Exploring healthcare providers' experiences with specialty medication and limited distribution networks.

Integrated health-system specialty pharmacies (IHSSP) have shown high medication access, adherence, and provider satisfaction. The goal of this study was to explore healthcare providers' experiences with specialty medications distributed via Limited Distribution Networks (LDN) that do not include IHSSPs. We investigated healthcare providers' perceived impact of LDNs on clinic workflow, clinical practice, and patient outcomes. Interviews and focus groups were conducted with fourteen healthcare providers from four outpatient specialty clinics at an academic health system with an IHSSP. Qualitative analysis using an iterative inductive/deductive approach of coded transcripts was used to identify themes. Participants discussed requirements and barriers to communicating with insurance providers, drug manufacturers, and external pharmacies; time and effort required to navigate LDNs and impact on workload and clinic workflow; financial awareness of medication costs and methods for communication about financial information with patients; and advocating for patients to ensure access to necessary therapy and avoid missed doses or treatment lapse. Participants reported barriers to navigating LDNs that can interfere with clinic workflow and patient care. IHSSPs may reduce clinic burden by helping patients access, afford, and remain on therapy.

Primary medication nonadherence to oral oncology specialty medications.

BACKGROUND: Patients prescribed specialty oncology medications face logistical and financial challenges to medication procurement, leading to primary medication nonadherence (PMN). Limited research has evaluated rates and reasons for PMN within a specialty oncology population. Addressing PMN is essential to ensuring patient access and uptake and realizing benefits of these therapies. OBJECTIVES: The objectives of this study were to compute the rates of and reasons for PMN in patients prescribed oral oncology medications at an integrated health-system specialty pharmacy (IHSSP). METHODS: We performed a single-center, retrospective analysis of specialty oncology prescriptions electronically prescribed between January and December 2018. Data were extracted from electronic health record (EHR) and pharmacy claims databases. Prescriptions were PMN eligible if none of the following were met: fill of any cancer medication within the previous 180-day lookback window, duplicate prescription, cancellation within 30 days, rerouting to an external pharmacy within 30 days of prescribing, filled through alternate method, or nononcology or hematology condition. PMN was calculated by dividing eligible prescriptions unfilled during the study period by all eligible prescriptions. Reasons for a lack of prescription fulfillment were assessed via EHR review. Data were analyzed using descriptive statistics. RESULTS: We evaluated 4482 prescriptions from 1422 patients, resulting in 861 PMN-eligible prescriptions. Most PMN-eligible prescriptions (n = 668, 78%) were filled within 30 days, leaving 193 prescriptions as potential instances of PMN. After EHR review, 158 prescriptions met the exclusion criteria, resulting in a PMN rate of 4%. Of PMN prescriptions (n = 35), most were caused by clinical reasons (n = 22, 63%); however, 10 prescriptions were unfilled owing to patient decision, 2 owing to unaffordable treatment, and 1 owing to inability to reach the patient. Patients with PMN had a median age of 72 years and were mostly male (60%), with a median Charlson comorbidity index score of 7. CONCLUSION: Low rates of PMN to prescribed anticancer medications were found among electronic prescriptions intended to be filled at an IHSSP.

Adherence and persistence in patients with rheumatoid arthritis at an integrated health system specialty pharmacy.

