Boutique Diagnostics

Digital Health Market Access Consulting Firm

Digital Health Solutions

June 2022: Access relevant diagnostics scientific publications

1.       Assessing the long-term effects of Basic Medical Insurance on catastrophic health spending in China

This study examines the long-term effects of Basic Medical Insurance (BMI) on individual catastrophic healthcare spending (CHS) in China. There were two main findings. First, BMI policy did not significantly reduce the probability of incurring CHS for BMI enrollees over time. Years after BMI was introduced, the policy even predicted a significant increase in the probability of incurring CHS for individuals who shifted their enrolments from traditional insurance to BMI. Second, BMI policy had spillover effects on the increase in the probability of incurring CHS for non-BMI individuals a few years after its inception.

2.       Effect of Point-of-Care Testing for Respiratory Pathogens on Antibiotic Use in Children: A Randomized Clinical Trial

The study aims to evaluate the effect of multiplex PCR point-of-care testing for respiratory pathogens on antibiotic use in acutely ill children. In this randomized clinical trial, point-of-care testing for respiratory pathogens did not reduce the use of antibiotics at the pediatric ED. Testing for respiratory pathogens appears to have a limited impact on clinical decision-making for acutely ill children.

3.       Screening is not always healthy: an ethical analysis of health screening packages in Singapore

In Singapore, screening tests are widely available in the form of a package, which bundles multiple tests in one session and commonly includes non-recommended tests. Several ethical issues were identified that should be addressed with regard to health screening packages in Singapore.

4.       Market access and value-based pricing of digital health applications in Germany

This paper aims to describe the legal framework for DiGA market access and pricing as well as the status quo of the DiGA market. Furthermore, it provides a basic approach to deriving value-based DiGA prices. DVG does not indicate how the benefits of a DiGA should be translated into a reasonable price. The researchers' evidence-based approach to value-based DiGA pricing approximates the SHI’s willingness to pay by the average cost-effectiveness of one or more established therapy in a field of indication and furthermore considers the positive healthcare effects of a DiGA.

5.       PROPOSe: A Real-life Prospective Study of Proclarix, a Novel Blood-based Test to Support Challenging Biopsy Decision-making in Prostate Cancer

This study evaluated the accuracy of Proclarix, a novel blood-based diagnostic test, to help in biopsy decision-making in this challenging patient population.

6.       Diagnostic Value and Cost-Effectiveness of Next Generation Sequencing-Based Testing for Treatment of Patients with Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer in the United States

The study evaluated the diagnostic value and cost-effectiveness of next-generation sequencing (NGS)-based testing versus various combinations of single-gene tests (SGTs) for the selection of first-line treatment for patients with advanced/metastatic non-squamous non-small cell lung cancer in the United States. Testing strategies with NGS are more comprehensive in the detection of actionable biomarkers and can improve the proportion of patients receiving biomarker-driven therapies. NGS testing may provide a cost-effective strategy for advanced/metastatic non-squamous non-small cell lung cancer; however, the value of NGS-directed therapy varies by the willingness-to-pay threshold of the decision-maker.

7.       Managing sepsis in the era of precision medicine: challenges and opportunities

Current diagnostic testing in sepsis relies primarily on conventional cultures (e.g. blood cultures), which are time-consuming and may delay critical therapeutic decisions. Nonculture-based techniques including nucleic acid amplification technologies (NAAT), other molecular methods (biomarkers), and genomic sequencing offer promise to overcome some of the inherent limitations seen with culture-based techniques.

8.       Digital health in medicine: Important considerations in evaluating health economic analysis

In light of challenges in evaluating digital health solutions, the following steps can be considered: 1. Define the intended use environment, 2. select appropriate relevant health economic model, 3. perform evaluation compared to the SOC, 4. evaluate direct and indirect costs for screening technologies, clinical services, hospital systems, and digital infrastructure.

9.       Accuracy and effectiveness of HPV mRNA testing in cervical cancer screening: a systematic review and meta-analysis

This study systematically reviewed the literature to assess whether tests targeting high-risk HPV (hrHPV) mRNA are as accurate and effective as HPV DNA-based screening tests.

10.   Up-front cell-free DNA next-generation sequencing improves target identification in UK first-line advanced non-small cell lung cancer (NSCLC) patients

The study compared upfront cell-free-DNA (cfDNA) NGS clinical utility against routine tissue testing in patients with NSCLC. cfDNA-NGS increased the tier-1 variant detection rate with the high concordance with tissue and halved time-to-treatment.

11.   Colon carcinoma: With liquid biopsy, chemotherapy can be saved without increasing the risk

Testing of plasma samples for circulating tumor DNA (ctDNA) 4 and 7 weeks after surgery makes it possible to reliably predict which patient will benefit from subsequent adjuvant chemotherapy and who will not benefit. Half of the chemotherapy treatments are thus avoided.

12.   Colorectal cancer: the detection of adenomas by colonoscopy improved by an AI

Colonoscopy coupled with an artificial intelligence device (Skout, Iterative Scopes) improves the overall detection rate of adenomas compared to colonoscopy alone, according to a study presented at Digestive Disease Week (DDW) in San Diego.

13.   UnitedHealth links CGM use in people with Type 2 diabetes to improved blood sugar control

An analysis by UnitedHealth Group has linked the use of continuous glucose monitors to drops in blood sugar levels in people with Type 2 diabetes, providing a data point to support the expansion of the technology into a larger patient population.