Are beta-blockers safe and effective after myocardial infarction in patients with COPD?

ABSTRACT: Clinicians may be hesitant to prescribe beta-blockers in patients with chronic obstructive pulmonary disease (COPD) who have a comorbid compelling cardiovascular indication for beta-blocker therapy. This article summarizes the available data on the safety and efficacy of beta-blockers in patients with COPD and recent myocardial infarction.

Outcome Benefits Seen With 1 Year of Optimized Sacubitril/Valsartan for the Treatment of Systolic Heart Failure Managed by Pharmacists in a Cardiology Practice.

BACKGROUND: Pharmacists' care in heart failure (HF) management has been shown to better clinical outcomes, including use of guideline-directed medical therapy and hospital readmission, although the impact observed has varied among studies. OBJECTIVE: To investigate the rates of all-cause hospitalization and hospitalization from HF (hHF) and changes in surrogate markers (left-ventricular ejection fraction, New York Heart Association Functional Classification [NYHA FC], diuretic requirements) for patients with HF with reduced ejection fraction (HFrEF) on angiotensin receptor-neprilysin inhibitor (ARNi) therapy optimized within a pharmacist clinic. METHODS: Retrospective chart review of patients with HFrEF on sacubitril/valsartan from July 7, 2015, through January 1, 2018. RESULTS: For the primary outcome analysis, 70 patients with pre/post hospitalization data had a reduction in the rate of all-cause hospitalization from 45.7% in the 12 months prior to ARNi therapy initiation to 24.3% during the first year on optimized ARNi therapy (P = 0.004). The rate of hHF reduced from 24.3% to 8.6% (P = 0.003). For the secondary outcome analyses at the 6-month assessment point, which included 104 patients, ejection fraction improved from 26% to 34% (P < 0.001), NYHA FC improved or remained unchanged in 86.6% of patients, and weekly loop diuretic dosing requirements were significantly reduced. CONCLUSION AND RELEVANCE: Real-world use of sacubitril/valsartan optimized within a pharmacist clinic was associated with reduced prevalence of all-cause and hHF during the first year of ARNi therapy. This study corroborates pharmacist involvement in HF management, which could be used to support further research and expanded pharmacist services.

The Diuretic Potential of Sacubitril/Valsartan: A Tale of 2 Patients.

BACKGROUND: Heart failure prevalence continues to rise in the United States causing significant morbidity and mortality and costing billions in healthcare expenditures. Consensus guidelines updated in 2016 recommend an angiotensin receptor-neprilysin inhibitor (ARNi) as a therapeutic option in lieu of an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker for the management of stage C heart failure with reduced ejection fraction (HFrEF). For chronic HFrEF patients with New York Heart Association class II or III symptoms tolerating an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, a change in therapy to an ARNi is recommended to further reduce morbidity and mortality. PURPOSE: We present a brief case series of 2 patients initiated on ARNi therapy for treatment of HFrEF and evaluate their fluid status and diuretic needs before and after ARNi dose optimization. CONCLUSIONS: After titration to target-dose ARNi therapy, both patients demonstrated improved fluid and electrolyte balance, as well as a reduction in diuretic therapy requirements, suggesting a mechanism of diuresis attributable to ARNi therapy. CLINICAL IMPLICATIONS: Angiotensin receptor-neprilysin inhibitor therapy seems to promote a clinically relevant diuresis in heart failure patients because of increased levels of functioning natriuretic peptides. Awareness of this diuretic potential may allow for optimization of heart failure regimens with pharmacologic agents demonstrated to improve morbidity and mortality, while preventing adverse effects that may occur with overdiuresis.

Combined angiotensin receptor and neprilysin inhibition therapy for heart failure.

The FDA has approved sacubitril/valsartan, an angiotensin-receptor-neprilysin inhibitor, for the treatment of chronic symptomatic heart failure (stage C) in patients with a left ventricular ejection fraction of 35% or less. This article discusses results from a major clinical trial, PARADIGM-HF, and the role of this new drug in heart failure treatment.

