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Background Increasing the number of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) providers expands PrEP access to more eligible patients to help end the HIV epidemic. Previous studies have noted providers perceive financial barriers as a limitation to prescribing PrEP. Objective Describe PrEP medication access and affordability in patients seen at a multidisciplinary PrEP clinic. Method We conducted a single-center, retrospective, cohort study of adults initiating tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in the Vanderbilt PrEP Clinic between 9/1/2016 and 3/31/2019 with prescriptions filled by Vanderbilt Specialty Pharmacy. Data were gathered from the electronic health records and pharmacy claims. We evaluated three different time periods: initial evaluation to PrEP initiation, prescription of PrEP to insurance approval, and insurance approval to initiation. Treatment initiation was considered delayed when >7 days from initial evaluation, and reasons for delay were recorded. Continuous variables are presented as median (interquartile range, IQR) and categorical variables are presented as percentages. Results We included 63 patients; most were male (97%), White (84%), commercially insured (94%) with a median age of 38 years (IQR 29—47). Primary indication for PrEP was men who have sex with men at high risk for acquiring HIV (97%). Median time from initial appointment to treatment initiation was 7 days (IQR 4—8). Treatment delays occurred in 25% of patients and were mostly driven by patient preference (50%). Insurance prior authorization was required in 27% of patients; all were approved. Median total out-of-pocket medication costs for the entire study period were $0 (IQR $0 – $0). Most patients (86%) used manufacturer copay cards. Conclusion In this cohort of mostly commercially insured men, the majority were able to access PrEP with low out-of-pocket costs facilitated by manufacturer assistance. Though generalizability beyond this population is limited, these results contradict perceived financial barriers to PrEP access.

Background Emerging data supports expanding the solid organ donor pool with transplantation from hepatitis C virus (HCV)-positive donors into HCV-negative recipients. However, concerns exist regarding the ability to access direct-acting antivirals (DAAs) post-transplant in a real-world setting. Methods This single-center, retrospective study evaluated DAA access rates, time to first dose, and patient cost in donor-derived HCV solid-organ transplant recipients utilizing an integrated specialty pharmacy process. Results Among 91 patients, all accessed DAAs through prescription insurance (97%) or patient assistance programs (3%). Of those who received DAAs through insurance, only 65% received approval on initial insurance submission. Median time from transplant to first dose was 45d [IQR 34–66]. The on-site specialty pharmacy was used by 69% of patients. Copay assistance programs reduced the median monthly patient cost from $1914 [range $7-7536] to $0 [range $0–5]. Conclusion Our findings indicate that access to DAAs in donor-derived HCV post-transplant is achievable and affordable; however, significant added administrative efforts may be required for insurance approval as well as obtaining copay assistance, which is a limited resource.

PURPOSE: Abiraterone and enzalutamide are commonly used oral cancer therapies for patients with prostate cancer, both with potentially high out-of-pocket costs for patients. We investigated the prevalence of financial assistance mechanisms used to alleviate out-of-pocket costs and the association of these mechanisms with timing of treatment initiation of abiraterone or enzalutamide. METHODS: Using data from the medical center's specialty pharmacy, we identified first prescriptions for abiraterone or enzalutamide between January 1, 2017, and March 31, 2019. Prescriptions dispensed at an external pharmacy or that were discontinued for reasons unrelated to cost were excluded. Patient demographics, insurance coverage, out-of-pocket cost, and number of days between prescribed date and pill-to-mouth date were collected. RESULTS: Among 220 prescriptions in our final cohort, 185 were filled through our internal specialty pharmacy, 23 through a manufacturer-sponsored patient assistance program (PAP), and 12 were never filled because of cost. One third of the prescriptions in our final cohort (n = 66) were filled with financial assistance: PAP (10%), copay cards (9%), and grants (11%). The median amount of assistance received for the first fill was $2,860 US dollars (USD) (interquartile range $1,856-$10,717 USD). Prescriptions with an out-of-pocket cost < $100 USD were filled in the shortest time (median 5 days), whereas those filled through a PAP had the longest time to initiation (median 30.5 days). CONCLUSION: Among patients prescribed oral therapies for prostate cancer at a single institution, one third of patients received financial assistance. Although receiving assistance is likely to improve financial toxicity, waiting for assistance may lead to longer time to initiation of medication.

Introduction Oral chemotherapy agents are a growing area of oncology treatment, but some are associated with a high incidence of hypertension. Management of hypertension in oncology patients may be insufficient due to a variety of reasons. A pharmacist-led hypertension management service within the specialty pharmacy setting has the potential to help patients on oral chemotherapy achieve and maintain adequate blood pressure control. The objective of this study was to assess the impact of a pharmacist-led hypertension management program on the blood pressure control of patients on oral chemotherapy. Methods This retrospective, single-center study compared data from two groups of patients receiving oral chemotherapy agents from a health systems specialty pharmacy within an academic medical center, before and after the establishment of a pharmacist-led hypertension management program. Results Twenty-one of 50 (0.42) patients in the control group had blood pressure overall at goal, compared to 19 of 29 (0.66) patients in the intervention group who had blood pressures at goal at the end of the specified 3-month time period (p = 0.04). In cases where a pharmacist intervention was necessary per the hypertension management program's protocol, the rate of provider acceptance of recommendations regarding modifying or initiating antihypertensive therapy was high. Conclusion When followed with a pharmacist-led hypertension management program, patients on oral chemotherapy showed improved blood pressure control and reduced mean blood pressure readings over time.

Background Processes such as prior authorization (PA) for medications, implemented by health insurance companies to ensure that safe, appropriate, cost-effective, and evidence-based care is provided to all members, have created inefficiencies within healthcare systems. Thus, healthcare systems have implemented supplemental processes to reduce burden and ensure efficiency, timeliness, and appropriate care. Objective Evaluate implementation outcomes of two initiatives related to PA for medications: a common record that records all PA-related information that was integrated into the health record and an auto-routing of specialty prescriptions to a hospital-owned specialty pharmacy. Methods We conducted semi-structured interviews with medical staff to understand their experience, acceptability, adoption, and feasibility of these initiatives guided by Proctor’s Framework for Implementation Outcomes. Transcripts were analyzed using consensus coding. Results Eleven medical staff participated in semi-structured interviews. The two initiatives were analyzed together because the findings were similar across both for our outcomes of acceptability, adoption, and feasibility. Participants found the implemented initiatives to be acceptable and beneficial but felt there were still challenges with the new workflow. The initiatives were fully adopted by only one clinic site within the healthcare system, but limitations arose when adopting to another site. Individuals felt the initiatives were feasible and improved workflow, communication, and transparency. However, participants described future adaptations that would help improve this process including improved standardization, automation, and transparency. Conclusion The acceptability, adoption, and feasibility of two initiatives to improve the PA process within the one clinical site were well received but issues of generalizability limited the initiatives adoption system wide.

Treprostinil is a prostacyclin approved for the treatment of pulmonary arterial hypertension. Commercial data sets indicate that approximately 20–25% of patients are prescribed a higher dose than the maximum recommended dosage of nine breaths per treatment session (bps) (54 μg), four times a day (QID) and numerous studies have demonstrated the safety of doses >9 bps QID. This phase 4, retrospective analysis of specialty pharmacy records assessed the effects of inhaled treprostinil at doses >9 bps QID. Patients receiving inhaled treprostinil between September 2009 and June 2018 were included, and a random sampling of 5000 patients was selected for further analysis. Subjects were grouped based on the highest dose reached for ≥2 months within a rolling six-month window and were followed for up to three years. Of the total of 5000 patients analyzed, 28.5% received >9 bps QID. Survival rates were significantly higher in the >9 bps QID dosing group for years one, two, and three ( P 9 bps (17.5 months) compared to doses ≤9 bps (9.5 moths; P 9 bps at years 1, 2, and 3 ( P 9 bps QID had a higher rate of survival and drug persistence over a three-year period, suggesting that higher doses may provide clinically relevant benefits while remaining tolerable.

