June 09, 2021
By Douglas L Jennings, PharmD, FACC, FAHA, FCCP, FHFSA, BCPS
Volume 4, Issue 2
So far in the annals of this new column, we focused mostly the latest clinical research. Although, we have also branched out to cover late-breaking clinical trials from impactful meetings, new drug approvals, and even some basic science data. In this week’s issue of Talking Therapeutics, we diversify a bit more, and focus on a cost-effectiveness analysis for the first time.
Point 1: Dapaglifozin Appears Cost-Effective According to the Current Pricing
SGLT2 inhibitors have proven significantly effective in reducing cardiovascular mortality in patients with heart failure with reduced ejection fraction (HFrEF), which prompted the American College of Cardiology to recommend these agents broadly for patients in addition to current guideline-directed medical therapy. However, they still carry a branded copay, which equates to an estimated monthly cost of $470 per month for the average Medicare recipient. A recent analysis published in JAMA Cardiology explored the cost-effectiveness of dapagliflozen when added to standard HF therapies at its current price point. Their modelling found that dapagliflozin therapy yielded a mean of 0.78 additional life-years and 0.46 additional QALY, resulting in a cost per QALY gained, or incremental cost-effectiveness ratio (ICER), of $83,650. This is higher than the high-value landmark ICER of $50,000. Importantly, the authors found that dapagliflozin’s intermediate value largely depends on the effect estimate on cardiovascular mortality. They found that dapagliflozin must reduce cardiovascular mortality by at least 8% and 14% for the cost per QALY gained to remain below $150,000 and $100,000, respectively. The DAPA-HF 95% CI ranged from a reduction of 2% to 31%. This finding emphasizes the importance of additional data to better estimate the extent to which dapagliflozin can reduce cardiovascular mortality.
Point 2: Things Could Get Better Soon
The ICER seen in the US model in the study referenced above is significantly higher than those performed in other countries—owing to the higher costs of prescription drugs here. For instance, in the UK, the ICER was £5822 (US $7681), in Australia it was $12,482 (US $8759), and in China it was $3828. Most notably, the US patent for dapagliflozin expired in October 2020, and multiple generic options can be expected to enter the market in the coming years. If generic options enter the market, it is expected that this will drive pricing competition, which could significantly lower the cost of dapagliflozin. If the introduction of generic drugs drops the price below $270, dapagliflozin would have high value.
Dr Jennings is currently an Associate Professor of Pharmacy at Long Island University and the clinical pharmacist for the Heart Transplant and LVAD teams at New York- Presbyterian Hospital Columbia University Irving Medical Center. He is an active researcher in his field, and he has published over 120 peer-reviewed abstracts and manuscripts, primarily focusing on the pharmacotherapy of patients under mechanical circulatory support. As a recognized expert in this area, he has been invited to speak at numerous national and international venues, including meetings in France, Saudia Arabia, and India. Finally, Dr Jennings has been active in professional organizations throughout his career. He is a fellow of the American College of Clinical Pharmacy, the American College of Cardiology, the Heart Failure Society of America, and the American Heart Association.
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