Should patients with chronic liver disease receive venous thromboembolism prophylaxis?

Chronic liver disease has long been considered the prime example of acquired bleeding disorders due to its associated coagulopathies, namely elevated international normalized ratio (INR) and thrombocytopenia. Recent evidence has shown that patients with chronic liver disease also are at risk for hospital-acquired venous thromboembolism (VTE). The safety and efficacy of low-dose anticoagulants for VTE prophylaxis have not been firmly established in this patient population. However, recent studies also indicate pharmacologic VTE prophylaxis can be used with caution in hospitalized patients with chronic liver disease.

Finding our Voice: Evaluation of Goal Setting Using the Habits of Preceptors Rubric in Terms of Focus, "SMARTness," and Impact.

INTRODUCTION: Effective leadership propels teams from effectiveness to greatness and is accomplished when everyone achieves and contributes their full potential, or "voice." The Clinician Educators Program Teaching and Learning Curriculum fosters preceptor development using the Habits of Preceptors Rubric (HOP-R) to guide participants in finding their precepting "voice." After the HOP-R self-assessment, participants select a habit of focus (HOF) and craft a SMART (specific/measurable/achievable/relevant/time-bound) goal. This report describes a pilot rubric, SMART-EP (emotional intelligence(EI)/professionalism), exploring goal "SMARTness" alongside change (impact) in participants' perceived precepting capabilities. METHODS: HOP-R self-ratings (2018-2020) and HOF/SMART goals (2019-2020) were retrospectively reviewed by two raters. Perceived preceptor capabilities were measured by analyzing the change in self-assessed habit level ratings between the first/fourth-quarter surveys. SMART goals were categorized by HOF and inclusion of SMART-EP components. Participants were guided in the inclusion of SMART, but not -EP, components. RESULTS: In aggregate, 120 participants completed HOP-R surveys (2018-2020). Within-subject changes across all 11 habits were significant (P < .001). For the SMART-EP rubric analysis (2019-2020), 71 participants had an average "SMARTness" score of 3.92 (of 5) with corresponding interrater reliability of 0.91. Goals included 2.77 (of 4) EI traits and 1.72 (of 3) professionalism components. DISCUSSION: The SMART-EP rubric provided insights into preceptor development opportunities among participants. Beyond SMART components, participants often included elements of EI and professionalism. Ratings confirm and support the consistency of the HOP-R as a tool to assess precepting habits.

Geriatric Pharmacotherapy Case Series: Neurogenic Orthostatic Hypotension.

This case illustrates the pharmacist's role in the outpatient management of neurogenic orthostatic hypotension (nOH) in a community-dwelling older person. In this case, the patient has a long-standing history of asymptomatic hypotension with recent onset of falls with temporary loss of consciousness prompting initiation of pharmacologic therapy. This case reviews nonpharmacological and pharmacological treatment options for older people with symptomatic nOH.

Understanding medication use behaviors and perspectives in an older cardiovascular patient population: Opportunities for patient-centered deprescribing.

