Table 21:
Probabilistic Sensitivity Analysis Scenarios: Changes in Structural and Parameter Assumptions
| Parameter/Assumption: Population of Interest | Reference Case Analysis | Scenario Analysis: Major Changes in Parameter Values or Assumptions |
|---|---|---|
| Inclusion of paternal phenotyping: both populations | Maternal testing only: intervention with noninvasive fetal RhD genotyping | Paternal RhD testing, assuming patient consent; paternal testing included in both strategies (intervention and usual care) |
| Probability of inconclusive results after genotyping: both populations | 0.067 (0.004)37,39 | 2% to 10%37 |
| Test accuracy: both populations | Sn: 99.7%; Sp: 96.1% 39 | Sn: 99.7%; Sp: 98.7% (see Table 15)39 |
| Probability of alloimmunization: nonalloimmunized population only | ||
| • RhIG at 28 weeks and birth | 0.00262 | 0.0031 (95% CI 0.0021 – 0.0040)57 |
| • RhIG after birth only | 0.01662 | 0.0067 (95% CI 0.0050 – 0.0084)57 |
| • No RhIG | 0.12 | 0.166,11 |
| Compliance with testing and RhIG: nonalloimmunized population only | ||
| • Fetal RhD genotyping | 100% | Assumed 0.78 for the scenario analysis, based on the range reported in our clinical review: 0.78 to 0.93 (Clausen et al, 201489) |
| • RhIG | 100% | Probability of receiving universal prophylaxis at 28 weeks and birth: 0.99 (Soothill et al, 201549; Saramago et al, 201837) Probability of receiving RhIG after a potentially alloimmunization event: 0.958 (0.006)37 |
| Analysis perspective: alloimmunized population only | Ministry of Health perspective | Societal perspective |
| Cost of noninvasive RhD fetal genotyping: both populations | Estimated (Table 17) | Estimated, provided by OOC-PA Program (Table 22) Lower cost: nonalloimmunized pregnancies (Table 22) |
| Cost of cord blood sampling: both populations | Procedure cost: $772 (SE: $24) (Tables 18 and 19) | Lab fee cost solely: $6.81 (Tables 18 and 19) |
| Probability of long-term neurodevelopmental problems: alloimmunized population only | 0.048 (SE: 0.003)93 | 3 times smaller than reference case estimate |
| Long-term costs and HSUs of the state associated with major developmental problems: alloimmunized population only | HSUs and costs, combined for major developmental problems and cerebral palsy (see Table 16 and Table 20): HSUs = 0.4237 and 0.3087 | Scenario A assumed:
Scenario B assumed:
Scenario C assumed:
Scenario D assumed:
|
| Discount rate: both populations | 1.5% | 5% |
| Time horizon: both populations | Long-term: 10 years | Shorter: 1 year, 5 years, and lifetime |
| Multiple pregnancies: nonalloimmunized population only | Nonalloimmunized population only, one pregnancy | Approximation, time horizon: 10 years and lifetime 2 pregnancies: first nonalloimmunized pregnancy followed by either a nonalloimmunized or alloimmunized pregnancy |
Abbreviations: CI, confidence interval; HSU, health state utilities; NA, not applicable; OOC-PA Program, Out-of-Country Prior Approval Program; RhD, rhesus D blood group; RhIG, Rh immunoglobulin; SE, standard error; Sn, sensitivity; Sp, specificity.