Reduced Cost of Care Associated with Switching Hypoallergenic Amino Acid-Based Formulas During 2022 US Nationwide Formula Shortage

Boccella J., Cekola P., Desai A., et al
2024 JACI; 153:2,Supplement AB204:623

Background:

In February 2022, during a nationwide pediatric formula shortage it was necessary for some children to switch formulas, including. amino acid-based formulas (AAFs). AAFs are hypoallergenic, provide complete nutrition and effective dietary management for cow’s milk protein allergy, multiple food allergies, malabsorption, and related gastrointestinal and allergic conditions. While switching formulas can cause concerns related to potential intolerance, increased healthcare resource utilization (HCRU) and associated costs, limited data exist on the actual impact.

Objectives:

This study assessed costs related to healthcare resource utilization (HCRU) in children that switched hypoallergenic amino acid-based formulas during the nationwide formula shortage.

Study design:

A retrospective study using nationally representative US claims data obtained from the Decision Resources Group Real World Evidence Data Repository (Clarivate), which covers 98% of US health plans, including medical and pharmacy claims.

Patient characteristics, comorbidities, HCRU and costs of care were assessed in children ≤ 18 years; with a history of receiving EleCare® or EleCare® Jr formulas (AAAF, Abbott Nutrition, US) and having switched to Alfamino® Infant or Alfamino® Junior formulas (NAAF, Nestlé HealthCare Nutrition, US); in post acute care settings between June 2021 and April 2023.

Methods:

HCRU were defined as emergency department (ED), inpatient, outpatient, urgent care (UC), telemedicine and visits to other places of service.

Outcomes compared 6-months pre-index (index defined as the date patients switched from AAAF to NAAF), and post-index (last record in study period at 1-, 3- and 6-months post-switch).

Descriptive statistics were presented as mean [standard deviation (SD)] or N(%). Multivariate costs associated with HCRU after adjusting for age, sex, and pediatric comorbidity index (PCI) were compared in pre-index and post-index time periods.

Results:

402 children (40% female; mean [standard deviation (SD)] age 5.3 [4.7] years) from all US regions, switched from AAAF to NAAF. The most common comorbidities pre-switch were GI conditions (51%), congenital conditions (49%) and developmental delays (27%). Among 355 patients (88%) with ≥1 comorbidity, the mean (SD) pediatric comorbidity index (PCI) score was 4.8 (3.4). (Table 1)

Total mean adjusted costs associated with healthcare visits decreased significantly (p<0.001) from $679,401 (pre-switch) to $92,923, $244,305 and $416,063 at 1-, 3- and 6-months post-switch, respectively. Mean adjusted costs associated with outpatient visits decreased significantly (p<0.001) from $654,087 (pre-switch) to $89,460, $234,968 and $399,343 at 1-, 3- and 6-months post-switch, respectively. Significant cost reductions (p<0.001) were observed for inpatient, emergency department, urgent care, telemedicine and other visits at all post-index periods. (Table 2)

Discussion:

GI intolerance and allergy symptoms were previously reported to have significantly decreased with
a switch from AAAF to NAAF during the 2022 formula shortage, suggesting potential clinical
benefits with a change from AAAF to NAAF.^2,3 Furthermore, this transition was previously
associated with a significant reduction in healthcare visits, where all included children had
significantly fewer ED, inpatient, UC, telemedicine, or other services at 1-month post-switch
compared with pre-switch (p<0.05), and significant reductions in mean total number of visits were
also observed at 3-months post-switch (76 vs 45, p< 0.001).³

Conclusion:

Significant reduction in cost of care was observed in children in the post-acute care setting who switched to NAAF (Alfamino® Infant or Junior by Nestle Healthcare Nutrition, US) from AAAF (Elecare® Infant and Junior by Abbott Nutrition, US) as a necessity during the 2022 nationwide formula shortage.

These results build on previous research by showing significant reductions in costs associated to healthcare visits were maintained after adjusting for age, sex, and PCI score.

References: 
(1) US FDA. Abbott Voluntarily Recalls Powder Formulas Manufactured at One Plant. Available at
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-recalls-powder-formulasmanufactured-
one-plant. Accessed 30 May 2023;
(2) Cekola P, et. al JPGN 2023;77(1): A 761, S552-553;(3) Desai A., et al. JPGN 2023;77(1): A 748, S538-539

Study summary prepared by Nestlé Healthcare Nutrition. Download PDF of Summary

The poster presented at AAAAI 2024 may be accessed  online here

The complete abstract may be accessed online:  Reduced Cost of Care Associated with Switching Hypoallergenic Amino Acid-Based Formulas During 2022 US Nationwide Formula Shortage - Journal of Allergy and Clinical Immunology (jacionline.org)

EleCare® is a registered trademark of Abbott Laboratories. All other trademarks are owned by Société des Produits Nestlé S.A., Vevey, Switzerland

Presented at AAAAI Annual Meeting, February 23-26, 2024, Washington D.C.