BACKGROUND: Disease-modifying anti-rheumatic drugs (DMARDs) improve symptoms and delay progression of rheumatoid arthritis (RA), but adherence is often sub-optimal and many patients change medication (either "switching" to a medication with a different mechanism of action or "cycling" to a medication with the same mechanism of action) during the first year of therapy. Some integrated health-system specialty pharmacies embed pharmacists in clinics to help patients access and adhere to specialty medication. OBJECTIVE: This study assessed DMARD switching, cycling, adherence, and persistence at an outpatient rheumatology clinic with an integrated health-system specialty pharmacy. METHODS: We conducted a retrospective cohort study of adults with RA, naïve to biologic or targeted synthetic DMARDs, who filled ≥ 2 biologic or targeted synthetic DMARD prescriptions within 12 months. Adherence was measured using proportion of days covered (PDC); persistence was computed at 12 months. Univariate analyses compared adherence and persistence between patients with and without a medication change. Ordinal logistic regression examined whether PDC was associated with patient age, gender, race, insurance type, and medication change. RESULTS: We included 772 patients: 79% female/21% male, 89% White/11% non-White, median age 56 years (interquartile range = 48-63). Most patients (84%) did not change medication during the study period, 5% cycled medication one or more times (but did not switch), 9% switched medication one or more times (but did not cycle), and 2% of patients both switched and cycled during the study period. Median PDC of the sample was 0.94 and 73% of patients were persistent. Patients with a medication change had lower PDC than those without (0.89 vs 0.95, P = 0.004), but rate of persistence did not significantly differ between groups (77 vs 72%, P = 0.300). Odds of higher PDC was more likely for men (Odds ratio [OR] = 1.82, 95% confidence interval [CI]: 1.34-2.48, P < 0.001) and less likely for patients who changed medication (OR = 0.65, CI: 0.47-0.91, P = 0.011); age, race, and insurance type were not significant. CONCLUSIONS: Patients with RA demonstrated high medication adherence and persistence, and low rates of switching and cycling. Findings support evidence that integrated health-system specialty pharmacies with clinical pharmacists embedded in outpatient clinics help patients overcome barriers to medication adherence to persist on therapy. DISCLOSURES: This study was funded by Sanofi, Inc. James and J. Choi were employed by Sanofi, Inc., at the time of this study. Peter, Zuckerman, DeClercq, L. Choi, and Tanner, received research funding from Sanofi, Inc., for work on this study. Tanner has also received advisory board/speaker bureau fees from Pfizer, Regeneron, and Sanofi-Aventis. This study was presented as a poster at AMCP Nexus in October 2019 at National Harbor, MD.

Development, implementation, and evaluation of a health outcomes and research program at an integrated health-system specialty pharmacy.

PURPOSE: Health-system specialty pharmacies (HSSPs) provide high-quality, efficient, and collaborative care to patients receiving specialty therapy. Despite proven benefits of the integrated model, manufacturer and payer restrictions challenge the viability and utility of HSSPs. Vanderbilt Specialty Pharmacy developed a health outcomes and research program to measure and communicate the value of this model, drive improvement in patient care delivery, and advocate for recognition of HSSP pharmacists' role in patient care. The purpose of this descriptive report is to describe the development and results of this program. SUMMARY: The health outcomes and research program began as an initiative for pharmacists to evaluate and convey the benefits they provide to patients, providers, and the health system. Early outcomes data proved useful in communicating the value of an integrated model to key stakeholders and highlighted the need to further develop research efforts. The department leadership invested resources to build a research program with dedicated personnel, engaged research experts to train pharmacists, and fostered internal and external collaborations to facilitate research efforts. As of March 2021, the health outcomes and research program team has published 33 peer-reviewed manuscripts, presented 88 posters and 7 podium presentations at national conferences, and received 4 monetary research awards. Further, the program team engages other HSSP teams to initiate and expand their own health outcomes research in an effort to empower all HSSPs in demonstrating their value. CONCLUSIONS: The health outcomes and research program described has pioneered outcomes research among HSSPs nationwide and has proven valuable to specialty pharmacists, the health system, and key specialty pharmacy stakeholders.

Comparison of provider satisfaction with specialty pharmacy services in integrated health-system and external practice models: A multisite survey.

PURPOSE: The purpose of this study is to obtain insight into providers' satisfaction with services offered by health-system integrated specialty pharmacies and to determine whether providers' perceptions of services offered under an integrated model differ from perceptions of external specialty pharmacy services. METHODS: A multi-site, cross-sectional, online survey of specialty clinic healthcare providers at 10 academic health systems with integrated specialty pharmacies was conducted. The questionnaire was developed by members of the Vizient Specialty Pharmacy Outcomes and Benchmarking Workgroup and was pretested at 3 pilot sites prior to dissemination. Prescribers of specialty medications within each institution were identified and sent an email invitation to participate in the study that included a link to the anonymous questionnaire. Respondents were asked to rate their agreement with 10 statements regarding quality of services of integrated and external specialty pharmacies on a 5-point scale (1 = strongly disagree, 5 = strongly agree). An analysis to determine differences in providers' overall satisfaction with the integrated and external specialty pharmacy practice models, as well as differences in satisfaction scores for each of the 10 statements, was performed using paired-samples t tests. RESULTS: The mean (SD) score for overall satisfaction with integrated specialty pharmacies was significantly higher than the score for satisfaction with external specialty pharmacies: 4.72 (0.58) vs 2.97 (1.20); 95% confidence interval, 1.64-1.87; P < 0.001. Provider ratings of the integrated specialty pharmacy model were also higher for all 10 items evaluating the quality of services (P < 0.05 for all comparisons). CONCLUSION: The study results confirm that the health-system integrated specialty pharmacy practice model promotes high rates of provider satisfaction with services and perceived benefits.

