Prescription digital therapeutics: Applying Medicaid experience to value assessment and formulary management.

Digital therapeutics (DTx) are a rapidly growing therapeutic category with more than 150 clinical trials evaluating US Food and Drug Administration-regulated DTx to develop additional evidence by the end of 2022. Investments in DTx development have doubled since 2019, reaching $14.7 billion in 2021. Prescription DTx are regulated by the US Food and Drug Administration and require demonstration of efficacy and safety prior to commercialization and reimbursement by payers. Drawing insights from the Massachusetts Medicaid program's early experience with prescription DTx, we provide an overview of this new category of therapeutics and suggest a roadmap for payers and policymakers to evaluate the value of prescription DTx for their member population. Finally, we propose solutions to potential challenges that may be encountered in the DTx coverage and reimbursement management.

Innovation in care for individuals with cognitive impairment: Can reimbursement policy spread best practices?

There is now an unprecedented opportunity to improve the care of the over 5 million people who are living with Alzheimer's disease and related dementias and many more with cognitive impairment due to brain injury, systemic diseases, and other causes. The introduction of a new Medicare care planning benefit-long sought openly by advocacy organizations and clinicians and badly needed by patients and families-could greatly improve health care quality, but only if widely and fully implemented. We describe the components of this new benefit and its promise of better clinical care, as well as its potential to create a new platform for clinical and health outcomes research. We highlight external factors-and some that are internal to the benefit structure itself-that challenge the full realization of its value, and we call for broad public and professional engagement to ensure that it will not fail.

Cognitive impairment over the age of 85: hospitalization and mortality.

The risks of cognitive impairment among hospitalized patients over age 85 are not adequately understood. We used electronically recorded ICD-9 codes of inpatients over 85 years old to identify patients age > or =85 who showed signs of cognitive impairment during hospitalization at our institution. We randomly selected patient records showing cognitive impairment and patient control records matched for age and admission date but without cognitive impairment and obtained mortality information up to 18 months after discharge. Records were further examined to characterize hospital stay including reason for admission. After adjustment for comorbidities and potential confounders, patients over age 85 with ICD-9-defined cognitive impairment had increased risk of death within the hospital (hazard ratio (HR)=3.99; 95% confidence interval (CI) 0.42-37.90; p=0.229), in the first year after hospitalization (HR=2.35; 95% CI 1.15-4.78; p=0.019), and cumulatively (HR=2.46; 95% CI 1.26-4.82; p=0.009). In this matched cohort of hospitalized patients > or =85 years old, cognitive impairment was associated with an increased mortality rate. Because of this additional risk of death, hospitalized geriatric patients who are cognitively impaired may merit closer monitoring.

The risk of dementia with increased body mass index.

BACKGROUND: identification of modifiable risk factors is crucial in the prevention of dementia, given its limited treatment options. Studies on increased body mass index (BMI) as a risk factor for dementia show conflicting results. METHODS: we systematically retrieved and reviewed longitudinal population-based studies on increased BMI and dementia using a standard protocol. We searched Medline (1966-2006), Ageline (1978-2006), PsychInfo (1966-2006), CINAHL (1982-2006), and other relevant databases, including the reference lists of the eligible articles for review. Included studies were subjected to a quality assessment protocol. RESULTS: we identified eight studies that met our selection criteria. These studies covered 1,688 cases of dementia from 28,697 participants. After adjustment for age, smoking, comorbidities, and other confounders, four studies presented significantly increased risk of dementia with elevated BMI. CONCLUSION: this systematic review supports the hypothesis that increased BMI is independently associated with increased risk of dementia. Long-term studies to examine the mechanisms underlying the relationship between obesity and dementia are needed.

Ethnicity and diabetic heart disease.

Ethnicity is a complex yet important construct and an independent risk factor for diabetic heart disease (DHD) with paramount clinical significance. Clinicians should try to better understand the role of ethnicity through more questions. The risk of DHD is modified by ethnicity through more questions. The risk of DHD is modified by ethnicity, and its management may require a culturally sensitive individualized approach. Findings from Caucasian populations cannot be fully extrapolated to other ethnic groups, thereby emphasizing the importance of future research with ethnicity-based threshold for obesity. Available limited data support the interaction between genetic predisposition, environmental risk, and lifestyle choices and disparities based on ethnicity as the likely cause for ethnic variations in DHD.

The influence of outpatient comprehensive geriatric assessment on survival: a meta-analysis.

Although outpatient Comprehensive Geriatric Assessment (CGA) has shown certain benefits in functional status and quality of life by many randomized controlled trials, no survival benefit has been reported. We hypothesized that the lack of survival benefit may be due to insufficient power of individual trials. In order to assess the influence of outpatient CGA on survival of older persons, we performed a meta-analysis of all randomized controlled trials of outpatient CGA. Nine studies consisting of 3750 subjects fulfilled the predetermined eligible criteria and were included in the meta-analysis. Combined mortality risk ratio with outpatient CGA intervention compared to usual care group was 0.95 (95% confidence interval, CI 0.82-1.12, P = 0.62). Treatment effects were homogeneous across the trials. This meta-analysis did not demonstrate survival benefit for outpatient CGA. Inadequate statistical power is unlikely to explain the results. Future researches of outpatient CGA should focus on coordinated and standardized measurement of outcomes related to functional status, institutionalization rate, and quality of life.

Dapsone-induced acute pancreatitis.

OBJECTIVE: To report a case of acute pancreatitis associated with dapsone use. CASE SUMMARY: An 87-year-old white man was prescribed dapsone for dermatitis herpetiformis. Four weeks later, he developed acute abdominal pain requiring hospitalization. The patient had elevated serum amylase and lipase levels. Laboratory test results for other possible etiologies were negative. His symptoms resolved when dapsone was discontinued. Dapsone was reintroduced for exacerbation of dermatitis herpetiformis 4 months later. The patient again had severe abdominal pain with high amylase and lipase levels. Again, symptoms resolved following dapsone discontinuation. DISCUSSION: Only 1 other case of pancreatitis associated with dapsone was found in a MEDLINE search of the literature (1966-June 2003) using the key terms dapsone and pancreatitis. An objective causality assessment revealed dapsone to be a probable cause of acute pancreatitis, based on the Naranjo probability scale. Drugs should always be considered as causative factors for pancreatitis in patients without known risk factors. Dapsone is increasingly used as a second line of treatment of Pneumocystis carinii pneumonia (PCP). The recognition of dapsone-induced pancreatitis is of particular importance in these patients. CONCLUSIONS: While dapsone is traditionally used for the treatment of leprosy and dermatitis herpetiformis, its use for PCP prophylaxis, malaria, brown recluse spider bites, and acne is not uncommon. Pancreatitis is an uncommon adverse effect of dapsone, and greater awareness of this association will prompt a high index of suspicion in an appropriate clinical setting. Further reporting of cases and clinical research of drug-induced pancreatitis is indicated.