Specialty Medication Use Research Articles

Medication‐related problems in chronic inflammatory conditions: A pharmacy claims and electronic health record analysis

AbstractBackgroundSpecialty medications have transformed management of chronic inflammatory conditions. There is a critical need to elucidate underlying barriers and medication‐related problems (MRPs) that might contribute to specialty medication non‐adherence in order to minimize disease progression, treatment failure, and increased healthcare utilization.ObjectiveTo characterize MRPs for patients taking specialty medications for chronic inflammatory conditions and identify factors associated with experiencing MRPs.MethodsRetrospective cohort study of patients prescribed specialty medications for chronic inflammatory conditions at a single, regional, tertiary medical center, who filled their prescriptions at Walgreens pharmacy between 1/1/2014 and 12/31/2016. Electronic health records were manually reviewed to find documented medication problems. MRPs were then analyzed to identify common themes. Differences in baseline characteristics for patients with or without documented MRPs were compared using Fisher's exact test for categorical variables and Mann Whitney U test for continuous variables. Student's t test was used to determine associations between 12‐month proportion of days covered (PDC) and the presence of any MRP.ResultsOf 272 patients who were prescribed specialty medications for chronic inflammatory conditions, 98 patients (36%) experienced a total of 131 documented MRPs. Four major themes associated with these problems emerged: prescription processing issues (31%), insurance problems (24%), medication use problems (22%), and side effects (18%). Patients were less likely to have a documented MRP if they were African American (P = .032) and patients with MRPs had a greater proportion of missed clinic visits. Mean 12‐month PDC (n = 167) was 0.61 and was not significantly associated with having a documented MRP (P = .7).ConclusionUse of specialty medications for patients with chronic inflammatory conditions continues to increase. Gaining a greater understanding of the MRPs that affect specialty medication use for chronic inflammatory conditions can help identify practice innovations and policies to improve patient care.

Multidisciplinary practice advancement: Role of a clinical pharmacy specialist in a pediatric specialty clinic.

To describe clinical pharmacy specialists' role in improving the use of specialty medications within a pediatric outpatient setting. The outpatient pediatric specialty clinic (PSC) at the University of Iowa added a clinical pharmacy specialist to multidisciplinary teams within the PSC to focus on patient education, providing clinical recommendations, coordinating insurance approval, addressing barriers to adherence, and performing follow-up monitoring. Supplemental activities include coordinating between the electronic health record-integrated on-site specialty pharmacy and the PSC, assisting with quality improvement projects, developing policy revisions, negotiating access to specialty products, and answering medication information questions. Benefits in workflow efficiency, documentation, and revenue generation resulting from implementation of the pharmacist within the PSC have been identified by the clinic and the specialty pharmacy. The specialty pharmacy identified an increase in the rate of specialty prescription capture from 14% to 50%, leading to an increase in revenue for the health system. Within 12 months of the addition of the pharmacist to the team, an improvement in the rate of 13-valent pneumococcal conjugate vaccine administration to pediatric patients of 25.7 percentage points, medication adherence of >90%, and a 75% relative increase in appropriate hydroxychloroquine dosing were recognized. Due to the pharmacist's impact on the PSC, a full-time pharmacist was added to the pediatric team to cover additional clinics, and 2 benefits investigation technicians were hired and funded by the PSC. An interdisciplinary team with an integrated pharmacist has facilitated sustainable improvements in medication access and adherence and clinical and quality measures, benefiting patients, the pediatric clinic, the specialty pharmacy, and the hospital organization.

The Impact of the Pharmaceutical Care Management Model of Hepatitis C Medications on the Cost at Health Insurance Level