Study objective: Describe self-reported medication use behaviors and perspectives to identify opportunities for collaborative deprescribing among older cardiovascular patients. Design: Patient survey using convenience sampling. Setting: Private cardiology practice in Maricopa County, Arizona, USA. Participants: Established patients aged ≥65 years with an active medication list indicating prescription polypharmacy (≥5 medications) and/or use of ≥1 high risk medication (anticoagulant, antiarrhythmic, anti-hypotensive, insulin). Intervention: Anonymous online survey. Main outcome measures: Current medication use (prescription and over-the-counter), self-reported medication use behaviors measured by the Adherence to Refills and Medications Scale (ARMS-12), and perspectives on deprescribing. Results: Overall, 138 participants were recruited, with a mean age of 76.7 years. All but two self-identified as Caucasian. Prescription polypharmacy was reported by 80 (58.0 %), with use of 5-9 medications by 66 (47.8 %) and use of ≥10 medications (excessive polypharmacy) by 14 (10.1 %). Approximately one-third (n = 45, 32.6 %) had ARMS = 12, indicating adherence to taking and refilling medications. More than 1 in 10 patients (11.6 %) used >1 high-risk medication. About 4 in 10 (40.6 %) used ≥5 OTC medications. Most highly prioritized reasons for continuing medications were to prolong life (40 %), feel better (17 %), and reduce stroke risk (15 %). Despite 66.7 % of patients indicating taking "just the right amount of medications," willingness to stop ≥1 medication was very high at 80.4 %. Conclusion: Among older cardiovascular patients, prescription polypharmacy is prevalent as are medication use behaviors associated with some degree of nonadherence. Patients are supportive of deprescribing. Prioritizing what matters most to patients and focusing efforts to deprescribe potentially inappropriate medications is recommended.

Evaluating the impact of integrating SMART goal setting in preceptor development using the Habits of Preceptors Rubric.

PURPOSE: The impact of goal setting in pharmacy preceptor development was evaluated using the Habits of Preceptors Rubric (HOP-R), a criterion-referenced assessment developed to assess, quantify, and demonstrate growth across 11 preceptor habits. METHODS: This study retrospectively evaluated initial and follow-up survey responses from the 2019-2020 Clinician Educators Program cohort at Midwestern University College of Pharmacy, Glendale Campus. Enrollees in this teaching and learning curriculum (TLC) were invited to assess their precepting habits using the HOP-R after attending the first seminar and again toward the end of the longitudinal program. Using online surveys, participants rated their precepting capabilities as developing, proficient, accomplished, or master level for each habit. In the initial survey, each participant selected a habit of focus for deliberate development and established an individualized goal using the specific, measurable, achievable, relevant, and time-bound (SMART) framework. In the follow-up survey, participants indicated their satisfaction with and progress toward accomplishing their precepting goal. RESULTS: Initial survey results from 55 study participants identified developing as the most frequently self-reported habit level (53%; n = 605 ratings), while master was the least frequently reported (1%). In the follow-up assessment, accomplished (45%) was the most frequently self-reported habit level, while master (5%) remained the least reported. The cohort reported a median progress in SMART goal accomplishment of 69% (range, 12% to 100%; n = 54). CONCLUSION: Preceptor and resident pharmacists reported perceived advancement in precepting capabilities within the conceptual framework of the HOP-R encompassing both their self-selected habit of focus and adjacent habits while enrolled in a TLC. SMART goals facilitated qualitative and quantitative assessment of development.

Fostering Mindfulness in Continuing Pharmacy Education Using a Board Game: Initial Experiences and Perceptions.

INTRODUCTION: Expansion of pharmacists' scope of practice creates a need to optimize learning within continuing professional development (CPD) that can simultaneously promote mindfulness and enhance clinical decision-making. An educational board game embracing the principles of situated learning was developed with the purpose of promoting clinical reasoning skills and mindfulness. METHODS: Iter Vitae was used in a national pharmacy meeting CPD session. An evaluation was conducted by a voluntary survey to gather perceptions of game-based instruction. RESULTS: Ninety of 115 session-attendees completed the anonymous survey. Participants strongly agreed that Iter Vitae is an effective learning tool of appropriate complexity for CPD sessions. Participant perceptions suggest that playing Iter Vitae may enhance clinical knowledge, foster critical thinking, and influence provider empathy. Open-ended responses revealed appreciation of collaborative learning within authentic case scenarios. DISCUSSION: This game-based CPD session gave participants an opportunity to develop elements of mindful practice embedded within authentic case scenarios. Further research on game-based instruction is needed to determine its effects on knowledge and skill acquisition, retention, and impact on clinical practice.

