Cost-Effectiveness of Nadofaragene Firadenovec and Pembrolizumab in Bacillus Calmette-Guérin Immunotherapy Unresponsive Non-Muscle Invasive Bladder Cancer.

OBJECTIVES: Nadofaragene firadenovec is a gene therapy for bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) undergoing Food and Drug Administration review. Pembrolizumab is approved for treating patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS). We evaluated the cost-effectiveness of these treatments compared with a hypothetical therapeutic alternative, at a willingness-to-pay threshold of $150 000 per quality-adjusted life-year (QALY) gained, in CIS and non-CIS BCG-unresponsive NMIBC populations. METHODS: We developed a Markov cohort simulation model with a 3-month cycle length and lifetime horizon to estimate the total costs, QALYs, and cost per additional QALY from the health sector perspective. Clinical inputs were informed by results of single-arm clinical trials evaluating the treatments, and systematic literature reviews were conducted to obtain other model inputs. Sensitivity analyses were conducted to assess uncertainty in model results. RESULTS: Nadofaragene firadenovec, at a placeholder price 10% higher than the price of pembrolizumab, had an incremental cost-effectiveness ratio of $263 000 and $145 000 per QALY gained in CIS and non-CIS populations, respectively. Pembrolizumab had an incremental cost-effectiveness ratio of $168 000 per QALY gained for CIS. A 5.4% reduction in pembrolizumab's price would make it cost-effective. The model was sensitive to many inputs, especially to the probabilities of disease progression, initial treatment response and durability, and drug price. CONCLUSIONS: The cost-effectiveness of nadofaragene firadenovec will depend upon its price. Pembrolizumab, although not cost-effective in our base-case analysis, is an important alternative in this population with an unmet medical need. Comparative trials of these treatments are warranted to better estimate cost-effectiveness.

Cost-Effectiveness Analysis of a Pharmacist-Led Medication Therapy Management Program: Hypertension Management.

OBJECTIVES: Uncontrolled hypertension is a common cause of cardiovascular disease, which is the deadliest and costliest chronic disease in the United States. Pharmacists are an accessible community healthcare resource and are equipped with clinical skills to improve the management of hypertension through medication therapy management (MTM). Nevertheless, current reimbursement models do not incentivize pharmacists to provide clinical services. We aim to investigate the cost-effectiveness of a pharmacist-led comprehensive MTM clinic compared with no clinic for 10-year primary prevention of stroke and cardiovascular disease events in patients with hypertension. METHODS: We built a semi-Markov model to evaluate the clinical and economic consequences of an MTM clinic compared with no MTM clinic, from the payer perspective. The model was populated with data from a recently published controlled observational study investigating the effectiveness of an MTM clinic. Methodology was guided using recommendations from the Second Panel on Cost-Effectiveness in Health and Medicine, including appropriate sensitivity analyses. RESULTS: Compared with no MTM clinic, the MTM clinic was cost-effective with an incremental cost-effectiveness ratio of $38 798 per quality-adjusted life year (QALY) gained. The incremental net monetary benefit was $993 294 considering a willingness-to-pay threshold of $100 000 per QALY. Health-benefit benchmarks at $100 000 per QALY and $150 000 per QALY translate to a 95% and 170% increase from current reimbursement rates for MTM services. CONCLUSIONS: Our model shows current reimbursement rates for pharmacist-led MTM services may undervalue the benefit realized by US payers. New reimbursement models are needed to allow pharmacists to offer cost-effective clinical services.

Impact of a Medication Therapy Management Clinic on Glycosylated Hemoglobin, Blood Pressure, and Resource Utilization.

