The aim of this study was to evaluate the budget impact of introducing tildrakizumab for moderate-to-severe plaque psoriasis from a US health plan perspective. A budget impact model estimated costs before and after the adoption of tildrakizumab to a hypothetical US health plan with 1 million covered lives over 5 years. Additionally, the model included adalimumab, brodalumab, etanercept, guselkumab, ixekizumab, secukinumab, ustekinumab, and apremilast; biosimilars were not included. Model input data were obtained from the published literature, clinical trials, and prescription data. Market uptake for tildrakizumab was assumed as 1% annually over 5 years. Patients initiating or switching treatments required induction dosing; all others treated required maintenance dosing. The model compared the total annual costs for tildrakizumab versus treatment without tildrakizumab to calculate budget impact in 2018 US dollars. Scenarios exploring alternative assumptions for adverse events and market uptake rates were assessed, and a one-way sensitivity analysis was conducted. Within a health plan of 1 million members with an estimated 1048 patients receiving biologics or apremilast for psoriasis, the total annual health plan cost after introducing tildrakizumab decreased by $5585, $137,025, $205,538, $274,051, and $342,563 in years 1–5, respectively, resulting in a cumulative reduction of $964,763 over 5 years. The impact on total cost was largely due to drug acquisition costs. The incremental per member per month (PMPM) cost reductions were negligible in year 1, $0.01 in year 2, $0.02 in years 3–4, and $0.03 in year 5. Scenario and sensitivity analyses confirmed the model robustness. The introduction of tildrakizumab with a 1% annual uptake over 5 years has the potential to reduce the cost of treating patients with moderate-to-severe plaque psoriasis for a US health plan.
Multiple sclerosis (MS) is a chronic, autoimmune disease affecting the central nervous system. The disease targets the myelin sheaths around nerves, leading to inflammation, myelin loss, and axonal destruction. MS is the most common cause of neurologic disability in people between the ages of 20 and 40. There are approximately 400,000 cases of MS in North America and approximately 2.5 million worldwide. The overall incidence of MS is increasing worldwide, as well, with 200 individuals diagnosed each week. The course of the disease can look different for every patient, as there are 4 classifications of MS: relapsing-remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), secondary progressive multiple sclerosis (SPMS), and progressive relapsing multiple sclerosis (PRMS). The signs and symptoms experienced by each patient vary widely and may include neuromuscular function impairments, pain, cognitive dysfunction, and mental health issues. Common symptoms of MS include visual problems, fatigue, paresthesia, bladder/ bowel/sexual dysfunction, gait problems, spasticity, dizziness, vertigo, pain, depression, and cognitive dysfunction. Some less common symptoms of MS include headache, hearing loss, itching, seizures, speech/swallowing difficulties, tremor, and loss of coordination.1 The medications used to treat the signs and symptoms of the disease do not produce a cure but can substantially improve symptoms and quality of life.
BACKGROUND: One of the most important and often overlooked challenges for accountable care organizations (ACOs) is ensuring the optimal use of pharmaceuticals, which can be accomplished by utilizing pharmacists’ skillsets and leveraging their full clinical expertise. Developing capabilities that support, monitor, and ensure appropriate medication use, efficacy, and safety is critical to achieving optimal patient outcomes and, ultimately, to an ACO’s success. The program described in this article highlights the best practices of Fairview Pharmacy Services’ Medication Therapy Management (MTM) program with additional thoughts and considerations on this and similar MTM programs provided by The Working Group on Optimizing Medication Therapy in Value-Based Healthcare. PROGRAM DESCRIPTION: Fairview Pharmacy Services utilizes 23 MTM pharmacists (approximately 18 full-time equivalents) working in 30 locations, who conduct pharmacotherapy workups as part of the MTM services that Fairview provides. Pharmacists focus on patients in a comprehensive manner and assess all of their diseases and medications. Responsibilities include (a) identification of a patient’s drug-related needs with a commitment to meet those needs; (b) an assessment and confirmation that all of a patient’s drug therapy is appropriately indicated, effective and safe, and that the patient is compliant; (c) achievement of therapy outcomes and ensuring documentation of those outcomes; and (d) collaboration with all members of a patient’s care team. OBSERVATIONS: Since 1998, pharmacists have cared for more than 20,000 patients and resolved more than 107,000 medication-related problems which, if left unresolved, could have led to hospital readmissions and emergency visits. Since becoming a Pioneer ACO, Fairview pharmacists have focused on the highest-risk members and have seen over 670 ACO patients, resolving over 2,780 medication-related problems. In terms of clinical outcomes, MTM contributed to optimal care in complex patients with diabetes. A review of 2007 data found that the percentage of diabetes patients optimally managed (as measured by a composite of hemoglobin A1c, low-density lipoprotein, blood