Disentangling the Cost of Orphan Drugs Marketed in the United States.

The increasing number and high prices of orphan drugs have triggered concern among patients, payers, and policymakers about the affordability of new drugs approved using the incentives set by the Orphan Drug Act (ODA) of 1983. This study evaluated the factors associated to the differences in the treatment cost of new orphan and non-orphan drugs approved by the FDA from 2017 to 2021. A generalized linear model (GLM) with the Gamma log-link analysis was used to ascertain the association of drug characteristics with the treatment costs of orphan and non-orphan drugs. The results of the study showed that the median and interquartile range (IQR) drug cost was USD 218,872 (IQR = USD 23,105) for orphan drugs and USD 12,798 (IQR = USD 57,940) for non-orphan drugs (p < 0.001). Higher market entry prices were associated with biologics (108%; p < 0.001), orphan status (177%; p < 0.001), US sponsor companies (48%; p = 0.035), chronic use (1083%; p < 0.001), treatment intent (163%; p = 0.004), and indications for oncology (624%; p < 0.001) or genetic disorders (624%; p < 0.001). Higher market entry treatment cost for newly approved drugs were associated with biologics, orphan status, US sponsor companies, chronic use, therapeutic intent, and indications for oncology or genetic disorders.

A Motivational Interviewing Intervention to Improve Adherence to ACEIs/ARBs among Nonadherent Older Adults with Comorbid Hypertension and Diabetes.

BACKGROUND: Hypertension and diabetes mellitus are independent risk factors for cardiovascular diseases. Due to the cardioprotective nature of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs), they are recommended for patients with comorbid hypertension and diabetes. However, poor adherence to ACEIs/ARBs among older adults is a major public health concern. This study aimed to assess the effectiveness of a telephonic motivational interviewing (MI) intervention conducted by pharmacy students among a nonadherent older population (≥ 65 years old) with diabetes and hypertension. METHODS: Patients continuously enrolled in a Medicare Advantage Plan who received an ACEI/ARB prescription between July 2017 and December 2017 were identified. Group-based trajectory modeling (GBTM) was used to identify distinct patterns of ACEI/ARB adherence during the 1-year baseline period: adherent, gaps in adherence, gradual decline, and rapid decline in adherence. Patients from the three nonadherent trajectories were randomized into MI intervention or control group. The intervention consisted of an initial call and five follow-up calls administered by MI-trained pharmacy students and tailored to the baseline ACEI/ARB adherence trajectories. The primary outcome was adherence to ACEI/ARB during the 6- and 12-month periods post-MI implementation. The secondary outcome was discontinuation, defined as no refills for ACEI/ARB during the 6- and 12-month periods post-MI implementation. Multivariable regression analyses examined the impact of MI intervention on ACEI/ARB adherence and discontinuation while adjusting for baseline covariates. RESULTS: A total of 240 patients in the intervention group and 480 patients as randomly selected controls were included in this study. At 6 months, patients receiving the MI intervention had significantly better adherence (ß = 0.06; p = 0.03) compared with the controls. Linear and logistic regression models also showed patients in the intervention group were more likely to be adherent than controls within 12 months of intervention implementation (ß = 0.06; p = 0.02 and OR: 1.46; 95% CI 1.05-2.04, respectively). MI intervention did not have any significant impact on the ACEI/ARB discontinuation. CONCLUSION: Patients who received the MI intervention were more likely to be adherent at 6 and 12 months following the intervention initiation, despite gaps in the follow-up calls due to COVID-19. Pharmacist-led MI intervention is an effective behavioral strategy to improve medication adherence among older adults and tailoring the intervention to past adherence patterns may enhance the intervention effectiveness. This study was registered with the United States National Institutes of Health (ClinicalTrials.gov identifier NCT03985098).

Impact of geographic access to primary care providers on pediatric behavioral health screening.

Behavioral Health (BH) screening is critical for early diagnosis and treatment of pediatric mental disorders. The objective of this study was to assess the impact of geographic access to primary care providers (PCP) on pediatric BH screening in children with different race/ethnicity. A retrospective cohort study was conducted using the 2013-2016 administrative claims data from a large pediatric Medicaid Managed Care Plan that have been linked to 2010 US Census data and the 2017 National Provider Identifier (NPI) Registry. Geographic access was defined as the actual travel distance to nearest PCP and the PCP density within 10-mile travel radius from each individual's residence. Stratified multivariate logistic regression was conducted to examine the association between the geographic access to PCP and the likelihood of receiving screening for behavioral disorders within each racial/ethnic group. BH screening rate was 12.6% among 402,655 children and adolescents who met the inclusion criteria. Multivariable analysis stratified by individual race/ethnicity revealed that Hispanic and Black children were more vulnerable to the geographic access barriers than their non-Hispanic White counterparts. The increase in travel distance to the nearest PCP was negatively associated with screening uptake only among Hispanics (10-20 miles vs. 0-10 miles: OR = 0.78, 95% CI [0.71-0.86]; 20-30 miles vs. 0-10 miles: OR = 0.35, 95% CI [0.23-0.54]). In a subgroup that had access to at least one PCP within 10 miles of travel distance, the variation in PCP density had a greater impact on the screening uptake among Hispanics and Blacks than that in non-Hispanic Whites.