BACKGROUND: Medication therapy management is widely promoted to improve care. However, few well-controlled studies have evaluated its impact. OBJECTIVES: We evaluated whether enrollment in a comprehensive medication therapy management clinic (MTMC) was associated with improved 12-month outcomes. METHODS: This institutional review board approved study was a retrospective controlled cohort study in an academic health center serving low-income, African American and Latino populations. Between 2001 and 2011 MTMC patients were matched to control patients by age, gender, and comorbidities. Outcomes were mean change in glycosylated hemoglobin (A1C), diastolic (DBP) and systolic blood pressure (SBP), and emergency department (ED) and hospital admissions at 6 and 12 months. A difference-in-difference analysis was conducted for each outcome of interest, adjusting for observed, unmatched confounders. RESULTS: Patients with diabetes and receiving MTMC had greater A1C improvements, compared with controls, of 0.54% (P = 0.0067) at 6 months and 0.63% (P = 0.0160) at 12 months. At 6 months, SBP and DBP decreased in MTMC patients by 6.5 mm Hg (P = 0.0108) and 3.8 mm Hg (P = 0.0136) more than controls, respectively. At 12 months, those receiving MTMC services had SBP and DBP decreases, respectively, of 8.2 mm Hg (P = 0.0018) and 1.7 mm Hg (P = 0.2691) compared with controls. ED and hospital visits were not statistically significantly different between groups. Conclusion and Relevance: This MTMC potentially improved outcomes for referred patients in whom target goals were difficult to achieve and can serve as a model for other similar medication management programs.

Cost-Effectiveness of Strategies to Personalize the Selection of P2Y12 Inhibitors in Patients with Acute Coronary Syndrome.

PURPOSE: Perform a cost-effectiveness analysis comparing strategies for selecting P2Y12 inhibitors in acute coronary syndrome (ACS). METHODS: Six strategies for selection of P2Y12 inhibitors in ACS were compared from the US healthcare system perspective: (1) clopidogrel for all (universal clopidogrel); (2) ticagrelor guided by platelet reactivity assay (PRA; clopidogrel + phenotype); (3) ticagrelor use only in CYP2C19 poor metabolizers (genotype + conservative ticagrelor); (4) ticagrelor use in both CYP2C19 intermediate and poor metabolizers (genotype + liberal ticagrelor); (5) ticagrelor use only in patients with CYP2C19 polymorphisms and clopidogrel nonresponse by PRA (genotype + phenotype); and (6) ticagrelor for all (universal ticagrelor). A decision model was developed to model major adverse cardiovascular events and bleeding during 1 year of treatment with a P2Y12 inhibitor. Model inputs were identified from the literature. Lifetime costs were adjusted to 2017 US dollars; quality-adjusted life-years (QALYs) were projected using a Markov model. The primary endpoint was the incremental cost-effectiveness compared to the next best option along the cost-effectiveness continuum. Sensitivity analyses were performed on all model inputs to assess their influence on the incremental cost-effectiveness. RESULTS: In the base case analysis, incremental cost-effectiveness ratios (ICER) for the clopidogrel + phenotype, genotype + liberal ticagrelor, and universal ticagrelor strategies were $12,119/QALY, $29,412/QALY, and $142,456/QALY, respectively. Genotype + conservative ticagrelor and genotype + phenotype were not cost-effective due to second-order dominance. Genotype + liberal ticagrelor compared to clopidogrel + phenotype demonstrated the highest acceptance (97%) at a willingness to pay (WTP) threshold of $100,000/QALY. CONCLUSION: Cost-effective strategies to personalize P2Y12 inhibition in ACS include clopidogrel +phenotype and genotype + liberal ticagrelor. Universal ticagrelor may be considered cost-effective at a higher WTP threshold ($150,000/QALY). Genotype + liberal ticagrelor exhibited the highest acceptability compared to clopidogrel + phenotype over the widest range of WTP thresholds and may be preferred.

Cost evaluation of a nurse coordinated outpatient parenteral antimicrobial therapy (OPAT) program.

A structured, nurse-driven outpatient parenteral antimicrobial therapy (OPAT) program within an academic healthcare system was associated with reduced odds of 60-day unplanned OPAT readmissions and costs after hospital discharge. These findings may facilitate justifying additional resources for OPAT programs to improve care while decreasing costs.

Cost-effectiveness of eculizumab and efgartigimod for the treatment of anti-acetylcholine receptor antibody-positive generalized myasthenia gravis.

