Longitudinal medication adherence group-based trajectories of aging adults in the US: A retrospective analysis using monthly proportion of days covered calculations.

BACKGROUND: It is thought that half of the patients with chronic conditions are not adherent to their medications, which contributes to significant health and economic burden. Many studies estimate medication non-adherence by implementing a threshold of ≥80% of Proportion of Days Covered (PDC), categorizing patients as either adherent or non-adherent. Healthcare quality metrics pertaining to medication use are based on this dichotomous approach of medication adherence, including the Medicare Part D Star Ratings. Among others, the Medicare Part D Star Ratings rewards part D plan sponsors with quality bonus payments based on this dichotomous categorization of beneficiaries' medication adherence. OBJECTIVES: Describe the longitudinal adherence trajectories of adults ≥65 years of age covered by Medicare for 3 classes of drugs in the Part D Star Ratings: diabetes medications, statins, and select antihypertensives. METHODS: This study used Medicare healthcare administrative claims data linked to participants from the Health Retirement Study between 2008 and 2016. Group-based trajectory models (GBTM) elicited the number and shape of adherence trajectories from a sample of N = 11,068 participants for the three pharmacotherapeutic classes considered in this study. Medication adherence was estimated using monthly PDC. RESULTS: GBTM were estimated for the sample population taking antihypertensives (n = 7,272), statins (n = 8,221), and diabetes medications (n = 3,214). The hypertension model found three trajectories: high to very high adherence (47.55%), slow decline (32.99%), and rapid decline (19.47%) trajectories. The statins model found 5 trajectories: high to very high adherence (35.49%), slow decline (17.12%), low then increasing adherence (23.58%), moderate decline (12.62%), and rapid decline (11.20%). The diabetes medications model displayed 6 trajectories: high to very high adherence (24.15%), slow decline (16.84%), high then increasing adherence (25.56%), low then increasing (13.58%), moderate decline (10.60%), and rapid decline (9.27%). CONCLUSIONS: This study showed the fluid nature of long-term medication adherence to the medications considered in the Medicare Part D Star Ratings and how it varies by pharmacotherapeutic class. These challenge previous assumptions about which patients were considered adherent to chronic medications. Policy and methodological implications about medication adherence are discussed.

The relationship between palliative radiotherapy and opioid prescribing patterns among patients with metastatic cancer.

BACKGROUND: While randomized trials have established that palliative radiotherapy, especially to bone, can improve qualitative measures of pain, its quantitative relationship to opioid prescribing patterns has remained underexplored. We aimed to identify the association of palliative radiotherapy on opioid prescriptions received among patients with metastatic cancer. METHODS: The Virginia Commonwealth University Institutional Review Board approved retrospective analysis extracted prescription data from all adult patients with metastatic cancer who underwent outpatient palliative external beam radiation therapy at Virginia Commonwealth University Health System from 2008-2018. Institutional prescribing data were used to calculate the average opioid oral morphine milligram equivalent (MME) dose 30, 60 and 90 days both before and after radiotherapy. Univariate and bivariate ordinary least squares (OLS) regression models were used to estimate the relationship of MME changes with clinical, radiation-related, and demographic patient factors. RESULTS: A total of 182 patients met inclusion criteria. Overall, patients required higher opioid doses after radiotherapy, with mean MME 30, 60, and 90 days prior to radiotherapy of 24.6, 20.2, and 16.8 mg, respectively; which increased to 62.9, 77.7 and 82.4 mg post-radiation therapy (P<0.01). Multivariate OLS models predicting the change of MME 60 days pre- and post-radiation treatment showed that younger age and comorbid depression predicted increased MME after radiotherapy. CONCLUSIONS: Patients with metastatic cancer face a relatively high opioid burden, which increases over time, even among those who receive palliative radiation therapy. Patients who are younger and have comorbid depression may have a higher risk of increased opioid burden after radiotherapy.

Cost minimization analysis of short-duration antiviral prophylaxis for hepatitis C positive donor kidney transplants.