BACKGROUND: Direct-acting antiviral (DAA) regimens for hepatitis C virus (HCV) have varying potentials for drug-drug interactions (DDIs). OBJECTIVES: To (1) identify prevalence of potential DDI with glecaprevir-pibrentasvir (GLE-PIB) and sofosbuvir-velpatasvir (SOF-VEL) and (2) describe health care provider actions in response to pharmacist recommendations based on potential interactions with GLE-PIB or SOF-VEL, using 2 complementary data sources. METHODS: Possible interacting drugs were identified among adult patients in a United States electronic medical record database covering 21 health care organizations and 26 million patients in 2018. DDIs were categorized as potential weak interaction (Level 1), potential interaction (Level 2), or contraindicated (Level 3). Real-world recommendations and resultant actions regarding DDIs with GLE-PIB and SOF-VEL were obtained from a specialty pharmacy database. Categorical variable comparisons were done via chi-square analysis with subsequent z-tests of column proportions. RESULTS: DDI prevalence was higher for patients prescribed GLE-PIB (317/769 [41%]) compared with those prescribed SOF-VEL (170/633 [27%]), and the prevalence of a Level 3 (contraindicated) interaction was higher with GLE-PIB than SOF-VEL (61/769 [8%] vs 2/633 [< 1%]). Across all DDI levels, analgesics (139/317 [44%]), proton-pump inhibitors (129/317 [41%]), and lipid-lowering agents (59/317 [19%]) were the top drug classes for the GLE-PIB group with potential for DDI. For SOF-VEL prescribed patients, the top drug classes were proton-pump inhibitors (83/170 [49%]), histamine-2 blockers (42/170[25%]), and lipid-lowering agents (42/170 [25%]). In real-world care management, the overall prevalence of pharmacist recommendations regarding DDIs was significantly lower for SOF-VEL (28/419 [7%]) relative to GLE-PIB (151/1,216 [12%]). Recommended guidance from pharmacists was not followed for 39% (69/179) of patients, 36% (54/151) for GLE-PIB, and 54% (15/28) for SOF-VEL. CONCLUSIONS: The potential for DDIs with pangenotypic HCV DAAs is frequent and may be more frequent with GLE-PIB than SOF-VEL. Physician responses to pharmacist alerts regarding potential interaction can be highly variable, even in cases of contraindication. DISCLOSURES: Funding for this study was provided by Gilead Sciences, Inc. Trio Health Analytics received funding from Gilead Sciences, Inc., to conduct research for this study. Tsai consults for and has received grants and honoraria from Gilead, AbbVie, Merck, and Bristol Myers Squibb; he has also received lecture fees from Gilead and AbbVie. Curry consults for Trio Health Analytics and Gilead and has also consulted for and received grants from Mallinckrodt. Flamm consults for and has received lecture fees from Gilead and AbbVie; he has also received grants from Gilead and AbbVie. Milligan and Wick are employed by Trio Health Analytics and have received research support from Gilead, Merck, and AbbVie. Younossi has received grants from Gilead, Intercept, Bristol Myers Squibb, GlaxoSmithKline, and Novo Nordisk. Afdhal is a paid consultant/advisory board member for Gilead, Echosens, Ligand, Shionogi, and Trio Health; owns stock in Spring-Bank and Allurion and has stock options in SpringBank; receives royalty income from UpToDate; and is on the board of directors for the nonprofit Liver Institute for Education and Research. Data from this study were presented at the American Association for the Study of Liver Disease (AASLD) Liver Meeting 2019; November 8-12, 2019; Boston, MA, and the European Association for Study of the Liver (EASL) International Liver Congress 2020; August 27-29, 2020; virtual.

Purpose Results of the first ASHP National Survey of Health-System Specialty Pharmacy Practice are presented. Methods A sample of 230 leaders in health-system specialty pharmacies were contacted by email and invited to participate in a survey hosted using an online survey application. The survey sample was compiled from ASHP member lists, through review of data from other ASHP surveys indicating the presence of specialty pharmacies, and by outreach to ASHP member organizational leaders. Results The response rate was 53.0%. Most health-system specialty pharmacies dispense 30,000 or fewer specialty prescriptions per year, have an annual revenue of $100 million or less, are part of an entity eligible to participate in the 340B Drug Pricing Program, operate 1 specialty pharmacy location, have at least 1 specialty pharmacy accreditation, dispense nonspecialty medications in addition to specialty medications, and employ an average of 13 pharmacists and 15 technicians. More than two-thirds of health-system specialty pharmacies (68.8%) dispense no more than half of the prescriptions written by their providers due to payer network restrictions or limited distribution drugs. The health-system specialty pharmacy practice model includes access to the electronic health record (100% of respondents), pharmacists and technicians dedicated to specific clinics (64.9% and 57.7%, respectively), specialty pharmacist involvement in treatment decisions and drug therapy selection prior to the prescription being written (64.9%), and documenting recommendations and progress notes in patients’ electronic health record (93.4%). Most health-system specialty pharmacies (83.3%) offer experiential or formal education in specialty pharmacy. Top challenges that survey respondents expected to face in the next year included restricted access to payer networks and limited distribution drugs, 340B Drug Pricing Program changes, and shrinking reimbursement from payers. Conclusion The health-system specialty pharmacy represents an integrated advanced practice model that incorporates specialty medication-use management across the continuum of care.

BACKGROUND Cystic fibrosis (CF) patients who grow Pseudomonas aeruginosa on respiratory culture are commonly prescribed inhaled tobramycin (TIS) to eradicate the organism. The objective of this study was to determine the impact of a pharmacy technician/pharmacist team, in conjunction with an integrated health-system specialty pharmacy (IHSSP), on the time from positive culture to prescribing and access to TIS in a pediatric CF clinic. METHODS A retrospective study of CF patients positive for P. aeruginosa who were prescribed TIS for eradication. RESULTS The study included 20 patients in the pregroup and 42 patients in the postgroup. Total median (interquartile range) days from positive culture to TIS being shipped to the patient from the pharmacy was significantly different: 15 (10.25-21) days in the pregroup and 9 (7-14) days in the post groups (p = .005). The time from positive culture to TIS prescribing was significantly different: 6 (5-12.75) days in the pregroup and 5 (3.75-6) days in the postgroup (p = .01). In the postgroup median time from prescription to the patient receiving the TIS was significantly different between the two groups 2 (2-5) days IHSSP group versus 6 (3-9) external specialty pharmacy group (p = .003). Time from prescription to prior authorization approval was the same in both groups. CONCLUSIONS The addition of the pharmacy team reduced time from culture to TIS being received by the patient. Patients able to fill at the IHSSP received their medication sooner than an external specialty pharmacy. The study shows the benefit of an integrated pharmacy model in conjunction with an IHSSP.

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, naive 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.

