Economics of Pfizer maternal 

RSVpreF vaccine

David W. Hutton, PhD, MS

Associate Professor, Health Management and Policy, School of Public Health

Associate Professor of Global Public Health, School of Public Health

Associate Professor, Industrial and Operations Engineering, College of Engineering

University of Michigan

Presentation to the ACIP 

June 22, 2023
Research team

University of Michigan

• David Hutton, PhD

• Lisa Prosser, PhD

• Angela Rose, MPH

• Kerra Mercon, MS

CDC

• Jefferson Jones, MD, MPH, 

FAAP

• Mila Prill, MSPH

• Meredith McMorrow, MD, 

MPH, FAAP

• Jamison Pike, PhD

• Katherine Fleming-Dutra, MD, 

FAAP

• Ismael Ortega-Sanchez, PhD

• Fiona Havers, MD

• Betsy Gunnels, MSPH

• Andrew Leidner, PhD

2
Conflicts of interest statements

– Authors have no known conflict of interests.

3
Methods: Study question

• Determine the cost-effectiveness of RSVpreF by:

• Evaluating the population impact in terms of 

• annual resource utilization 

• total cases

• total costs 

• deaths

• quality-adjusted life-years (QALYs)

• Comparing the incremental cost-effectiveness ratio (ICER) of 

RSVpreF to natural history/no vaccine.

• Running scenario analyses outcomes that explore key areas of 

uncertainty.

• Perspective: Societal

4
Methods: Intervention(s)

• Target population: US pregnant persons

• Interventions:

1. No vaccination (Natural history)

2. RSVpreF against RSV illness

• Timeframe: 1 year (1 RSV season)

• Analytic horizon: infant’s lifetime

• Discount rate: 3%

5
Methods: Decision tree model

6

Natural

History

RSVpreF

Infection 

Hospitalization

ED

None of the above

Outpatient

Alive

Dead

Infection

Adverse 

Events

Prematurity

Injection site reaction

None of the above

Serious adverse event Infection 

Infection
Methods: Epidemiology

Hospitalization

7

Base Case Range Source

Respiratory syncytial virus (RSV) 

incidence, per 100,000 See Above See Above CDC NVSN, 

December 2016 to September 2020

Proportion with LRTI

Age 0-5 months 1.0 0.5-1.0 Rainisch, 2020

Age 6-11 months 1.0 0.5-1.0 Rainisch, 2020

CDC New Vaccine Surveillance Network (NVSN) hospitalization rates for children under 2 years of age from December 2016 to September 2020

 -

 1,000

 2,000

 3,000

 4,000

0 2 4 6 8 10 12 14 16 18 20 22

Hospitalization 

rate per 100,000 

children

Age in months
Methods: Epidemiology

ED and Outpatient

8

Respiratory syncytial virus 

(RSV) incidence, per 100,000 

Base 

Case

Range Source

Emergency Department

Age 0-5 months 7,500 5,500 – 7,500 Lively 2019 (base case and range), 

Hall 2009 (range)

Age 6-11 months 5,800 5,700 – 5,800 Lively 2019 (base case and range), 

Hall 2009 (range)

Age 12-23 months 3,200 3,200 – 5,300 Hall 2009 (base case and range), 

Lively 2019 (range)

Proportion with LRTI

Age 0-5 months 0.65 0.25-1.0 Rainisch, 2020

Age 6-11 months 0.5 0.25-1.0 Rainisch, 2020

Outpatient

Age 0-5 months 21,600 13,200 –

21,600

Lively 2019 (base case and range), 

Hall 2009 (range)

Age 6-11 months 24,600 17,700 –

24,600

Lively 2019 (base case and range), 

Hall 2009 (range)

Age 12-23 months 18,440 6,600 – 29,620 Jackson 2021 (base case and 

range), Hall 2009 (range)

Proportion with LRTI

Age 0-5 months 0.65 0.25-1.0 Rainisch, 2020

Age 6-11 months 0.3 0.1-1.0 Rainisch, 2020

LRTI= Lower respiratory tract infection
Methods: Epidemiology

Mortality

9

Base 

Case

Range Source

RSV mortality per 

hospitalization

Age 0-5 months 0.04% 0.03-0.05% Doucette 2016

Age 6-11 months 0.04% 0.03-0.05% Doucette 2016

Age 12-23 months 0.3% 0.28%-

0.34%

Gupta 2016
Seasonality

10

0%

5%

10%

15%

20%

25%

30%

Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar

Fraction of Annual Infections

Source: National Respiratory and Enteric Virus Surveillance System (NREVSS) (2015-2019)
11

