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Objective Treatment options for HER-2-positive metastatic breast cancer (mBC) patients have expanded markedly since trastuzumab approval in 1998. Several other regimens are now available, including pertuzumab plus trastuzumab plus docetaxel, T-DM1, capecitabine plus lapatinib, and trastuzumab plus lapatinib. This study assesses the cost-effectiveness of four treatment sequences for HER-2-positive mBC according to the Taiwanese National Health Insurance Administration (TNHIA). Methods Costs (U.S. Dollars) and effectiveness (quality-adjusted life years) of four treatment sequences for HER-2-positive mBC patients were examined using a Markov model over a lifetime horizon. Transition probabilities, disease progression, and probability of adverse events and survival were derived from clinical trial data. Costs and health utilities were estimated from TNHIA, Taipei Medical University Hospital, and the literature. Deterministic, probabilistic sensitivity analyses and a scenario analysis examined parameter uncertainty and accounted for drug wastage in dosage and cost calculations. Results Sequence 3 (1st line: trastuzumab plus docetaxel; 2nd line: T-DM1; 3rd line: trastuzumab plus lapatinib) was the most cost-effective sequence followed by sequence 1 (1st line: pertuzumab plus trastuzumab plus docetaxel; 2nd line: T-DM1; 3rd line: capecitabine plus lapatinib), and sequence 4 (1st line: trastuzumab plus docetaxel; 2nd line: trastuzumab plus lapatinib; 3rd line: trastuzumab plus capecitabine), respectively. The model was sensitive to costs and transition probabilities, but not particularly sensitive to the wastage assumption. Conclusions From the perspective of the TNHIA, trastuzumab plus docetaxel as 1st line followed by T-DM1 and trastuzumab plus lapatinib as 2nd and 3rd line represents the most cost-effective strategy among the four sequences considered for treating HER-2-positive mBC patients., Highlights • In health systems in which resources are scarce, treatment selection should be carefully considered to preserve efficiency. • We conducted a CEA of four treatment sequences for HER-2-positive mBC in Taiwan, accounting for intravenous drug wastage. • Results of such analyses can be useful to policymakers as they decide on coverage of expensive new anticancer treatments.

PURPOSE: US Food and Drug Administration approvals of immune checkpoint inhibitors and targeted therapies revolutionized the treatment of metastatic melanoma. Our aim was to assess health care resource utilization and costs for patients with metastatic melanoma treated with systemic therapies in first line between January 2012 and December 2017. METHODS: We conducted a retrospective cohort study of patients with metastatic melanoma using MarketScan data. We included patients diagnosed with melanoma and secondary malignant neoplasm who used pembrolizumab, nivolumab, ipilimumab, ipilimumab plus nivolumab, BRAF-inhibitor (BRAF-i) plus MEK inhibitor (MEK-i), BRAF-i or MEK-i monotherapy, or chemotherapy in first line. We compared health care utilization and costs per patient per month (PPPM) using two-part and generalized linear models. RESULTS: We identified 1,870 patients, including 185 pembrolizumab, 103 nivolumab, 689 ipilimumab, 185 nivolumab plus ipilimumab, 214 BRAF-i plus MEK-i, 240 BRAF-i or MEK-i monotherapy, and 254 chemotherapy users. Highest PPPM rates of hospitalizations, emergency room visits, and outpatient visits were observed in patients with ipilimumab plus nivolumab therapy (adjusted difference v pembrolizumab [aDiff], 0.18, 0.12, and 0.88, respectively; all P < .001). Ipilimumab monotherapy users (aDiff, 0.07 and 0.93; all P < .001) and chemotherapy users (aDiff, 0.10 and 2.63; all P < .001) showed higher PPPM rates of hospitalizations and outpatient visits compared with pembrolizumab users, respectively. Utilization rates in nivolumab, BRAF-i plus MEK-i, and BRAF-i or MEK-i groups were similar to the pembrolizumab group. Highest PPPM total costs and drug-related costs were observed in the ipilimumab group ($80,139 US dollars [USD] and $70,051 USD; all P < .001), followed by the ipilimumab plus nivolumab ($71,689 USD and $56,217 USD; all P < .001) and the BRAF-i plus MEK-i group ($31,184 USD and $19,648 USD; all P < .001). PPPM costs in the nivolumab group were similar to the pembrolizumab group. CONCLUSION: Significant differences in health care resource utilization and costs were found across first-line metastatic melanoma regimens. Utilization rates were highest in patients using ipilimumab-containing therapies. High drug costs constituted a major fraction of total PPPM health care costs.

