By Counterforce Health Team in Vyndaqel / Vyndamax (tafamidis) —

Humana's Coverage Criteria for Vyndaqel/Vyndamax (Tafamidis) in California: What Counts as "Medically Necessary"?

Getting Vyndaqel/Vyndamax (tafamidis) covered by Humana in California requires confirmed ATTR-CM diagnosis via PYP scan (Grade 2-3) or biopsy, NYHA Class I-III heart failure, and cardiology oversight. Submit prior authorization with diagnostic reports, clinical notes, and specialist documentation through Humana's provider portal. If denied, file internal appeal within 65 days, then request California DMHC Independent Medical Review for binding external review with 49% overturn rate for experimental/specialty drug denials.

Table of Contents

Policy Overview

Humana requires prior authorization (PA) for both Vyndaqel (tafamidis meglumine 20mg capsules) and Vyndamax (tafamidis 61mg capsules) across all Medicare Advantage and Part D plans. The coverage policies are updated as of December 2025 and apply to:

  • Medicare Advantage Plans: HMO and PPO products with integrated Part D
  • Stand-alone Part D Plans: Prescription drug coverage only
  • Employer Group Plans: Medicare supplement coverage through Humana

Official policy documents are accessible through the Humana provider portal, though specific plan formularies may vary. Both medications are typically placed on specialty tiers (Tier 4-5) requiring prior authorization and specialty pharmacy dispensing.

Note: California residents enrolled in Humana Medicare Advantage plans are subject to both federal Medicare appeals rights and additional California Department of Managed Health Care (DMHC) protections.

Indication Requirements

FDA-Approved Indication

Vyndaqel and Vyndamax are FDA-approved for transthyretin amyloid cardiomyopathy (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalizations. Humana covers both medications exclusively for this labeled indication—off-label use for ATTR polyneuropathy requires separate justification.

Diagnostic Confirmation Required

Humana's medical necessity criteria mandate confirmed ATTR-CM diagnosis through one of these methods:

  • Technetium-99m pyrophosphate (PYP) cardiac scan: Grade 2-3 uptake with negative monoclonal protein screening
  • Endomyocardial or tissue biopsy: Histologic confirmation of TTR amyloid deposits
  • Genetic testing: Pathogenic TTR mutation with documented cardiac involvement

Documentation must include ICD-10 code E85.4 (Organ-limited amyloidosis) and exclude AL amyloidosis through serum/urine immunofixation and free light chain analysis.

Step Therapy & Exceptions

Unlike many specialty medications, step therapy typically does not apply to tafamidis for ATTR-CM due to the lack of therapeutic alternatives. However, some Humana plans may require documentation of:

  • Heart failure optimization: Evidence of guideline-directed medical therapy (ACE inhibitors, beta-blockers, diuretics as appropriate)
  • Symptom progression: Documentation that standard heart failure management is insufficient

Medical Exception Pathways

If step therapy is imposed, exceptions are available for:

  • Contraindications: Medical reasons preventing use of required first-line therapies
  • Prior failures: Previous intolerance or lack of efficacy with required medications
  • Clinical urgency: Rapid disease progression requiring immediate stabilizer therapy

Submit exception requests through the Humana formulary exception process with supporting clinical documentation.

Quantity and Frequency Limits

Standard Dosing Limits

  • Vyndaqel: 4 capsules (80mg total) once daily - maximum 120 capsules per 30-day supply
  • Vyndamax: 1 capsule (61mg) once daily - maximum 30 capsules per 30-day supply
Important: Vyndaqel and Vyndamax are not interchangeable due to different pharmacokinetics. Switching between formulations requires new prior authorization.

Renewal Requirements

Initial approvals are typically granted for 12 months. Renewal requires:

  • Clinical stability: Documentation of stable or improved functional status
  • Adherence: Pharmacy records showing consistent medication pickup
  • Ongoing monitoring: Recent cardiology follow-up within 6 months

Early refill limits apply—typically no more than 75% of previous fill consumed before next dispensing.

Required Diagnostics

Essential Laboratory Values

Test Requirement Documentation
BNP/NT-proBNP Elevated above normal range Lab report within 6 months
Serum/Urine Immunofixation Negative for monoclonal proteins Required to exclude AL amyloidosis
Serum Free Light Chains Normal ratio (0.26-1.65) Part of AL exclusion workup
Basic Metabolic Panel Baseline kidney/liver function Within 3 months

Required Imaging

  • Echocardiogram: Evidence of increased wall thickness (>12mm), restrictive filling pattern, or reduced ejection fraction
  • PYP Scan: Grade 2-3 cardiac uptake (if biopsy not performed)
  • Cardiac MRI: May be required to assess extent of cardiac involvement

Timing Requirements

All diagnostic tests must be recent and relevant:

  • Laboratory values: Within 6 months of PA submission
  • Imaging studies: Within 12 months unless clinically stable
  • Biopsy results: No time limit if confirming ATTR-CM diagnosis

Site of Care Requirements

Specialty Pharmacy Mandate

Both Vyndaqel and Vyndamax must be dispensed through Humana-contracted specialty pharmacies. Common network pharmacies include:

  • Humana Pharmacy (primary specialty provider)
  • Accredo Health Group
  • CVS Specialty
  • Express Scripts Specialty
Tip: Verify your specific plan's specialty pharmacy network through the Humana drug list finder before PA submission.