BACKGROUND: Eculizumab and efgartigimod were approved to treat anti-acetylcholine receptor antibody-positive generalized myasthenia gravis (anti-AChR Ab-positive gMG). These relatively new biological treatments provide a more rapid onset of action and improved efficacy compared with conventional immunosuppressive treatments, but at a higher cost. OBJECTIVE: To assess the cost-effectiveness of eculizumab and, separately, efgartigimod, each added to conventional therapy vs conventional therapy alone, among patients with refractory anti-AChR Ab-positive gMG and those with anti-AChR Ab-positive gMG, respectively. METHODS: A Markov model with 4 health states was developed, evaluating costs and utility with a 4-week cycle length and lifetime time horizon from a health care system perspective and a modified societal perspective including productivity losses from patients and caregiver burden. Model inputs were informed by key clinical trials and relevant publications identified from targeted literature reviews, and drug costs were identified from Micromedex Red Book. Costs and outcomes were discounted at 3% per year. Incremental cost-effectiveness ratios (ICERs; cost per quality-adjusted life-year [QALY] gained) were calculated for each comparison. RESULTS: Among the corresponding populations, lifetime costs and QALYs, respectively, for eculizumab were $5,515,000 and 11.85, and for conventional therapy, $308,000 and 10.29, resulting in an ICER of $3,338,000/QALY gained. For efgartigimod, lifetime costs and QALYs, respectively, were $6,773,000 and 13.22, and for conventional therapy, $322,000 and 9.98, yielding an ICER of $1,987,000/QALY gained. After applying indirect costs in a modified societal perspective, the ICERs were reduced to $3,310,000/QALY gained for eculizumab and $1,959,000/QALY gained for efgartigimod. CONCLUSIONS: Eculizumab and efgartigimod are rapidly acting and effective treatments for myasthenia gravis. However, at their current price, both therapies greatly exceeded common cost-effectiveness thresholds, likely limiting patient access to these therapies.

ACE inhibitor and ARB medication use among Medicaid enrollees with diabetes.

OBJECTIVE: To examine ace-inhibitor (ACEI) and angiotensin receptor blockers (ARB) prescription and adherence patterns by race in diabetic public aid recipients. DESIGN, PARTICIPANTS, AND MEASURES: We analyzed prescription records of 27,529 adults aged 18-64 with diabetes who had at least one clinical indication for receiving an ACEI/ ARB prescription and were enrolled in the State of Illinois public aid program during 2007. We calculated proportion of days covered (PDC) to assess adherence. Multivariate models adjusted for age, sex, ACEI/ARB indication, and any significant interaction terms. RESULTS: Only 47.4% of individuals with at least one indication for ACEI/ARB had filled an ACEI/ARB prescription. African American men were more likely than Caucasian men to ever fill an ACEI/ARB prescription (adjusted odds ratio, [AOR] [95% CI] 1.69 [1.55-1.83]). Hispanic English and Spanish speaking men were also more likely than Caucasian men to ever fill an ACEI/ARB prescription (AOR [95% CI] 1.37 [1.16-1.62] and 1.27 [1.05-1.53], respectively). Similarly, African American and Hispanic English and Spanish speaking women were more likely than Caucasian women to ever fill an ACEI/ARB prescription (AOR [95% CI] 1.70 [1.59-1.81], 1.55 (1.36-1.76), and 1.98 (1.73-2.28), respectively. However, African Americans and Hispanics were less likely than Caucasians to achieve a PDC> or =80%. Compared to Caucasians, Hispanic Spanish speakers were the least likely to be adherent (AOR [95% CI] .49 [.41-.58]). Furthermore, older individuals were more likely to achieve a PDC> or =80% than younger individuals. CONCLUSION: African Americans and Hispanics with diabetes receiving public aid in Illinois were more likely than Caucasians to have filled at least one ACEI/ARB prescription. However, they were less adherent with these medications. Future studies should assess barriers to medication adherence in this population.