Introduction In 2015, Boehringer Ingelheim (BI) created a support program for patients with idiopathic pulmonary fibrosis (IPF) treated with nintedanib, to help patients obtain their prescription, learn about their disease and medication, and provide support in the management of their IPF. The purpose of this study was to measure the impact of the program on nintedanib persistence among patients with IPF newly treated with the medication. Methods A retrospective cohort analysis of BI Pharmaceuticals, Inc.’s Specialty Pharmacy (SP) database was conducted. Patients at least 18 years of age, newly treated with nintedanib from April 1, 2015 to January 31, 2018, and with at least one diagnosis of IPF were included in the study; earliest nintedanib prescription was the index date. Patients were classified into two mutually exclusive cohorts: enrolled in the patient support program within 60 days of index or not enrolled in the program at any time. The cohorts were compared in terms of patient characteristics, time to nintedanib discontinuation (a gap of more than 60 days between refills), and proportion of persistent patients at 6, 12, 18, and 24 months after index. Time to discontinuation was compared between the cohorts using Kaplan–Meier analysis. A multivariable Cox proportional hazards model assessed the impact of program participation on time to discontinuation within the first 12 months. Results A total of 3114 enrolled and 9388 non-enrolled patients were identified. The proportion of patients persistent on nintedanib was higher among enrolled patients throughout the post-index period (57.8% vs. 49.7% at 6 months, 34.7% vs. 28.9% at 12 months; p

Background There have been significant advances in Cystic Fibrosis (CF) treatment, with the introduction of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulators. Adherence is an important goal for CF management, as nonadherence is linked to poor health outcomes. Objective To calculate the medication adherence in patients taking CFTR modulators using a national specialty pharmacy database. Methods This retrospective observational cohort study utilized de-identified specialty pharmacy data from September 2017 to August 2018 to assess medication adherence for three CFTR modulators: ivacaftor, lumacaftor/ivacaftor, and tezacaftor/ivacaftor & ivacaftor. The primary outcome was proportion of days covered (PDC) for each medication, with mean PDC values compared across age groups and insurance characteristics. All analyses were performed using the SAS 9.4 University Edition (SAS Institute, Cary, NC). Results A total of 2,548 patients were analyzed, including 1,289 (50.59%) patients on lumacaftor/ivacaftor, 784 (30.77%) on ivacaftor, and 475 (18.64%) on tezacaftor/ivacaftor & ivacaftor. The mean PDC value for all CFTR modulators was above 0.80. Tezacaftor/ivacaftor & ivacaftor had the highest overall PDC of 0.92, while PDC values for both lumacaftor/ivacaftor and ivacaftor were 0.84. Children/adolescents on lumacaftor/ivacaftor (p = 0.0001) and tezacaftor/ivacaftor & ivacaftor (p = 0.001) had significantly higher mean PDC values compared to adults but not for ivacaftor (p = 0.3744). No statistical differences were seen in PDC across insurance characteristics. Conclusion To the best of our knowledge, this is the first study to assess the adherence of three CFTR modulators using a large nationwide specialty database. With high acquisition costs of CFTR modulator therapies, there is a need to improve rates of adherence in patients with CF.

BACKGROUND: The economic burden of food allergy is large; however, costs specific to individuals with peanut allergy experiencing reactions to peanuts remain to be evaluated. As the prevalence of peanut allergy continues to increase in children, a better understanding of the cost of care is warranted. OBJECTIVE: To assess the cost of care of peanut allergy among privately insured and Medicaid-insured pediatric patients in the United States. METHODS: This retrospective matched-cohort study included patients aged 4-17 years from the Optum Health Care Solutions and Medicaid Claims databases (January 1, 2007-March 31, 2017). Patients were classified into 2 cohorts: peanut allergy (with peanut allergy diagnosis codes and reactions triggering health care resource utilization [HRU]) and peanut allergy-free (no peanut allergy diagnosis codes in claims). Peanut allergy patients were matched 1:10 to peanut allergy-free patients based on baseline covariates. Comorbidities including anxiety and depression, HRU, and direct health care costs were compared between cohorts and reported for both perspectives separately. RESULTS: Compared with peanut allergy-free patients (n = 30,840 privately insured; n = 12,450 Medicaid), peanut allergy patients (n = 3,084 privately insured; n = 1,245 Medicaid) had higher prevalence of asthma, atopic dermatitis/eczema, other food allergies, allergic rhinitis, depression, and anxiety (all P < 0.01). Peanut allergy patients had higher HRU per patient per year (PPPY), including 90% more emergency department visits among both privately insured and Medicaid patients (P < 0.01) and higher direct health care costs PPPY, with incremental costs of $2,247 total or $1,712 excluding asthma-related costs for privately insured patients and $2,845 total or $1,844 excluding asthma-related costs for Medicaid patients (all P < 0.01). CONCLUSIONS: Pediatric patients in the United States with peanut allergy and reactions triggering HRU had significantly higher comorbidity burdens, HRU, and direct health care costs, regardless of asthma-related costs, versus those without peanut allergy. DISCLOSURES: This study was funded by Aimmune Therapeutics, a Nestle Health Science company. The study sponsor was involved in several aspects of the research including the study design, the interpretation of data, the writing of the manuscript, and the decision to submit the manuscript for publication. Yu and Tilles are employees of Aimmune Therapeutics, a Nestle Health Science company. Robison and Norrett were employees of Aimmune Therapeutics at the time this study was conducted. Blaiss, Meadows, and Hass provided paid consulting services to Aimmune Therapeutics. Guerin and Latremouille-Viau are employees of Analysis Group, a consulting company that provided paid consulting services to Aimmune Therapeutics. Parts of the results were presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting held March 25-28, 2019, in San Diego, CA, and at the ISPOR Annual Meeting held May 18-22, 2019, in New Orleans, LA.

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.

OBJECTIVES: Poly(ADP-ribose) polymerase (PARP) inhibitors are expensive and their use is expanding. We aimed to evaluate cost sharing patterns between patients, payors, and financial assistance programs. METHODS: We identified ovarian cancer patients prescribed a PARP inhibitor from 5/2015–9/2019 using our pharmacy database. Cost information was collected for patients who filled their prescription at our specialty pharmacy. We calculated descriptive statistics for monthly PARP inhibitor costs for patients, payors, and financial assistance programs. We used Wilcoxon rank sum tests to evaluate monthly costs based on insurance characteristics. RESULTS: Seventy-six patients filled 94 different PARP inhibitor prescriptions with 42 (45%) prescriptions obtained using any type of financial assistance program. We analyzed 232 prescription months for the 41 prescriptions with available cost data. This included 18 (44%) prescriptions for rucaparib, 18 (44%) for niraparib, and 5 (12%) for olaparib. The total monthly drug cost was average $12,422 and median $13,700. The monthly out-of-pocket (OOP) cost for patients was average $46 and median $0 (IQR $0–4). Payors had the highest monthly costs with average $12,019 and median $13,662 (IQR $9,914–14,709). Financial assistance programs contributed average $358 and median $0 per month (IQR $0–150). Patients with public (p

OBJECTIVE The lack of randomized controlled trials comparing biologics for the treatment of juvenile idiopathic arthritis (JIA) has led to wide variation in treatment approaches. The objective of this study is to compare the efficacy and safety of abatacept, adalimumab, and etanercept in JIA patients treated at a tertiary pediatric institution. METHODS This was a single-center, retrospective chart review of patients initiated on abatacept, adalimumab, or etanercept from December 1, 2015, to August 31, 2018, at Monroe Carell Jr. Children's Hospital at Vanderbilt (VCH). The primary outcome was the change in the Physician Global Assessment (PGA) score after 4 to 6 months of biologic therapy. Secondary outcomes included change in laboratory markers of JIA disease activity, change in the number of joints with active disease or limitation of motion, reduction in corticosteroid dose, adverse effects, adherence among patients who have their medications filled at the institution's specialty pharmacy, and reason for discontinuation of therapy. RESULTS A total of 139 patients were included, with a median age of 13 years. Most patients, 80.6%, experienced a reduction in their PGA score after starting biologic therapy. There was not a statistically significant difference among the agents (p = 0.64). Adverse effects were reported in only 26.6% of patients, with the most frequent being injection site reactions or pain (n = 35). Ultimately, 32% of patients discontinued biologic therapy with a lack of efficacy being the most common reason. CONCLUSIONS Abatacept, adalimumab, and etanercept were not significantly different in efficacy and safety for the treatment of JIA at this single institution.