BACKGROUND: Trials describing 4-12 week courses of direct-acting antiviral drugs (DAAs) to treat hepatitis C virus (HCV) transmission from infected donors to uninfected kidney transplant recipients (D+/R-transplants), may be limited in application by costs and delayed access to expensive DAAs. A short prophylactic strategy may be safer and cost-effective. Here, we report a cost minimization analysis using the health system perspective to determine the least expensive DAA regimen, using available published strategies. OBJECTIVES: To conduct cost-minimization analyses (CMAs) from the health system perspective of four DAA regimens to prevent and/or treat HCV transmission from D+/R-kidney transplants. METHODS: CMAs comparing 4 strategies: 1) 7-day prophylaxis with generic sofosbuvir/velpatasvir (SOF/VEL), with 12-week branded glecaprevir/pibrentasvir (G/P) for those with transmission; 2) 8-day branded G/P prophylaxis, with 12-week branded SOF/VEL/voxilaprevir for those with transmission; 3) 4-week perioperative generic SOF/VEL prophylaxis, with 12-week branded G/P for those with transmission; and 4) 8-week branded G/P "transmit-and-treat." We included data from published literature to estimate the probability of viral transmission in patients who received DAA prophylaxis, and assumed a 100% transmission rate for those who received the "transmit-and-treat" approach. RESULTS: In base-case analyses, strategies 1 (expected cost [EC]: $2326) and 2 (expected cost: $2646) were less expensive than strategies 3 (EC: $4859) and 4 (EC: $18,525). Threshold analyses for 7-day SOF/VEL versus 8-day G/P suggested that there were reasonable input levels at which the 8-day strategy may be least costly. The threshold values for the SOF/VEL prophylaxis strategies (7-day vs. 4- week) indicated that the 4-week strategy is unlikely to be less costly under any reasonable value of the input variables. CONCLUSIONS: Short duration DAA prophylaxis using 7 days of SOF/VEL or 8 days of G/P has the potential to yield significant cost savings for D+/R- kidney transplants.

Healthcare costs and resource utilization associated with renal cell carcinoma among older Americans: A longitudinal case-control study using the SEER-Medicare data.

OBJECTIVES: To determine 1-year and 5-year total healthcare costs and healthcare resource (HRU) associated with renal cell carcinoma (RCC) in older Americans, from a healthcare sector perspective. MATERIALS AND METHODS: This was a longitudinal, retrospective cohort study using the Surveillance, Epidemiology and End Results-Medicare linked data (2006-2014), which included older (≥66 years) patients with primary RCC and 1:5 matched noncancer controls. Patients/controls were followed from diagnosis (pseudo-diagnosis for controls) until death or up to loss-to-follow-up (censored). Per-patient average 1-year and 5-year cumulative total and incremental total healthcare costs and HRU were reported. RESULTS: A total of 11,228 RCC patients were matched to 56,140 controls. Per-patient cumulative average 1-year (incremental = $38,291 [$36,417-$40,165]; $57,588 vs. $19,297) and 5-year (incremental = $68,004 [$55,123-$80,885]; $183,550 vs. $115,547) total costs (excluding prescription drug costs) were 3 and 1.6 times higher for RCC vs. controls. These estimates were 3.6 and 1.7 times higher for RCC vs. controls when prescription costs were included in total costs. Prescription drug costs accounted for 8.4% (incremental = $3,715) and 18.1% (incremental = $15,375) of the 1-year and 5-year incremental total costs, respectively. RCC patients had greater cumulative number of hospitalizations, emergency department visits and prescriptions in 1- and 5-years, compared to controls. CONCLUSIONS: Average first year total cost for a patient with incident diagnosis of RCC is substantially higher than that for controls and it varies depending on the stage at diagnosis. Study findings could help in planning future resource allocation and in determining research and unmet needs in this patient population.

Outcomes of short-duration antiviral prophylaxis for hepatitis C positive donor kidney transplants.

Trials describing 4- to 12-week courses of direct-acting antiviral drugs (DAAs) to treat hepatitis C virus (HCV) transmission from infected donors to uninfected kidney transplant recipients (D+/R- transplants) may be limited in "real-world" application by costs and delayed access to DAAs. We previously reported HCV transmission of 13% among D+/R- transplants with 2- to 4-day pangenotypic sofosbuvir/velpatasvir (SOF/VEL) perioperative prophylaxis, where one patient with HCV transmission was a nonresponder to first-line full-course DAA. Here, we report new data with a 7-day prophylaxis protocol (N = 50), as well as cumulative treatment and outcome data on all HCV D+/R- transplants (N = 102). Overall, nine patients (9/102; 9%; 95% CI: 5%-16%) developed HCV transmission, with a significant decline noted in the 7-day group (2/50; 4%; 95% CI: 0%-13%) compared with 2- to 4-day prophylaxis (7/52; 13%; 95% CI: 5%-25%). All patients with HCV transmission achieved sustained virologic response post full-course therapy (including one nonresponder from initial trial). A 1:1 matched analysis (N = 102) with contemporary HCV D-/R- transplants (controls) showed that although the pretransplant wait time was significantly shorter for D+/R- compared with D-/R- (mean: 1.8 vs. 4.4 years; p < .001), there were no differences in infections, rejection, development of de novo donor-specific antibody, or transplant outcomes up to 6 months of transplant.

Community pharmacists in Virginia dispensing naloxone under a standing order: A qualitative study.

