CurrentCignaPolicy V061520

tafamidis (Vyndaqel/Vyndamax) prior authorization for ATTR-CM

Form and criteria governing prior authorization requests for tafamidis products (Vyndaqel, Vyndamax) for treatment of transthyretin-mediated cardiomyopathy; applies to providers submitting to Cigna Pharmacy Services.

Policy Summary

PayerCigna

Policytafamidis (Vyndaqel/Vyndamax) prior authorization for ATTR-CM

Policy CodePolicy V061520

Change TypeNo material change

Effective Date

Next Review Date

Key ActionComplete and submit the prior authorization form (fax or online) with medication, dose, duration, ICD‑10 and supporting documentation confirming ATTR-CM diagnosis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

1 phone numberurgent request phone contact

AccredoCigna's nationally preferred specialty pharmacy named

Coverage Criteria for tafamidis (Vyndaqel / Vyndamax)

Initial and continuation therapy requirements

Covered when documentation supplied with the prior authorization request supports a diagnosis of transthyretin-mediated cardiomyopathy (ATTR-CM) and the clinical indication for tafamidis (new start or continuation) as described below.

ref

title": "Initial and continuation therapy requirements"

Requests will be excluded or may be denied when documentation does not confirm a diagnosis of transthyretin-mediated cardiomyopathy. Acceptable diagnostic confirmation must include one of the following: genetic testing demonstrating a pathogenic or likely pathogenic TTR variant (or documentation of wild‑type ATTR) OR a Tc‑99m PYP imaging scan with Grade 2 or 3 myocardial uptake OR a cardiac tissue biopsy showing amyloid deposits. Requests that lack any of these confirmatory findings and that also fail to document clinical signs or symptoms of heart failure may be excluded from coverage.

For continued tafamidis therapy, the request must include documentation that the patient has experienced a clinically beneficial response while on treatment. The form explicitly asks whether there has been a documented beneficial clinical response and lists examples such as reduction in cardiovascular-related hospitalizations, improvement or stabilization in 6‑Minute Walk Test, improvement in symptom burden or frequency, and improvement in quality of life. Continued coverage may be denied if these response measures are not documented and supporting clinical records are not attached.

Policy Summary

PayerCigna

Policytafamidis (Vyndaqel/Vyndamax) prior authorization for ATTR-CM

Policy CodePolicy V061520

Change TypeNo material change

Effective Date

Next Review Date

Key ActionComplete and submit the prior authorization form (fax or online) with medication, dose, duration, ICD‑10 and supporting documentation confirming ATTR-CM diagnosis.

SourceLink

On This Page

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.

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for tafamidis products. Complete and fax the prior authorization form (or submit online) with the requested medication, dosing, duration, ICD-10 diagnosis code, and all required attachments.

Affected products: Vyndaqel (tafamidis meglumine) 20 mg, Vyndamax (tafamidis) 61 mg, and other tafamidis formulations
Submit via fax with form or online at www.covermymeds.com/main/prior-authorization-forms/cigna/ or via SureScripts in your EHR

Documentation Required

Concurrent Therapy Rationale Required

Concurrent use of tafamidis with other transthyretin-targeted therapies (for example, Onpattro/patisiran or Tegsedi/inotersen) requires a clear clinical rationale. The prescriber must explain why concurrent therapy is necessary and provide supporting clinical justification.

If concurrent therapy is planned or possible, include an explanation in the request and attach supporting clinical rationale and documentation
List names, doses, and administration schedules of any agents to be used concurrently

Documentation Required

Supportive Documentation Required

Supportive documentation must be attached with the prior authorization request. Lack of required documentation may result in denial of the request.

Attach chart notes, relevant lab/test results, genetic testing reports (identification of pathogenic or likely pathogenic TTR variant or documentation of wild-type), cardiac tissue biopsy results (if performed), and Tc-99m PYP imaging showing Grade 2 or 3 myocardial uptake when applicable
Indicate NYHA class, presence of clinical signs/symptoms of heart failure, and documentation of beneficial response for continuation requests

Denial Risk

Denial Risk for Missing Documentation

Requests missing required supportive documentation or the required attestations (for example, diagnostic confirmation by genetic testing, biopsy, or Tc-99m PYP imaging) are at risk for denial. Ensure all requested fields on the form are completed and all attachments are included.

Incomplete forms (missing ICD-10, dose, duration, or indication of new start vs continuation) increase denial risk
For continuation requests, document clinical benefit (eg, reduced hospitalizations, stabilization/improvement in 6-minute walk test, symptom or quality-of-life improvement)

Vyndaqel 20mg	Vyndaqel 20mg oral capsules
Vyndamax 61mg	Vyndamax 61mg oral capsules

OpenPayer

tafamidis (Vyndaqel/Vyndamax) prior authorization for ATTR-CM

Coverage Criteria for tafamidis (Vyndaqel / Vyndamax)

Requested Medications and Billing / Diagnosis Codes

What Providers Must Do

Background

Definitions