Introduction Oral chemotherapy agents have become increasingly common for the treatment of various malignancies, specifically in the metastatic setting. In metastatic breast cancer, oral chemotherapy is now considered the standard of care for first-line treatment due to progression-free survival and overall survival benefits. Oral agents are also considered to be a convenient and less toxic therapy option, improving quality of life. However, these benefits are offset by challenges in the delay to initiation of therapy, adherence, and toxicity management which may lead to high co-pays, delays in treatment, increased clinic visits, and non-adherence. These issues can be augmented at a safety net hospital charged to care for the most vulnerable patients. Close monitoring and follow-up are critical but can be complex and pose an additional burden on the treating oncologist. Pharmacists can serve as an extender to the oncologist and may help mitigate many of these clinical and operational barriers through adherence strategies, toxicity management, care coordination, and optimization of dosing schedules and regimens. Methods/Materials We conducted a quality improvement (QI) initiative aimed to decrease the average number of treatment day delays experienced by patients receiving oral chemotherapy for the treatment of MBC during the first six cycles of chemotherapy. A secondary aim was to improve adherence and patient-provider satisfaction. A protocol was designed and implemented utilizing pharmacists to provide assistance with obtaining the medications through a specialty pharmacy, oral chemotherapy counseling, toxicity assessments, and strategies to help optimize oral adherence (OPTIMAL protocol). Pharmacists conducted live in-person visits and telemedicine visits at weekly to monthly intervals to supplement the ongoing routine care of the oncology provider. All treatment and supportive care recommendations, in addition to any identified barriers, were communicated to the provider. Results A baseline assessment of 63 patients receiving oral oncolytic therapy from December 1st, 2018 through November 26th, 2019 was completed. Patients experienced most delays during cycle 1, with an average of 14.5 days of delay (range 1 - 34 days). The most common reasons for delay throughout the first six cycles of therapy were toxicity development, receipt of medication from the pharmacy, and patient adherence. A separate analysis of patients on CDK4/6 inhibitors (n=8) identified an average treatment day delay of 7.7 days (range 3.2 - 15.3 days) during the first six cycles of chemotherapy. Over a 7-month period, fifteen patients were enrolled in the OPTIMAL protocol and experienced an average treatment day delay of 2.9 days (range 0 - 6.8 days) during the first six cycles. Pharmacists made 206 documented interventions amongst the patients on the protocol, encompassing medication reconciliations, therapy counseling, and clinical recommendations. Eleven patients reported treatment-related toxicities, resulting in six therapy modifications and two-dose modifications. Four patients experienced progression on oral oncolytic therapy and subsequently went on to other treatment options. Conclusion Our protocol to incorporate pharmacists in initial and follow-up clinic visits at an outpatient breast cancer clinic within a safety net hospital was associated with decreased treatment day delays. Pharmacists performed a large number of meaningful clinical and operational interventions to facilitate medication treatment in a, particularly vulnerable population. This intervention supports the valuable and versatile role pharmacists can play in co-managing patients with the rest of the healthcare team. Citation Format: Jasmine Patel, David Michael Hughes, Kathryn Quinn, Tsion Fikre, Naomi Ko. Effect of an outpatient pharmacy team to improve management and adherence to oral chemotherapy [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS13-26.

Introduction Gleevec, Imatinib mesylate, is the first in class BCR-ABL tyrosine kinase inhibitor initially approved to treat CML. In February 2016, generic imatinib products became available. As generic products are not required to offer comparative efficacy and safety data, differences may arise. Small reports have found no significant differences in response durability and tolerability in patients transitioned from Gleevec to generic imatinib. Further, lower cost of generic products often influence treatment decisions and patient compliance. We sought to evaluate response durability, tolerability, financial costs, and adherence in patients with chronic phase CML (cpCML) who switched from Gleevec to generic imatinib and newly diagnosed cpCML patients initiated on generic imatinib. Methods We conducted a single-center, retrospective chart review of adult patients who received imatinib therapy for cpCML between June 1, 2015 to November 14, 2019. Patients who received ≥6 months of brand through the Specialty Pharmacy Service (SPS) at Atrium Health prior to switching to generic were included in Group 1 (Switch). Patients who initiated therapy with generic imatinib dispensed from SPS were included in Group 2 (New Start). Durability of response was described determined via peripheral blood BCR-ABL transcripts by PCR and reported major molecular response (MMR) after 12 months generic imatinib therapy. Additional factors characterizing the durability and tolerability of therapy included adverse effects due to drug, dose modifications, adherence rate, prescription cost per month, and frequency of switch between generic products. Results Of 298 patients assessed, 12 patients were evaluable. There were 7 Switch patients and 5 New Start patients. Figure 1. All 12 patients met WHO diagnostic cpCML criteria. No patients in either group had accelerated or blast phase CML, no patients received maintenance imatinib following allogeneic HCT. In the Switch Group, 4 patients (57%) achieved MMR after 12 months of generic therapy. Of the 3 patients that did not achieve MMR, 1 patient relocated prior to 12-month assessment, 1 patient was noted to be non-compliant, and 1 patient had several treatment delays and dose reductions due to toxicities. 1 New Start patient achieved MMR at 12 months. Of those not achieving MMR, 1 was started on a reduced dose (100 mg /day) due to renal dysfunction, 1 had a PDC of 49.10% due to treatment delays while receiving treatment for a different malignancy, and 2 patients had logarithmic decreases in BCR-ABL but had not crossed the MMR threshold after 12 months of therapy. 5 Switch patients (71.4%) reported at least 1 adverse effect related to therapy, 3 of these (42.9%) required dose reduction. The adverse effects requiring dose reductions in the New Start patients included thrombocytopenia (n=2) and myalgia (n=1). All New Start patients reported at least 1 adverse effect with none of these patients requiring a dose reduction. Cost stayed the same or was reduced for 85.7% of the Switch patients, 1 patient experienced a cost increase and did not have co-pay assistance, and 2 patients received copay assistance. Cost of generic therapy was 90% after 12 months on generic therapy for 71.4% Switch patients and 80% New Start patients. Table 1. and Table 2. Conclusion Patients with cpCML switched from brand to generic imatinib and patients newly started on generic imatinib appear to have durable responses and tolerance to generic imatinib. Dose reductions and non-adherence may have contributed to inadequate disease control in patients not achieving MMR in both groups. Patients switched from brand to generic imatinib may develop new side effects necessitating dose reduction. Thrombocytopenia may be more common in patients switched from brand to generic imatinib. Adherence to brand and generic imatinib is high and medication is affordable with most patients paying Disclosures Knight: Foundation for Financial Planning: Research Funding. Ai:Celgene: Speakers Bureau; Incyte: Speakers Bureau. Grunwald:Premier: Consultancy; Astellas: Consultancy; Janssen: Research Funding; Merck: Research Funding; Janssen: Research Funding; Forma Therapeutics: Research Funding; Forma Therapeutics: Research Funding; Astellas: Consultancy; Premier: Consultancy; Trovagene: Consultancy; Trovagene: Consultancy; Daiichi Sankyo: Consultancy; Astellas: Consultancy; Daiichi Sankyo: Consultancy; Trovagene: Consultancy; Abbvie: Consultancy; Abbvie: Consultancy; Agios: Consultancy; Daiichi Sankyo: Consultancy; Agios: Consultancy; Abbvie: Consultancy; Merck: Consultancy; Merck: Consultancy; Agios: Consultancy; Amgen: Consultancy; Amgen: Consultancy; Cardinal Health: Consultancy; Merck: Consultancy; Cardinal Health: Consultancy; Pfizer: Consultancy; Amgen: Consultancy; Pfizer: Consultancy; Cardinal Health: Consultancy; Celgene: Consultancy; Celgene: Consultancy; Pfizer: Consultancy; Incyte: Consultancy, Research Funding; Incyte: Consultancy, Research Funding; Celgene: Consultancy; Incyte: Consultancy, Research Funding; Genentech/Roche: Research Funding; Premier: Consultancy; Genentech/Roche: Research Funding; Genentech/Roche: Research Funding; Forma Therapeutics: Research Funding. Avalos:Juno: Membership on an entity's Board of Directors or advisory committees; Best Practice-Br Med J: Patents & Royalties: receives royalties from a coauthored article on evaluation of neutropenia. Copelan:Amgen: Membership on an entity's Board of Directors or advisory committees. Chojecki:Novartis: Other: Investigator Meeting Attendance; Incyte: Research Funding.

