Burden in Infants in the Kingdom of Saudi Arabia and the Impact of All-Infant RSV Protection

Methods

STUDY DESIGN

Compare passive immunization with LA mAb for all infants to the current standard of care using a static decision-analytic model in a cohort of KSA infants experiencing their first RSV season

Subpopulations:

term and late preterm infants (≥35 wGA)
Healthy preterm infants (29w GA - 34w6d GA, not eligible for palivizumab)
palivizumab-eligible infants*
According to the SIBRO guidelines

PARTICIPANTS & SEASON

Entire KSA infant birth cohort(<12 months of age) during their 1st RSV season

(October – March)

IMMUNIZATION STRATEGIES

Standard of Care: healthy infants born at least 29w GA, administered monthly to eligible infants during the season

LA mAb (Nirsevimab) Single dose administered to all infants at the beginning of the RSV season or at birth

ANALYSIS

Static decision-analytic model

RSV burden and nirsevimab impact were considered and stratified by:

Population-based approach (comorbidities, monoclonal antibody)
Age-based approach

References

Alharbi, A. S., Alqwaiee, M., Al-Hindi, M. Y., Mosalli, R., Al-Shamrani, A., Alharbi, S., Yousef, A., Al Aidaroos, A., Alahmadi, T., Alshammary, A., Miqdad, A., Said, Y., & Alnemri, A. (2018). Bronchiolitis in children: The Saudi initiative of bronchiolitis diagnosis, management, and prevention (SIBRO). Annals of thoracic medicine, 13(3), 127–143. https://doi.org/10.4103/atm.ATM_60_18

Assumptions

Hospitalizations rates per age groups & subpopulations in local birth cohort in KSA

2021 Saudi birth = 509,139

Highest risk of hospitalizations

Per subpopulation

Palivizumab eligible: early preterm ≤28 weeks of GA, with CHD or CLDP
Preterm infants >28 weeks of GA

Per chronological age

with risk decreasing with increasing age in months

CHD, congenital heart disease; CLDP, chronic lung disease of prematurity; GA, gestational age; mo, month.
Ahmed A, Parveen S, Al-Hassinah SM, Al-Amery SF. An overview of respiratory syncytial virus infections in Saudi Arabia. The Journal of Infection in Developing Countries. 2018;12(11):929-36

References

Ministry of Health. Premature Babies 2019 [August 2023]. Available from: https://www.moh.gov.sa/en/awarenessplateform/ChildsHealth/Pages/PrematureBabies.aspx

Results

Disease burden under the current standard of care

428,264 RSV cases

84% from KSA birth cohort

Distribution of RSV MALRTIs by health event over the first RSV season of KSA infants

SAR ~607 million

Direct economic burden of RSV in infants

Distribution of RSV MALRTIs by related direct medical costs over the first RSV season of KSA infants

Percentages may not add to 100% due to rounding. All costs are in 2021 United States dollars.
ED, emergency department; ICU, intensive care unit; MV, mechanical ventilation; LRTI, lower respiratory tract illness; MA, medically attended; RSV, respiratory syncytial virus; SoC, standard of care; US, United States.

Red Flags

84 % from KSA birth cohort infected annually by RSV
Among those hospitalized, 18% were admitted to a PICU , and 2% required MV
RSV hospitalized cases accounted for <6% of overall RSV-LRTIs burden, the associated with 60% direct cost.
607 million Annually direct cost of RSV burden in Saudi Arabia
Indirect effects were not captured, so potential benefits on indirect costs and virus spread were not estimated

Results

Impact of LA mAb for all KSA infants

Cases Vs budget saving

RSV-related health events

Primary Care Visits

ER Visits

Hospitalizations^*

Direct costs saving (374 millions)

Reduce RSV cases by more than 50% and associated healthcare costs by more than 60%

^*Includes hospitalization that resulted in ICU admission or MV.

ED, emergency department; ICU, intensive care unit; MV, mechanical ventilation; RSV, respiratory syncytial virus; US, United States.

Read the Full Article

SIBRO Recommendation

Read article

Nirsevimab International Recommendation

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Real World Evidence Impact of universal immunization with Nirsevimab

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MAT-KW-2400551-V1- November 2024