Document text
Economics of combined use of Pfizer
maternal RSVpreF vaccine and
nirsevimab
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 MichiganPresentation to the ACIP
June 22, 2023
Research team
University of Michigan
•David Hutton, PhD
•Lisa Prosser, PhD
•Angela Rose, MPH
•Kerra Mercon , MSCDC
•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 questions
•Determine the cost -effectiveness of:
•Nirsevimab in children born to mothers who received RSVpreF at least 2
weeks prior to delivery
•RSVpreF for pregnant persons who will give nirsevimab to their newborns
•Single individual
•Evaluate by month of year
•Perspective: Societal
•Timeframe: 1 year (1 RSV season)
•Analytic horizon: infant’s lifetime
•Discount rate: 3%
4
Overview of nirsevimab
changes/additions
•Since February
•Nirsevimab cost $500/dose
•Nirsevimab reduces palivizumab use
•Old base case ICER: $ 102,805/QALY
•New base case ICER: $157,537/QALY
5
Methods: Intervention effectiveness
•NO evidence of efficacy on the combined use of
these products
•Assumption:
•Efficacy equal to the highest of nirsevimab or RSVpreF :
•Efficacy would not be higher than from the most effective
product
6
Methods: Intervention effectiveness
7* Assuming administration of nirsevimab at birth0%20%40%60%80%100%
0 2 4 6 8 10 12 14Hospitalization Efficacy
Months since birth
RSVPreF Both Nirsevimab
Incremental benefit of adding
nirsevimab on top of RSVpreF
8•For infants of persons vaccinated with RSVpreF
during pregnancy
0%20%40%60%80%100%
0 2 4 6 8 10 12 14Hospitalization Efficacy
Months since birth
RSVPreF Both NirsevimabMethods: Intervention effectiveness
9
Additional benefit of adding nirsevimab
* Assuming administration of nirsevimab at birth
0%10%20%30%40%50%60%70%80%90%100%
0 2 4 6 8 10 12Hospitalization Efficacy
Month
Both RSVpreF OnlyMethods: Intervention effectiveness
Example: Off -peak (Aug) birth
Additional benefit of adding nirsevimab
Note: Peak infections are typically Dec -Feb
10
110.0%5.0%10.0%15.0%20.0%25.0%30.0%
Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb MarFraction of Annual Infections
Source: National Respiratory and Enteric Virus Surveillance System (NREVSS) (2015 -2019)Reminder: Seasonality
Results: Incremental benefit of adding
nirsevimab on top of RSVpreF
Nirsevimab given in Oct -Mar
ICER= Incremental cost effectiveness ratio ($/QALY)Birth Month $- $500,000 $1,000,000 $1,500,000 $2,000,000 $2,500,000 $3,000,000ICER ($/QALY)
12
Results: Adding nirsevimab to all
infants born to vaccinated mothers
Nirsevimab given at birth for infants born October -March, and in October/November for infants born in April through
September
13
Results: Adding nirsevimab to all
infants born to vaccinated mothers
Nirsevimab given at birth for babies born October -March, and in October/November for babies born in April through
September
14
Results: Adding nirsevimab to all
infants born to vaccinated mothers
QALYs
GainedAdditional
CostsICER
($/QALY)
0.000781 $522.12 $ 668,735
Notes: Nirsevimab given at birth for babies born October -March, and in October/November for babies born in April
through September
ICER= Incremental cost effectiveness ratio; QALY= Quality -adjusted life -year
15
Results: Adding nirsevimab only for
infants born during Apr -Sept
Nirsevimab given in October/November for babies born in April through September born to mothers who received
RSVpreF
16
Nirsevimab given in October/November for babies born in April through September born to mothers who received
RSVpreFResults: Adding nirsevimab only for
infants born during Apr -Sept
17
Nirsevimab given in October/November for babies born in April through September born to mothers who received
RSVpreF
ICER= Incremental cost effectiveness ratio; QALY= Quality -adjusted life -yearQALYs
GainedAdditional
CostsICER
($/QALY)
0.001032 $502.40 $486,882 Results: Adding nirsevimab only for
infants born during Apr -Sept
18
•Marginal additional benefit beyond RSVpreF
protection
•ICER is very highSummary: Incremental benefit of
adding nirsevimab on top of RSVpreF
19
Incremental benefit of adding RSVpreF
on top of nirsevimab
20
0%20%40%60%80%100%
0 2 4 6 8 10 12 14Hospitalization Efficacy
Months since birth
RSVPreF Both NirsevimabMethods: Intervention effectiveness
21
Additional benefit of adding RSVpreF
* Assuming administration of nirsevimab at birth
0%10%20%30%40%50%60%70%80%90%100%
