What is the cost of Tafamidis (transthyretin stabilizer)?

The Cost of Tafamidis for Transthyretin Amyloid Cardiomyopathy

Tafamidis is extremely expensive with an annual cost of approximately $225,000, making it the most expensive cardiovascular drug ever approved in the United States. 1

Price Details and Formulations

Tafamidis is available in two formulations:

• Tafamidis meglumine (VYNDAQEL): 20 mg capsules, with FDA-approved dose of 80 mg (4 capsules) once daily
• Tafamidis (VYNDAMAX): 61 mg capsules, with FDA-approved dose of 61 mg once daily 2

Economic Value and Cost-Effectiveness

Despite its proven clinical benefits, tafamidis provides low economic value based on cost-effectiveness analyses:

• The 2022 AHA/ACC/HFSA heart failure guidelines explicitly state that at 2020 list prices, tafamidis provides low economic value (>$180,000 per QALY gained) 2
• A detailed cost-effectiveness analysis found that tafamidis has an incremental cost-effectiveness ratio of $880,000 per quality-adjusted life-year gained 1
• The drug would need a price reduction of approximately 80-90% (from $225,000 to approximately $16,563 annually) to meet conventional cost-effectiveness thresholds of $100,000 per QALY 1

Impact on Healthcare System

The economic burden on the healthcare system is substantial:

• With an estimated 120,000 patients with ATTR-CM in the United States, treating all eligible patients would increase annual healthcare spending by approximately $32.3 billion 2, 1
• This significant cost has led to concerns about access to this effective therapy unless there is a substantial reduction in drug price 1

Out-of-Pocket Costs for Patients

Patient costs vary significantly based on insurance coverage:

• Medicare patients: Out-of-pocket costs could approach $18,000 per year, which is particularly burdensome as most patients with ATTRwt-CM are over 65 years old and on fixed incomes 2
• Commercially insured patients: May access copayment assistance programs from pharmaceutical companies, resulting in more manageable expenses 2
• Medicare/Medicaid patients: Cannot legally receive direct copayment assistance from manufacturers due to anti-kickback statutes 2

Financial Assistance Options

Several options exist to help patients access tafamidis:

1. Independent patient assistance foundations provide grants based on income limits (typically 500% of Federal Poverty Level) 2
2. Pharmaceutical manufacturers may provide free drug to uninsured patients or those on government insurance programs 2
3. Some 340B healthcare centers may help patients navigate medication access 2

Clinical Considerations

Despite the high cost, it's important to note that:

• Tafamidis is clinically effective, reducing all-cause mortality and cardiovascular hospitalizations in patients with ATTR-CM 3
• Treatment increases average survival by 1.97 years and quality-adjusted life years by 1.29 2, 1
• Early treatment with tafamidis provides greater benefits than delayed initiation 4

The high cost of tafamidis presents a significant barrier to access for this effective but expensive therapy, requiring careful consideration of financial assistance options and potentially advocacy for price reductions to improve its economic value.