Impact of a Best Practices Program in Patients with Relapsed/Refractory Multiple Myeloma Receiving Selinexor.

Best practice (BP) in cancer care consists of a multifaceted approach comprising individualized treatment plans, evidence-based medicine, the optimal use of supportive care and patient education. We investigated the impact of a BP program in patients with relapsed/refractory multiple myeloma (RRMM) receiving selinexor. Features of the BP program that were specific to selinexor were initiating selinexor at doses ≤80 mg once weekly and the upfront use of standardized antiemetics. Study endpoints included time to treatment failure (TTF), duration of therapy, dose limiting toxicities and overall survival. Comparative analysis on TTF and duration of therapy was conducted using a log-rank test and multivariate Cox proportional hazard regression. Over the ensuing 12-month post-BP period, 41 patients received selinexor-based therapy compared to 68 patients who received selinexor-based therapy pre-BP implementation. Patients treated in the post-BP period had reductions in TTF (hazard ratio [HR] = 0.50; 95% CI: 0.27 to 0.92). Patients in the pre-BP period were four times more likely to stop therapy than those in the post-period (odds ratio [OR] = 4.0, 95% CI: 1.75 to 9.3). The findings suggest a BP program tailored to selinexor could increase the time to treatment failure, increase treatment duration and lower the incidence of drug limiting toxicities.

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.

Oral buprenorphine utilization, concomitant benzodiazepines and opioid analgesics, and payment source: Trends from 2015 to 2019.

INTRODUCTION: This study describes utilization patterns of oral buprenorphine products indicated for the treatment of opioid use disorder with a focus on patterns consistent with prescribing guidelines and the safe use conditions during induction and maintenance treatment outlined by the Risk Evaluation and Mitigation Strategy (REMS) Program, including trends over time. METHODS: Using an anonymized longitudinal patient-level dataset that captures information on medical and pharmacy claims in the United States (October 1, 2014 through March 31, 2020), buprenorphine prescriptions, days' supply, and daily dose were described overall and stratified by induction (month 1) vs. maintenance (month 2-6) treatment, along with duration of concomitant benzodiazepines or opioid analgesics. RESULTS: Overall, there were 1.5 million buprenorphine treatment episodes initiated between January 1, 2015 to September 30, 2019 (2015: 258,899; 2019: 351,378). Treatment episodes included an average of 6.8 buprenorphine prescriptions (standard deviation [SD] = 6.7), 16.8 days' supply per prescription (SD = 10.5), 94.2 total days' supply per treatment episode (SD = 71.4), and a mean daily dose of 13.6 mg (SD = 6.3), with the number of prescriptions and total days' supply per treatment episode declining over the study period. There was a lower mean number of days' supply per prescription in the first month of treatment compared to months 2-6 (month 1: 15.8 [SD = 11.0]; month 2-6: 19.0 [SD = 10.1]) and daily dose per prescription (month 1: 13.3 mg [SD = 6.4]; months 2-6: 14.3 mg [SD = 6.2]), and a higher mean number of prescriptions per month (month 1: 2.5 per month [SD = 1.7]; months 2-6: 1.8 per month [SD = 1.2]). From 2015 to 2019, there appeared to be a shift in payer mix, with increases in Medicaid/Medicare and declines in cash and commercial insurance. Concomitant benzodiazepine and opioid analgesic use declined over time; in 2019, 16.6 % and 14.3 % of treatment episodes had any concomitant benzodiazepine or opioid analgesic, respectively, and <5 % had chronic (>90 overlapping days) concomitant use (3.0 % and 0.4 %, respectively). CONCLUSIONS: The number of oral buprenorphine treatment episodes increased over the study period, and prescribing was generally consistent with the REMS and other treatment guidelines. There was a decline in concomitant buprenorphine and benzodiazepine or opioid analgesics, and chronic concomitant use was rare.

The cost-effectiveness of pharmacist-physician collaborative care models vs usual care on time in target systolic blood pressure range in patients with hypertension: a payer perspective.

BACKGROUND: Hypertension is highly prevalent in the United States, affecting nearly half of all adults (43%). Studies have shown that pharmacist-physician collaborative care models (PPCCMs) for hypertension management significantly improve blood pressure (BP) control rates and provide consistent control of BP. Time in target range (TTR) for systolic BP is a novel measure of BP control consistency that is independently associated with decreased cardiovascular risk. There is no evidence that observed improvement in TTR for systolic BP with a PPCCM is cost-effective. OBJECTIVE: To compare the cost-effectiveness of a PPCCM with usual care for the management of hypertension from the payer perspective. METHODS: We used a decision analytic model with a 3-year time horizon based on published literature and publicly available data. The population consisted of adult patients who had a previous diagnosis of high BP (defined as office-based BP ≥ 140/90 mmHg) or were receiving antihypertensive medications. Effectiveness data were drawn from 2 published studies evaluating the effect of PPCCMs (vs usual care) on TTR for systolic BP and the impact of TTR for systolic BP on 4 cardiovascular outcomes (nonfatal myocardial infarction [MI], stroke, heart failure [HF], and cardiovascular disease [CVD] death). The model incorporated direct medical costs, including both programmatic costs (ie, direct costs for provider time) and downstream health care utilization associated with acute cardiovascular events. One-way sensitivity and threshold analyses examined model robustness. RESULTS: In base-case analyses, PPCCM hypertension management was associated with lower downstream medical expenditures (difference: -$162.86) and lower total program costs (difference: -$108.00) when compared with usual care. PPCCM was associated with lower downstream medical expenditures across all parameter ranges tested in the deterministic sensitivity analysis. For every 10,000 hypertension patients managed with PPCCM vs usual care over a 3-year time horizon, approximately 27 CVD deaths, 29 strokes, 21 nonfatal MIs, and 12 incident HF diagnoses are expected to be averted. CONCLUSIONS: This is the first study to evaluate the cost-effectiveness of PPCCM compared to usual care on TTR for systolic BP in adults with hypertension. PPCCM was less costly to administer and resulted in downstream health care savings and fewer acute cardiovascular events relative to usual care. Although further research is needed to evaluate the long-term costs and outcomes of PPCCM, payer coverage of PPCCM services may prevent future health care costs and improve patient cardiovascular outcomes. DISCLOSURES: No funding was received for the completion of this research. The authors have nothing to disclose. Study results were presented as an abstract at the AMCP 2021 Virtual, April 12-16, 2021.

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.