Cost-effectiveness of full and partial opioid agonists for opioid use disorder in outpatient settings: United States healthcare sector perspective.

INTRODUCTION: Studies show that medications for opioid use disorder (MOUD) reduce illicit opioid use, emergency healthcare services, opioid-related overdose, and death. However, few studies have investigated the long-term cost-effectiveness of MOUD in office-based opioid treatment (OBOT) and opioid treatment program (OTP) settings. We aimed to estimate the cost, utility, quality-adjusted life years gained (QALYs), and incremental cost-effectiveness ratios (ICERs) of three MOUD compared to each other and counseling without medication from a US healthcare sector perspective. METHODS: Our study developed a Markov model to conduct a cost-effectiveness analysis of counseling and three MOUD in the OBOT and OTP settings: sublingual buprenorphine/naloxone (BUPNX), buprenorphine extended-release (XR-BUP) injection, and oral methadone. The model included five health states representing combinations of receiving or off treatment while either using or not actively using illicit opioids, and death. The cycle length was one month; the time-horizon was ten years. The study obtained model inputs from systematic reviews of published literature and public data. A 3 % annual discount rate was applied to cost and utility calculation. The primary outcomes included total costs, life-years (LYs), QALYs, and ICERs. We also conducted a scenario analysis using a hypothetical OBOT outpatient setting with methadone. RESULTS: In the base-case OBOT setting, the total costs and QALYs, respectively, were counseling $22,848, 5.60; BUPNX $29,875, 5.82; and XR-BUP $63,936, 5.87. ICERs were $32,345/QALY (BUPNX vs. counseling) and $625,858/QALY (XR-BUP vs BUPNX). In the OTP setting, the total costs of counseling, methadone, BUPNX, and XR-BUP were $20,124, $27,000, $33,500, and $75,272, respectively. QALYs of methadone were 5.86. QALYs of counseling, BUPNX, and XR-BUP remained the same as in the OBOT setting. Incremental ICERs were $26,714/QALY (methadone vs counseling) and $3,337,623/QALY (XR-BUP vs methadone). BUPNX was dominated by methadone. In the scenario analysis, BUPNX was also dominated by methadone. CONCLUSIONS: Outpatient MOUD resulted in important gains in quality of life and life expectancy. In both OBOT and OTP settings, XR-BUP was not cost-effective. BUPNX was cost-effective in the OBOT setting, while it was dominated by methadone in the OTP setting. The cost-effectiveness of BUPNX and XR-BUP could be enhanced if the costs of these medications were reduced.

Exacerbations and Real-World Outcomes After Single-Inhaler Triple Therapy of Budesonide/Glycopyrrolate/Formoterol Fumarate, Among Patients with COPD: Results from the EROS (US) Study.

Purpose: Triple therapy to prevent exacerbations from chronic obstructive pulmonary disease (COPD) is associated with improved health compared to single and dual-agent therapy in some populations. This study assessed the benefits of prompt administration of budesonide/glycopyrrolate/formoterol fumarate (BGF) following a COPD exacerbation. Patients and methods: EROS was a retrospective analysis of people with COPD using the MORE2 Registry®. Inclusion required ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment. Within 12 months following the index exacerbation, ≥1 pharmacy claim for BGF was required. Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly (within 30 days of index exacerbation) versus delayed (31-180 days) and very delayed (181-365 days). The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model. Results: 2409 patients were identified: 434 prompt, 1187 delayed, and 788 very delayed. The rate (95% CI) of total exacerbations post-index increased as time to BGF initiation increased: prompt 1.52 (1.39-1.66); delayed 2.00 (1.92-2.09); and very delayed 2.30 (2.20-2.40). Adjusting for patient characteristics, each 30-day delay in receiving BGF was associated with a 5% increase in the average number of subsequent exacerbations (rate ratio, 95% CI: 1.05, 1.01-1.08; p<0.05). Prompt initiation of BGF was also associated with lower post-index annualized COPD-related costs ($5002 for prompt vs $7639 and $8724 for the delayed and very delayed groups, respectively). Conclusion: Following a COPD exacerbation, promptly initiating BGF was associated with a reduction in subsequent exacerbations and reduced healthcare utilization and costs.

Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with diabetes.

BACKGROUND: Given the increasing prevalence of diabetes and the lack of patients reaching recommended therapeutic goals, novel models of team-based care are emerging. These teams typically include a combination of physicians, nurses, case managers, pharmacists, and community-based peer health promoters (HPs). Recent evidence supports the role of pharmacists in diabetes management to improve glycemic control, as they offer expertise in medication management with the ability to collaboratively intensify therapy. However, few studies of pharmacy-based models of care have focused on low income, minority populations that are most in need of intervention. Alternatively, HP interventions have focused largely upon low income minority groups, addressing their unique psychosocial and environmental challenges in diabetes self-care. This study will evaluate the impact of HPs as a complement to pharmacist management in a randomized controlled trial. METHODS/DESIGN: The primary aim of this randomized trial is to evaluate the effectiveness of clinical pharmacists and HPs on diabetes behaviors (including healthy eating, physical activity, and medication adherence), hemoglobin A1c, blood pressure, and LDL-cholesterol levels. A total of 300 minority patients with uncontrolled diabetes from the University of Illinois Medical Center ambulatory network in Chicago will be randomized to either pharmacist management alone, or pharmacist management plus HP support. After one year, the pharmacist-only group will be intensified by the addition of HP support and maintenance will be assessed by phasing out HP support from the pharmacist plus HP group (crossover design). Outcomes will be evaluated at baseline, 6, 12, and 24 months. In addition, program and healthcare utilization data will be incorporated into cost and cost-effectiveness evaluations of pharmacist management with and without HP support. DISCUSSION: The study will evaluate an innovative, integrated approach to chronic disease management in minorities with poorly controlled diabetes. The approach is comprised of clinic-based pharmacists and community-based health promoters collaborating together. They will target patient-level factors (e.g., lack of adherence to lifestyle modification and medications) and provider-level factors (e.g., clinical inertia) that contribute to poor clinical outcomes in diabetes. Importantly, the study design and analytic approach will help determine the differential and combined impact of adherence to lifestyle changes, medication, and intensification on clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01498159.

Safety-focused medication therapy management: a randomized controlled trial.

OBJECTIVE: To evaluate the effect of a medication therapy management (MTM) intervention on adverse drug events (ADEs), health care visits, and drug-related problems (DRPs). DESIGN: Randomized, controlled, clinical trial. SETTING: Academic medical center community pharmacies and family medicine clinics at three U.S. sites between December 2007 and January 2010 PATIENTS: Individuals aged 65 years or older with three or more chronic illnesses, six or more prescription medications, and at risk for a DRP. INTERVENTION: At 0 and 3 months, pharmacists conducted comprehensive medication reviews and screened for and resolved DRPs through patient education and recommendations to physicians. MAIN OUTCOME MEASURES: Frequency of ADEs reported by patients and confirmed by clinical algorithm, health care visits at 3 and 6 months, and number of DRPs, pharmacist recommendations, and medication discrepancies. RESULTS: 637 participants enrolled. No differences were observed in potential ADEs or health care visits among the usual care and MTM groups. DRPs declined in both MTM intervention groups over time. Physicians responded to 54.6% of pharmacist recommendations. Enhanced MTM patients had fewer medication list discrepancies than basic MTM patients (33.8% vs. 47.1%, P < 0.001). CONCLUSION: This specific design of MTM was associated with reduced DRPs but did not reduce potential ADEs or health care visits.

The effectiveness and value of eculizumab and efgartigimod for generalized myasthenia gravis.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Sun Life Financial, uniQure, and United Healthcare. Agboola, Nikitin, and Pearson are employed by ICER. Through their affiliated institutions, Tice, Touchette, and Lien received funding from ICER for the work described in this summary.

PRIMUS - Prompt Initiation of Maintenance Therapy in the US: A Real-World Analysis of Clinical and Economic Outcomes Among Patients Initiating Triple Therapy Following a COPD Exacerbation.

