Bilirubinometers for Newborn Hyperbilirubinemia

Health Technology Assessment Committee Recommendations¹

1. Transcutaneous bilirubinometers (TcB) are effective in screening for hyperbilirubinemia in late preterm and term newborns (≥ 35 weeks gestation). Positive TcB results for hyperbilirubinemia must be confirmed by a total serum bilirubin blood test (TSB).
2. Transcutaneous bilirubinometers (TcB) provide value for money and there may be some operational contexts where the use of TcB could result in cost avoidances. This is most likely when a TSB cannot be obtained at the same time as the newborn screen, and obtaining a TSB is associated with additional time in hospital. However, TSB is more cost-effective when obtained at the same time as other newborn blood work and additional time in hospital is not required.
3. While it may not be appropriate to replace the TSB in all circumstances, due to the potentially substantial patient benefits associated with fewer heel-pricks and greater convenience, and the potential in some contexts for reducing the number of TSB tests and more timely discharge from hospital, it is recommended that the use of transcutaneous bilirubinometers (TcB) in the provision of care be determined by Health Authorities at the operational level.
4. Where applicable, Health Authorities should ensure implementation challenges identified by health professionals (calibration, ongoing maintenance, development and application of appropriate nomograms, and confidence in results) are addressed through appropriate quality assurance strategies.

Health Technology Assessment Committee Findings

1. Transcutaneous bilirubinometers (TcB) is more effective than visual assessment, but less effective than TSB. Evidence of diagnostic accuracy is robust. Sensitivity of TcB devices range from 72%-100% and specificity from 58%-88% when compared with TSB (assuming TSB has perfect accuracy).
2. Transcutaneous bilirubinometers (TcB) can be considered a useful screening tool for hyperbilirubinemia in late preterm and term newborns. However, cases where bilirubin levels exceed acceptable levels still need to be confirmed with a follow-up TSB.
3. Studies on clinical outcomes show a decrease in the number of TSB blood tests, with estimates ranging from a 23% to 34% reduction, and an overall trend towards reduced health care resources including TSB testing, phototherapy, and hospital readmissions after TcB implementation.
4. Non-health patient benefits include potentially fewer painful and invasive heel-pricks, which is stressful on newborns (and is associated with an increased risk of inflammation of the bone or infection), as well as increased comfort and convenience for families. 
5. Device and associated maintenance costs would be the primary cost to health authorities. Evidence suggests about 127 devices would be required to screen all babies born in the province annually (currently, there are about 34 devices in use) and initial costs would range from approximately $10,039 (for 1 device) to $180,701 (18 devices) per hospital, which would be amortized over the five-year lifespan of the device.
6. Due to the rarity of kernicterus (estimated to occur in 1:50,000 births), cost-effectiveness analysis showed no difference in QALYs across screening techniques (visual assessment, TcB, and TSB) therefore economic analysis focused on identifying the least expensive option.
7. Economic analysis suggests TcB is cost-effective, but whether screening with TcB is less costly than screening with TSB depends on the operational context. Analysis shows that if a longer hospital stay is associated with TSB, such as if newborns are required to wait in hospital for results, TcB is the less costly screening option. If there is no associated longer stay in hospital with TSB, then TSB is the least costly screening option. This scenario is even more favourable if TSB is done at the same time as other blood tests such as the newborn screen.
8. The technology is easy to use and anticipated risks to implementation are minimal. However, cited implementation challenges to be aware of include calibration and ongoing maintenance of devices, development and application of appropriate nomograms, and appropriate training, which could require additional resources.

The Health Technology Assessment Committee’s recommendations on Bilirubinometers for Newborn Hyperbilirubinemia were accepted by a committee of senior health authority and ministry executives in June 2018. Please note: health authorities determine how health technologies are implemented within their programs and services. Other relevant scientific findings may have been reported since the completion of the reference documents used to form the basis of the Committee's recommendations.