0 2 4 6 8 10 12Hospitalization Efficacy
Month
Both Nirsevimab OnlyMethods: Intervention effectiveness
example: Off -peak (Aug) birth
Additional benefit of adding RSVpreF
22
Results: Incremental benefit of adding
RSVpreF on top of nirsevimab
Birth Month $- $1 $2 $3 $4 $5 $6 $7 $8 $9 $10ICER ($ Millions)
ICER= Incremental cost effectiveness ratio23
•Very marginal additional benefit beyond
Nirsevimab protection
•ICERs are extremely highSummary: Incremental benefit of
adding RSVpreF on top of nirsevimab
24
•Limitation:
•No efficacy data for combination of products
•Combinations of RSVpreF and Nirsevimab add
marginal effectiveness at very high cost in the
general populationOverall summary: Combinations
25
Thank You
•Please send comments to:
•[email protected]
26
Appendix
27
Additional Input
Assumptions
28
Methods: Provision of Nirsevimab
•Base case:
•At birth for those born
•October 1 –March 31
•October for those born in
•April (~6 -month visit)
•June (~4 -month visit)
•August (~2 -month visit)
•November for those born in
•May (~6 -month visit)
•July (~4 -month visit)
•September (~2 -month visit)
29
Methods: Intervention effectiveness
30•Assuming Administration of Nirsevimab at birth
•MA-LRTI= medically attended lower respiratory tract infection0%20%40%60%80%100%
0 2 4 6 8 10 12 14MA-LRTI Efficacy
Months since birth
RSVPreF Nirsevimab Both
Additional combination
Results
Incremental benefit of adding on
nirsevimab top of RSVpreF
Results: Incremental benefit of adding
nirsevimab on top of RSVpreF
by month of birth
Birth Month0.0000.0100.0200.0300.0400.0500.0600.070
Outpatient ED Inpatient ICU Inpatient Day ICU DayEvents Averted per Birth
October November December January February March
April May June July August September0.0000.0010.0010.002
ICU
Nirsevimab given at birth for babies born October -March, and in October/November for babies born in April through September
Results: Incremental benefit of adding
nirsevimab on top of RSVpreF
Birth Month0100200300400500600700800900
Outpatient ED InpatientNumber Needed to Immunize to Avoid One...
November December January February March April
May June July August September01000200030004000
ICU Inpatient
DayICU Day
Nirsevimab given at birth for babies born October -March, and in October/November for babies born in April through September
Results: Incremental benefit of adding
nirsevimab on top of RSVpreF
Birth Month $- $50,000 $100,000 $150,000 $200,000 $250,000 $300,000 $350,000 $400,000 $450,000 $500,000
Outpatient ED InpatientCost per Event Averted
October November December January February March
April May June July August September $- $500,000 $1,000,000 $1,500,000 $2,000,000 $2,500,000
ICU Inpatient
DayICU Day
Nirsevimab given at birth for babies born October -March, and in October/November for babies born in April through September
Incremental benefit of adding RSVpreF
on top of nirsevimab
00.00050.0010.00150.0020.00250.0030.00350.0040.00450.005
Outpatient ED Inpatient ICU Inpatient Day ICU DayEvents Averted per Birth
October November December January February March
April May June July August SeptemberResults: Incremental benefit of adding
RSVpreF on top of nirsevimab
Impact of adding RSVpreF in addition
to nirsevimab is bigger for births in
April -Sept since nirsevimab does not
provide protection in April -Sept for
those born in those months
Birth Month
Results: Incremental benefit of adding
RSVpreF on top of nirsevimab
Birth Month010002000300040005000600070008000900010000
Outpatient ED Inpatient ICU Inpatient Day ICU DayNumber Needed to Immunize to Avoid One...
October November December January February March
April May June July August September
Results: Incremental benefit of adding
RSVpreF on top of nirsevimab
Birth Month $- $100,000 $200,000 $300,000 $400,000 $500,000 $600,000 $700,000 $800,000 $900,000 $1,000,000
Outpatient ED Inpatient ICU Inpatient Day ICU DayCost per Event Averted
October November December January February March
April May June July August September
Results: Adding RSVpreF
What if RSV season is early?
•Scenario:
•RSVpreF provided in off -peak
•RSV season starts 2 months early
•Nirsevimab still provided in October
0.0%10.0%20.0%30.0%
Apr Jun Aug Oct Dec FebIncidence
(% of annual)Seasonality
Original Model
$6.86
$2.72
$2.25
$0.71
$1.42
$0.43
$- $2.00 $4.00 $6.00 $8.00 $10.00ICER ($ Millions)ICER (Millions)Results: Adding RSVpreF
What if RSV season is early?