BACKGROUND: In 2016, the Virginia Health Commissioner signed a standing order into law allowing licensed pharmacists to dispense opioid receptor antagonists (ORAs) for overdose reversal. OBJECTIVES: Using the theory of planned behavior as an initial guide to study development, the aim of this qualitative study was to explore community pharmacists' attitudes, subjective norm, perceived behavioral control, and behavioral intention toward dispensing ORAs under a standing order in Virginia. METHODS: Semi-structured interviews were conducted with community pharmacists across the Commonwealth between June 2018 and October 2019. Interviews were recorded, transcribed verbatim, and thematically analyzed. RESULTS: Twenty-one community pharmacists were interviewed. Pharmacists were confused about the specifics and the processes involved with dispensing naloxone under the standing order. Furthermore, many recognized the underuse of the standing order. Positive attitudes focused on the life-saving action of ORAs. Negative attitudes included encouraging risky behaviors by patients, negatively affecting the patient-pharmacist relationship, offending or contributing to stigmatizing patrons, and having liability issues to the pharmacy. Subjective norms regarding dispensing of ORAs under the standing order were perceived to be favorable among peer pharmacists and primary care and emergency department physicians but may be seen as profit-seeking by patients. Barriers to service provision included lack of guidance from corporate offices (in chain pharmacies), inadequate training, patient out-of-pocket costs, reimbursement issues, inadequate staffing and time, and stigma. Facilitators comprised the existence of practice site-specific protocols, the REVIVE! training, technician support, increased community awareness, physician collaboration, pharmacist training, and employer guidance. Whereas some pharmacists intended to become more familiarized with the standing order, others did not intend to actively identify patients who were at risk of an opioid overdose. CONCLUSION: Pharmacists expressed mixed behavioral intention toward dispensing ORAs under the standing order. Future research should focus on quantifying the uptake of the standing order at the state level.

Cost-effectiveness of syringe service programs, medications for opioid use disorder, and combination programs in hepatitis C harm reduction among opioid injection drug users: a public payer perspective using a decision tree.

BACKGROUND: The hepatitis C virus (HCV) prevalence rate among injection drug users (IDUs) in North America is 55.2%, with 1.41 million individuals estimated to be HCV-antibody positive. Studies have shown the effectiveness of syringe service programs (SSPs) alone, medications for opioid use disorder (MOUD) alone, or SSP+MOUD combination in reducing HCV transmission among opioid IDUs. OBJECTIVE: To evaluate the cost-effectiveness of SSP alone, MOUD alone, and SSP + MOUD combination in preventing HCV cases among opioid IDUs in the United States. METHODS: We used a decision tree analysis model based on published literature and publicly available data. Effectiveness was presented as the number of HCV cases avoided per 100 opioid IDUs. A micro-costing approach was undertaken and included both direct medical and nonmedical costs. Cost-effectiveness was assessed from a public payer perspective over a 1-year time horizon. It was expressed as an incremental cost-effectiveness ratio (ICER) and an incremental cost savings per HCV case avoided per 100 opioid IDUs compared with cost savings with "no intervention." Costs were standardized to 2019 U.S. dollars. RESULTS: The incremental cost savings per HCV case avoided per 100 opioid IDUs compared with no intervention were as follows: SSP + MOUD combination = $347,573; SSP alone = $363,821; MOUD alone = $317,428. The ICER for the combined strategy was $4,699 compared with the ICER for the SSP group. Sensitivity analysis showed that the results of the base-case cost-effectiveness analysis were sensitive to variations in the probabilities of injection-risk behavior for the SSP and SSP + MOUD combination groups, probability of no HCV with no intervention, and costs of MOUD and HCV antiviral medications. CONCLUSIONS: The SSP + MOUD combination and SSP alone strategies dominate MOUD alone and no intervention strategies. SSP had the largest incremental cost savings per HCV case avoided per 100 opioid IDUs compared with the no intervention strategy. Public payers adopting the SSP + MOUD combination harm-reduction strategy instead of SSP alone would have to pay an additional $4,699 to avoid an additional HCV case among opioid IDUs. Although these harm-reduction programs will provide benefits in a 1-year time frame, the largest benefit may become evident in the years ahead. DISCLOSURES: This research had no external funding. The authors declare no financial interests in this article. Ijioma is a Health Economics and Outcomes Research (HEOR) postdoctoral Fellow with Virginia Commonwealth University and Indivior. Indivior is a pharmaceutical manufacturer of opioid addiction treatment drugs but was not involved in the design, analysis, or write-up of the manuscript.

Economic burden of pediatric prescription opioid poisonings in the United States.