PURPOSE: Patients with chronic obstructive pulmonary disease (COPD) may experience moderate (requiring outpatient care) or severe (requiring hospitalization) disease exacerbations. Guidelines recommend escalation from dual to triple therapy (inhaled corticosteroid + long-acting beta agonist + long-acting muscarinic antagonist) after two moderate or one severe exacerbation in a year. This study examined whether prompt initiation of triple therapy lowers risk of future exacerbations and reduces healthcare costs, compared to delayed/very delayed triple therapy after an exacerbation. PATIENTS AND METHODS: This retrospective observational study of US healthcare claims included patients ≥40 years old with COPD who initiated triple therapy (1/1/2011-3/31/2020) after ≥2 moderate or ≥1 severe exacerbation in the prior year. The earliest of the second moderate or first severe exacerbation was the index date. Patients were stratified by triple therapy timing: prompt (≤30 days post-index), delayed (31-180 days), very delayed (181-365 days). COPD exacerbations, all-cause and COPD-related healthcare utilization and costs were assessed during 12 months post-index (follow-up). Multivariable regression estimated the effect of each 30-day delay in triple therapy on the odds of exacerbations, number of exacerbations, and costs during follow-up, controlling for patient characteristics. RESULTS: A total of 24,770 patients were included: 7577 prompt, 9676 delayed, 7517 very delayed. Each 30-day delay of triple therapy was associated with 11% and 7% increases in the odds of any exacerbation and a severe exacerbation, respectively (odds ratio [95% CI]: 1.11 [1.10-1.13] and 1.07 [1.05-1.08]), a 4.3% (95% CI: 3.9-4.6%) increase in the number of exacerbations, a 1.8% (95% CI: 1.3-2.3%) increase in all-cause costs, and a 2.1% (95% CI: 1.6-2.6%) increase in COPD-related costs during follow-up. CONCLUSION: Promptly initiating triple therapy after two moderate or one severe exacerbation is associated with decreased morbidity and economic burden in COPD. Proactive disease management may be warranted to prevent future exacerbations and lower costs among patients with COPD.

Prompt initiation of triple therapy following hospitalization for a chronic obstructive pulmonary disease exacerbation in the United States: An analysis of the PRIMUS study.

BACKGROUND: Severe exacerbations requiring hospitalization contribute a substantial portion of the morbidity and costs of chronic obstructive pulmonary disease (COPD). Triple therapy (inhaled corticosteroid + long-acting ß-agonist + long-acting muscarinic antagonist) is a recommended option for patients who experience recurrent COPD exacerbations or persistent symptoms. Few real-world studies have specifically examined the effect of prompt initiation of triple therapy, specifically among patients hospitalized for a COPD exacerbation. OBJECTIVE: To assess whether prompt initiation of triple therapy following a severe COPD exacerbation was associated with lower risk of subsequent exacerbations and lower health care use and costs and the effects of each 30-day delay of initiation. METHODS: Adults aged 40 years or older with COPD were identified in the Merative MarketScan Databases between January 1, 2010, and December 31, 2019, and were required to meet the following criteria: open or closed triple therapy (date of first closed prescription or last component of open=index treatment date), more than 1 inpatient admission with a primary COPD diagnosis (ie, severe exacerbation) in the prior 12 months (index exacerbation), 12 months of continuous enrollment before (baseline) and after (follow-up) index exacerbation, and absence of select respiratory diseases and cancer. Patients were stratified based on timing of open or closed triple therapy after the index exacerbation: prompt (≤30 days), delayed (31-180 days), or very delayed (181-365 days). Multivariable regression controlled for baseline characteristics (age, sex, insurance type, index year, comorbidities, prior treatment, and prior exacerbations) and estimated the odds of subsequent exacerbations, change in the number of exacerbations, and change in health care costs during 12-month follow-up associated with each 30-day delay of triple therapy initiation. RESULTS: A total of 6,772 patients met inclusion criteria (2,968 [43.8%] prompt, 1,998 [29.5%] delayed, and 1,806 [26.7%] very delayed). The adjusted odds of any exacerbation and a severe exacerbation during 12-month follow-up increased by 13% (odds ratio [95% CI]: 1.13 [1.11-1.15]) and 10% (1.10 [1.08-1.12]), respectively, for each 30-day delay in triple therapy initiation, and the mean number of exacerbations increased by 5.4% (95% CI = 4.7%-6.1%). There was a 3.0% increase (95% CI = 2.2%-3.8%) in mean all-cause costs and a 3.7% increase (95% CI = 2.9%-4.6%) in total COPD-related costs for each 30-day delay of triple therapy initiation. CONCLUSIONS: Longer delays in triple therapy initiation after a COPD hospitalization result in greater risk of subsequent exacerbations and higher health care resource use and costs. Adequate post-discharge follow-up care and earlier consideration of triple therapy may improve clinical and economic outcomes among patients with COPD. DISCLOSURES: This study was funded by AstraZeneca. Dr Evans is employed by Merative, formerly IBM Watson Health, and Mr Tkacz was employed by IBM Watson Health at the time of this study; Merative/IBM Watson Health received funding from AstraZeneca to conduct this study. Mr Pollack, Dr Staresinic, Dr Feigler, and Dr Patel are employed by AstraZeneca. Dr Touchette, Dr Portillo, and Dr Strange are paid consultants to AstraZeneca. Dr Strange also participates in research grants paid to the Medical University of South Carolina by AstraZeneca, CSA Medical, and Nuvaira, and is a consultant to GlaxoSmithKline, Morair, and PulManage regarding COPD.