Evaluating the impact of a "grand rounds" elective course on students' perceived motivations, comfort, and confidence in providing constructive and reinforcing feedback to guest lecturers.

BACKGROUND AND PURPOSE: Providing feedback is an important skill for all healthcare professionals both within and outside of their discipline. Although student pharmacists frequently receive feedback during both didactic and experiential education, training on how to provide feedback to others is less common. EDUCATIONAL ACTIVITY AND SETTING: An elective was designed to expose second-year pharmacy students to "grand rounds" with practicing pharmacists as the presenters. Students provided feedback to presenters on presentation style and assessment questions. The primary objective of this research project was to determine if the elective improved students' motivations, comfort, and confidence in providing constructive written feedback. FINDINGS: Over two course offerings, 54% (19 of 35) of enrolled students completed both the pre- and post-surveys. At baseline, the majority of students self-identified as being motivated, comfortable, and confident with providing quality written feedback with the exception of two specific areas: motivation to provide quality written feedback and comfort with providing difficult or sensitive written feedback. At the end of the course, the majority of students self-identified as being motivated, comfortable, and confident across all areas queried. All students agreed or strongly agreed that the efficiency and quality of their written feedback improved during the course. SUMMARY: The course offered several benefits to students, including learning clinical topics from a variety of presenters and developing feedback skills. The implementation of the grand rounds elective provided students an opportunity to develop their motivation, comfort, and confidence with providing quality constructive written feedback.

Estimating the Lactate Threshold Using Wireless Near-Infrared Spectroscopy and Threshold Detection Analyses.

The present investigation examined the ability of two threshold detection analyses (maximum distance, Dmax; modified maximum distance, mDmax) in identifying the near-infrared spectroscopy (NIRS) threshold, a lactate threshold (LT) estimate, from exercising tissue oxygen saturation (StO2) responses. Additionally, the test-retest reliability of exercising StO2 and total hemoglobin concentration (THC) responses were examined at moderate and peak cycling intensities. Fourteen healthy, recreationally active participants performed maximal incremental step cycling tests (+25 W / 3 minutes) to volitional fatigue on two separate occasions while StO2 and THC of the vastus lateralis were monitored. Exercising blood [lactate] was collected during Session One. LT and NIRS thresholds (NIRS1, NIRS2) were then determined using Dmax and mDmax threshold analyses. Significant (p < 0.05), moderate correlations were detected between LT and NIRS1 when using Dmax (LT = 130 ± 49 W, NIRS1 = 136 ± 34 W, r = 0.690), but not for mDmax (r = 0.487). No significant test-retest reliability for the NIRS thresholds were observed for Dmax (ICC = 0.351) or mDmax (ICC = 0.385). Exercising StO2 responses demonstrated good reliability (ICC = 0.841-0.873) while exercising THC responses demonstrated moderate-good reliability (ICC = 0.720-0.873) at moderate and peak exercise intensities. The results of this study suggest that neither the Dmax nor mDmax threshold analyses should be used to estimate the LT due to the unreliable detection of the NIRS threshold from session to session.

A Retrospective Chart Review Evaluating Efficacy, Tolerability, and Cost of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors (PCSK9i) in Older Adults.