0%

20%

40%

60%

80%

100%

0 3 6 9 12

Efficacy

Month

Against medically-attended RSV-associated LRTI

Against hospitalization

Methods: RSVpreF efficacy

average 6-month efficacy 

= trial efficacy 

Zero efficacy

Source: Kampmann et al 2023

LRTI= Lower respiratory tract infection
0%

20%

40%

60%

80%

100%

0 3 6 9 12

Efficacy

Month

Against medically-attended RSV-associated LRTI

Against hospitalization

12

Methods: RSVpreF efficacy

alternate scenario

average 6-month efficacy 

= trial efficacy 

Zero efficacy

Source: Kampmann et al 2023

LRTI= Lower respiratory tract infection
Methods: Efficacy

13

Variable Base case 

value

Range for 

sensitivity 

analysis

Source

RSVpreF

Initial efficacy (months 0-5) 

against medically-attended 

RSV-associated LRTI 51.3% 29.4% - 66.8%

Kampmann

et al, 2023

Initial efficacy (months 0-5) 

against hospitalized RSVassociated LRTI 56.8% 10.1% - 80.7%

Kampmann

et al, 2023

Efficacy months 6-12 0

Assumed 0% efficacy against upper respiratory tract infections

LRTI= Lower respiratory tract infection
Methods: Provision of RSVpreF

14

• Base case:

– Year round

• Scenarios

– During June-February (no vaccine given in 

March-May)

– During May-February (no vaccine given in 

March-April) 

– During April-February (no vaccine given in 

March) 
• Mother vaccinated 

– During 24-36 weeks gestation, based on 

distribution of Tdap vaccination by week in 

that time period

• Birth 

– Must be >2 weeks after vaccination for 

protective efficacy to pass to infant, based on 

historical gestational age

TDAP vaccination timing from internal CDC analysis of 2018-2021 MarketScan data. 15

Methods: Provision of RSVpreF
16

100 

Pregnant 

persons

50 

Not 

vaccinated

50 

Vaccinated

47 

Vaccinated

in time

3 

Not 

vaccinated

in time

Methods: Provision of RSVpreF

Uptake

Timing

Timing= >2 weeks prior to delivery
Methods: Medical Costs

Variable Value Range Source

Disease-specific 

hospitalization costs 

(per hospitalization) 

Age 0-11 months $11,487 4,804 - 86,646

Bowser 2022

Age 12- 23 months $11,469 4,804 - 86,646

Disease-specific ED 

costs (per ED visit) $563 544 - 581 Bowser 2022

Disease-specific 

outpatient costs (per 

outpatient visit)

$82 46 - 118 Bowser 2022

17

• Bowser, 2022 is a systematic review using studies from 2014-2021

• Funded by Sanofi

• All numbers updated to 2022 dollars using GDP Deflator
Methods: Productivity costs

Variable Value Range Source

Productivity burden of 

RSV disease (caregiver 

losses)

Days of lost productivity

Outpatient* 2.5 0-5

Fragaszy, 2018; Petrie, 

2016; Van Wormer, 2017

ED* 2.5 0-5

Fragaszy, 2018; Petrie, 

2016; Van Wormer, 2017

Hospitalization^ 7.4 0-14

Lifetime productivity for 

those <1 year old (lost 

from death)

1,795,936 1,346,951-

2,244,919

Grosse, 2019

18

*Productivity for outpatient and ED based on adult influenza

^Hospitalization productivity loss = length of hospitalization + 2 days
Methods: Intervention cost

Variable Value Range Source

Immunization-related 

costs

RSVpreF, per dose $200 50 – 300 Assumption: Manufacturer 

costs for adult vaccine

RSVpreF administration $16.96 15 - 22 Medicare: HCPCS 90460

19

Both assume no additional visits, but do include costs of administration
Methods: Adverse event costs

Variable Value Range Source

RSVpreF Maternal 

Adverse Events

Rate of injection site 

reaction 0.41 0.38 – 0.44 Pfizer Phase 3 Trial

Probability of healthcare 

visit, given injection site 

reaction

0.02 0.015 – 0.025 Curran, 2020

Cost of outpatient visit $367.76 23.15 – 1,758 (Deluca, 2023)

Recipient time, physician 

office for injection site 

reaction (hours)

2 1 - 3 Assumption 

Hypothetical serious 

adverse event 0.000001 0 - 0.0002

Base: Prosser, 2006

High: 95% CI Phase 3 data for 

RSV adult vaccines

20
21 Kampmann B, Madhi SA, Munjal I, Simões EA, Pahud BA, Llapur C, Baker J, Pérez Marc G, Radley D, Shittu E, Glanternik J. 

Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. New England Journal of Medicine. 2023 Apr 5.

Methods: Prematurity?

1% Difference?
Methods: Prematurity scenario

Variable Value Range Source

RSVpreF infant adverse 

events

Higher Rate of Prematurity 0% 0-2% Pfizer Phase 3 Trial

22 * All costs updated to 2022 using GDP Deflator

Outcomes, per 

prematurity

Lifetime cost of late 

prematurity

Medical $ 23,241 $11,621 –

$46,482 Waitzman, Jalali, Grosse, 2021

Productivity $ 11,447 $5,724 –

$22,894 Waitzman, Jalali, Grosse, 2021

QALYs lost from late 

prematurity 0.03 0 – 1.2

Werner, Hauspurg, Rouse, 2015

Petrini et al, 2008, Hirvonen et al, 2014, Crump 

et al, 2021, Darcy-Mahoney et al, 2016, Carroll 

et al, 2009, Payakachat et al, 2014
Methods: RSV 

health-related quality of life

23

LRTI quality-adjusted life DAYS lost Base Lower (Regnier) Upper (JIVE)

Outpatient: Child 3.1 1.8 16.6

Outpatient: Caregiver 1.5 0 9.1

ED: Child 4.9 2.9 16.6

ED: Caregiver 2.5 0 9.1

Hospitalized: Child 6.2 3.7 26.5

Hospitalized: Caregiver 2.4 0 13.6

Measured in 

Days Lost

Most 

Likely
Methods: Uncertainty analyses

• One-way sensitivity

• Scenarios:

– Prematurity

– Cost 

– Month of administration

– Upper respiratory tract infection effect 

– Efficacy waning

24
Results: Base case

25

• Base case:

– Population of 1,000 births

– 50% uptake in the RSVpreF group

– First RSV season

– $200/dose

– RSVpreF only impacts LRTI
Results: Health outcomes

Cohort:1,000 births, assuming 50% uptake in RSVpreF group 26

URTI= upper respiratory tract infection; LRTI= lower respiratory tract infection

 -

 50

 100

 150

 200

 250

Natural

History

RSVpreF Natural

History

RSVpreF Natural

History

RSVpreF

Outpatient Emergency

Department

Inpatient

Number of Events in Cohort

URTI LRTI
Results: Events Averted

Cohort:1,000 births, assuming 50% uptake in RSVpreF group 27

12.9

4.5

2.1

0.5

11.6

1.4

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

Outpatient ED Inpatient ICU Inpatient Day ICU Day

Events Averted per 1000 births

RSVPreF
Results: Number Needed to 

Vaccinate

Cohort:1,000 births, assuming 50% uptake in RSVpreF group 28

39 

112 

234 

1,062 

43 

354 

 -

 200

 400

 600

 800

 1,000

 1,200

Outpatient ED Inpatient ICU Inpatient Day ICU Day

Number needed to Vaccinate to avoid

RSVPreF
Results: Costs

29

Base costs of RSVpreF: $200/dose, both natural history and RSVPreF involve palivizumab for high-risk children