BACKGROUND: Among the different drugs involved in pediatric exposures and poisonings, opioids are the most important, given their rise in nonmedical use. Opioid poisonings in children can result in serious symptoms or complications, including respiratory disorders such as apnea, respiratory failure, and respiratory depression; psychiatric or nervous system disorders such as agitation, seizures, and coma; and cardiac disorders such as tachycardia, bradycardia, and cardiac arrest. Opioid poisonings in children can have delayed onset of symptoms as well as severe and prolonged toxic effects. Many studies have examined the economic burden of opioid poisoning in the general population, but very little is known about the pediatric population. OBJECTIVE: To estimate the economic burden associated with pediatric prescription opioid poisonings. METHODS: This study examined opioid poisonings in pediatric patients, defined as patients aged less than 18 years, for the 2012 base year. Costs were estimated using the 2012 Nationwide Emergency Department Sample (NEDS), Kids' Inpatient Database (KID), Multiple Cause-of-Death (MCOD) file, and other published sources, while applying a societal perspective. The Bottom Up approach was used to estimate the total cost of pediatric prescription opioid poisonings. Direct costs included costs associated with emergency department (ED) visits, hospitalizations, and ambulance transports. Indirect costs were estimated using the human capital method and included productivity costs due to caregivers' absenteeism and premature mortality among children. Descriptive statistics were employed in calculating costs. RESULTS: The total costs of pediatric prescription opioid poisonings and exposure in the United States were $230.8 million in 2012. Total direct costs were estimated to be over $21.1 million, the majority resulting from prescription opioid poisoning-related inpatient stays. Total indirect (productivity) costs were calculated at $209.7 million, and 98.6% of these costs were attributed to opioid poisoning-related mortality. Pediatric prescription opioid poisoning-related ED visits, inpatient stays, and deaths were most common in patients aged 13-17 years and those in mid to large urban areas. Most were unintentional. CONCLUSIONS: Pediatric prescription opioid poisonings resulted in direct and indirect costs of $230.8 million in 2012. While these costs are low in comparison with the costs of prescription opioid poisoning in the general population, the number of pediatric poisonings represents only a small fraction of total poisonings. Quantified costs associated with pediatric prescription opioid poisonings can help decision makers to understand the economic trade-offs in planning interventions. DISCLOSURES: This research had no external funding but was funded by an unrestricted research grant made to the Department of Pharmacotherapy & Outcomes Science by kaléo Pharma, maker of a naloxone product. The authors declare no conflicts of interest or financial interests. Portions of this study were presented as an abstract at the 22nd Annual ISPOR Meeting; May 22, 2017; Boston, MA.

Potential cost savings by prevention of adverse drug events with a novel medication review program.

OBJECTIVES: Preventable adverse drug events (ADEs) account for appreciable health care costs and patient morbidity and offer an attractive opportunity for health care providers to improve patient care and decrease costs. It has been suggested that pharmacist intervention can prevent admissions and readmissions due to ADEs. This study assessed the ADEs prevented through a novel medication review program, then estimated the potential cost savings of the prevented ADEs using the literature on cost and prevalence of ADEs that were treated. METHODS: An innovative pharmacist-run medication review was implemented in 2 pharmacies from November 2016 to July 2017. Patients with diabetes, chronic obstructive pulmonary disease, congestive heart failure, prior myocardial infarction, or stroke were included. Pharmacists recorded information about each potential ADE prevented using a standard tracking form which was de-identified and retrospective cost analysis was conducted. Estimates of ADE cost and prevalence requiring treatment were extracted from the literature and incorporated into a model to estimate the potential savings in prevented ADEs overall and per patient. Because ADE costs vary with severity, ADEs in this study were scored for potential severity. RESULTS: This study included 436 patients with a total of 272 likely and 385 likely or possible ADEs identified. ADEs prevented resulted in an estimated total potential savings of $94,832 (sensitivity analysis [SA]: $2261-$828,921) for likely ADEs and $138,914 (SA: $13,520-$264,308) for likely and possible ADEs. Per patient estimated medication review savings were $218 (SA: $5-$1901) for likely ADEs and $319 (SA: $31-$606) for likely and possible ADEs. The benefit of potential cost savings from providing this medication review was 3.6-5.3 times the pharmacists' time and salary cost. CONCLUSIONS: Pharmacists in this study identified a numerous potential ADEs. By intervening to prevent these ADEs, pharmacists could generate substantial cost savings.

Should the United States government regulate prescription prices? A critical review.