INTRODUCTION: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are proven to have profound lowering of low-density lipoprotein cholesterol (LDL-C) in patients with clinical atherosclerotic cardiovascular disease or familial hypercholesterolemia. AIM: The primary purpose of this study was to evaluate PCSK9i utilization in older adults, with a focus on efficacy outcomes within 6 months of initiation. Secondary outcomes included tolerability, out-of-pocket expenses (OPE), and barriers to initiation of therapy. METHODS: We conducted a retrospective chart review of patients ≥ 65 years prescribed PCSK9i therapy by a pharmacist-run lipid clinic within a cardiology practice. RESULTS: A total of 136 older adults were prescribed PCSK9i therapy for a Food and Drug Administration-approved indication between September 2015 and March 2019 with 98 patients included in the analyses. In terms of efficacy, 51 patients who took ≥ 3 doses of PCSK9i with baseline and follow-up lipid panels were assessed. On average, LDL-C reduced by 60% (169-67 mg/dL, p < 0.001). For tolerability, 15 patients reported treatment-emergent side effects, resulting in 10 therapy discontinuations. For the cost analysis, 72 patients reported anticipated OPE for 1 month of therapy. Ultimately 17 patients were approved for manufacturer patient assistance with $0 OPE and 31 patients utilized insurance coverage to obtain therapy reporting a median OPE of $9 United States Dollars ($0-$450). The main barrier to initiation was high OPE. CONCLUSIONS: PCSK9i are effective at lowering LDL-C in older adults. Tolerability was high among patients without a history of statin intolerance. PCSK9i remain high-cost medications to both insurance companies and patients in terms of cost-sharing responsibilities.

Development of a tool to assess and advance the effectiveness of preceptors: The Habits of Preceptors Rubric.

PURPOSE: Present the research performed to identify and describe habits of effective pharmacy preceptors and provide a framework for targeted preceptor assessment and development. METHODS: A 5-round Delphi consensus-building process was used to refine the initial Habits of Preceptors Rubric (HOP-R) developed by the research team. Twenty experts in pharmacy experiential education participated. During the Delphi process, feedback and agreement on all parts of the HOP-R were sought, including the premise, introductory content, framework, preceptor domains, habits, habit level descriptions, and continuous professional development (CPD) plan. After each Delphi round, the research team grouped responses into themes and modified the draft rubric accordingly. These themes were used to frame the response document sent to the expert panel for the following Delphi round; this document explained modifications made to the HOP-R. Consensus was defined as a mean score of ≥3.25 on a 4-point scale (4 = strongly agree, 1 = strongly disagree) for posed statements or ≥70% agreement for ranked items. RESULTS: In the final Delphi round (response rate, 95%), consensus was achieved for all HOP-R individual structural and content elements except the habit level descriptors, for which a secondary rank order analysis was performed. The final HOP-R has 3 domains encompassing 11 preceptor habits that can be displayed across 4 habit levels progressing from developing to master. CONCLUSION: The HOP-R was developed to assess, quantify, and demonstrate growth across a wide variety of pharmacy preceptor habits. Potential utility includes use as a framework to articulate the knowledge, skills, and behaviors of effective preceptors, facilitate the creation of individualized CPD plans, and assess the impact of participation in teaching and learning curricula.

Evaluating the Safety and Tolerability of Sacubitril/Valsartan for HFrEF Managed Within a Pharmacist Clinic.

OBJECTIVE: The objective of this research was to describe the use of pharmacist-managed sacubitril/valsartan therapy in a multi-center, outpatient cardiac group. BACKGROUND: Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNi), is a novel agent for the treatment of heart failure. An ARNi is recommended by national guidelines to be used in place of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) therapy for patients who remain symptomatic. METHODS: A retrospective chart review was performed to identify patients initiated and fully titrated on sacubitril/valsartan therapy from July 7, 2015 to March 7, 2017. RESULTS: Fifty-two of the 72 symptomatic heart failure with reduced ejection fraction (HFrEF) patients prescribed sacubitril/valsartan during the 21-month period were included in this analysis. The average ejection fraction was 26%. The average age was 69 years. At baseline, 26.9% of patients were not on ACEi/ARB therapy and 13.5% were on target-dose therapy. After completing the uptitration process, the maximally tolerated dose of sacubitril/valsartan was 5.8% low-dose, 7.7% mid-dose, and 86.5% target-dose. Loop and thiazide diuretic use decreased significantly. There was a significant mean reduction in systolic blood pressure of 6 mmHg with no significant changes in serum creatinine, blood urea nitrogen, or potassium levels. CONCLUSIONS: With close monitoring and follow-up, ARNi therapy was a safe alternative to ACEi/ARB therapy for chronic symptomatic HFrEF when initiated within a pharmacist clinic.