Inclusion in limited distribution drug network reduces time to dalfampridine access in patients with multiple sclerosis at a health-system specialty pharmacy.

BACKGROUND: Dalfampridine improves walking speed in patients with multiple sclerosis (MS), but accessing specialty medications such as dalfampridine can be hindered by insurance restrictions, high costs, and limited distribution networks (LDNs) imposed by manufacturers. Some integrated health-systems specialty pharmacies (HSSPs) embed pharmacists in clinics and dispense medications from their internal pharmacies if included within the LDN. OBJECTIVE: To assess access to dalfampridine in patients at an HSSP before and after gaining admission to the LDN. METHODS: This study was conducted at Vanderbilt Specialty Pharmacy (VSP), an integrated HSSP at Vanderbilt University Medical Center (VUMC) with 2 clinical pharmacists embedded in the MS clinic. VSP gained access to the dalfampridine LDN on May 1, 2018, at which time the embedded pharmacists began to manage the comprehensive therapy initiation process. We performed a retrospective review of adult patients with MS who were prescribed dalfampridine from March 2010 to December 2018. Eligible prescriptions were new starts (no previous use) or restarts (after previous use and discontinuation). Prescriptions were classified as pre-VSP and post-VSP, which differentiates before and after VSP gained access to dispense dalfampridine. Study outcomes were insurance approval, initiation of therapy, and time from treatment decision to medication access. We used a proportional odds logistic regression model for time to medication access using the following covariates: pre-VSP versus post-VSP time period, insurance prior authorization (PA) denied versus approved/not needed, and baseline timed 25-foot walk. RESULTS: We included 262 patients and 290 prescriptions (260 pre-VSP and 30 post-VSP). In pre-VSP and post-VSP prescriptions, 97% were approved by insurance, and 93% of patients started therapy. Median time to medication access was 22 days (IQR = 11-45) for pre-VSP prescriptions and 1 day (IQR = 0-3) for post-VSP prescriptions. In the proportional odds logistic regression model, the odds of having a longer medication access time were significantly higher for pre-VSP prescriptions (OR = 83.219, P < 0.001) and prescriptions whose PA was initially denied (OR = 9.50, P < 0.001); 25-foot walk time was not significant (OR = 0.95, P = 0.277). CONCLUSIONS: After obtaining access to dispense dalfampridine, the time to access therapy was reduced, suggesting that LDNs delay patient access to therapy at HSSPs. DISCLOSURES: No funding was provided for this study. The authors have no conflicting interests to disclose. Preliminary results have been previously presented at the American Society of Health-Systems Pharmacy Midyear Meeting in December 2019, the Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit in August 2020, and the National Association of Specialty Pharmacy Annual Meeting in September 2020.

Rheumatoid arthritis medication adherence in a health system specialty pharmacy.

OBJECTIVES: To assess adherence to specialty medications for rheumatoid arthritis (RA) at an integrated health system specialty pharmacy (HSSP) and identify characteristics associated with adherence. STUDY DESIGN: Single-center, retrospective cohort study. METHODS: Study patients were adults with RA who filled at least 3 prescriptions for biologic disease-modifying antirheumatic drugs (bDMARDs) between July 1, 2016, and June 30, 2017, at an integrated HSSP. Data were collected from pharmacy claims and electronic health records. The primary outcome, adherence, was measured using proportion of days covered (PDC). Proportional odds logistic regression was used to test association between PDC and age, gender, race, insurance type, and out-of-pocket costs. RESULTS: We included 675 patients: 77% were female, 90% were White, 29% were naive to treatment at initial dispensing, 60% held commercial insurance, and the median age was 56 years. Median (interquartile range [IQR]) patient out-of-pocket cost per fill was $1.50 ($0-$5). Median (IQR) PDC was 0.95 (0.84-1.00); 80% of patients achieved PDC of 0.80 or higher. Higher adherence was more likely in patients who were male (odds ratio [OR], 1.58; 95% CI, 1.15-2.18; P = .005], naive to specialty medication treatment (OR, 3.04; 95% CI, 2.21-4.18; P < .001), and older in age (per 10 years: OR, 1.17; 95% CI, 1.04-1.32; P = .008), and adherence had a significant nonlinear association with average cost per fill (P = .006); associations with race and insurance type were not significant. CONCLUSIONS: At an integrated HSSP, patients with RA paid low out-of-pocket costs for bDMARD therapy and achieved high treatment adherence. Data suggest that integrated HSSPs assist patients in removing financial barriers to treatment.

Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial.

BACKGROUND: The effectiveness of specialty medications in complicated clinical conditions depends on adherence to therapy. However, specialty medications pose unique barriers to adherence. OBJECTIVE: This study aims to determine whether pharmacist interventions improve specialty medication adherence. METHODS: This is a single-center, pragmatic, randomized controlled trial ongoing since 10 May 2019 at an integrated health system specialty pharmacy. This study evaluates usual care compared with usual care plus patient-tailored adherence interventions. Study design and procedures were informed by focus groups with patients and specialty pharmacists. Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC) < 90% in the previous 4 months are identified by a daily query of the electronic pharmacy database. A pharmacist reviews these patients' electronic health records to identify and exclude ineligible patients. Eligible patients are randomized evenly to the control or intervention arm and stratified by historical clinic nonadherence rates. Patients randomized to the intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons. Interventions and follow-up are provided at the discretion of the intervening pharmacist. The primary outcome is PDC calculated at 8 months post-enrollment. Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum. DISCUSSION: This trial will evaluate the effect of patient-tailored interventions on specialty medication adherence and will inform how often and why patients are misidentified as nonadherent. REGISTRATION: The trial was deemed a quality improvement initiative by the Vanderbilt University Institutional Review Board. It was registered in ClinicalTrials.gov (NCT03709277) on 17 October 2018.

Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial.

BACKGROUND: The effectiveness of specialty medications in complicated clinical conditions depends on adherence to therapy. However, specialty medications pose unique barriers to adherence. OBJECTIVE: This study aims to determine whether pharmacist interventions improve specialty medication adherence. METHODS: This is a single-center, pragmatic, randomized controlled trial ongoing since 10 May 2019 at an integrated health system specialty pharmacy. This study evaluates usual care compared with usual care plus patient-tailored adherence interventions. Study design and procedures were informed by focus groups with patients and specialty pharmacists. Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC) < 90% in the previous 4 months are identified by a daily query of the electronic pharmacy database. A pharmacist reviews these patients' electronic health records to identify and exclude ineligible patients. Eligible patients are randomized evenly to the control or intervention arm and stratified by historical clinic nonadherence rates. Patients randomized to the intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons. Interventions and follow-up are provided at the discretion of the intervening pharmacist. The primary outcome is PDC calculated at 8 months post-enrollment. Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum. DISCUSSION: This trial will evaluate the effect of patient-tailored interventions on specialty medication adherence and will inform how often and why patients are misidentified as nonadherent. REGISTRATION: The trial was deemed a quality improvement initiative by the Vanderbilt University Institutional Review Board. It was registered in ClinicalTrials.gov (NCT03709277) on 17 October 2018.

Development of quality measures for use of self-injectable biologic therapy in inflammatory bowel disease: An integrated specialty pharmacy initiative.

PURPOSE: The development of a tool to measure medication safety, therapeutic efficacy, and other quality outcomes in patients receiving self-injectable biologic therapy for the management of inflammatory bowel disease (IBD) at a health-system specialty pharmacy is described. SUMMARY: Through a collaborative initiative by pharmacists, gastro-enterologists, and representatives of a pharmacy benefit manager and a pharmaceutical company, a set of clinical and specialty pharmacy quality measures was developed. The clinical measures are intended for use in assessing patient safety, disease status, treatment efficacy, and healthcare resource utilization during 3 assessments (pre-treatment, on-treatment, and longitudinal). The specialty pharmacy measures can be used to assess medication adherence, medication persistence, specialty pharmacy accreditation, and patient satisfaction. The proposed quality measures provide a foundation for evaluating the quality of IBD care and improving patient outcomes within a health-system specialty pharmacy. Future efforts to validate and implement the tool in clinical practice are planned. CONCLUSION: The proposed quality measures provide a foundation for future inquiry regarding the appropriateness and feasibility of integrating the measures into clinical care. Further work is needed to implement and validate these quality measures and determine their impact in optimizing health outcomes.