Prescriber Requirements

  • Cardiology specialist: Prescribed by board-certified cardiologist or heart failure specialist
  • Amyloidosis center: Preference for prescribers affiliated with amyloidosis treatment centers
  • DEA registration: Valid prescriber credentials required for controlled substance dispensing protocols

Evidence to Support Medical Necessity

Primary Clinical Evidence

When submitting PA requests, include references to:

  1. FDA Prescribing Information: Vyndamax official labeling demonstrating efficacy in ATTR-ACT trial
  2. ATTR-ACT Trial Data: 30-month study showing reduced cardiovascular mortality and hospitalizations
  3. Heart Failure Society Guidelines: Recognition of tafamidis as disease-modifying therapy for ATTR-CM

Supporting Documentation Checklist

  • Complete medical history with symptom progression timeline
  • Prior heart failure therapy trials and responses
  • Functional status assessment (6-minute walk test, NYHA class)
  • Quality of life measures (Kansas City Cardiomyopathy Questionnaire)
  • Specialist consultation notes confirming diagnosis and treatment plan

Sample Medical Necessity Narrative

The following template can be adapted for PA submissions:

"This 67-year-old patient has biopsy-confirmed wild-type ATTR-CM (ICD-10: E85.4) with NYHA Class II symptoms despite optimal heart failure management including lisinopril 10mg daily and metoprolol succinate 50mg daily. PYP scan demonstrates Grade 3 cardiac uptake, and echocardiogram shows increased wall thickness (15mm) with restrictive filling pattern. Serum/urine immunofixation is negative, excluding AL amyloidosis.

Tafamidis 61mg daily (Vyndamax) is medically necessary as the only FDA-approved disease-modifying therapy proven to reduce cardiovascular mortality and hospitalizations in ATTR-CM. The ATTR-ACT trial demonstrated significant benefit in patients with similar clinical presentation. Standard heart failure therapy addresses symptoms but does not target the underlying amyloid deposition process. Patient will be monitored by cardiology every 3-6 months for treatment response and medication tolerance."

Appeals Process for California

Internal Humana Appeals

If your PA is denied, you have 65 days to file an internal appeal:

Standard Appeals (7 days for decision):

  • Submit via MyHumana portal or mail to address on denial letter
  • Include denial notice, medical records, and prescriber statement
  • Humana reviews and issues written decision

Expedited Appeals (72 hours for decision):

  • Required if delay could seriously jeopardize health
  • Submit same documentation with expedited request form
  • Prescriber must certify urgent medical need

California DMHC Independent Medical Review

California residents have unique external appeal rights through the Department of Managed Health Care:

When to Use IMR:

  • After internal Humana appeal denial
  • For experimental/investigational denials (may bypass internal appeal)
  • When coverage is denied as "not medically necessary"

IMR Process Timeline:

  • Standard Review: 45 days maximum
  • Expedited Review: 7 days (3-day extension possible)
  • No Cost: California pays for independent medical expert review

Success Rates: DMHC data shows 49.1% overturn rate for experimental/investigational drug denials, with specialty rare disease medications having favorable outcomes.

California Advantage: Unlike many states, California's IMR decisions are binding on health plans—if overturned, Humana must authorize coverage immediately.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Insufficient diagnostic evidence Submit complete PYP scan or biopsy report Grade 2-3 PYP uptake, pathology report
Step therapy not completed Request medical exception Contraindication letter, prior trial documentation
Not prescribed by specialist Transfer prescription to cardiologist Board certification, hospital affiliation
Experimental/investigational Cite FDA approval and clinical guidelines FDA label, peer-reviewed studies, society guidelines
Quantity limit exceeded Confirm appropriate dosing Prescriber attestation of correct daily dose
Non-formulary medication Request formulary exception Medical necessity letter, alternative failures

Quick Reference Criteria Table

Requirement Meets Criteria Documentation Source
Prior Authorization Required for all plans Humana pharmacy policies
Diagnosis Confirmed ATTR-CM (E85.4) PYP scan, biopsy, or genetic testing
NYHA Class Class I-III preferred Cardiology assessment notes
Specialist Cardiology/heart failure DEA/NPI verification
AL Exclusion Negative monoclonal screen Immunofixation, free light chains
Formulary Tier Specialty (Tier 4-5) Plan-specific drug list
Pharmacy Specialty network only Humana contracted facilities
Appeals Deadline 65 days from denial CMS Medicare guidelines

FAQ

How long does Humana prior authorization take for tafamidis in California? Standard PA decisions are issued within 14 days of complete submission. Expedited requests (when health is jeopardized) receive decisions within 72 hours.

What if Vyndamax is not on my Humana formulary? Request a formulary exception through the Humana coverage determination process. Include medical necessity documentation and evidence that formulary alternatives are ineffective.

Can I get temporary coverage while appealing? Yes, Humana provides up to 31 days of temporary coverage for non-formulary medications during the exception review process, and continued coverage during appeals for previously approved medications.

Does California's 2025 Medicare Part D redesign affect tafamidis costs? Yes, the new $2,000 annual out-of-pocket cap significantly reduces patient costs. Specialty tier coinsurance (25-33%) applies until the cap is reached, with monthly payment options available.

What happens if DMHC overturns Humana's denial? DMHC Independent Medical Review decisions are binding. If overturned, Humana must authorize coverage and implement the decision immediately, including retroactive coverage if applicable.

Can my doctor request a peer-to-peer review with Humana? Yes, prescribers can request peer-to-peer consultations with Humana medical directors during the PA review process. This often resolves coverage issues without formal appeals.

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies specific coverage criteria, and generates point-by-point rebuttals aligned with each payer's policies and requirements.

When facing a tafamidis denial from Humana, Counterforce Health can help identify the exact documentation gaps and draft appeals that address Humana's specific medical necessity criteria, increasing your chances of approval while saving valuable time for both patients and providers.

Sources & Further Reading

This article provides educational information about insurance coverage processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance plan directly for coverage determinations. For assistance with California insurance appeals, contact the DMHC Help Center at 888-466-2219 or visit healthhelp.ca.gov.

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