Diagnoses of Cardiovascular Disease or Substance Addiction/Abuse in US Adults Treated for ADHD with Stimulants or Atomoxetine: Is Use Consistent with Product Labeling?

BACKGROUND: Among US adults, utilization of pharmacotherapy for attention-deficit hyperactivity disorder (ADHD) has increased more than ninefold since 1995-1996. Potential contraindications to ADHD pharmacotherapy include serious cardiovascular disease (CVD) and, for stimulants, addictions and bipolar disorder (BPD). OBJECTIVE: To assess the prevalence of potential contraindications among adults treated with ADHD pharmacotherapy. METHODS: A retrospective cohort analysis was performed using the Truven Health MarketScan® database. Subjects filled ≥ 1 prescription for atomoxetine or ≥ 1 stimulant in 2014-2015, were aged 18-64 years, commercially insured throughout observation, and diagnosed with ADHD on two or more medical claims. Diagnoses and medical procedures were measured in the 12 months prior to pharmacotherapy initiation. Metrics included serious CVD (cardiomegaly, cardiomyopathy, cerebrovascular occlusion, congestive heart failure, myocardial infarction, pacemaker, or valvular disorder) and any CVD (serious CVD, other atherosclerotic CVD, arrhythmia, congenital heart anomaly, or hypertensive heart disease). Rates of substance addiction or abuse were measured in a range to address nonspecific diagnostic coding. RESULTS: Only 2.0% of treated adults (n = 91,588) had one or more diagnosis indicating serious CVD. CVD prevalence increased monotonically with age. Of patients aged 55-64 years (n = 5,237), 7.2% had serious CVD; 15.9% had any CVD; and 1.9% had been hospitalized with one or more CVD. Of patients treated with stimulants (n = 87,167), 11.3-18.5% were diagnosed with addiction/abuse and 4.1% with BPD. CONCLUSIONS: CVD prevalence is generally low among adults using ADHD medication but increases with age. Although difficult to estimate precisely, the rate of addiction/abuse among stimulant-treated patients appears unexpectedly high. Further research should assess cardiovascular events and other potential harms associated with contraindicated use in high-risk adults.

A Pilot Study on an Interprofessional Course Involving Pharmacy and Dental Students in a Dental Clinic.

Objective. To assess the effect of a dental clinical rotation program involving pharmacy students and dental students. Methods. An interprofessional education (IPE) course was offered as an elective to second-year pharmacy students and required for third-year dental students. The course included two in-class sessions, one online lecture, and five clinic sessions. Program evaluation analyses included a comparison of participating versus nonparticipating students on a knowledge survey of pharmacotherapy and IPE, and a descriptive analysis of IPE course evaluation results. Results. Among pharmacy students, mean scores were significantly higher for participants than nonparticipants on the 31-item pharmacy knowledge component of the survey. On the eight-item IPE component of the survey, scores were significantly higher for participants than for nonparticipants, both among pharmacy students and among dental students. Awareness and attitudes about IPE were generally high among course participants. Conclusion. An IPE course that integrates second-year pharmacy students with third-year dental students in the dental clinic to provide medication history, education, and identification of potential drug-related problems improved pharmacy students' knowledge of pharmacotherapy related to or associated with dental conditions and improved pharmacy and dental students' knowledge and attitudes about IPE.

Real-world use of PCSK-9 inhibitors by early adopters: cardiovascular risk factors, statin co-treatment, and short-term adherence in routine clinical practice.