Initial legalization of medical marijuana (MM) in Florida required providers to submit initial and follow-up treatment plan forms to the University of Florida to support research on MM safety and efficacy. This study retrospectively analyzed all treatment plan forms submitted between program inception (August 2016) through July 2017 and describes early Florida MM registrants by clinical conditions and prescription drug utilization. Among 7,548 unique treatment plans, the initial visit was characterized by registrants who were mostly white (83.7%), 52.3 (SD 16.4) years of age on average, and who were assessed by the provider as at least moderately ill (79.6%). Musculoskeletal and spasticity-related conditions (44.8%), chronic pain (41.9%), and mental health disorders (17.0%) were the most frequent medical complaints for seeking MM treatment with more than one condition per patient possible. One in four (25.9%) patients reported use of prescription opioids and over one-fifth of patients frequently utilized at least one psychotropic medication as well as cardiovascular agents. There were 2,075 unique follow-up plans available which were mostly characterized by clinical improvement and reported reductions in utilization of some drug classes. Further research is needed to guide clinicians on the risks and benefits of MM used concomitantly with prescription drugs.

The present data article aims to describe the input parameters for a Markov model assessing the cost-effectiveness of four treatment sequences for patients with HER-2 positive metastatic breast cancer. The model input parameters include costs for physician visits, drugs, adverse event management, computed tomography (CT) scan, laboratory tests, echocardiogram, utilities, disutilities as well as the shape and scale parameters of a log-logistic distribution used for the transition probabilities. Keywords: Markov model, Metastatic breast cancer, Cost-effectiveness analysis, Treatment sequence

This systematic review and meta-analysis evaluates the immune checkpoint inhibitor regimens used along with the incidence of adverse events reported in randomized clinical trials for treatment of advanced melanoma., Key Points Question Does the risk of immune-related adverse events differ across immune checkpoint inhibitors used by patients with advanced melanoma? Findings In this systematic review and network meta-analysis of randomized clinical trials of advanced melanoma treatment, the risk of immune-related adverse events varied by the immune checkpoint inhibitors used and by the different doses of these same immune checkpoint inhibitors. Pembrolizumab, 2 mg/kg, every 3 weeks and 10 mg/kg every 3 weeks as well as nivolumab, 3 mg/kg, every 2 weeks were the 3 immune checkpoint inhibitor regimens associated with the lowest risk of any or severe immune-related adverse events. Meaning Results of this study suggest that network analysis comparing different treatment regimens for advanced melanoma may be valuable for clinical decision-making in the absence of evidence from randomized clinical trials with head-to-head comparisons., Importance Since 2011, immune checkpoint inhibitors (ICIs) have been effective treatment options for advanced melanoma. Little is known about how risks of immune-related adverse events (irAEs) vary by ICIs. Objective To compare the risk of irAEs across different treatment regimens for advanced melanoma using network meta-analysis. Data Sources PubMed/MEDLINE, Embase, Web of Science, and Scopus were searched for all randomized clinical trial (RCT) articles published from January 1, 2010, through June 30, 2019. Study Selection Studies included phases 2 and 3 RCTs in the treatment of advanced melanoma that compared ICIs (ipilimumab, nivolumab, and pembrolizumab) with chemotherapy drugs (eg, dacarbazine, carboplatin, and paclitaxel) or different ICI regimens. Data Extraction and Synthesis Different treatment regimens were compared using bayesian network meta-analysis with Markov chain Monte Carlo simulation with noninformative prior distribution and random-effects generalized linear models. Main Outcomes and Measures Primary outcomes were the cumulative incidence of any irAEs (regardless of severity) and severe irAEs (grades 3-5). Based on the pooled odds ratios (ORs) and 95% credible intervals (95% CrI), the probability of being associated with the lowest irAE risks was estimated for each treatment regimen. Results Nine RCTs with 8 different treatment regimens for advanced melanoma and involving a total of 5051 patients were included. Overall, the 3 ICI treatment regimens associated with the lowest risk of any or severe irAEs were pembrolizumab, 2 mg/kg, every 3 weeks; nivolumab, 3 mg/kg, every 2 weeks; and pembrolizumab, 10 mg/kg, every 3 weeks. Compared with ipilimumab, 10 mg/kg, every 3 weeks, only nivolumab, 3 mg/kg, every 2 weeks, was associated with a decreased risk for any irAEs (OR, 0.34; 95% CrI, 0.13-0.94). A decreased risk for severe irAEs was observed for ipilimumab, 3 mg/kg, every 3 weeks (OR, 0.35; 95% CrI, 0.14-0.74); pembrolizumab, 10 mg/kg, every 2 weeks (OR, 0.22; 95% CrI, 0.05-0.95) and 10 mg/kg every 3 weeks (OR, 0.20; 95% CrI, 0.06-0.68); and nivolumab, 3 mg/kg, every 2 weeks (OR, 0.20; 95% CrI, 0.07-0.48) compared with ipilimumab, 10 mg/kg, every 3 weeks. An increased risk for severe irAEs was associated with nivolumab, 1 mg/kg, every 3 weeks combined with ipilimumab, 3 mg/kg, every 3 weeks compared with other ICI regimens (ORs ranging from 4.09 [95% CrI, 1.73-10.99] to 7.40 [95% CrI, 1.12-49.29]) except ipilimumab, 10 mg/kg, every 3 weeks. Conclusions and Relevance These findings suggest that for patients with advanced melanoma at high risk of irAEs, pembrolizumab, 2 mg/kg, every 3 weeks, nivolumab, 3 mg/kg, every 2 weeks, and pembrolizumab, 10 mg/kg, every 3 weeks may be the preferred treatment regimens (with respect to irAE risks) among the ICI regimens reported, whereas ipilimumab, 10 mg/kg, every 3 weeks alone and nivolumab, 1 mg/kg, every 3 weeks combined with ipilimumab, 3 mg/kg, every 3 weeks should be used with caution. A network analysis may be valuable for clinical decision-making when evidence from head-to-head comparisons is lacking.