Psychiatrist and Psychiatric Pharmacists Beliefs and Preferences for Atypical Antipsychotic Treatments in Patients With Schizophrenia and Bipolar Disorders.

BACKGROUND: Selection of schizophrenia or bipolar disorder treatments is complicated by treatment-effect heterogeneity. OBJECTIVES: This study assessed how clinicians' beliefs and health system/ insurace policies impact choice of atypical antipsychotic agent in schizophrenia and bipolar disorder. METHODS: A cross-sectional survey was conducted of members of the American College of Clinical Pharmacy and College of Psychiatric & Neurologic Pharmacists. Beliefs regarding atypical antipsychotic effectiveness and safety, impact of comorbidity on drug selection, and factors influencing atypical antipsychotic therapy selection were assessed. RESULTS: Twenty-four psychiatric pharmacists and 18 psychiatrists participated. Mean age was 39.6 years, 57.1% were female. Most clinicians (64.3%) believed medication effectiveness and safety equally important, while 26.2% believed safety and 9.4% believed effectiveness more important. The most important medication properties for schizophrenia were reducing positive symptoms (92.7%) and hospitalizations (87.8%) and for bipolar disorder were reducing manic episodes (87.8%), episode relapse (53.7%), and hospitalizations (53.7%). Agranulocytosis (78.1%), arrhythmias (70.7%), and extrapyramidal side effects (68.3%) were most concerning. Restrictions affected antipsychotic choice at 80.5% of sites and were believed to affect medication adherence (55.0%) and outcomes (53.4%). CONCLUSION: Efficacy and safety were considered equally important when choosing atypical antipsychotics. Formulary restrictions were perceived as impacting treatment choice and outcomes.

Trend in Tyrosine Kinase Inhibitor Utilization, Price, and Out-of-Pocket Costs in Patients With Chronic Myelogenous Leukemia.