ObjectiveThe aim of this study is to evaluate the impact of adopting a pharmaceutical care model on clinical outcomes, patient satisfaction, and cost at a health payer level. MethodsAll patients with hepatitis C virus (HCV) who were insured by Bupa Arabia, with a direct-acting antivirals prior authorization drug request between April 2015 and October 2018 were included in this retrospective quasi-experimental study. The clinical outcome was the achievement of a sustained virologic response at least 12 weeks from end of treatment. Economic and patients’ satisfaction outcomes were included in this study. The differences in cost of treatment was analyzed by using the paired t test. Stata statistical software package (StataCorp, College Station, TX) was used for data analysis. ResultsA total of 371 patients were enrolled in this program of which 74% (n = 273) required clinical intervention. Among those, HCV treatment was modified for 64%. The overall cure rate was 97% among 267 patients for which sustained virologic responses were available. The results of the paired t test show that there was a 38% reduction in the mean direct cost of medications before and after intervention (95% confidence interval, 33%-43%; P<.001) and the calculated patients’ satisfaction was 98%. ConclusionsA structured pharmaceutical care program for HCV patients can guide the use of specialty medications to achieve optimal clinical outcomes, with lower expenditures and high patients’ satisfaction. We can conclude that healthcare insurance can play a key role in managing specialty pharmaceuticals like HCV medications. Because this is a preliminary study, further studies are needed in an experimental design to strengthen the evidence behind the effectiveness of such a program.

An Integrated Health-System Specialty Pharmacy Model for Coordinating Transitions of Care: Specialty Medication Challenges and Specialty Pharmacist Opportunities.

Adherence and persistence to specialty medications are necessary to achieve successful outcomes of costly therapies. The increasing use of specialty medications has exposed several unique barriers to certain specialty treatments’ continuation. Integrated specialty pharmacy teams facilitate transitions in sites of care, between different provider types, among prescribed specialty medications, and during financial coverage changes. We review obstacles encountered within these types of transitions and the role of the specialty pharmacist in overcoming these obstacles. Case examples for each type of specialty transition provide insight into the unique complexities faced by patients, and shed light on pharmacists’ vital role in patient care. This insightful and real-world experience is needed to facilitate best practices in specialty care, particularly in the growing number of health-system specialty pharmacies.

The Relationship Between Health Plan Type, Use of Specialty Medications, and Worker Productivity

Specialty medications have piqued the attention of employers because spending on specialty medications has been increasing. In 2012, specialty medications accounted for 24 percent of total drug spending in the commercial market, but by 2016 specialty medications accounted for 36 percent. By 2020, specialty medications are expected to account for nearly one-half of total drug spending in the commercial market. Managing specialty medications is considered one of the most effective tactics when it comes to controlling health care costs. In this Issue Brief, the Employee Benefit Research Institute (EBRI) examines the impact of plan type on use of specialty medications. This paper also focuses on the impact that use of specialty medications both among workers and their dependents has on worker productivity. The analysis was conducted on nearly 100,000 unique individuals with rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis, psoriasis, and multiple sclerosis (MS) using data from the Truven Health Analytics MarketScan® Research Commercial Claims and Encounters Database. Use of specialty medications among individuals with multiple sclerosis (MS): Among individuals with MS, there was no difference in the likelihood of filling a prescription for a specialty medication by type of health plan. However, among individuals with MS that had filled a specialty medication prescription, individuals with preferred provider organization/point of service (PPO/POS) and health reimbursement arrangement (HRA) plans used more specialty medications than those with health maintenance organization/exclusive provider organization (HMO/EPO) plans. There was no difference between those with health savings account (HSA)-eligible health plans and those with HMO/PPO coverage. Use of specialty medications among individuals with rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis, and psoriasis: Plan type had no impact on whether any specialty medications were used, with one exception. Among individuals with RA, those with an HRA were less likely than those in HMO/EPO plans to use any specialty medications. Among individuals that had filled specialty medication prescriptions, we found mixed effects on the number of fills. For the most part, there were no differences in the number of fills by plan type. However, among individuals with RA, those in HRA plans filled fewer specialty medications than those in HMO/EPO plans. Among individuals with Crohn’s disease, those in PPO/POS plans used more specialty medications than those in HMO/EPO plans. Use of Specialty Medications and Worker Productivity: Any Use: We found few instances where productivity was affected by use of specialty medications. We did not find any relationship between any use of specialty medication and any use of sick or vacation leave, or number of days absent. We also did not find that any use of specialty medications affected whether a worker took short-term disability. However, we did find that any use of specialty medications reduced the number of days on short-term disability for workers with Crohn’s disease by 37.6 days and for workers with psoriasis by 42.6 days. Number of Medications: Regarding the impact of the number of specialty medications fills on productivity, we did not find an impact on the likelihood of taking any days off or on the likelihood of being on short-term disability. There was evidence that a higher number of specialty medication fills increased the number of absentee days for individuals with Crohn’s disease and psoriasis. However, the magnitude of these effects was quite small, increasing absenteeism by 0.53 days for those with Crohn’s disease and by 0.25 days for those with psoriasis. There was also evidence that a higher number of specialty medication fills increased the length of short-term disability for individuals with MS by 5.6 days. Dependent Use: We also examined the impact of use of specialty medications on worker productivity by examining whether worker productivity was affected by use of specialty medications among dependents. We tested this by examining the impact of spousal use of specialty medications for married workers. We found nearly no evidence that any use of specialty medications reduced worker absenteeism with one exception — among spouses using specialty medications for ulcerative colitis, workers were absent from work 6.5 fewer days. With respect to the number of specialty medications filled among those who had filled at least one prescription, we found mixed results. There was no impact on worker absenteeism among spouses with Crohn’s disease, psoriasis or MS. Higher use of specialty medications reduced absenteeism among workers with spouses treated for ulcerative colitis, but it increased absenteeism among workers with spouses treated for RA.