BACKGROUND: Inconsistency of real-world medication use with labeled indications may affect cost and clinical value of pharmacotherapy. PCSK-9 inhibitors are labeled in the US for use with statins to reduce low-density lipoprotein cholesterol in patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH). OBJECTIVE: To assess consistency with labeled indications and treatment persistency for early (first 5 post-launch months) adopters of PCSK-9 inhibitor pharmacotherapy. METHODS: Retrospective analysis of commercially insured cohorts derived from the Truven Health MarketScan® database was performed. Subjects were aged 18-64 years, initiated PCSK-9 inhibitor or highest-intensity statin (rosuvastatin 40 mg/day or atorvastatin 80 mg/day) pharmacotherapy from August to December 2015, and were enrolled throughout 2015 and during separate baseline (pre-treatment) periods of 6 and 18 months. Baseline ASCVD, FH, and ASCVD events (myocardial infarction, transient ischemic attack, and cerebrovascular occlusion) were measured. Persistency was measured through December 2015 for subcohorts of patients initiating treatment from August to September 2015. RESULTS: Baseline disease rates were higher for patients treated with PCSK-9 inhibitors (n=390) compared with highest-intensity statins (n=26,306): ASCVD (68.5% vs 33.4%, respectively); FH (39.7% vs 15.5%); both P<0.001. In 18 months pre-treatment, 35.6% of PCSK-9 inhibitor-treated patients had ≥1 ASCVD event, and 87.9% had a labeled indication. Rates of 60-day nonpersistency for PCSK-9 inhibitors and highest-intensity statins were 33.3% and 39.8%, respectively (P=0.207). During PCSK-9 inhibitor pharmacotherapy, 33.8% of patients had evidence of statin supply and, of those initiating treatment from August to September, 40.9% filled ≥1 statin prescription. Of those with sustained pre-treatment statin use, 34.8% had no statin supply during PCSK-9 inhibitor pharmacotherapy. CONCLUSION: Among early-adopting PCSK-9 inhibitor-treated patients, the off-label diagnosis rate was 12%; a majority lacked statin co-treatment; and one third filled prescriptions for ≤60 days. Inconsistency with labeled uses may reflect prescriber/patient decisions, health-insurance coverage determinations, or statin intolerance not reported on claims.

Financial Impact of Direct-Acting Oral Anticoagulants in Medicaid: Budgetary Assessment Based on Number Needed to Treat.

BACKGROUND: Faced with rising healthcare costs, state Medicaid programs need short-term, easily calculated budgetary estimates for new drugs, accounting for medical cost offsets due to clinical advantages. OBJECTIVE: To estimate the budgetary impact of direct-acting oral anticoagulants (DOACs) compared with warfarin, an older, lower-cost vitamin K antagonist, on 12-month Medicaid expenditures for nonvalvular atrial fibrillation (NVAF) using number needed to treat (NNT). METHOD: Medicaid utilization files, 2009 through second quarter 2015, were used to estimate OAC cost accounting for generic/brand statutory minimum (13/23%) and assumed maximum (13/50%) manufacturer rebates. NNTs were calculated from clinical trial reports to estimate avoided medical events for a hypothetical population of 500,000 enrollees (approximate NVAF prevalence × Medicaid enrollment) under two DOAC market share scenarios: 2015 actual and 50% increase. Medical service costs were based on published sources. Costs were inflation-adjusted (2015 US$). RESULTS: From 2009-2015, OAC reimbursement per claim increased by 173 and 279% under maximum and minimum rebate scenarios, respectively, while DOAC market share increased from 0 to 21%. Compared with a warfarin-only counterfactual, counts of ischemic strokes, intracranial hemorrhages, and systemic embolisms declined by 36, 280, and 111, respectively; counts of gastrointestinal hemorrhages increased by 794. Avoided events and reduced monitoring, respectively, offset 3-5% and 15-24% of increased drug cost. Net of offsets, DOAC-related cost increases were US$258-US$464 per patient per year (PPPY) in 2015 and US$309-US$579 PPPY after market share increase. CONCLUSIONS: Avoided medical events offset a small portion of DOAC-related drug cost increase. NNT-based calculations provide a transparent source of budgetary-impact information for new medications.