pressure, aspirin use, and no smoking) was significantly higher for MTM patients (21% vs. 45%, P < 0.01). The Fairview MTM also showed a 12:1 return on investment (ROI) when comparing the overall health care costs of patients receiving MTM services with patients who did not receive those services. IMPLICATIONS: Developing an MTM program to manage and optimize pharmaceuticals will be a cornerstone to managing the health of a population. Important lessons have been learned that may be helpful to other health systems developing MTM programs. In an accountable care environment measuring the return on the investment of all care interventions, including MTM will be essential to maintain the program. The ACO will also have to be able to correctly identify which patients are candidates for MTM services and provide pharmacists with enough autonomy, including scheduling face-to-face interactions with patients and the ability to change prescriptions if necessary, to ensure that timely and effective care is delivered. In order for an ACO to deliver high quality patient-centered medication services, there must be clear lines of communication between providers, pharmacists, and the other care providers within the organization. Finally, a strong and visionary leader is critical to ensuring the success of an MTM program and ultimately the ACO itself. RECOMMENDATIONS: While there is a plethora of literature touting the benefits of either in-person or telephonic-based MTM, there is little research to date that directly compares these 2 MTM delivery types. It is critical for research to address the direct and indirect costs associated with starting and maintaining an MTM program. Information such as technologies required to start a program and length of time until a program breaks even or meets a sufficient ROI can be helpful for health care providers in similar health systems pitching a similar type of program. Finally, there has yet to be significant empirical research into the cost savings of utilizing a pharmacist and MTM services associated with meeting quality and cost benchmarks in an accountable care payment arrangement.
BACKGROUND: The number of patients using methotrexate (MIX) has increased during the last decade. Because of the narrow therapeutic range and potential risks of Incorrect use, vigilance Is required when dispensing MIX. In 2009, the Royal Dutch Pharmacists Society, in accordance with the Dutch Health Care Inspectorate, published safe MIX dispensing recommendations for community pharmacies.OBJECTIVE: To examine adherence to recommendations aimed at safe MIX dispensing.METHODS: This study was conducted within a convenience sample of 78 community pharmacies belonging to the Utrecht Pharmacy Practice Network for Education and Research (UPPER). Data were collected In May 2011.RESULTS: 95 pharmacists and 337 pharmacy technicians were interviewed to assess self-reported adherence with dispensing recommendations. In addition, medication records for patients using MIX were extracted in 52 pharmacies in order to objectively assess adoption of recommendations. More than 75% of the pharmacists and pharmacy technicians reported to be adherent to 6 of the 11 recommendations. There are variations in reported adherence between team members working in 1 pharmacy; higher adherence rates (>75%) for the pharmacy team as a whole were only shown for 2 recommendations (recording of day of intake on the label and moment of authorization by the pharmacist). The medication records showed that adherence with working procedures significantly Increased: The number of dispensed records with notification of the day of intake on the medication label increased from 9.9% of the records per pharmacy in 2008 to 77.1% in 2010 (P<0.001).CONCLUSIONS: Dutch community pharmacies seem to be adherent to most safe dispensing recommendations. However, inconsistencies exist between team members that emphasize the importance of addressing this issue and discussing recommendations within the team, as there is still room for improvement to ensure safe dispensing. Copyright (C) 2014, Academy of Managed Care Pharmacy. All rights reserved.
In the wake of new recommendations to offer HIV screening to everyone aged 13-64 years and to start all people living with HIV/AIDS on highly active antiretroviral therapy (HAART) regardless of CD4 count, the need to generate widespread, scalable HIV screening programs is greater than ever. Nearly 50,000 new HIV infections occur in the United States each year, and the Centers for Disease Control and Prevention estimates that approximately half of these new infections are transmitted by individuals who are unaware of their HIV serostatus. Numerous barriers to screening exist, including the lack of primary care for many at-risk patients, expense of screening in traditional settings, and need for repeat testing in high-risk populations. With their relative accessibility and affordability, community pharmacies and retail clinics within those pharmacies are practical and appealing venues for expanded HIV screening. For widespread pharmacy-based testing to become a reality, policymakers and corporate pharmacy leadership would need to develop innovative solutions to the existing time pressures of pharmacists' behind-the-counter functions and absence of reimbursement for direct patient care services. Pharmacists nationwide should also receive training to assist with risk reduction counseling and linkage to care for customers purchasing the new over-the-counter HIV test.