Enhancing Statin Adherence Using a Motivational Interviewing Intervention and Past Adherence Trajectories in Patients with Suboptimal Adherence.

BACKGROUND: Statins have been shown to be effective in reducing the occurrence of cardiovascular (CV) events and are widely prescribed for the risk reduction of CV diseases and recurrent CV events. However, poor adherence prevents some patients from receiving the maximum benefit of the therapy. Motivational interviewing (MoI) is a patient-centered collaborative approach that can be used to improve medication adherence. Group-based trajectory modeling depicts patterns of adherence over time and may help tailor the MoI intervention to further enhance adherence. OBJECTIVE: To assess the effect of a phone-based MoI intervention tailored by patients' past adherence trajectory in improving adherence to statins among patients in a Medicare Advantage prescription drug plan (MAPD). METHODS: Patients continuously enrolled in an MAPD from 2013 to 2017 with a statin prescription between January and June 2015 to allow 2 years of pre-index period and 1 year of follow-up were included in the study. Adherence to statins was measured monthly during the 1-year follow-up as proportion of days covered (PDC) and incorporated into a group-based trajectory model to provide 4 distinct patterns of adherence: adherent, rapid decline, gradual decline, and gaps in adherence. Patients in the 3 nonadherent groups were randomized to either control or intervention. The intervention was an initial counseling call and up to 2 monthly follow-up calls by pharmacy students trained in MoI, providing education consistent with a previously identified pattern of use. Refill data at 6 months post-intervention were evaluated to examine the intervention's effect on PDC, as continuous and dichotomized as PDC ≥ 0.8, as well as discontinuation. Multivariable regression adjusted for baseline demographics, clinical characteristics, and past adherence trajectory. RESULTS: There were 152 patients included in the analysis who received MoI phone calls and 304 randomly selected controls. Mean PDC for the intervention group (0.67 ± 0.3) was significantly higher than the control (0.55 ± 0.4; P < 0.001). The intervention group was also less likely to discontinue (OR = 0.38; 95% CI = 0.19-0.76) and more likely to be adherent in the linear regression model (ß = 12.4; P < 0.001) as well as in the logistic regression model (OR = 1.87; 95% CI = 1.18-2.95). Previous adherence trajectories were significantly associated with adherence in the follow-up. CONCLUSIONS: Patients who received the MoI intervention were more likely to be adherent and less likely to discontinue the statin in the 6 months follow-up compared with controls. Future research can identify other approaches to tailor interventions and expand the intervention to other languages. This intervention may also prove valuable to improve adherence to other medications for chronic and asymptomatic diseases. DISCLOSURES: This study was funded by Regeneron Pharmaceuticals, which provided critical input during study design, implementation, and manuscript preparation. Abughosh reports grants from Sanofi, BMS/Pfizer, and Valeant Pharmaceuticals, unrelated to this study. Vadhariya reports a past internship at Regeneron Pharmaceuticals, unrelated to this study. Esse, Serna, and Gallardo are employees of CareAllies, a Cigna subsidiary. Boklage is an employee of Regeneron Pharmaceuticals. Choi was an employee of Sanofi during this study. Johnson, Essien, Fleming, and Holstad have nothing to disclose. A poster based on this study was presented at AMCP Nexus 2018; October 22-25, 2018; Orlando, FL.

The association between geographic access to providers and the treatment quality of pediatric depression.

