Intravenous iron therapy was predicted to be highly cost-effective or even cost-saving when used in high-risk, iron-deficient patients with heart failure (HF) in each of four different countries with different healthcare payment systems, in an analysis based on outcomes in the randomized AFFIRM-AHF trial.
Gains in quality-adjusted life-years (QALY) associated with IV iron therapy were driven mostly by fewer repeat hospitalizations for HF, and were consistent in models based on economic data from Italy, Switzerland, the United Kingdom, and the United States.
The hospitalization benefit and related savings on other care in patients who received injectable ferric carboxymaltose (FCM) more than offset the added cost of management in models based on the contrasting health economics standards of Switzerland, the United Kingdom, and the United States.
Although FCM wasn’t cost-saving in the model based on Italy, it still would be considered highly cost-effective based on healthcare economic standards there, observed Phil McEwan, PhD, when reporting the analysis last week at HFA 2021. The annual meeting of the Heart Failure Association of the European Society of Cardiology (ESC-HFA) was conducted both virtually and live in Florence, Italy.
“In addition to AFFIRM-AHF demonstrating that ferric carboxymaltose is well tolerated and effective, our study would suggest that it represents good value for money, as well,” said McEwan, of Swansea University and Health Economics and Outcomes Research, Cardiff, United Kingdom. He is also lead author of the study published online June 30 in the European Journal of Heart Failure.
Most impressive about the analysis is that FCM emerged as cost-saving in the three countries when used in such high-risk patients as those in AFFIRM-AHF, all of whom had experienced a recent hospitalization for acute decompensation, Derek S. Chew, MD, who was not affiliated with the study, told theheart.org | Medscape Cardiology. “There are not many examples of cardiovascular therapies that offer a true cost savings,” offered Chew, of Duke Clinical Research Institute, Durham, North Carolina.
For example, recently emerging and important HF medications such as angiotensin-receptor neprilysin inhibitors and the SGLT2 inhibitors “provide additional clinical benefit but at added costs.” Although those drugs have been estimated to be good value according to willingness-to-pay standards, “good value does not necessarily translate to affordability, as adoption of these medications will increase overall healthcare,” Chew said.
AFFIRM-AHF, with its more than 1100 iron-deficient, recently hospitalized patients with HF, assigned them to receive placebo or a bolus of FCM (Ferinject/Injectafer, Vifor) starting before discharge on top of other standard therapy. The 1-year risk of HF hospitalization fell by a significant 26% in the FCM group compared with controls, but there was no apparent effect on cardiovascular mortality.
In the cost-effectiveness models, predicted QALY gains from FCM compared with placebo were less than 0.5 in each of the four countries, but those benefits “would be deemed clinically meaningful” given the AFFIRM-AHF trial’s high-risk population, McEwan said. In addition to having experienced recent decompensation, they were advanced in age with reduced ejection fractions and typically had multiple comorbidities.
The country-specific models based on outcomes in AFFIRM-AHF accounted for the cost of FCM and all other medical care, any hospitalizations, and any management resulting from adverse events or other complications. Disease progression, functional status, and quality of life were tracked throughout the follow-up using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Treatment with FCM was associated with QALY gains of 0.43 years in both Italy and the United Kingdom, and of 0.44 years in both Switzerland and the United States. Greater life expectancy on FCM was a function of more time spent with favorable KCCQ clinical summary scores plus the reduced HF-hospitalization risk, McEwan explained.
Indeed, projected lifetime estimates for FCM therapy compared with placebo suggested 199 fewer HF hospitalizations per 1000 patients, he reported. With such hospitalizations making up a vast proportion of management costs, the estimated cost savings per patient associated with FCM reached 1389 euros in Italy, 2709 Swiss francs in Switzerland, 561 pounds sterling in the United Kingdom, and 5422 dollars in the United States.
Other background management costs were higher in Italy than in the other countries and overwhelmed any savings. The incremental cost-effectiveness ratio in Italy reached 1269 euros per QALY gained, a small fraction of the willingness-to-pay standard of 30,000 per QALY gained in that country, observed McEwan. That means FCM in a population like that of AFFIRM-AHF would be “highly cost-effective” in Italy.
The overall findings were consistent across a range of patient subgroups and in sensitivity analyses that applied varying costs of therapies. In an analysis limited to patients with left ventricular ejection fraction < 25%, the models showed FCM to be cost-saving in all four countries.
It’s possible the analysis would have reached different conclusions had it included a broader range of countries, observed Gerasimos Filippatos, MD, National and Kapodistrian University of Athens Medical School, Greece, at a panel discussion following McEwan’s presentation. Possibly, he said, more realistic insights might require country-by-country analysis. For example, Italy, Switzerland, the United Kingdom, and the United States “probably have a higher willingness to pay.”
In another caution, Chew observed when interviewed, the cost implications of FCM therapy “were predicated on a reduction of HF hospitalizations from a trial that primarily enrolled patients from Europe, South America, and Singapore.” Because of geographic variation in use of healthcare resources and hospitalization rates, “we need to be cautious when extrapolating these data to areas outside where the trial was conducted, such as North America.”
The study was supported by Vifor Pharma. McEwan is an employee of Health Economics and Outcomes Research, which received fees from Vifor Pharma in relation to this study. Two other coauthors are full-time employees of Vifor Pharma. Disclosures for the other coauthors are listed in the report. Chew has reported no relevant financial relationships. Filippatos has disclosed receiving lecture fees from or serving on committees for trials or registries sponsored by Bayer, Novartis, Vifor Pharma, Medtronic, Servier, Amgen, and Boehringer Ingelheim.
Eur J Heart Fail. Published online June 30, 2021. Full text
ESC-HFA: Late-Breaking Trials 2. Presented June 30, 2021.
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