BACKGROUND: Nonmedical use of prescription medication is a significant and growing public health concern in the United States. Drug utilization measures that can reliably quantify the extent of nonmedical use of a given medication or medication class would greatly facilitate efforts to identify, monitor, and constrain nonmedical prescription drug use. Measures making use of prescription claims data would be especially valuable given the ready availability of these data among health care plans and payers.OBJECTIVE: To explore the extent to which claims-based utilization measures can provide information that aids in identifying and quantifying nonmedical drug use.METHODS: Prescription claims from a large employer-based administrative claims database (MarketScan) were used to evaluate drug utilization during the first year after an index prescription for 6 classes of drugs with a known abuse potential and 3 classes without. Traditional population-level measures of adherence (i.e., medication possession ratio [MPR] and proportion of days covered [PDC]) and a novel measure of overlapping days supply (MPR/PDC ratio) were calculated for all medications. Measures of asymmetrical use within a population were evaluated with the Lorenz curve, representing the total drug supply used by the heaviest 1%, 5%, and 50% of all users. All of the measures across compounds were compared with Spearman nonparametric rank correlations, and the Friedman's test was performed to determine whether the rankings were consistent in pairwise analysis. The ability of each measure to discriminate between abusable and nonabusable compounds was evaluated using the c-statistic.RESULTS: The study cohort included 6,291,810 patients, mean age 52 years, 57.9% female. The mean MPR and mean PDC for drugs with known abuse potential were both lower than for drugs without known abuse potential. The MPR/PDC ratio (MPR:PDC) ranged from 1.02-1.09. Highest values for the Lorenz-1 curve were seen for acetaminophen with codeine, acetaminophen with oxycodone, oxycodone, and acetaminophen with hydrocodone. The individual MPR and PDC were strongly correlated to each other (r = 0.99; P < 0.001 for both), moderately correlated with the MPR:PDC (r = 0.62 and 0.57, respectively) and moderately inversely correlated with Lorenz 1 (r = -0.83 and -0.86, respectively, P < 0.001 for both). The MPR:PDC was inversely correlated with the Lorenz-1 (r = -0.39; P = 0.02). After rank ordering individual drugs by each measure from highest to lowest value, the MPR:PDC resulted in consistent distributions with the individual MPR (P = 0.0097) and PDC (P = 0.0018), but not the Lorenz-1 (P = 0.0835), nor Lorenz-50 (P = 0.1343). The MPR, PDC, Lorenz-1, and Lorenz-50 were able to discriminate between the drugs with known abuse potential and those without (c-statistic 0.979 to 1), while the MPR:PDC was not (c-statistic 0.592).CONCLUSIONS: When comparing classes of drugs with a known abuse potential with classes of drugs not prone to such use, using an array of drug utilization measures, significantly different patterns emerge, although the ability of these measures to serve as reliable indicators of the extent of nonmedical prescribing may be limited. There is a need for valid and reliable algorithms to detect the extent of nonmedical use at a population level to help target public health interventions aimed at constraining illicit use. Further work is warranted on the development of novel measures that make use of individual patient-level use patterns. Copyright (C) 2014, Academy of Managed Care Pharmacy. All rights reserved.