Cohort:1,000 births, assuming 50% uptake in RSVpreF group

$0

$100,000

$200,000

$300,000

$400,000

$500,000

$600,000

Natural History

RSVPreF

Natural History

RSVPreF

Natural History

RSVPreF

Natural History

RSVPreF

Natural History

RSVPreF

Natural History

RSVPreF

Intervention Outpatient ED Inpatient Deaths Total

Total Costs in Cohort

Medical Productivity
Results: Cost per Event Averted

30

Base costs of RSVpreF: $200/dose

$5,459 

$15,722 

$32,945 

$149,751 

$6,101 

$49,917 

 $-

 $20,000

 $40,000

 $60,000

 $80,000

 $100,000

 $120,000

 $140,000

 $160,000

Outpatient ED Inpatient ICU Inpatient Day ICU Day

Cost per Event Averted

RSVPreF
Results: QALYs Lost

31

Adverse 

Events Outpatient ED Inpatient Deaths Total Grand

Child Caregiver Child Caregiver Child Caregiver Child Child Caregiver Total

Natural 

History 1.95 0.98 0.90 0.45 0.22 0.09 0.15 3.22 1.51 4.73 

RSVpreF 0.0001 1.85 0.93 0.84 0.42 0.19 0.07 0.12 3.00 1.42 4.42 

Cohort:1,000 births, assuming 50% uptake in RSVpreF group

QALY= quality-adjusted life-year
Results: Cost-Effectiveness

32

Base costs of RSVpreF: $200/dose

QALY= quality-adjusted life-year; ICER= incremental cost-effectiveness ratio

Cohort:1,000 births, assuming 50% uptake in RSVpreF group, ICER is not affected by uptake

Overall Costs ($) QALYs lost

ICER ($/QALY)

Vs. NH

Natural History 418,556 4.73 

RSVpreF 489,038 4.40 214,087 
Sensitivity: Tornado RSVpreF

33

Base cost of RSVpreF: $200/dose

MA= Medically-attended

LRTI= Lower respiratory tract infection

QALY= Quality adjusted life year

$14 million

$0 $100,000 $200,000 $300,000 $400,000 $500,000

Probability of Prematurity

Disease-specific inpatient costs (per inpatient case) Age 0-5

months

RSV QALYS Lost

RSVpreF vaccine cost/dose

Vaccination Efficacy, Hospitalized RSV LRTI through 180 days

Vaccination Efficacy, RSV MA-LRTI through 180 days

Proportion of RSV infections with an LRTI diagnosis Outpatient Age

0-5 months

RSV-related QALYs lost Outpatient Child

RSV-related QALYs lost Outpatient Caregiver

Proportion of RSV infections with an LRTI diagnosis ED Visits Age

0-5 months

Incremental Cost-Effectiveness Ratio

Low High
 $-

 $500,000

 $1,000,000

 $1,500,000

 $2,000,000

 $2,500,000

 $3,000,000

 $3,500,000

 $4,000,000

 $4,500,000

 $5,000,000

0.0% 0.5% 1.0% 1.5% 2.0%

ICER

Excess Prematurity

Scenario: Prematurity

34

Base Case
 $-

 $50,000

 $100,000

 $150,000

 $200,000

 $250,000

 $300,000

 $350,000

$0 $50 $100 $150 $200 $250 $300

ICER

Cost of RSVpreF

Sensitivity: Cost RSVpreF

35

Base Case
Results: RSVpreF timing 

scenarios

36

• Scenarios

– Base: vaccine given year-round

– During April-February (no vaccine given in 

March) 

– During May-February (no vaccine given in 

March-April) 

– During June-February (no vaccine given in 

March-May)
Results: RSVpreF timing 

scenarios

214,087 

162,136 

137,871 

119,398 

 -

 50,000

 100,000

 150,000

 200,000

 250,000

Base Apr-Feb May-Feb Jun-Feb

ICER ($/QALY)

ICER: RSVpreF vs. Natural History

37
 $-

 $50,000

 $100,000

 $150,000

 $200,000

 $250,000

 $300,000

 $350,000

$0 $50 $100 $150 $200 $250 $300

ICER

Total Cost of RSVpreF

Scenario: Upper Respiratory 

Tract Infection Effect

38 RSVpreF is assumed to have 37.9% efficacy for upper respiratory tract infections based on overall respiratory tract 

efficacy from phase 3 trial (Kampmann, 2023)

ICER= incremental cost effectiveness ratio; QALY= Quality adjusted life year

$153,674/QALY
39

Methods: RSVpreF efficacy

“flat efficacy” scenario

Overall Costs ($) QALYs lost ICER ($/QALY)