Clinical and economic impact of a comprehensive specialty pharmacy oral oncology patient management program

Background: There is a significant clinical and economic burden of cancer and oral oncolytic non-adherence on healthcare systems, payers, and patients. As part of an integrated healthcare system, Credena Health (CH) specialty pharmacy provides patients with a unique level of service promoting the safe and effective use of specialty medications. Specialty Medication Management Services (SMMS) includes patient education and pharmacy follow-up assessments/interventions. All CH oncology patients are enrolled in SMMS, but can opt out of these services.Objectives: The goal of this study was to evaluate the clinical and economic value of a specialty pharmacy oral oncology patient management program.Methods: Data was collected using CPR+® specialty pharmacy software for 695 patients receiving oral chemotherapy in 2017. All CH patients receive financial coordination and new patient consults (therapy appropriateness assessed, monitoring parameter evaluated, medications reconciled, drug interaction review, and therapy/disease education). Patients are then enrolled in SMMS for monthly/cycle follow-up, coordinated with medication refills. Follow-up assessments are focused on adherence, medication/allergy reconciliation, drug interaction review, monitoring parameter evaluation, and adverse event management. Assigned intervention values are derived from a Truven Health Analytics® national review of pharmacist interventions. Adherence was evaluated using medication possession ratio (MPR).Results: Of 695 unique patients, 480 new patient consults were completed. All 480 (100%) patients were evaluated for therapy appropriateness, 259 (54.0%) checked for laboratory monitoring, 464 (96.7%) assessed for drug interactions, 467 (97.3%) received medication reconciliation, 380 (79.2%) received education, and 435 (90.6%) enrolled in SMMS (along with 197 previously enrolled patients). There were 716 pharmacist interventions identified during the study period, with 520 (72.6%) related to adverse event management and 94 (13.1%) drug interactions. Medication issues were addressed using multiple strategies, including patient counseling (76.1%) and contacting providers (14.1%). Total cost avoidance value attributed to pharmacist interventions and patient education in 2017 was $299,415. Additionally, CH coordinated $1,067,572 in patient assistance. Average MPR was 0.93.Conclusions: The CH oral oncology clinical management program not only improved patient care and adherence, but also reduced healthcare and patient costs within this integrated health system.

Characteristics of patients using specialty medications.

Specialty medications include innovative drugs and biologic agents requiring special handling and close monitoring. Although specialty medications have been widely used for various chronic conditions, increased use of these medications has contributed a growing share of total health care expenditures. The aim of this study was to examine patient characteristics related to specialty medication use. Using Medical Expenditure Panel Survey (MEPS) data from 2000 through 2013, this study identified U.S. adults using specialty medications. Andersen's Health Services Utilization model was used to identify potential factors related to specialty medication use. Associations between the variables identified by Andersen's model and specialty medication use were analyzed using logistic multilevel modelling. Sampling weights were considered and standard errors were adjusted to account for the complex survey design. A fully adjusted model suggested that older adults, individuals with prescription drug insurance, or those using mail order services were more likely to use specialty medications regardless of whether they used traditional medications concurrently. Behaviors of using specialty medications were positively associated with married and active working status and negatively associated with middle or high income and having a usual source of care (visiting a doctor's office, clinic, or health center when sick) when comparing individuals using traditional medications and those using specialty medications. In addition, when comparing individuals using traditional medications with those using both specialty medications and traditional medications, behaviors of using specialty medications were positively associated with female gender, worse health state, and more comorbidities. This study identified characteristics of patients using specialty medications. Some sociodemographic, economic, and clinical factors were related to specialty medication use among U.S. adults.