ICERs improve, but still
very expensive
Birth Month
ICER -Incremental cost -effectiveness ratio
Nirsevimab base case
update
Nirsevimab results: Base case
43•Base case:
•Population of 1,000 births
•50% uptake in the nirsevimab group
•First RSV season
•$500/dose
•Nirsevimab only impacts LRTI
LTRI= Lower respiratory tract infection
Results: Health outcomes
44Cohort:1,000 nirsevimab and 1,000 natural history, assuming 50% uptake in nirsevimab group
URTI -Upper respiratory tract infection; LRTI -Lower respiratory tract infection - 50 100 150 200 250
Natural
History Nirsevimab Natural
History Nirsevimab Natural
History Nirsevimab
Medically attended
outpatientEmergency Department InpatientNumber of Events in Cohort
URTI LRTI
Results: Health outcomes
45Cohort:1,000 nirsevimab and 1,000 natural history, assuming 50% uptake in nirsevimab group29.3
10.4
3.9
0.921.1
2.6
0.05.010.015.020.025.030.035.0
Outpatient ED Inpatient ICU Inpatient Day ICU DayEvents Averted per 1000 births
Nirsevimab
Results: Health outcomes
4617 48 128 581
24 194
- 100 200 300 400 500 600 700
Outpatient ED Inpatient ICU Inpatient Day ICU DayNumber needed to Prophylax to avoid
Nirsevimab
Results: Costs
47Base costs of nirsevimab : $500/dose, Cost of palivizumab for high -risk included in “Natural History”Cohort:1,000 births, assuming 50% uptake in nirsevimab group$0$100,000$200,000$300,000$400,000$500,000$600,000
Natural History
Nirsevimab
Natural History
Nirsevimab
Natural History
Nirsevimab
Natural History
Nirsevimab
Natural History
Nirsevimab
Natural History
Nirsevimab
Intervention Outpatient ED Inpatient Deaths TotalTotal Costs in Cohort
Medical Productivity
Results: Health outcomes
48Base costs of nirsevimab : $500/dose$3,794 $10,650 $28,372 $128,963
$5,254 $42,988
$- $20,000 $40,000 $60,000 $80,000 $100,000 $120,000 $140,000
Outpatient ED Inpatient ICU Inpatient Day ICU DayCost per Event Averted
Nirsevimab
Results: QALYs lost
49Adverse
EventsOutpatient 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
Nirsevimab 0.01 1.70 0.85 0.76 0.38 0.15 0.06 0.10 2.73 1.29 4.03
Cohort:1,000 births, assuming 50% uptake in nirsevimab group
Results: Cost -effectiveness
50Cohort:1,000 births, assuming 50% uptake in nirsevimab group $- $100,000 $200,000 $300,000 $400,000 $500,000 $600,000
(4.80) (4.60) (4.40) (4.20) (4.00) (3.80)Costs
QALYs (lost) from RSV
Natural History Nirsevimab
Base costs of nirsevimab : $500/dose, Cost of palivizumab for high -risk included in “Natural History”
Results: Cost -effectiveness
51OverallCosts ($) QALYsICER ($/QALY)
Vs. NH
Natural History 418,556 4.73
Nirsevimab 529,597 4.03 157,537
Cohort:1,000 births, assuming 50% uptake in nirsevimab group
Base costs of nirsevimab : $500/dose, Cost of palivizumab for high -risk included in “Natural History”
Sensitivity: Tornado nirsevimab
52Base cost of $500/dose$0 $50,000 $100,000 $150,000 $200,000 $250,000 $300,000 $350,000 $400,000
nirsevimab cost/dose
Disease-specific inpatient costs (per inpatient case) Age 0-5 months
RSV QALYS Lost
Initial Efficacy
RSV-related QALYs lost Outpatient Child
Fraction Receiving Palivizumab Natural History
RSV-related QALYs lost Outpatient Child caregiver
Proportion of RSV infections with an LRTI diagnosis Outpatient Age 0-5 months
Disease-specific inpatient costs (per inpatient case) Age 6-11 months
RSV-related QALYs lost ED ChildIncremental Cost -Effectiveness Ratio
Low High
$- $50,000 $100,000 $150,000 $200,000 $250,000
$0 $100 $200 $300 $400 $500 $600ICER
Total Cost of Nirsevimab (drug + administration)Sensitivity: Cost nirsevimab
53Base cost of $500/dose
Scenario: Upper respiratory infection
effect
5455.4
17.1
3.9
0.921.1
2.6
0.010.020.030.040.050.060.0
Outpatient ED Inpatient ICU Inpatient Day ICU DayEvents Averted per 1000 births
Nirsevimab
$- $20,000 $40,000 $60,000 $80,000 $100,000 $120,000 $140,000
$0 $100 $200 $300 $400 $500 $600ICER
Total Cost of Nirsevimab (drug + administration)Scenario: Upper respiratory infection
effect
55 Nirsevimab is assumed to be equally efficacious in preventing upper respiratory tract infections as lower respiratory tract infections.
Scenario: Timing analysis
56•Cost -effectiveness of an infant receiving nirsevimab
as a newborn in
•Oct-Feb
•Oct-March
•Oct-April
•With varying efficacy in months 6 -10
•0%
•25%
•50%
Cohort:1,000 nirsevimab and 1,000 natural history, assuming 50% uptake in nirsevimab group
57Scenario: Timing and efficacy in months 6 -10
Slightly lower ICERs for Oct -MarBase cost of $500/dose
ICER= Incremental cost -effectiveness ratioCohort:1,000 nirsevimab and 1,000
natural history, assuming 50% uptake in
nirsevimab group $- $20,000 $40,000 $60,000 $80,000 $100,000 $120,000 $140,000 $160,000 $180,000
0% efficacy 25% efficacy 50% efficacyICER
Oct-Feb Oct-Mar Oct-Apr