Natural History 418,556 4.73 

RSVpreF 486,812 4.38 191,749 

Slightly lower costs with 

RSVpreF, slightly fewer 

QALYs lost, slightly lower 

ICER 0%

20%

40%

60%

80%

100%

0 3 6 9 12

Efficacy

Month

Against medically-attended RSV-associated LRTI

Against hospitalization

ICER: Incremental cost-effectiveness ratio

LRTI= Lower respiratory tract infection
Limitations

• Model Structure

– No risk groups

– No dynamic transmission. No impact of the vaccine 

on transmission and indirect effects

• Uncertain inputs

– RSVpreF cost 

– QALYs lost 

– Upper respiratory tract infections

– Prematurity

40
Summary

• RSVpreF may improve RSV outcomes, but will 

also increase costs

• RSVpreF has the potential to be cost-effective

• Results sensitive to:

– Rate of prematurity 

– Cost per dose (Cost-Saving – 350,000 $/QALY)

– Efficacy (~150,000 - 350,000 $/QALY)

– QALYs lost (~50,000 - 480,000 $/QALY)

• Hospitalization, Outpatient, ED

• Child, Parent

– Month of Administration (~120,000 – 215,000 $/QALY)

41 QALY: Quality-Adjusted Life-Year
Thank You

• Please send comments to:

• dwhutton@umich.edu

42
Appendix

43
Methods: Epidemiological model

Seasonality

Incidence

• Outpatient

• ED

• Hospitalizations

Nirsevimab

Waning 

Protection

Health Effects

• Outpatient

• ED

• Hospitalizations

• Deaths

Economic Effects

• Intervention

• Disease

• Societal

• QALYs

• ICER

Interventions

Epidemiology

Timing

Cost Burden/

• Outpatient

• ED

• Hospitalizations

Health Economics

Health Burden/

• Outpatient

• ED

• Hospitalizations

44
Methods: Inputs

• Incidence

– Raw reported incidence may be 

underreported because of imperfect PCR 

sensitivity, so we consider an additional 

scenario in sensitivity analysis:

• based on CDC Unpublished re-analysis of raw 

data from Zhang et al study which found 

decreased RSV PCR sensitivity in light of paired 

serology testing (adjustment factor: 87.6%).

45
Health-Related Quality-of-Life

• Sources

– Glaser (2022)

• Estimate based on comparison of utility losses between premature 

children who had RSV vs. premature children without RSV and their 

caregivers

• Used as base case for hospitalization for children and their caregivers

– Regnier (2013) 

• Estimate QALY losses for hospitalization, ED visits, and outpatient visits 

for children with pertussis 

• Use relative QALYs between hospitalization, ED, and outpatient to 

estimate base losses for ED and outpatient in base case

– JIVE RSV Utilities Survey (2021)

• Estimates QALY losses for hospitalization and outpatient visits for child 

and caregiver

• Estimates may be impacted by COVID-related concerns about 

respiratory viruses

• Inform upper bound of range

46
Timing of those who received vaccination during pregnancy 47

RSVpreF is assumed to start earlier at week 24 (vs. week 27)

0

0.02

0.04

0.06

0.08

0.1

0.12

0.14

0.16

0.18

1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39

Fraction Vaccinated (given 

receipt of vaccine)

Gestational Age

Reported Tdap Modeled RSVpreF vaccination timing

Methods: Provision of RSVpreF
48

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

45.0%

0 10 20 30 40 50

Gestational Age (Week)

Source: NCHS from 2019 and 2021

Methods: Birth Timing
Validation

231

66

8

225 

65 

13 

0

50

100

150

200

250

Outpatient Clinic

Visits

ED Visits Hospitalizations

Rates of Medically

-Attended 

RSV (per 1000 births)

Rainisch et al, Vaccine, 2020 JIVE model

49
Methods: Maternal Adverse 

Event Health Effects

Variable Value Range Source

Adult Quality-Adjusted LifeYears lost due to adverse events

Injection Site Reaction 0 Assumed

Serious Adverse Event 0.141 0.092-0.199 Prosser, 2006

50
Results: Cost-Effectiveness

51

Base costs of RSVpreF: $200/dose

Cohort:1,000 births, assuming 50% uptake in RSVpreF group

 $410,000

 $420,000

 $430,000

 $440,000

 $450,000

 $460,000

 $470,000

 $480,000

 $490,000

 $500,000

 (4.80) (4.70) (4.60) (4.50) (4.40) (4.30)

Costs 

QALYs (lost) from RSV 

Natural History RSVPreF
Results: RSVpreF Administration 

June-February

52

Overall

Costs ($) QALYs

ICER 

($/QALY)

Vs. NH

Natural 

History 418,556 4.73 

RSVpreF 454,928 4.43 119,398