BACKGROUND Cystic fibrosis (CF) is a genetic disease requiring patients to take multiple medications per day. Multiple barriers exist affecting access and adherence. Studies have demonstrated the positive outcomes of pharmacist involvement in CF care. The purpose of this study is to characterize the impact of pharmacy technicians on medication access in the care of CF patients. METHODS A retrospective review and analysis of patient medication profiles for patients followed by the integrated pharmacy care process model was performed. Two electronic prescription pathways with pharmacy technician involvement were analyzed. One pathway using a specialty pharmacy CF pharmacy technician (SP technician) examined CF specialty medication delivery times. The other pathway examined the impact of the clinic-based CF pharmacy technician (CB technician) on the number of filling pharmacies for patients. RESULTS One-hundred and fifty-three patients met inclusion criteria in the CF specialty medication delivery analysis, and 56 patients met inclusion criteria filling pharmacy analysis. The median delivery time for dornase alfa decreased from 8 days to 3 days, p

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)

PurposeTo describe clinical pharmacy specialists’ role in improving the use of specialty medications within a pediatric outpatient setting.SummaryThe 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.ConclusionAn 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.

Johns Hopkins Specialty Pharmacy Services recognized the need to identify and develop standardized collection methods for clinical outcome measures (COMs) to demonstrate program quality and value to third-party payers, manufacturers, and internal stakeholders.To define specialty COMs and develop a framework for standardized data collection and reporting.COMs for specialty pharmacy disease states (cystic fibrosis; hepatitis C; inflammatory conditions in dermatology, gastroenterology and rheumatology; and multiple sclerosis) were identified through a literature search, collaboration with specialty pharmacists, and committee review. Once identified, these measures were distributed to internal and external stakeholders that included specialty clinic team members, drug manufacturers, and third-party payers for input and validation. A standardized process for discrete documentation and data collection of these measures was implemented using case management software, electronic medical record integration, and informatics support.28 COMs were identified. The various data sources used to collect the COMs were incorporated into an automated virtual dashboard to allow for regular review and sharing with clinicians, leadership, and other key stakeholders. The virtual dashboard included COMs with data derived from electronic medical records (n = 9), patient-reported outcomes based on responses to pharmacist-delivered questions (n = 11), and pharmacist assessment of outcomes (n = 8). The completed virtual dashboard was further refined to allow for reporting of both population and patient-level outcome results on a quarterly basis.This project describes methods to standardize documentation, data collection, and reporting of clinical outcomes data for multiple specialty conditions in a health system-integrated specialty pharmacy program. Through literature review and stakeholder consultation, a variety of potential COMs were identified for further evaluation of feasibility and value considering documentation and data collection requirements. Incorporation of COMs into a virtual dashboard will help facilitate the evaluation of program effectiveness, quality improvement planning, and sharing with stakeholders. Additional opportunities exist to further standardize COMs across the pharmacy industry to allow for future benchmarking and standardized evaluation of patient care programs.No funding supported the writing of this article. The authors have no relevant conflicts of interest to disclose. This study was presented as a poster presentation at the APhA Annual Meeting, March 2018, Nashville, TN, and as a platform presentation at the Eastern States Conference, May 2018, Hershey, PA.

Purpose Results of the 2019 ASHP national survey of pharmacy practice in hospital settings are presented. Methods Pharmacy directors at 4,863 general and children’s medical/surgical hospitals in the United States were surveyed using a mixed-mode method of contact by email and mail. Survey completion was online, using an online survey application. IQVIA supplied data on hospital characteristics; the survey sample was drawn from the IMS Health hospital database. Results The response rate was 10.8%. Pharmacists are increasingly managing medication use in the areas of vancomycin therapy, antibiotic selection and dosing, and anticoagulation. Electronic health record (EHR) decision support is guiding prescribing, and nearly 50% of hospitals are customizing drug warnings. Adoption of compounding technology continues, with 43.6% of hospitals using technology in their sterile compounding processes. Nearly half of hospitals have active opioid stewardship programs, and pharmacists are leading these efforts. Specialty pharmacy operations are growing in health systems. Human resource commitments to support new services are increasing; however, vacancy rates for technicians are challenging. Staff credentialing continues to expand for pharmacist and technicians. Conclusion Pharmacists continue to assume greater responsibility for writing medication orders, dosing, ordering laboratory tests, and monitoring outcomes. Health-system pharmacists are taking a leading role in addressing the opioid crisis, advancing safety in compounded sterile preparations through adoption of intravenous workflow technologies, and optimizing EHR applications to leverage clinical decision support tools to improve the safe prescribing and use of medications.

Purpose The primary objective of the study described here was to compare rates of patient adherence to anticancer medications filled at an internal health system specialty pharmacy (HSSP) vs external specialty pharmacies. The primary outcome was the medication possession ratio (MPR), and the secondary outcomes included proportion of days covered (PDC), and time to treatment (TTT). Methods A retrospective chart review was conducted to compare the MPR, PDC, and TTT for patients who received oral anticancer therapy using prescriptions claim data. A t test or Wilcoxon test was used to explore the effect of demographic and other factors on adherence and TTT. A multiple regression model with backward elimination was used to analyze significant factors to identify covariates significantly associated with the outcomes. Results Of the 300 patients screened for study inclusion, 204 patients whose records had complete MPR and PDC data and 164 whose records had TTT data were included in the analysis. There were significant between-group differences in mean MPR and mean PDC with patient use of the HSSP vs external pharmacies (1.00 vs 0.75 [P < 0.001] and 0.95 vs 0.7 [P < 0.001], respectively). Pharmacy type (P = 0.024) and tumor type (P = 0.048) were significantly associated with TTT. Conclusion The multiple regression analysis indicated that oncology patients who filled their anticancer medication precriptions at an internal HSSP at an academic medical center had significantly higher adherence, as measured by MPR and PDC, and quicker TTT than those who filled their prescriptions at an external specialty pharmacy.