BACKGROUND: With the growing use of oral anticancer mediations, understanding adherence patterns has become increasingly important. Abiraterone acetate (AA) is a prodrug of abiraterone, a novel androgen biosynthesis inhibitor. AA is approved for use in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer.OBJECTIVE To evaluate AA and concomitant prednisone utilization and adherence patterns for patients with prostate cancer in the United States. MET-M This study used data from 2 administrative health care claims databases Dataset 1: Truven Health Analytics MarketScan (December 2010 to August 2012) and Dataset 2: S.,Symphony Health Solutions' ProMetis Lx (June 2009 to IVIarch 2013). To evaluate the consistency of medication-taking behavior, adherence was measured using medication possession ratio (MPR), which was calculated as the sum of days of supply divided by the days on therapy in patients with at least 2 AA prescriptions. Additional outcomes included the proportion of patients taking prednisone, mean and median daily dose of AA, and concomitant prednisone use. Adherence was also studied by age, health care plan type, or previous recent chemotherapy subgroups.RESULTS 515 patients (mean age: 72.2) and 3,228 patients (mean age: 72.2) with at least 1 M claim were selected from Dataset 1 and Dataset 2, respectively. The mean (medIan) daily AA dose per person per prescription was 998.8 (1,000) mg for Dataset 1 and 994.2 (1,000) mg for Dataset 2, which is within 1% of the recommended daily dose (1,000 mg). Mean (median) MPR was 93% (98%; n=492) in Study Population 1 and 93% (100%; n= 2,449) in Study Ropulation 2. The mean (median) daily prednisone dose per person per prescription was similar in both datasets with 10.1 (10.0; n=488) mg and 10.6 (10.0; n=2,425) mg in Dataset 1 and 2, respectively. Smiler adherence patterns were observed for patients in different age groups, for patients with commercial health care plans versus patients with Medicare coverage, and for patients with recent chemotherapy compared with patients without.CONCLUSIONS Results from 2 observational studies reported high levels of adherence to AA dosing and administration patterns consistent with prescribing information. These finings provide useful insights into the treatment patterns in patients with prostate cancer treated with AA and can contribute to the current discussion in oncologic research and practice. Copyright (C) 2014, Academy of Managed Care Pharmacy. All rights reserved.
BACKGROUND: Accountable care organizations (ACOs) have the potential to lower costs and improve quality through incentives and coordinated care. However, the design brings with it many new challenges. One such challenge is the optimal use of pharmaceuticals. Most ACOs have not yet focused on this integral facet of care, even though medications are a critical component to achieving the lower costs and improved quality that are anticipated with this new model. OBJECTIVE: To evaluate whether ACOs are prepared to maximize the value of medications for achieving quality benchmarks and cost offsets. METHODS: During the fall of 2012, an electronic readiness self-assessment was developed using a portion of the questions and question methodology from the National Survey of Accountable Care Organizations, along with original questions developed by the authors. The assessment was tested and subsequently revised based on feedback from pilot testing with 5 ACO representatives. The revised assessment was distributed via e-mail to a convenience sample (n=175) of ACO members of the American Medical Group Association, Brookings-Dartmouth ACO Learning Network, and Premier Healthcare Alliance. RESULTS: The self-assessment was completed by 46 ACO representatives (26% response rate). ACOs reported high readiness to manage medications in a few areas, such as transmitting prescriptions electronically (70%), being able to integrate medical and pharmacy data into a single database (54%), and having a formulary in place that encourages generic use when appropriate (50%). However, many areas have substantial room for improvement with few ACOs reporting high readiness. Some notable areas include being able to quantify the cost offsets and hence demonstrate the value of appropriate medication use (7%), notifying a physician when a prescription has been filled (9%), having protocols in place to avoid medication duplication and polypharmacy (17%), and having quality metrics in place for a broad diversity of conditions (22%). CONCLUSIONS: Developing the capabilities to support, monitor, and ensure appropriate medication use will be critical to achieve optimal patient outcomes and ACO success. The ACOs surveyed have embarked upon an important journey towards this goal, but critical gaps remain before they can become fully accountable. While many of these organizations have begun adopting health information technologies that allow them to maximize the value of medications for achieving quality outcomes and cost offsets, a significant lag was identified in their inability to use these technologies to their full capacities. In order to provide further guidance, the authors have begun documenting case studies for public release that would provide ACOs with examples of how certain medication issues have been addressed by ACOs or relevant organizations. The authors hope that these case studies will help ACOs optimize the value of pharmaceuticals and achieve the "triple aim" of improving care, health, and cost. DISCLOSURES: There was no outside funding for this study, and the authors report no conflicts of interest related to the article. Concept and design were primarily from Dubois and Kotzbauer, with help from Feldman, Penso, and Westrich. Data collection was done by Feldman, Penso, Pope, and Westrich, and all authors participated in data interpretation. The manuscript was written primarily by Westrich, with help from all other authors, and revision was done primarily by Lustig and Westrich, with help from all other authors.