Prescription drug pricing in the United States continues to generate considerable debate. This critical review and commentary summarizes the evidence surrounding four factors often cited as contributing to high drug prices and/or as rationale for increasing government involvement in drug prices: (1) pharmaceutical industry profits, (2) government funding of basic and biomedical research, (3) "me-too" products, and (4) pharmaceutical advertising. Furthermore, it describes the potential impact of increased governmental regulations on prices and innovation in the pharmaceutical industry. Literature indicates that drug companies have consistently made higher profits than companies in other industries. Research suggests that the magnitude of that difference may be smaller than typically reported due to treatment of research and development (R&D) and marketing and promotional expenses. Research provides inconsistent results on the magnitude of that difference and the need for higher profits to compensate for the industry's level of risk. Evidence suggests that me-too drugs effectively decrease innovator products' period of market exclusivity and may modestly reduce drug prices directly or by increasing manufacturer rebates. The direct impact of advertising expenditures on drug prices is likely limited. The literature suggests that restrictions on advertising and me-too drug development would have minimal effects on prices. Government involvement in pricing products developed from government-funded research has been tried and found neither effective nor workable. These findings suggest that more widespread price regulation would likely result in decreased R&D and fewer new products. The impact of reduced R&D would, in turn, depend on the degree to which lower profits and R&D investments would stymie the development high-value, innovative new products or simply decrease the output of low-value duplicative products. In summary, this critical review of the literature found little evidence that targeted or broad government regulation of prescription prices in the United States would provide net positive societal benefits.

Economic burden of renal cell carcinoma among older adults in the targeted therapy era.

OBJECTIVE: This study examined the economic burden of renal cell carcinoma (RCC) among older adults. The study also examined healthcare costs by types of resources used and stage at which RCC was diagnosed. METHODS: The study analyzed the Surveillance Epidemiology and End Result-Medicare linked data. We included a prevalent cohort of RCC patients from 2013, diagnosed and continuously enrolled in Medicare from 2005 to 2013. RCC patients were matched to controls selected from a 5% sample of noncancer beneficiaries using propensity score matching to calculate incremental costs. Total healthcare costs (THC) were calculated using a phase-based approach, which classified patients into early, continuing, and late phases of care. Costs were also examined by types of resources used and stage at which RCC was diagnosed. Generalized linear models estimated annual incremental costs per patient. The number of older RCC patients was calculated using SEER-Stat and ProjPrev software. The average incremental THC was multiplied by the estimated number of RCC patients to calculate the total economic burden of RCC among older adults. RESULTS: The study included 10,392 each of RCC and control patients. The average annual THC associated with RCC was $7,419 for all phases, $22,752 for the initial phase, $4,860 for the continuing phase, and $13,232 for the late phase of care. The average THC was $4,584 for patients diagnosed at stage I, $4,727 for stage II, $9,331 for stage III, and $31,637 for stage IV. For patients diagnosed at stages I to III, hospital cost (approximately $1,500-$3,400) was the largest component of THC. For stage IV patients, prescription drug cost ($11,747) was the largest component of THC. The projected number of older RCC patients in 2015 was 204,256. The annual economic burden of RCC after weighting for proportion of patients diagnosed at various stages was estimated to be $2.1 billion. CONCLUSIONS: RCC was associated with a significant economic burden on Medicare. Healthcare costs associated with RCC varied substantially between early stage and metastatic patients. This research provided a baseline that can be used to assess the economic value of emerging therapies among older RCC patients.

Prevalence and Characteristics of Pediatric Opioid Exposures and Poisonings in the United States.

OBJECTIVE: To examine the prevalence and characteristics of pediatric opioid exposures and poisonings in the US. STUDY DESIGN: This was a retrospective, cross-sectional analysis using the National Poison Data System from January 1, 2010 to December 31, 2014. Records of children aged <18 years with exposure to opioid-containing medications were identified. Standardized prevalence rates were calculated, and the annual trend was examined. Pediatric opioid exposures were characterized descriptively, and logistic regression was performed to estimate the association between various clinical and sociodemographic characteristics and exposures with serious (ie, moderate, major, or death) outcomes. The association of pediatric opioid exposures and area-level socioeconomic status factors at 5-digit ZIP code level was examined descriptively. RESULTS: The prevalence of opioid exposures was 22.6 per 100 000 children and was particularly high among ≤5-year-olds. Prevalence declined from 25.5 to 20 per 100 000 children from 2010 to 2014. There were 83 418 pediatric opioid exposures over the 5-year period and nearly one-half resulted in poisoning. Over 60% of exposures were among children ≤5 years of age, 73.4% were unintentional, and over 90% occurred at home. One in every 2 pediatric opioid exposures was evaluated in a healthcare facility. Annually 4912 children aged ≤5 years were treated in the emergency department or admitted for care. Older age, nonaccidental intent, and single-substance opioid, especially buprenorphine and methadone, were associated with serious outcomes (P < .05). Positive correlations were observed for area-level socioeconomic status factors including proportion of adults and pediatric opioid exposures. CONCLUSIONS: Pediatric opioid exposures and poisonings decreased from 2010 to 2014 but morbidity remains high. The epidemiology of opioid exposures differed considerably by age.