Objective The goal of this pilot study was to measure patient satisfaction, pain scores associated with injection, and patient perceptions of a pharmacist-led specialty injection clinic. Setting The Medical University of South Carolina Specialty Pharmacy. Practice description The specialty pharmacy comprises decentralized clinical pharmacy specialists who provide medication education to patients via phone. Many of the medications dispensed are self-administered injectables, but patients often request in-person assistance to learn the best way to use the drug. The investigators sought to provide an avenue for patients to receive teaching and drug administration from a pharmacist without scheduling a formal nurse visit or enrolling the patients in a manufacturer program. Practice innovation Clinical pharmacy specialists offered every patient a referral to the Assistance with Injectable Medication clinic for in-person injection teaching during the initial clinical assessment. At the first clinic visit, the patients were provided with printed injection instructions, and a demo injector from the manufacturer was available for practice before the actual drug administration. Evaluation This was a prospective pilot study conducted from January 2019 to April 2019. Patient identification occurred directly through our clinical pharmacy specialists via referrals and informational flyers. The eligible patients were aged 18 years or older and had received a qualifying subcutaneous injection via the Medical University of South Carolina Specialty Pharmacy. The outcomes included pain score and patient satisfaction. Results As of April 30, 2019, 17 patients had completed 24 clinic visits. The average reported pain and satisfaction scores (scale 0-10) were 2.5 and 9.6, respectively. The 2 most commonly administered medications in the clinic were alirocumab and adalimumab. Conclusion A clinic to assist with specialty injectable medications resulted in high patient satisfaction scores and low pain scores associated with injection.

Purpose To develop and implement an interprofessional framework to increase the capture of health system–generated prescriptions within health system–owned pharmacies. Summary Low prescription capture rates within a health system’s internal pharmacies led to an interdisciplinary process improvement effort. A framework was developed to assess the baseline prescription capture rate, select clinics for improvement, understand clinic workflows and key drivers of pharmacy selection, design strategies to increase prescription capture, implement targeted efforts, and measure the effectiveness of the intervention(s). Employing this framework provided revised workflows for nursing and medical assistant staff scripting and for referral of patients to internal pharmacies. These workflows were pilot tested at 3 system clinics. Results indicated that overall prescription capture increased by 2.9 to 4.1 percentage points (range, 10 to 86 prescriptions per month) and specialty prescription capture increased by 11.6 to 26.7 percentage points (range, 4 to 26 prescriptions per month) for each clinic within the first 2 months. A total of 99 new patients were referred to internal pharmacies within the first month. Conclusion Development and implementation of a framework to increase prescription capture from health system clinics helped increase capture, enhanced clinic engagement and knowledge about pharmacy services, and supported positive clinic-pharmacy relationships.

Twenty years ago, the Journal of Managed Care & Specialty Pharmacy published an article titled "The Emergence of Specialty Pharmacy." While the industry was in its relative infancy at the time, the specialty pharmacy model has since grown, expanded, and matured, largely following some of the trends outlined at the time. Now, with changes in legislation, a progressive approach within the FDA, a second coming of novel therapies and supplemental indications, along with an involvement in cell and gene therapy, a reemergence of the specialty model is taking place, and the market must adapt to the new challenges associated with this era of modern medicine. DISCLOSURES: No funding contributed to the writing of this article. Ogurchak reports speaker fees from MJH Live Events and WellSky, unrelated to this work. The other authors have nothing to disclose with respect to research, authorship, and/or publication of this article.

BACKGROUND: Oral oncolytics are becoming increasingly common in the treatment of solid and hematological malignancies. Medication adherence is especially important to ensure adequate drug levels to...

PURPOSE: High-cost drugs impose a financial burden on patients with cancer. Karmanos Specialty Pharmacy (KSP) developed a process to automate financial assistance (FA) applications to decrease patient drug cost. We evaluate the outcomes of this program on cost to patients and payers. METHODS: This is an observational, retrospective study of the KSP claims data set from January to December 2019, accessed by 13 statewide cancer centers within Michigan. Drug cost of patients, payers, FA (funds to lower patient drug cost), and types of FA were obtained. A subset analysis was performed to determine drug delivery times. RESULTS: In 2019, 869 prescriptions and 1,722 prescription fills were provided to 463 patients through KSP. The total cost of drug claims was approximately $10 million US dollars (USD) among Medicare patients (58%), approximately $3.4 million USD for privately insured patients (20%), and approximately $3.7 million USD for Medicaid patients (22%). Twenty-seven percent of patients (22% of all prescription fills) required additional FA with initial total co-payment claims of $335,216 USD. $280,988 USD of FA was obtained, which substantially lowered total patient costs by 81%. $250,818 USD of FA obtained was from foundation grants (327 fills), and $21,441 USD from manufacturer co-pay cards (47 fills). An additional $12,260 USD (12 fills) from a Karmanos Patient Assistance Fund was used. There was high dependence on foundation grant assistance among Medicare patients (33% of claims). In a subset analysis, the median time from prescription written to delivery to the patient was < 7 days (0-56 days). CONCLUSION: Twenty-seven percent of patients (22% of prescriptions fills) in 2019 required additional FA for high-cost drugs. KSP substantially reduced patient cost by implementing an efficient process using additional pharmacy assistants to obtain FA.

Background : Pharmaceutical services in Brazil provide access, supply, and rational use of drugs for all population and an effort has been made to improve the quality of these services. Biological drugs are high - cost drugs supplied in Brazil t hat can inhibit disease progression and improve the quality of life of psoriatic arthritis (PsA) patients. However, some patients did not achieve the rapeutic goals. Objective : T o evaluate the medication adherence and persistence of PsA patients treated with tumor necrosis factor inhibitors (anti - TNF) drugs and their associated factors. Methods : A prospective observational study was performed at a single - specialty pharmacy in Belo Horizonte, Brazil. Medication adherenc e, persistence, and clinical outcomes were evaluated at 12 months of follow - up. Medication persistence was historically compared to overall PsA patients treated in Brazil. Associated factors were identified through log - binomial regression. Results : One hu ndred ninety - seven PsA patients were included in the study, of whom 147 (74.6%) and 142 (72.1%) had medication adherence and persistence, respectively. Patients treated with infliximab presented the highest adherence (90.5%) and persist ence rate (95.2%) in comparison to patients treated with other drugs, except for adalimumab versus infliximab for adherence outcome. All clinical measures significantly improved in patients with medication adherence and persistence. Medication persistence was hi gher for patie nts attended by specialty pharmacy than other PsA patients in Brazil. The associated factors to higher medication adherence w ere lower disease activity by BASDAI, being non - white race, and intravenous drug use. The associated factors to higher medication p ersistence were lower disease activity by Bath Ankylosing Spondylitis Activity Index (BASDAI), intravenous drug use, non - use of corticoids and non - steroidal anti - inflammatory drugs, and comorbidity. Conclusions : Patients with medication adherence and pers istence had significant improvements in clinical measures, functionality, and quality of life. High medication adherence and persistence to biological therapy were observed and associated with lesser dis ease activity at baseline. Also, medication persisten ce to PsA patients attended in specialty pharmacy was higher than the overall PsA population in Brazil, which indicates the importance of pharmaceutical services to provide health care and promote the effect iveness and safety of biological therapies.