BACKGROUND: Drug interaction studies selecting patients in a real-life setting are scarce, and most studies to date are characterized by a small sample size. OBJECTIVES: To evaluate the effect of amiodarone on warfarin maintenance dose and adverse events in an anticoagulation cohort from a tertiary cardiovascular service. METHODS: This study recruited 866 patients, and oral anticoagulant therapy was monitored by the prothrombin time expressed as the international normalized ratio (INR). Genotyping of CYP2C9*2, CYP2C9*3, and VKORC1 3673 polymorphisms was performed. RESULTS: Of the 866 patients, 111 (12.8%) were taking amiodarone and warfarin simultaneously, and 514 (59.4%) reached the therapeutic target dose. The warfarin maintenance dose was significantly lower in patients simultaneously using amiodarone (23.8 ± 11.3 mg/wk) compared with other patients (29.5 ± 14.3 mg/wk; P less than 0.001). Patients taking amiodarone had higher INR/current dose ratios (0.83 ± 0.04 per mg) compared with patients not using amiodarone (0.71 ± 0.02 per mg, P = 0.001). Adverse event frequency was not different between the groups (P = 0.40). No genotype effect was noted on the odds of bleeding associated with amiodarone use. CONCLUSIONS: Simultaneous use of amiodarone influences warfarin maintenance dose, but is not associated with adverse events.
BACKGROUND: Immunoglobulin (Ig) is a costly blood product prescribed as immune replacement or modulation therapy to treat a wide spectrum of medical conditions. While the FDA has approved Ig for a limited number of indications, there are multiple off-label uses that have demonstrated proven clinical benefit or are currently in various phases of clinical study. There are also diagnoses for which Ig is prescribed, but for which no evidence-based efficacy data are available. Many conditions for which Ig has been prescribed are extremely rare, and a controlled clinical trial is not logistically possible. These conditions may be denied insurance authorization because of limited medical evidence that supports the use of Ig in their treatment. This limited evidence consists of uncontrolled studies, case series and reports, and expert opinion. Limiting the use of Ig therapy to cases with the best supporting evidence may control health care expenditure, but it may also limit the potential body of knowledge from publications by physicians with experience in treating these conditions. Specialty pharmacy providers can collect longitudinal outcomes, and data from their publications could provide support for improved managed care criteria or areas of future medical research. OBJECTIVES: To (a) assess levels of supporting evidence by diagnosis for a sample of Ig requests submitted through the managed care prior authorization (PA) process and (b) provide a descriptive review of such requests and resultant benefit coverage determinations by individual diagnosis, overarching diagnostic category, patient age group, and assessed levels of evidence. METHODS: Through collaboration with 6 health plans, we obtained and analyzed 2,548 managed care PA requests for Ig therapy received between February 2008 and August 2012, as well as resulting benefit coverage determinations. A literature review of 7 established treatment guidelines and expert consensus statements was conducted and used to evaluate all indications for Ig treatment presented among obtained requests and to assign each request to 1 of 5 categorical levels of supporting evidence. RESULTS: Of the 2,548 Ig requests reviewed, 1,467 (57.6%) were found to be “supported” in the relevant literature; 830 (32.6%) were designated “conditional”; 127 (5%) were “lacking consensus”; 74 (2.9%) were “currently not supported”; and 50 (2%) were “undetermined.” Overall, 2,094 (82.2%) of the requests were authorized by the health plans. Of the total requests, 1,633 (64.1%) were for FDA-approved diagnostic indications, of which 1,393 (85.3%) were authorized by the sampled health plans. The majority of requests for Ig were for treatment of neurological and immunological conditions. A total of 181 unique indications were identified, yet 833 (32.7%) of the requests were for just 2 indications—common variable immunodeficiency and chronic inflammatory demyelinating polyneuropathy. Patients aged 45 to 64 years represented 1,318 (51.7%) of all requests. CONCLUSIONS: This analysis provides insight into the prescribed medical usage of Ig and the conditions for which it may be authorized through the managed care PA process. We identified 181 unique diagnostic indications for Ig, for which only 97 had established expert consensus. Although many diagnostic indications were identified, most requests were for indications with strong supporting evidence, and most of these were authorized by the health plans. The number of indications identified highlights the ongoing need for publications from physicians and specialty pharmacies with experience in treating these conditions in order to increase the body of knowledge surrounding use of this therapy.