OBJECTIVE: To examine the association of geographic access to providers with racial/ethnic variations in treatment quality among youth with depression. METHODS: The geographic access to providers who initiated the depression treatment was measured using the travel distance estimated based on Google Maps® and the provider density within a 5-mile radius of each patient residence. Depression treatment quality was measured as treatment engagement, defined as having ≥2 prescriptions or psychotherapy with 2-month following a new depression diagnosis, and treatment completion defined as having ≥8 sessions of psychotherapy within 12 weeks or received ≥84 days of continuous treatment with antidepressants within 114 days following the treatment initiation. RESULTS: The results of multivariate logistic regression analysis have demonstrated that the travel distance to provider was only negatively associated with the treatment engagement of Hispanics (5.0 - 14.9 vs ≤ 4.9 miles: OR=0.74, 95% CI [0.54-0.88]; ≥15 vs ≤ 4.9 miles: OR=0.82, 95% CI [0.56-0.97]), while a higher mental health specialist density was only positively associated with the treatment engagement of Blacks (1.00-1.99 vs < 1.00: OR=1.63, 95% CI [1.03-4.51]; 2.00-4.99 vs < 1.0: OR=2.28, 95% CI [1.21-7.11]). Among those who have engaged in the treatment, travel distance was associated with a lower likelihood of treatment completion in all racial/ethnic groups. LIMITATIONS: The study did not account for types of transportation used by patients. CONCLUSION: Geographic access barriers had a negative association with treatment quality of pediatric depression. Minority children were more sensitive to the barriers than Whites.

Risk of Nondherence to Diabetes Medications Among Medicare Advantage Enrollees: Development of a Validated Risk Prediction Tool.

BACKGROUND: Low adherence to oral antidiabetic drugs (OADs) in the Medicare population can greatly reduce Centers for Medicare & Medicaid Services (CMS) star ratings for managed care organizations (MCOs). OBJECTIVE: To develop and validate a risk assessment tool (Prescription Medication Adherence Prediction Tool for Diabetes Medications [RxAPT-D]) to predict nonadherence to OADs using Medicare claims data. METHODS: In this retrospective observational study, claims data for members enrolled in a Medicare Advantage Prescription Drug (MA-PD) program in Houston, Texas, were used. Data from 2012 (baseline period) were used to identify key variables to predict adherence in 2013 (follow-up period). Members aged 65 years and older with a diabetes diagnosis, at least 1 prescription for OADs (biguanides, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, or meglitinides), and continuously enrolled for both years were included in the study. Patients with insulin prescriptions were excluded from the cohort. The study outcome, nonadherence in 2013, was defined as proportion of days covered (PDC) < 80%. Multivariable logistic models using 200 bootstrap replications (with replacement) identified factors associated with nonadherence. The final model was tested for discrimination and calibration statistics and internally validated using 10-fold cross-validation. Using weighted beta coefficients of the predictors, the RxAPT-D was created to stratify nonadherence risk and was tested for sensitivity, specificity, positive prediction value, and negative prediction value. The predictive ability of the tool was compared with that of past PDC values using net reclassification improvement (NRI) and integrated discrimination improvement (IDI) indices. RESULTS: Data from 7,028 MA-PD members were used for tool development. Seven predictors (age, total OAD refills, total OAD classes filled, days supply of last filled OAD, pill burden, coverage of last filled OAD, and past adherence) statistically significant in ≥ 50% of the bootstrapped samples were identified from the logistic models. The final model demonstrated good discrimination (c-statistics = 0.75) and calibration (Hosmer-Lemeshow goodness-of-fit P < 0.05) statistics, with good internal validity (area under the curve = 0.73). The RxAPT-D demonstrated adequate sensitivity statistics: sensitivity = 0.73, specificity = 0.63, positive prediction value = 0.74, and negative prediction value = 0.62. Compared with use of past adherence measures, the RxAPT-D had higher prediction ability, relative IDI = 2.09, and user defined NRI = 0.16 with 24% events correctly reclassified. CONCLUSIONS: The RxAPT is an effective tool to identify patients who are likely to become nonadherent to OADs in the follow-up year. Pharmacists in MCOs can use this tool to identify patients expected to be nonadherent to OADs and develop targeted intervention programs to assist in improving MCO CMS star ratings. DISCLOSURES: This study received unrestricted partial funding from the Pharmaceutical Research and Manufacturers of America (PhRMA) Foundation Adherence Research Starter Award. Serna is employed by Cigna-HealthSpring. Mhatre is now employed with Genentech. The authors report no other potential conflicts of interest. The material in this study is based on work supported (or supported in part) by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, and the Center for Innovations in Quality, Effectiveness and Safety (CIN 13-413). The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the U.S. government. The abstract for this article was presented at the Academy of Managed Care Pharmacy's 28th Annual Meeting & Expo, April 2016, San Francisco, California, with the title "Development and Validation of a Tool to Predict Nonadherence to Oral Antidiabetic Drugs in Medicare Beneficiaries." Study concept and design were primarily contributed by Sujit Sansgiry and Mhatre, with assistance from the other authors. Mhatre, Serna, and Sujit Sansgiry took the lead in data collection, assisted by the other authors, and data interpretation was performed by Mhatre, Shubhada Sansgiry, and Essien, assisted by the other authors. The manuscript was written by Mhatre and Fleming, assisted by the other authors, and revised primarily by Mhatre, along with Sujit Sansgiry and assisted by the other authors.