BACKGROUND: There is concern that increasingly common use of patient assistance programs (PAPs), out-of-pocket assistance provided by manufacturers or foundations, distorts our understanding of patient behavior and insurance design incentives. Yet the current literature on prescription drug cost sharing largely overlooks their use. PAPs prevalence and impact on drug demand and price elasticity is a major knowledge gap. OBJECTIVE: To examine the use of PAPs among patients with multiple sclerosis (MS) and the association with drug demand in a specialty pharmacy program within a regional integrated health system that facilitates their use. METHODS: We used pharmaceutical claims data from December 2017 to December 2018 linked to detailed payer information from Kaiser Permanente Washington to characterize the prevalence of PAPs for users of 7 MS specialty drug molecules. We estimated price elasticity of demand (PED) in a two-part model by using the presence of copayment assistance as a source of cost variation. The first part estimated marginal probability of a claim in a given month with a probit model, comparing PAP users and nonusers, whereas the second part estimated days supplied of a medication, given a claim was made as a measure for demand. RESULTS: Of 789 unique patients, 480 (60.7%) used PAPs in at least 1 drug claim during the 13-month time frame, and 248 patients (31.4%) used PAPs for all of their MS drug claims. When used, copay assistance covered 100% of out-of-pocket (OOP) charges for 98% of claims and reduced patient annual OOP cost by $3,493 on average. People who used PAPs had much higher OOP charges, a lower Charlson comorbidity score, and were more likely to have insurance through an exchange. The OOP costs charged to patients was higher for claims where patient assistance was used than claims where assistance was not used ($294 vs $42, P < 0.001). Total claim amount was higher for claims that used assistance ($6,169) than claims that did not ($5,503, P < 0.001). The probability of a patient having a drug claim in a given month was 1.9% higher among those using patient assistance, although this finding was not significant (P = 0.258). An average change in price of -$168.21 with PAP use led to an average change in demand of -0.05 days, for an overall price elasticity of demand (SD = 0.028, P = 0.852) given PAP use of 0.005, indicating that the presence of PAPs did not significantly affect demand. PED estimates were not statistically significant by drug, and the exclusion of Medicare patients did not change this interpretation. CONCLUSIONS: In a mid-size integrated health system in the state of Washington, a program that promotes adherence to specialty drugs via facilitated PAP use was found to reduce patient OOP costs but had no effect on prescription drug utilization. Payers may consider embracing PAPs to remove patient financial barriers to necessary medications and use tools other than cost sharing to influence patient consumption of specialty drugs. DISCLOSURES: This manuscript was funded in part through a Pre-Doctoral Fellowship in Health Outcomes from the PhRMA Foundation awarded to Brouwer for the completion of her dissertation work. Yeung receives some salary support from Kaiser Permanente. The other authors have nothing to disclose.

Introduction Access to pimavanserin, the only Parkinson disease–related psychosis treatment approved by the FDA, is restricted by insurance requirements, a limited distribution network, and high costs. Following initiation, patients require monitoring for safety and effectiveness. The primary objective of this study was to evaluate impact of specialty pharmacist (SP) integration on time to insurance approval. Additionally, we describe a pharmacist-led monitoring program. Methods This was a single-center, retrospective study of adults prescribed pimavanserin by the neurology clinic from June 2016 to June 2018. Patients receiving pimavanserin externally or through clinical trials were excluded. Pre- (June 2016 to December 2016) and post-SP integration (January 2017 to June 2018) periods were assessed. Proportional odds logistic regression was performed to test association of approval time with patient characteristics (age, gender, insurance type) postintegration. Interventions were categorized as clinical care, care coordination, management of adverse event, or adherence. Results We included 94 patients (32 preintegration, 62 postintegration), 80% male (n = 75) and 96% white (n = 90) with a mean age of 73 years. Median time to approval was 22 days preintegration and 3 days postintegration. Higher rates of approval (81% vs 95%) and initiation (78% vs 94%) were observed postintegration. Proportional odds logistic regression suggested patients with commercial insurance were likely to have longer time to approval compared with patients with Medicare/Medicaid (odds ratio 7.1; 95% confidence interval: 1.9, 26.7; P = .004). Most interventions were clinical (51%, n = 47) or care coordination (42%, n = 39). Conclusion Median time to approval decreased postintegration. The SP performed valuable monitoring and interventions.

OBJECTIVES Concerns about high and rising drug prices have prompted a call to manage prescription drugs according to their value. Although not all proposals referred to as "value based" are well suited to advance this mission, health plans must select among them under the influence of competing demands and constraints of their market and nonmarket environments. To understand the implications for health policy, we sought to explore how health plans might select among and implement these approaches for specialty pharmacy (SP) under the incentives and barriers that these conditions create. STUDY DESIGN An experienced research team conducted a qualitative study with Blue Cross Blue Shield health plans interested in implementing value-based SP management. METHODS Plans'objectives, operational strategies, and factors influencing their ability to execute on these strategies were elicited in 3 focus groups. RESULTS Four business objectives were identified, centering on spending levels, spending variability, access to new treatments, and evidence generation for new treatments. Supporting operational strategies included increased utilization management (UM), provider and patient engagement, expanded data analytics, and adjustments to staffing models. Factors that influence their ability to act on these strategies include regional and national scale, strength of provider network relationships, disease management capabilities, business and data silos, and potential legislative actions to limit UM. CONCLUSIONS Health plans' preferences for different forms of SP management may not be aligned with policy objectives, particularly those that advance innovation. Policy makers should consider market and nonmarket factors that influence these preferences, including the need to mitigate spending variability and generate evidence to guide coverage decisions.

PURPOSE: A national specialty pharmacy implemented a split-fill option within an oral oncology patient management program to reduce pharmacy costs and medication wastage resulting from early discontinuations. Payers covered dispensed medications at half-quantity intervals for each dispense up to 3 months. Proactive outreach to patients before they had used up the initial dispensed medication quantity helped assess the patient’s tolerance to the new medication and adverse effects. This study compared costs for patients with a split-fill option to similar costs for patients without this option taking into account patient discontinuation rates, patient-reported adverse effects rates, estimated pharmacy costs, and potential wastage. METHODS: This retrospective cohort study included patients who were new to therapy on a split-fill medication between September 2015 and August 2017. A 1:1 greedy match algorithm was conducted using propensity variables to match patients from each cohort. Per-month discontinuation rates were determined for both split-fill and non–split-fill groups. The non–split-fill potential wastage was calculated as monthly costs for discontinuations in the following month and weighted by split-fill discontinuation rates. RESULTS: Of the 2,363 program patients who met selection criteria for the 11 medications, 671 patients from each group were matched. Payers with a split-fill program had significant medication savings per covered month ($2,147.60 at 1 month) and at a cumulative 6 months. Modeled wastage indicated that payers without a split-fill program could expect to save $2,646.74 monthly by using this option. Both cohorts had similar rates of adverse effects and time until first reported adverse effect. CONCLUSION: In the first 6 months, the split-fill patient managed program had lower discontinuation rates, significantly reduced pharmacy costs, and reduced potential wastage.