PURPOSE: Treatment of chronic myelogenous leukemia (CML) with tyrosine kinase inhibitors (TKIs) has improved survival but is associated with significant financial burden. We measured the annual trend in TKI utilization, Medicare gross payment, and patient out-of-pocket (OOP) expenditure from 2007 to 2016. METHODS: We used SEER linked to Medicare part-D claims data to identify prevalent CML cases from 2007 to 2016. TKI utilization was measured as the proportion of cases with at least one TKI fill in each year. Average TKI gross payment and median per-member per-month OOP expenditure were calculated from claims data and plotted annually from 2007 to 2016. Year-to-year percent change in gross payment and OOP expenditure was compared with inflation indices. RESULTS: The cohort included 3,189 CML cases with at least one TKI claim. The proportion of prevalent patients with a TKI fill in a year increased from 17.9% in 2007 to 52.8% in 2015. The average annual gross payment per 30-day supply of a TKI increased by an average of 12.8% throughout the period from $9,000 to $10,000 US dollars in 2016. There was no increasing trend in median OOP expenditure per 30-day supply, which varied between $450 and $600 US dollars. CONCLUSION: Rising TKI use and TKI drug prices place considerable financial pressure on Medicare part-D insurers. Although there was no increasing trend in OOP expenditure, it may be burdensome for Medicare patients who are likely retired on a fixed income. Our findings support legislation that mitigates increasing drug prices to protect the Medicare system and its beneficiaries.

The Authors Respond.

DISCLOSURES: The writing of the original report referred to in this letter was sponsored by the Institute for Clinical and Economic Review (ICER). Agboola, Fazioli, and Pearson are employed by ICER. Touchette reports grants from ICER during the course of the original work and personal fees from Monument Analytics, unrelated to this work. Atlas has nothing to disclose.

The Effectiveness and Value of Esketamine for the Management of Treatment-Resistant Depression.

DISCLOSURES: Funding for this summary was contributed by the Laura and John Arnold Foundation, National Institute for Health Care Management, California Health Care Foundation, Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Healthcare, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, America's Health Insurance Plans, Anthem, AstraZeneca, Allergan, Alnylam, Biogen, Blue Shield of California, Cambia Health Services, CVS Caremark, Editas, Express Scripts, Genentech, GlaxoSmithKline, Harvard Pilgrim Health Care, Health Care Service Corporation, HealthPartners, HealthFirst, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinkrodt Pharmaceuticals, Merck, Novartis, National Pharmaceutical Council, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, and United Healthcare. Agboola, Fazioli, and Pearson are employed by ICER. Touchette reports grants from ICER during the course of this work and personal fees from Monument Analytics, unrelated to this work. Atlas has nothing to disclose.

Work-Sampling Study of an Innovative Care Coordination Program Aimed at Children With Chronic Health Conditions.

PURPOSE OF STUDY: To estimate time allocation and labor cost for care coordinators (CCs), community health workers (CHWs), and mental health workers (MHWs) to conduct care coordination tasks in a pediatric care coordination program. PRIMARY PRACTICE SETTING: A public tertiary academic medical center in Chicago, IL. METHODOLOGY AND SAMPLE: A work-sampling study was conducted using a text message-based survey on 5 CCs, 20 CHWs, and 4 MHWs who volunteered to participate. Workers were randomly sampled within working hours to collect information on who was the subject of interaction and what service was being delivered over a 6-month period. Time allocation of workers to different subjects and services was summarized using descriptive statistics. RESULTS: Care coordinators allocated 41% of their time to managing CHW teams. Community health workers allocated 37% of time providing services directly to children and 26% to the parent/caregiver. Mental health workers allocated 16% of time providing services to children and 29% to the parent/caregiver. The care coordination program serviced 5,965 patients, with a total annual labor cost of $1,455,353. IMPLICATIONS FOR CASE MANAGEMENT PRACTICE: Community health workers spent the majority of time working with patients and their families to conduct assessments. Mental health workers primarily addressed children's needs through their caregivers. Care coordinators primarily supported CHWs in coordinating care. Results may be used to inform development of such programs by determining services most often utilized, and labor cost may be used to inform program implementation and reimbursement.

The effectiveness and value of novel acute treatments for migraine.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, California Health Care Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, America's Health Insurance Plans, Anthem, Allergan, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, and United Healthcare. Agboola, Borrelli, Rind, and Pearson are employed by ICER. Touchette, through the University of Illinois at Chicago, received funding from ICER for development of the economic model described in this publication. Atlas has nothing to disclose.