Cost-effectiveness of hepatitis C-positive donor kidney transplantation for hepatitis C-negative recipients with concomitant direct-acting antiviral therapy.

Pilot studies suggest that transplanting hepatitis C virus (HCV)-positive donor (D+) kidneys into HCV-negative renal transplant (RT) recipients (R-), then treating HCV with direct-acting antivirals (DAA) is clinically feasible. To determine whether this is a cost-effective approach, a decision tree model was developed to analyze costs and effectiveness over a 5-year time frame between 2 choices: RT using a D+/R- strategy compared to continuing dialysis and waiting for a HCV-negative donor (D-/R-). The strategy of accepting a HCV+ organ then treating HCV was slightly more effective and substantially less expensive and resulted in an expected 4.8 years of life (YOL) with a cost of ≈$138 000 compared to an expected 4.7 YOL with a cost of ≈$329 000 for the D-/R- strategy. The D+/R- strategy remained dominant after sensitivity analyses including the difference in RT death probabilities or acute rejection probabilities between using D+ vs D- kidney; time that D-/R- patients waited for RT; dialysis death probabilities while waitlisted for RT in the D-/R- strategy; DAA therapy expected cure rate; costs of transplant, immunosuppressives, DAA therapy, dialysis, or acute rejection. The D+/R- strategy followed by treatment with DAA is less costly and slightly more effective compared to the D-/R- strategy.

A Comparison of Pharmacy Dispensing Channel Use and Adherence to Specialty Drugs Among Medicare Part D Beneficiaries.

BACKGROUND: Nonadherence to specialty drugs has been associated with poor clinical and economic outcomes. Studies conducted using commercial health plans suggest that patients who use specialty pharmacies have higher adherence compared with patients using retail pharmacies. However, little is known about the frequency of dispensing channel use or the association of dispensing channel use with adherence to specialty drugs among Medicare Part D beneficiaries. OBJECTIVES: To (a) describe the use of pharmacy dispensing channels by patients using self-administered specialty drugs in Medicare Part D and (b) study the association between dispensing channel use and adherence to specialty drugs in this population. METHODS: This study analyzed 2010 Medicare Part D data. Specialty drugs were defined as drugs with a mean cost ≥ $600 per month. We identified the top 13 specialty medications by cost and classified patients into the following classes: anticancer, disease-modifying therapy (DMT), and tumor necrosis factor inhibitor (TNFi). Dispensing channels included retail, specialty, mail order, long-term care, and other. We included patients continuously enrolled in Medicare Part D who had ≥ 1 prescription for a specialty medication before the end of June 2010. These patients were followed until the end of 2010. Patients with proportion of days covered (PDC) ≥ 0.8 were considered adherent. Adherence rates were calculated by weighting for therapeutic class after weighting for drug mix. Multivariable logistic regression analysis examined the association between dispensing channel and adherence. RESULTS: Of 5,430 patients, 1,248 were dispensed anticancer medications, 1,723 were dispensed DMTs, and 2,459 were dispensed TNFi drugs. About 16% used specialty, 74% used retail, 4% used mail order, 4% used long-term care, and 3% used other channels. The distribution pattern was similar when stratified by therapeutic class. In the descriptive analysis, patients using the specialty channel for the anticancer and TNFi classes had 7% and 10% higher adherence rates, respectively, compared with retail. For the DMT class, the adherence rate was higher for mail order but similar for retail and specialty channels. Adjusted analysis found that overall, specialty users had 23% higher odds for being adherent compared with retail users (P = 0.0104). For the anticancer and TNFi classes, specialty users had 39% (P = 0.0311) and 55% (P = 0.0005) higher odds, respectively, for being adherent than retail users. For the DMT class, no significant association was observed between dispensing channel and adherence (P = 0.9691). CONCLUSIONS: Nearly three quarters of Medicare patients on specialty therapies included in this study used the retail channel compared with one sixth who used the specialty channel. Overall, specialty channel use was associated with higher adherence compared with retail channel use. However, this relationship varied by therapeutic class. The specialty channel was associated with higher adherence among patients from the anticancer and TNFi classes but not among the DMT class. DISCLOSURES: No funding supported this study. The authors reported no potential conflicts of interest. Kale, Patel, and Carroll were responsible for study concept and design. Data analysis was conducted by Kale, assisted by Patel. The manuscript was written primarily by Kale, with assistance from Carroll. Some findings from this study were presented during the poster presentation at the Academy of Managed Care Pharmacy Nexus held in National Harbor, Maryland, on October 4, 2016.

Risk Factors for Serious Prescription Opioid-Induced Respiratory Depression or Overdose: Comparison of Commercially Insured and Veterans Health Affairs Populations.

