Cost Comparison of Venipuncture Versus Minimally-Invasive at Home Blood Collection in Newborn Screen Confirmation for Phenylketonuria

by Alyssa Abo

Coauthors: Sumedha Mongia, MD, MBA Senior Innovation Fellow, Office of Biotechnology, Children’s National Hospital smongiamd@gmail.com Preeti Krishnamani Student, MIT Sloan School of Management preetik@mit.edu Pranoot Tanpaiboon, MD, FACMGG Medical Director, Biochemical Genetics, R&D Molecular Genomics & Oncology, Quest Diagnostics Pranoot.x.tanpaiboon@questdiagnostics.com Rob Freishtat, MD, MPH Chief Biotechnology Officer, Children’s National Hospital rfreishtat@childrensnational.org Alyssa Abo, MD, MBA Executive Director, Office of Biotechnology, Children’s National Hospital aabo@childrensnational.org Debra Regier, MD Interim Division Chief, Genetics and Metabolism, Children’s National Hospital dregier@childrensnational.org

Medical Devices & Digital Health

OBJECTIVE:
The purpose of this study is to evaluate the financial and emotional burden of venipuncture versus newer, minimally-invasive methods of specimen collection in infants undergoing newborn screening (NBS) confirmation testing for phenylketonuria (PKU).

INTRODUCTION:
Newborn Screening (NBS) is a cost-effective public health program in the United States, with very high specificity and sensitivity, but the number of false positive (FP) tests remains a concern. The high number of positive screens and resulting confirmatory testing can be a financial and emotional burden for the healthcare ecosystem. Recent innovations in minimally-invasive blood collection techniques make it possible to rethink neonatal care in order to lower costs, make care more accessible, and reduce the patient's burden. To evaluate the financial and emotional burden of NBS phenylketonuria confirmation testing, we compared costs that healthcare stakeholders incur from standard venipuncture versus at-home specimen collection.

METHODS:
All costs of PKU confirmation testing for the Cost of Illness (COI) and Cost Benefit Analysis (CBA) were presented as totals and segmented by stakeholder. The figures in the COI and CBA were derived from industry averages, Quest Diagnostics costs, Children’s Hospital Lab costs, average reported wages, reported prevalence rates, the US Median Wage Rate, and device kit and shipping costs. Intangible costs and benefits (pain, anxiety, and suffering) were quantified using the Multiplier Method, giving each procedure a multiplier (1.5-5) to indicate the severity of the procedure. Microneedle collection was given a multiplier of 1.5 and venipuncture was given a multiplier of 2.0. Net Present Value was completed using costs over 5 years and discount rates of 3% and 7%.

RESULTS:
The COI for NBS confirmation testing using venipuncture and in-person evaluation for patients with a PKU positive screen showed costs of $1760/patient. Direct costs amounted to $1,608, and indirect costs were $152. Patients incurred $190 (11%) of the total cost. The CBA found an overall benefit of $248/patient(14.1% reduction) with at-home collection. Direct costs for health systems and payers were reduced by $127/patient (7.9%). Patient transportation expenses were reduced by $37.50 (100%). Patient indirect costs were reduced by $121 (80%). This translates to an annual benefit of $4.4 million annually for PKU patients in opportunity gains. The annual benefits translate to $9.1 million (14.1%). Payers save $3.08 million (5.9%). Health systems save $206,000 (3.8%) and patients save $5.8 million (88%). The Net Present Value (NPV) of the at-home collection method with telemedicine is $50 million and $44 million over 5 years for PKU patients with a discount rate of 3% and 7%. Intangible costs from pain and suffering, quantified using the Multiplier Method, went down from $253 to $190 (25%).

CONCLUSION:
Minimally invasive, at-home collection kits to complete NBS PKU confirmation testing can provide significant economic and intangible benefit to all healthcare stakeholders. Even for a relatively small cohort like PKU screen–positive patients, there were direct cost savings for payers, health systems, and patients from at-home care delivery. Additional benefits may be seen downstream with this method as infants treated at home have improved access to care and fewer exposures and secondary illnesses. The reduction in parental stress and anxiety could further add to the cost effectiveness.