Advances in personalized medicine are supported by companion diagnostic molecular tests. Testing accuracy is critical for selecting patients for optimal therapy and reducing treatment-related toxicity. We assessed the clinical and economic impact of inaccurate test results between laboratory developed tests (LDTs) and a US Food and Drug Administration (FDA)-approved test for detection of epidermal growth factor receptor (EGFR) mutations. Using a hypothetical US cohort of newly diagnosed metastatic non-small cell lung cancer (NSCLC) patients and EURTAC (erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer) clinical trial data, we developed a decision analytic model to estimate the probability of misclassification with LDTs compared to a FDA-approved test. We estimated the clinical and economic impact of inaccurate test results by quantifying progression-free and quality-adjusted progression-free life years (PFLYs, QAPFLYs) lost, and costs due to incorrect treatment. The base-case analysis estimated 2.3% (n = 1422) of 60,502 newly diagnosed metastatic NSCLC patients would be misclassified with LDTs compared to 1% (n = 577) with a FDA-approved test. An average of 477 and 194 PFLYs were lost among the misclassified patients tested with LDTs compared to the FDA-approved test, respectively. Aggregate treatment costs for patients tested with LDTs were approximately $7.3 million more than with the FDA-approved test, due to higher drug and adverse event costs among patients incorrectly treated with targeted therapy or chemotherapy, respectively. Invalid tests contributed to greater probability of patient misclassification and incorrect therapy. In conclusion, risks associated with inaccurate EGFR mutation tests pose marked clinical and economic consequences to society. Utilization of molecular diagnostic tests with demonstrated accuracy could help to maximize the potential of personalized medicine.

While vaginitis is a leading cause of primary care visits among women with a gynecologic-related diagnosis, there are limited contemporary data on the healthcare burden. This study describes the real-world healthcare resource utilization (HCRU) of patients presenting with vaginitis symptoms in the United States (US) at symptom presentation and over long-term follow-up. This retrospective study utilized IQVIA’s Longitudinal Prescription (LRx) and Medical Claims (Dx) databases to capture patients presenting with vaginitis symptoms from January 1, 2018 to September 30, 2022. The date of the first diagnosis code for vaginitis or related symptoms was considered the first clinical presentation (“index visit”). Healthcare visits, diagnostic testing, and treatments were assessed for patients at presentation (index date +2 days) and 12-month follow-up, stratified by pregnancy status at index. In a subset of patients with linkage to IQVIA Ambulatory EMR – US (AEMR), multivariable models were used to evaluate associations between insurance type, patient characteristics, diagnostic test(s) performed at presentation, and HCRU outcomes (subsequent vaginitis-related healthcare visits and ≥2 vaginitis treatment dates) over follow-up. A total of 18,745,351 people were documented with vaginitis symptoms or vaginitis in the study selection window, of which 4,000,615 patients met all selection criteria for analysis: 3,787,354 were not pregnant and 213,261 had evidence of pregnancy. About one-fourth (23.8%) of the non-pregnant cohort and half (47.6%) of the pregnant cohort had claims for at least 1 diagnostic test at symptom presentation, with traditional methods being most commonly used (44.1% and 36.4% for non-pregnant and pregnant patients, respectively), followed by direct probe (20.0% and 24.1%), and lastly nucleic acid amplification test (NAAT) panel (including bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis; 6.6% and 8.3%). Despite low diagnostic testing rates, 50.1% of the non-pregnant and 60.9% of the pregnant cohort received prescribed vaginitis treatment, most frequently metronidazole or fluconazole, and 28.8% of the non-pregnant and 30.9% of the pregnant cohort had subsequent vaginitis-related visits within 12 months. Among both the non-pregnant and pregnant cohorts, patients with Medicaid insurance had significantly higher odds of repeat healthcare visits and ≥2 treatment dates during follow-up relative to patients with commercial insurance. This study demonstrated that vaginitis poses a high clinical burden in the US, possibly attributed to low diagnostic testing rates, use of tests with poor performance, and high rates of empiric treatment. There is an unmet need for rapid, accurate vaginitis diagnostic testing at the point-of-care to reduce empiric prescribing and improve diagnostic and treatment accuracy and efficiency.

Objective: To critically evaluate published cost-effectiveness studies of novel drug products requiring less-frequent medication dosing compared to conventional formulations of the same drug substance.Methods: A search was conducted in the Medline and Embase databases for cost-effectiveness studies published before May 2009 that compared two or more drug delivery technologies formulated with the same active drug substance. The Quality of Health Economic Studies (QHES) grading criteria for cost-effectiveness studies was applied to the selected publications.Results: The literature search identified approximately 907 articles of which six cost-effectiveness studies met the inclusion criteria. The studies spanned four chronic conditions, were conducted from various international perspectives and used decision-analytic models to project economic outcomes. The base-case results of all six studies indicated that the drug product with sustained therapeutic efficacy was either more effective and less costly (‘domi...