Benefits of developing a collaborative, outcomes-based specialty pharmacy program.

The benefits of developing a collaborative, outcomes-based specialty pharmacy program are described. With the implementation of risk-based payment models and the rapid growth of specialty pharmacy spend, opportunities exist to establish collaborative and outcomes-focused specialty pharmacy contracts and related programs with regional third-party payers. University of Wisconsin (UW) Health and Unity Health Plans Insurance Corporation have established a contract that sets standards for patient management, pharmacist training and education, electronic medical record documentation, and prescription fulfillment for patients receiving specialty pharmaceuticals. Reporting on metrics of compliance, persistence, and outcomes relative to published benchmarks is required annually. While the contract defines patients by the traditional metric of specialty medication use and includes reimbursement for dispensing activities, it differentiates itself by establishing core services and longitudinal practice expectations for patient care rather than focusing on reimbursement for prescription fulfillment. While it focuses on specialty pharmacy practice, the contract provides an ancillary benefit to all patients using UW Health pharmacies by elevating ambulatory care pharmacy practice standards and improving the patient care process. The collaborative development of practice standards, service requirements, and patient management protocols offers the rapid elevation of specialty pharmacy services, which provides significant differentiation within the highly competitive specialty pharmacy and third-party payer marketplaces.

Implementation of a comprehensive medication prior-authorization service.

The development and successful implementation of a comprehensive medication prior-authorization service are described. At our 550-bed academic medical center, we found an increasing number of Medicare write-offs as a result of the off-label use of specialty medications. Furthermore, more insurers were requiring that prior authorization be attained before patients began treatment with a high-cost specialty medication. After investigating who was pursuing these prior authorizations and where they were documented, it became clear that no department within the hospital owned this responsibility. Our pharmacy department initiated a specialty medication prior-authorization and medication assistance program to review all medication orders written for high-cost specialty medications administered or infused in any of the health system's outpatient clinics, including chemotherapy infusions. A full-time specialty pharmacy coordinator was hired in fall 2010. This pharmacist was responsible for spearheading the overall specialty medication strategy for the health system. Our prior-authorization work across our health system has not only helped to reduce Medicare write-offs and commercial insurance denials but also has resulted in closer working relationships with individuals in other departments of the hospital. Several million dollars in additional write-offs were avoided because our prior-authorization staff identified prescribed therapies that would not be covered by Medicare or commercial insurers before they were started. In total, we decreased write-offs or increased revenues by over $6.2 million during this time frame, a return on investment exceeding 20:1. A comprehensive medication prior-authorization service generated additional revenue due to a decrease in lost charges and an increase in net reimbursement.

Specialty medications: traditional and novel tools can address rising spending on these costly drugs.

Spending on specialty medications, which represented a small proportion of US pharmacy spending at the beginning of this decade, is growing by more than 15 percent annually. It is expected to account for approximately half ($235 billion) of total annual pharmacy spending by 2018. Among the numerous reasons for the high cost of this heterogeneous group of medications are the increasing size of target patient populations, the high cost of drug development, and a complex and uncoordinated delivery system. In this article we describe the evolution of the specialty market, characterize the current state of specialty medication use, and articulate key challenges and potential solutions. Fully realizing the potential value of the expanding universe of specialty medications will require collaborative efforts to reduce waste and promote value. Those who prescribe, dispense, deliver, and pay for specialty medications will need to employ a combination of traditional and novel management approaches, such as prior authorization, step therapy, tiered formularies, administration at lower-cost sites, and the unique tools being developed for cancer medications.

Costs Of Severely Ill Members And Specialty Medication Use In A Commercially Insured Population

This study examines the overall profile and costs associated with severely ill commercially insured people. We found severely ill members to have the highest costs, from both the insurer and member perspective. Even for the most costly members where specialty medication use was highest, biologics represented less than one-third of the pharmacy spending and 6.6 percent of overall spending. Out-of-pocket spending rose dramatically when medications were paid for under the pharmacy benefit rather than the medical benefit. The advantages of paying for specialty medications under the pharmacy benefit should be evaluated in conjunction with the potential consequences of increased out-of-pocket burden.