Use of medical marijuana is increasing in the United States and older adults are the fastest growing user group. There is little information about the characteristics and outcomes related to medical marijuana use. This study is a descriptive analysis of older adults (aged &ge, 50 years old) who were early adopters of a medical marijuana program in the U.S. state of Florida. Per state legislation, initial and follow-up treatment plans were submitted to the University of Florida College of Pharmacy. Data collection included demographics, clinical history, medical conditions, substance use history, prescription history, and health status. Follow-up treatment plans noted changes in the chief complaint and actions taken since the initial visit. Of the state&rsquo, s 7548 registered users between August 2016 and July 2017, N = 4447 (58.9%) were older adults. Patients utilized cannabidiol (CBD)-only preparations (45%), preparations that had both tetrahydrocannabinol (THC) and CBD (33.3%) or were recorded to use both CBD-only and THC + CBD products (21.7%). The chief complaints indicating medical cannabis treatment were musculoskeletal disorders and spasms (48.4%) and chronic pain (45.4%). Among other prescription medications, patients utilized antidepressants (23.8%), anxiolytics and benzodiazepines (23.5%), opioids (28.6%), and cardiovascular agents (27.9%). Among all drug classes with potential sedating effects, 44.8% of the cohort were exposed to at least one. Patients with follow-up visits (27.5%) exhibited marked improvement as assessed by the authorizing physicians. However, the patient registry lacked detailed records and linkable information to other data resources to achieve complete follow up in order to assess safety or efficacy. Future improvements to registries are needed to more adequately capture patient information to fill knowledge gaps related to the safety and effectiveness of medical marijuana, particularly in the older adult population.

BACKGROUND: Despite the high efficacy and safety associated with direct-acting antivirals (DAAs), access to HCV treatment has been frequently restricted because of the high DAA drug costs. OBJECTIVES: To (1) compare HCV treatment initiation rates between HCV monoinfected and HCV/HIV coinfected patients before (pre-DAA period) and after (post-DAA period) all-oral DAAs became available; and to (2) estimate the HCV treatment costs for payers and patients. RESEARCH DESIGN AND METHODS: A retrospective analysis of the MarketScan® Databases (2009–2016) was conducted for newly diagnosed HCV patients. Multivariable logistic regression was used to estimate the odds ratio (OR) of initiating HCV treatments during the pre-DAA and post-DAA periods. Kruskal-Wallis test was used to compare drug costs for dual, triple and all-oral therapies. RESULTS: 15,063 HCV patients (382 [2.5%] HIV coinfected) in the pre-DAA period and 14,896 (429 [2.9%] HIV coinfected) in the post-DAA period were included. HCV/HIV coinfected patients had lower odds of HCV treatment uptake compared to HCV monoinfected patients during the pre-DAA period (OR, 0.59; 95% confidence interval [CI], 0.45–0.78), but no significant difference in odds of HCV treatment uptake was observed during the post-DAA period (OR, 1.08; 95% CI, 0.87–1.33). From 2009–2016, average payers’ treatment costs (dual, $20,820; all-oral DAAs, $99,661; p