ICER draft: Pfizer ATTR-CM drug effective, overpriced

The Institute for Clinical and Economic Review (ICER) recently published a draft report evaluating the cost-effectiveness of drugs used to treat cardiomyopathy caused by transthyretin amyloidosis (ATTR-CM). Among the drugs assessed was Pfizer's tafamidis, which is commercially known as Vyndaqel and Vyndamax. ICER’s analysis reveals that the drug is not cost-effective at its current pricing levels.

The report highlights that for Vyndaqel and Vyndamax to be considered cost-effective, their prices would need to be significantly lower than they are now. Specifically, the study indicates that the oral transthyretin stabilizer should be priced between $5200 and $16,000 annually. This price range is necessary to achieve cost-effectiveness ratios between $50,000 and $200,000 per quality-adjusted life year (QALY) gained. The QALY metric is a standard measure used to assess the value for money of medical interventions by considering both the quality and the quantity of life they provide.

Furthermore, when employing the equal-value of life years (evLY) gained metric, which is another way to measure cost-effectiveness, the acceptable price range for the drug increases. In this scenario, Vyndaqel and Vyndamax would need to be priced between $22,400 and $50,000 per year to meet similar cost-effectiveness thresholds.

Currently, the net price of tafamidis is just under $194,300 per year, which is substantially higher than the ranges suggested by ICER’s analysis. This disparity indicates that a significant reduction in the drug's price would be required to align it with common cost-effectiveness standards.

The report from ICER is significant as it suggests that the current pricing of Vyndaqel and Vyndamax is not justified by the health benefits they provide, according to economic evaluations. These findings could potentially influence future pricing strategies and negotiations between healthcare providers, insurers, and pharmaceutical companies.

In summary, the ICER draft report underscores the need for a substantial price reduction for Pfizer's tafamidis, marketed as Vyndaqel and Vyndamax, to be deemed cost-effective. The current price of nearly $194,300 per year far exceeds the suggested cost-effective price ranges, which are between $5200 and $16,000 annually for QALY gained, and between $22,400 and $50,000 annually for evLY gained. These findings may have significant implications for the future affordability and accessibility of these drugs for patients suffering from cardiomyopathy due to transthyretin amyloidosis.