labs, imaging, biopsy, genetic testing, and chart notes

Background

Transthyretin amyloid cardiomyopathy (ATTR-CM) is characterized by transthyretin (TTR) amyloid deposition in the heart, leading to increased left ventricular wall thickness and clinical heart failure. Evaluation and confirmation commonly include imaging (echocardiogram or cardiac MRI showing increased wall thickness), nuclear scintigraphy (e.g., Tc‑PYP), cardiac tissue biopsy demonstrating TTR amyloid deposits, and genetic testing when hereditary disease is suspected. Clinical assessment for treatment decisions typically incorporates functional status (NYHA class), objective measures such as the 6‑minute walk distance, quality‑of‑life scores (Kansas City Cardiomyopathy Questionnaire), prior heart failure hospitalizations, and cardiac biomarkers.

Definitions

Confirmed ATTR‑CM — acceptable diagnostic methods

Cardiac tissue biopsyHistologic confirmation of transthyretin (TTR) amyloid deposits

Nuclear scintigraphyImaging (e.g., Tc‑PYP) showing grade 2 or 3 cardiac uptake

Genetic testingGenetic test confirming a pathogenic transthyretin mutation (e.g., Val122Ile)

Initial Therapy

Initial therapy

Initial Authorization: 12 months when ALL criteria met

Age and prescriber: Member >=18 years; prescribed by or in consultation with a cardiologist

Confirmatory testing and AL rule-out: Imaging, biopsy, or genetic testing to confirm ATTR-CM AND testing to rule out light-chain (AL) amyloidosis (sFLC, SIFE, UIFE) are documented

Submit supporting documentation (imaging reports, biopsy results, genetic test results, and lab reports)

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization: 12 months when criteria met

Reauthorization duration: Reauthorization granted for 12 months if reauthorization criteria are met

Step Therapy and Prior Treatment Verification

Step	Requirement
1	Previous therapies will be verified through pharmacy paid claims or submitted chart notes; samples do not meet initiation criteria (use of samples to initiate therapy does not meet step edit/preauthorization criteria).

Quantity Limits

Attruby (acoramidis) quantity limit

Daily quantity limit4 tablets per day

Recommended dosing712 mg twice daily

Unittablets

Vyndamax (tafamidis) quantity limit

Daily quantity limit1 capsule per day

Recommended dosing61 mg once daily

Unitcapsule

Vyndaqel (tafamidis meglumine) quantity limit

Daily quantity limit4 capsules per day

Recommended dosing80 mg once daily

Unitcapsules

Site of Care / Dispensing

Billing Rule

Specialty pharmacy fulfillment (Proprium Rx)

This medication is dispensed through the specialty pharmacy Proprium Rx; coordinate fulfillment and any required specialty pharmacy processes with Proprium Rx.

Expect specialty pharmacy fulfillment via Proprium Rx for approved therapy

Policy Summary

PayerAvMed

PolicyTransthyretin (TTR) stabilizer prior authorization (Attruby, Vyndamax, Vyndaqel)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign and print name on the prior authorization request and submit required clinical documentation (labs, imaging, chart notes) by fax to 1-305-671-0200.

SourceLink

On This Page

OpenPayer

Transthyretin (TTR) stabilizer prior authorization (Attruby, Vyndamax, Vyndaqel)

Coverage Criteria

Coding and Diagnostic Criteria

Provider Actions and Submission Requirements

Background

Definitions

Initial Therapy

Reauthorization / Continuation Criteria

Step Therapy and Prior Treatment Verification

Quantity Limits

Site of Care / Dispensing