Objective: To characterize the risk factors associated with overdose or serious opioid-induced respiratory depression (OIRD) among medical users of prescription opioids in a commercially insured population (CIP) and to compare risk factor profiles between the CIP and Veterans Health Administration (VHA) population. Subjects and Methods: Analysis of data from 18,365,497 patients in the IMS PharMetrics Plus health plan claims database (CIP) who were dispensed a prescription opioid in 2009 to 2013. Baseline factors associated with an event of serious OIRD among 7,234 cases and 28,932 controls were identified using multivariable logistic regression. The CIP risk factor profile was compared with that from a corresponding logistic regression among 817 VHA cases and 8,170 controls in 2010 to 2012. Results: The strongest associations with serious OIRD in CIP were diagnosed substance use disorder (odds ratio [OR] = 10.20, 95% confidence interval [CI] = 9.06-11.40) and depression (OR = 3.12, 95% CI = 2.84-3.42). Other strongly associated factors included other mental health disorders; impaired liver, renal, vascular, and pulmonary function; prescribed fentanyl, methadone, and morphine; higher daily opioid doses; and concurrent psychoactive medications. These risk factors, except depression, vascular disease, and specific opioids, largely aligned with VHA despite CIP being substantially younger, including more females and less chronic disease, and having greater prescribing prevalence of higher daily opioid doses, specific opioids, and most selected nonopioids. Conclusions: Risk factor profiles for serious OIRD among US medical users of prescription opioids with private or public health insurance were largely concordant despite substantial differences between the populations in demographics, clinical conditions, health care delivery systems, and clinical practices.

The Medicaid Rebate: Changes in Oncology Drug Prices After the Affordable Care Act.

BACKGROUND: Prescription drug spending is a significant component of Medicaid total expenditures. The Affordable Care Act (ACA) includes a provision that increases the Medicaid rebate for both brand-name and generic drugs. This study examines the extent to which oncology drug prices changed after the increase in the Medicaid rebate in 2010. METHODS: A pre-post study design was used to evaluate the correlation between the Medicaid rebate increase and oncology drug prices after 2010 using 2006-2013 State Drug Utilization Data. RESULTS: The results show that the average annual price of top-selling cancer drugs in 2006, adjusted for inflation and secular changes in drug prices, have increased by US$154 and US$235 for branded and competitive brand drugs, respectively, following the 2010 ACA; however, generic oncology drug prices showed no significant changes. CONCLUSIONS: The findings from this study indicate that oncology drug prices have increased after the 2010 ACA, and suggest that pharmaceutical companies may have increased their drug prices to offset increases in Medicaid rebates.

Examination of the Link Between Medication Adherence and Use of Mail-Order Pharmacies in Chronic Disease States.

BACKGROUND: Higher medication adherence is associated with positive health outcomes, including reduction in hospitalizations and costs, and many interventions have been implemented to increase patient adherence. OBJECTIVES: To determine whether patients experience higher medication adherence by using mail-order or retail pharmacies. METHODS: Articles pertaining to retail and mail-order pharmacies and medication adherence were collected from 3 literature databases: MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and International Pharmaceutical Abstracts (IPA). Searches were created for each database and articles were compiled. Articles were screened for exclusion factors, and final articles (n=15) comparing medication adherence in patients utilizing mail and retail pharmacies were analyzed. For each study, various factors were identified including days supply, patients' out-of-pocket costs, prior adherence behavior, therapeutic class, measure of adherence, limitations, and results. Studies were then categorized by disease state, and relevant information from each study was compared and contrasted. RESULTS: The majority of studies-14 out of the 15 reviewed-supported higher adherence through the mail-order dispensing channel rather than through retail pharmacies. There are a number of reasons for the differences in adherence between the channels. Study patients who used mail-order pharmacies were more likely to have substantially higher prior adherence behavior, socioeconomic status, and days supply of medicines received and were likely to be offered financial incentives to use mail-order. The few studies that attempted to statistically control for these factors also found that patients using mail-order services were more adherent but the size of the differences was smaller. The extent to which these results indicate an inherent adherence advantage of mail-order pharmacy (as distinct from adherence benefits due to greater days supply, lower copays, or more adherent patients selecting mail-order pharmacies) depends on how well the statistical controls adjusted for the substantial differences between the mail and retail samples. CONCLUSIONS: While the research strongly indicates that consumers who use mail-order pharmacies are more likely to be adherent, more research is needed before it can be conclusively determined that use of mail-order pharmacies causes higher adherence. DISCLOSURES: No outside funding supported this study. Fernandez was partially funded by a Virginia Commonwealth University School of Pharmacy PharmD/PhD Summer Fellowship for work on this project. The authors declare no other potential conflicts of interest. Study concept and design were contributed by Carroll and Fernandez. Fernandez took the lead in data collection, along with Carroll and McDaniel, and data interpretation was performed by Carroll and Fernandez. The manuscript was written and revised by Carroll and Fernandez, with assistance from McDaniel.

