CurrentColorado Rocky Mountain Health PlansPolicy N/A

Tafamidis (Vyndaqel / Vyndamax) prior authorization

Defines prior authorization and reauthorization requirements for Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) for treatment of transthyretin-mediated cardiomyopathy in adults for members under the payer's pharmacy clinical programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTafamidis (Vyndaqel / Vyndamax) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization by documenting diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy and ensure tafamidis is not used with RNA-targeted ATTR therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

adultsindicated population

12 monthsreauthorization duration

prohibitedcombination therapy

P 1283-9program ID

Coverage Criteria for Tafamidis (Vyndaqel / Vyndamax)

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inv-01: Initial Authorization

Covered when ALL of the following are met:

Initial authorization: (1) Diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM); (2) Patient is not receiving Vyndaqel/Vyndamax (tafamidis) in combination with an RNA-targeted therapy for ATTR amyloidosis (examples: Amvuttra [vutrisiran], Attruby [acoramadis], Onpattro [patisiran], Tegsedi [inotersen], Wainua [eplontersen]).

See policy for examples of RNA-targeted therapies.

inv-02: Reauthorization (Continuation Therapy)

Covered when ALL of the following are met:

Reauthorization: (1) Documentation that the patient has experienced a positive clinical response to Vyndaqel/Vyndamax (e.g., improved symptoms, quality of life, slowing of disease progression, decreased hospitalizations); (2) Patient is not receiving Vyndaqel/Vyndamax (tafamidis) in combination with an RNA-targeted therapy for ATTR amyloidosis (examples: Amvuttra [vutrisiran], Attruby [acoramadis], Onpattro [patisiran], Tegsedi [inotersen], Wainua [eplontersen]).

Authorization will be issued for 12 months.

Use of tafamidis (Vyndaqel/Vyndamax) in combination with RNA-targeted therapies for transthyretin-mediated amyloidosis is excluded from approval. Requests will be denied when tafamidis is prescribed concurrently with agents that target transthyretin RNA, including but not limited to Amvuttra (vutrisiran), Attruby (acoramadis), Onpattro (patisiran), Tegsedi (inotersen), or Wainua (eplontersen).

Initial Therapy

inv-11: Initial Therapy

Initial approval criteria

Initial therapy: Diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM) AND patient is not receiving tafamidis in combination with an RNA-targeted therapy for ATTR amyloidosis (examples listed above).

Refer to policy for examples of RNA-targeted agents.

Reauthorization / Continuation Therapy

inv-12: Reauthorization

Reauthorization requires documentation of ongoing clinical benefit and absence of combination therapy with RNA-targeted agents.

Continuation: Documentation of positive clinical response to tafamidis (examples: improved symptoms, quality of life, slowing disease progression, decreased hospitalizations) AND patient is not receiving tafamidis in combination with an RNA-targeted therapy for ATTR amyloidosis.

Authorization duration: 12 months.

Provider Actions and Documentation Requirements

Prior Authorization

Initial authorization — documentation required

Prior authorization required for initial use. Provider must document a diagnosis of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM) and confirm the patient is not receiving tafamidis (Vyndaqel/Vyndamax) in combination with an RNA-targeted therapy for ATTR amyloidosis.

Required diagnosis: transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM).
Combination therapy exclusion: tafamidis must NOT be prescribed with RNA-targeted therapies for ATTR amyloidosis (examples: Amvuttra [vutrisiran], Attruby [acoramadis], Onpattro [patisiran], Tegsedi [inotersen], Wainua [eplontersen]).

Prior Authorization

Reauthorization — evidence of clinical benefit required

For reauthorization, the provider must document that the patient has experienced a positive clinical response to tafamidis (examples include improved symptoms, improved quality of life, slowed disease progression, decreased hospitalizations) and confirm the patient is not receiving tafamidis in combination with an RNA-targeted therapy for ATTR amyloidosis. Approvals are issued for 12 months.

Acceptable evidence of positive clinical response: symptom improvement, QoL improvement, slowed progression, reduced hospitalizations.
Reauthorization length: 12 months.

Documentation Required

Reauthorization evidence — acceptable documentation

Examples of acceptable documentation of positive clinical response include clinic notes describing symptom improvement, patient-reported outcomes or quality-of-life measures, objective markers of slowed disease progression, and records showing decreased hospitalizations or healthcare utilization.

Clinic visit notes documenting symptom change.
Patient-reported outcome scales or QoL assessments.
Objective testing or imaging showing stability or slower decline.
Hospitalization records showing fewer admissions.

Denial Risk

Combination therapy exclusion — denial risk

Requests will be denied if tafamidis is prescribed in combination with an RNA-targeted therapy for ATTR amyloidosis. Examples of excluded concurrent agents include Amvuttra (vutrisiran), Attruby (acoramadis), Onpattro (patisiran), Tegsedi (inotersen), and Wainua (eplontersen).

Do not combine tafamidis with listed RNA-targeted therapies; such combination use is a denial risk.

Note

Automated processes and program limits

Automated approval and re-approval processes may be used in some programs. UnitedHealthcare (and delegated programs) may approve initial or reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10), and claim logic. Supply limits or other medical necessity programs may also apply.

Automated decisions may use prior claims, medication history, and ICD-10 diagnosis codes.
Supply limits and other utilization management programs may affect approval.

Step Therapy and Automated Prior Authorization

Process	Operational note
Automated prior authorization / reauthorization	Automated approval and re-approval based on prior claim/medication history, diagnosis codes (ICD‑10), and/or claim logic may be used in some programs; use of these processes varies by program and therapeutic class.
Operational / step‑therapy note	Medical necessity criteria may still apply and supply limits can be in place; notwithstanding coverage criteria, the payer may approve based solely on prior claims or diagnosis codes in select programs.

Background

Tafamidis (marketed as Vyndaqel [tafamidis meglumine] and Vyndamax [tafamidis]) are transthyretin stabilizers indicated for the treatment of cardiomyopathy caused by wild-type or hereditary transthyretin-mediated amyloidosis in adults. These products are used to reduce cardiovascular mortality and related hospitalizations in patients with transthyretin-mediated cardiomyopathy (ATTR-CM).

Definitions

ATTR-CM (definition)

TermTransthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM)

Included formsWild-type and hereditary transthyretin-mediated amyloidosis involving the heart

Indicated therapyTafamidis (Vyndaqel [tafamidis meglumine] or Vyndamax [tafamidis])

PopulationAdults with ATTR-CM

Clinical goalReduce cardiovascular mortality and cardiovascular-related hospitalizations