Comparative Cognitive Profile of Second-Generation Antidepressants in Elderly Nursing Home Residents With Depression.

BACKGROUND: Past literature suggests that the use of second-generation antidepressants improves cognition in depressed elderly patients. OBJECTIVE: This study assessed the comparative cognitive profile of commonly used second-generation antidepressant classes in elderly residents with depression. METHODS: A multiple propensity score adjusted retrospective cohort study was conducted using 2007-2010 Medicare Part D claims and Minimum Data Set (MDS). Elderly nursing home residents (65 years or older) with depression using a new prescription of selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and tetracyclics constituted the study cohort. The outcome of interest was cognition, measured using the MDS Cognition Scale. Cognition was measured at each quarterly assessment after antidepressant initiation for a maximum of 1 year. The propensity score-adjusted repeated-measures mixed model was used to evaluate the comparative profile of SSRIs, SNRIs, and tetracyclics with respect to cognition. RESULTS: The study cohort comprised 1518 elderly nursing home residents. Of these, 1081 received SSRIs (71.21%), 320 received tetracyclics (21.08%), and 117 received SNRIs (7.71%). The propensity score-adjusted repeated-measures mixed model did not show any statistically significant difference in cognition with the use of SSRIs (ß = -0.14; 95% CI = -0.53, 0.25) or tetracyclics (ß = -0.36; 95% CI = -0.80, 0.08) when compared with SNRIs, after controlling for other factors. CONCLUSIONS: The cognitive effect of SSRIs, SNRIs, and tetracyclics was similar in elderly nursing home residents with depression. Further studies are needed to evaluate the long-term cognitive effects of second-generation antidepressants in this vulnerable population.

Education, training, and academic experience of newly hired, first-time pharmacy faculty members.

Objective. To describe the education, training, and academic experiences of newly hired faculty members at US colleges and schools of pharmacy during the 2012-2013 academic year. Methods. A survey regarding education, training, and academic experiences was conducted of all first-time faculty members at US colleges and schools of pharmacy hired during the 2012-2013 academic year. Results. Pharmacy practice faculty members accounted for the majority (68.2%) of new hires. Ambulatory care was the most common pharmacy specialty position (29.8%). Most new faculty members had a doctor of pharmacy (PharmD) as their terminal degree (74.8%), and 88.3% of pharmacy practice faculty members completed a residency. Of new faculty members who responded to the survey, 102 (67.5%) had at least 3 prior academic teaching, precepting, or research experiences. Conclusion. New faculty members were hired most frequently for clinical faculty positions at the assistant professor level and most frequently in the specialty of ambulatory care. Prior academic experience included precepting pharmacy students, facilitating small discussions, and guest lecturing.

Pharmacists' training, perceived roles, and actions associated with dispensing controlled substance prescriptions.

OBJECTIVES: To examine situations that prompt pharmacists to access a prescription drug monitoring program (PDMP) database and management of opioid abuse/addiction; assess pharmacists' actions when abuse is suspected; describe pharmacists' tasks when dispensing controlled substance prescriptions (CSPs); and their continuing pharmacy education (CPE). DESIGN Cross-sectional mail survey of 1,000 randomly selected pharmacists. SETTING: Texas from February 2012 to April 2012. PARTICIPANTS: 1,000 Texas community pharmacists. INTERVENTION: Mail survey instrument. MAIN OUTCOME MEASURES: Prompts to use a PDMP and pharmacists' views actions, and related CPE programs. RESULTS The usable response rate was 26.2%. Pharmacists were more supportive of mandated PDMP use by physicians than by pharmacists (mean ± SD 4.1 ± 1.2 versus 3.2 ± 1.5; P <0.001), based on a 5-point Likert scale (1, strongly disagree, to 5, strongly agree). Most pharmacists would be prompted to use a PDMP if the prescription contains mistakes (68.1%) or the patient requests an early refill (66.3%). Bivariate statistics showed that men pharmacists, those with BSPharm degrees, and pharmacists ≥50 years of age reported a greater number of CPE hours related to prescription opioid abuse and pain management. An analysis of variance showed that pharmacy owners reported significantly more (P <0.05) CPE compared with manager and staff pharmacists. CONCLUSION: Older pharmacists with a BSPharm degree may be more willing to provide counseling to patients with opioid addiction based on their work experience and additional CPE related to controlled substances. As PDMP use becomes more prevalent, pharmacists should be prepared to interact and counsel patients identified with aberrant controlled prescription drug use and properly deliver pain management care. Additionally, schools of pharmacy curricula must prepare new pharmacists to prevent abuse and diversion, as well as intervene when aberrant use is identified.