Economic burden of refractory chronic spontaneous urticaria on Kuwait's health system.

BACKGROUND: Chronic spontaneous urticaria (CSU) is a common problem worldwide. We evaluated the direct medical costs of treating patients with refractory CSU and the budget effect of omalizumab use in these patients in Kuwait. METHODS: The prevalence of CSU was estimated using the Delphi method. Medical records of patients with refractory CSU in Kuwait were reviewed. Costs were calculated from a health system perspective. One-way sensitivity analyses were conducted on the price and utilization of each cost component. RESULTS: Before omalizumab use, the total direct costs of treating 1,293 patients with refractory CSU were estimated to be USD 3,650,733 per year. This estimation was principally generated by outpatient visits. After omalizumab use, the cost was sensitive to price variation and estimated to be USD 15,828,612 per year. All other direct costs were reduced. CONCLUSION: The economic burden of refractory CSU in Kuwait is high. Omalizumab use is costly, but its administration reduces all other direct costs.

Prevalence of Antidiabetic and Antilipidemic Medications in Children and Adolescents Treated With Atypical Antipsychotics in a Virginia Medicaid Population.

BACKGROUND: Atypical antipsychotic use among children and adolescents is a cause for concern secondary to metabolic adverse effects. There have been reports of weight gain, metabolic syndrome, dyslipidemia, glucose abnormalities, and decreased insulin sensitivity in children aged 4 to 19 years using atypical antipsychotics. OBJECTIVE: To determine the prevalence of antidiabetic and antilipidemic medication use among children and adolescents receiving atypical antipsychotics and to evaluate whether the odds of receiving antidiabetic and antilipidemic medication differs among atypical antipsychotic agents. METHODS: This retrospective cross-sectional study included Virginia Medicaid beneficiaries (2-17 years) continuously enrolled from August 1, 2010, to July 31, 2011. The participants were categorized into atypical antipsychotic exposed and unexposed. The prevalence of antidiabetic and antilipidemic medication use within the groups was computed. Logistic regression was used to calculate the odds of receiving antidiabetic or antilipidemic medication after controlling for age, sex, and race. RESULTS: A total of 299593 and 4922 beneficiaries were identified in unexposed and exposed groups, respectively. The prevalence of antidiabetic medication use was 0.32% in the unexposed and 1.40% in the exposed group (P < 0.0001). Prevalence of antilipidemic medication use was 0.09% in the unexposed and 0.35% in the exposed group (P < 0.0001). Risperidone and quetiapine users had lower odds than olanzapine users of receiving antidiabetic medication. No differences between the odds of receiving antilipidemic medication among the different antipsychotics (P = 0.1653) were observed. CONCLUSIONS: Prevalence of antidiabetic and antilipidemic medication use was significantly higher among children and adolescent atypical antipsychotic users in a Virginia Medicaid population.

Self-reported financial burden of cancer care and its effect on physical and mental health-related quality of life among US cancer survivors.

BACKGROUND: Cancer-related financial burden has been linked to cancer survivors (CS) forgoing/delaying medical care, skipping follow-up visits, and discontinuing medications. To the authors' knowledge, little is known regarding the effect of financial burden on the health-related quality of life of CS. METHODS: The authors analyzed 2011 Medical Expenditure Panel Survey data. Financial burden was present if one of the following problems was reported: borrowed money/declared bankruptcy, worried about paying large medical bills, unable to cover the cost of medical care visits, or other financial sacrifices. The following outcomes were evaluated: Physical Component Score (PCS) and Mental Component Score (MCS) of the 12-Item Short-Form Health Survey (SF-12), depressed mood, psychological distress, and worry related to cancer recurrence. The authors also assessed the effect of the number of financial problems on these outcomes. RESULTS: Of the 19.6 million CS analyzed, 28.7% reported financial burden. Among them, the average PCS (42.3 vs 44.9) and MCS (48.1 vs 52.1) were lower for those with financial burden versus those without. In adjusted analyses, CS with financial burden had significantly lower PCS (ß = -2.45), and MCS (ß = -3.05), had increased odds of depressed mood (odds ratio, 1.95), and were more likely to worry about cancer recurrence (odds ratio, 3.54). Survivors reporting ≥ 3 financial problems reported statistically significant and clinically meaningful differences (≥3 points) in the mean PCS and MCS compared with survivors without financial problems. CONCLUSIONS: Cancer-related financial burden was associated with lower health-related quality of life, increased risk of depressed mood, and a higher frequency of worrying about cancer recurrence among CS.