DISEASE BURDEN

Disease Scenarios

For the purposes of the calculations in this report, the committee estimated that 90% of congenitally acquired CMV infections are asymptomatic at birth. Of these 36,000 new cases per year, 5,400 infants develop neurologic sequelae, such as deafness. These sequelae are estimated to lead to a health utility index (HUI) of .89 and persist for the duration of that infant's life. The committee estimated that 10% of the 4,000 congenitally acquired cases of CMV that are symptomatic at birth (400 cases annually) lead to death after a brief hospitalization following birth.

Of those 3,600 infants who live beyond the initial phase described above, the committee estimated that 90%, or 3,240 infants, experience severe sequelae, and 10%, or 360 infants, experience mild sequelae. These sequelae are life-long. The HUI associated with the mild and severe sequelae were estimated to be .89 and .48, respectively. Those experiencing severe sequelae were estimated to have a reduced lifespan to only 20 years. Table A4–1 illustrates the estimated number of cases in each health state, the duration of time that state is experienced, and the health utility index (HUI) associated with each state.

Table A4–1

Disease Scenarios for CMV Infection in Infants.

For the purposes of the calculations in this report, the committee estimated that there are 1,200 cases of moderate CMV disease (e.g., pneumonia and gastrointestinal disease) lasting 1 month, and 1,600 cases of severe CMV disease lasting 2 months in organ-transplant recipients each year. The HUI associated with moderate and severe CMV disease was estimated at .91 and .68 (further adjusted to reflect an altered baseline HUI for organ transplant patients compared to the general population). Further, the committee estimated that 10% of organ transplant patients with severe CMV disease die.

COST INCURRED BY DISEASE

Table A4–2 summarizes the health care costs incurred by cytomegalovirus infections. For the purposes of the calculations used in the report, it was assumed that costs for neurologic sequelae of CMV infection in newborns (whether symptomatic at birth or not) includes regular visits to a specialist for the lifetime of all infected individuals, and special schooling expenses. A small percentage of more severely affected newborns incur costs for hospitalization and long-term care. For infants who are symptomatic at birth, costs for hospitalization, diagnostics, and specialists are included in the calculations. Outpatient follow-up for these patients include several physician visits. For those infants who experience severe sequelae of the CMV infection, costs for 20 years of long-term care are included.

Table A4–2

Health Care Costs for CMV Infection in Infants and Transplant Patients.

The other group of patients with CMV infections assessed in this report are organ transplant recipients. Patients who develop CMV infections incur costs associated with hospitalization, diagnostics, and multiple physician visits.

VACCINE DEVELOPMENT

The committee assumed that the development of a CMV vaccine is feasible and that licensure can occur within 7 years. The estimates for the model are that 360 million needs to be invested. Table 4–1 summarizes vaccine development assumptions for all vaccines considered in this report.

VACCINE PROGRAM CONSIDERATIONS

RESULTS

If a vaccine program for CMV were implemented today and the vaccine was 100% efficacious and utilized by 100% of the target population, the annualized present value of the QALYs gained would be 70,000. Using committee assumptions of less-than-ideal efficacy and utilization and including time and monetary costs until a vaccine program is implemented, the annualized present value of the QALYs gained would be 18,000. The vast majority of these QALYs are attributable to the long-term sequelae experienced by infants who acquire congenital-CMV infections.

If a vaccine program for CMV were implemented today and the vaccine was 100% efficacious and utilized by 100% of the target population, the annualized present value of the health care costs saved would be $4 billion. Using committee assumptions of less-than-ideal efficacy and utilization and including time and monetary costs until a vaccine program is implemented, the annualized present value of the health care costs saved would be $1.1 billion.

If a vaccine program for CMV were implemented today and the vaccine was 100% efficacious and utilized by 100% of the target population, the annualized present value of the program cost would be $680 million. Using committee assumptions of less-than-ideal efficacy and utilization and including time and monetary costs until a vaccine program is implemented, the annualized present value of the program cost would be $240 million.

Using committee assumptions of time and costs until licensure, the fixed cost of vaccine development has been amortized and is $10.8 million for a CMV vaccine.

If a vaccine program were implemented today and the vaccine were 100% efficacious and utilized by 100% of the target population, the annualized present value of the cost per QALY gained is -$50,000. A negative value represents a saving in costs in addition to a saving in QALYs. Using committee assumptions of less-than-ideal utilization and including time and monetary costs until a vaccine program is implemented, the annualized present value of the cost per QALY gained is -$45,000.

See Chapters 4 and 5 for details on the methods and assumptions used by the committee for the results reported.

READING LIST

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