Estimating medication adherence through the use of pharmacy claims-based adherence calculations such as medication possession ratio (MPR) and proportion of days covered (PDC) plays a significant role in specialty pharmacy practice. Although MPR and PDC are frequently used in clinical practice, calculation methodologies vary, making meaningful comparisons of adherence rates difficult. In addition, MPR and PDC are increasingly used by insurance companies, pharmacies, accrediting bodies, and drug manufacturers to demonstrate quality differences or clinical benefit across the specialty pharmacy industry. Therefore, recognizing the source and effect of calculation variability is necessary to fully understand reported adherence results. This article highlights the challenges in standardizing adherence methodologies, minimum methodology considerations that should be reported with MPR and PDC results, and key elements to consider when interpreting and applying adherence results. Further, recommendations are provided to promote a more consistent description of calculation methods and to aid pharmacies in adherence measure analysis, interpretation, and application to practice, with a focus on specialty pharmacy programs. A detailed description of methodology as outlined in this article must be provided to ensure reproducibility, external validation, and scientific rigor. In the absence of standardization, specialty pharmacies should be prudent in their use of adherence calculations as a clinical benchmarking tool or comparative quality indicator with outside organizations. Furthermore, specialty pharmacies should consider using current adherence measure calculations to identify and provide targeted interventions to patients with potential adherence problems and strive to better demonstrate ties between adherence measures and direct clinical and cost outcomes. DISCLOSURES: No outside funding supported the writing of this article. Anguiano is a speaker and research consultant for United Therapeutics. The other authors have nothing to disclose.

PurposeThe 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.SummaryThrough 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.ConclusionThe 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.

The Biologics Price Competition and Innovation Act (BPCIA) of 2009, which included pathways for FDA approval of biosimilar products, was designed to promote more affordable, expanded patient access to biologic therapies. Achieving these BPCIA goals depends on overcoming formidable barriers to biosimilar adoption. Managed care and specialty pharmacy professionals are uniquely qualified to inform initiatives to address these barriers.To assess perceptions regarding strategies for overcoming barriers to biosimilar adoption among managed care and specialty pharmacy professionals by conducting a survey study.Invitations to complete the online survey were emailed by the Academy of Managed Care Pharmacy (AMCP) to members and customers and to contacts sourced from a commercial database. In addition to questions on respondent demographics and perceptions of biosimilars, the survey listed 16 strategies for overcoming key barriers to biosimilar adoption. On a 5-point scale, participants rated their opinion on the likelihood that each strategy would have the potential to assist in achieving BPCIA goals. The survey also listed 6 barriers to biosimilar adoption. On a 5-point scale, participants rated their perceived difficulty in overcoming each barrier. The survey concluded with an open-text item that asked participants to list 3 additional strategies for overcoming biosimilar adoption barriers. Response frequencies were calculated to describe participants' ratings of the strategies and barriers. Statistical analyses were conducted to assess whether the ratings differed among respondents grouped by work organization. For the open-text item, we conducted qualitative content analyses to categorize strategies by stakeholder groups that might take primary implementation roles.A total of 300 managed care and specialty pharmacy professionals completed the survey. There was considerable variation in the preferences, policies, and practices regarding biosimilar adoption among respondents' work organizations. Responses to several survey items reflected positive attitudes about the safety and efficacy of biosimilars; for example, 84% agreed or strongly agreed that FDA-approved biosimilars are safe and effective for patients who switch from a reference biologic. Based on pooled percentages for ratings of likely and extremely likely to overcome barriers to biosimilar adoption, the highest-rated strategies were for prescriber education about evidence from switching studies (91%) and FDA guidance on pharmacy-level substitution of reference biologics with biosimilars (90%). The lowest-rated strategies were for requiring therapeutic drug monitoring for patients who switch to biosimilars (39%) and using quotas to incentivize providers to prescribe biosimilars (40%). For the qualitative analysis, the highest numbers of respondents' suggested strategies indicated primary implementation roles of biosimilar manufacturers (40%), the federal government (26%), and managed care organizations (15%).Reflecting the unique knowledge, perspectives, and practices of managed care and specialty pharmacy professionals, the study findings are relevant to informing and advancing initiatives for achieving BPCIA goals.The survey study reported in this article was part of a continuing education program funded by an independent educational grant, which was awarded by Sandoz, a Novartis Division, to PRIME Education. The Academy of Managed Care Pharmacy (AMCP) received grant funding from PRIME to assist in developing the survey and writing the manuscript. The grantor had no role in the study design, execution, analysis, or reporting. Greene and Pardo are employed by PRIME. Singh and Carden are employed by AMCP. Greene, Singh, Carden, and Pardo have no other disclosures. Lichtenstein received an honorarium from PRIME for serving as faculty for the continuing education program and has been a consultant for Pfizer, Cellceutix, and Merck.

Objectives To measure and compare the perception of immunizations, immunization status, and recommendation sources in persons living with HIV (PLWHs) and persons without HIV and determine a strategy for improving immunization rates by increasing awareness of pharmacy services. Design A 19-item survey based on the Health Belief Model assessed patients’ perceptions and recommendation sources regarding immunization acceptance for specific vaccines: Tdap, pneumococcal, and hepatitis B (HepB). Survey items used a 5-point Likert-type scale assessing participants’ perceptions, with questions identifying participants’ most trusted sources of immunization information and patient demographics. Survey questions were designed to identify perceived susceptibility and severity of vaccine-preventable illness, barriers, benefits, and self-efficacy regarding immunization acceptance, and sources of patient-trusted immunization information. Setting and participants Survey recruitment occurred in Indiana and included any patient 18 years of age or older picking up medications at a specialty pharmacy predominantly serving PLWHs or a traditional community chain pharmacy. Main outcome measures Primary outcomes included perceived barriers to immunization acceptance obtained from Likert-type scale questions, patient-reported immunization rates of selected vaccines (Tdap, pneumococcal pneumonia, and HepB), and trusted immunization recommendation sources. Logistic regression was performed to model association between perceived barriers, HIV status, and immunization recommendation sources. Results A total of 142 participants (68 PLWHs, 74 persons without HIV) completed the survey. PLWHs were more likely to have immunization barriers, but this was not statistically significant (odds ratio 2.537, 95% confidence interval 0.585–10.996). Both participant groups reported “family doctor” as the most trusted source, with only 5% selecting “pharmacist.” Significantly fewer PLWHs reported completing the HepB series (18% vs. 52%; P = 0.0224). Conclusion PLWHs possess barriers to immunization acceptance similar to persons without HIV yet report lower rates of HepB vaccine completion. Although pharmacists were less frequently selected as the most trusted source, additional studies on percptions of pharmacists’ role in immunizing PLWHs should be considered.

Patients with cancer often face financial toxicity. They may face financial distress because of high out-of-pocket costs that in turn can result in delays in treatment, treatment abandonment, and higher overall costs of care, all of which can have have a negative effect on patient care. A specialty pharmacy practice model can play a role in decreasing financial toxicity.To evaluate the patient out-of-pocket costs after enrollment in manufacturer patient assistance programs, copay cards, and foundation grants by an oncology specialty pharmacy at University of Chicago Medicine (UCM).For this quality improvement project, a retrospective analysis of prescription claims from January 2017 to June 2017 was performed. The primary outcomes included the number of patients enrolled in manufacturer patient assistance programs, copay cards, and foundation grants, along with the total dollars applied to pharmacy claims. The secondary outcome was the average days to approval of a foundation grant. Inclusion criteria for this quality improvement project included prescriptions filled at UCM Specialty Pharmacy in the 6-month time frame for an oncology indication. Exclusion criteria were prescriptions that were not filled at UCM Specialty Pharmacy due to out-of-network insurance and prescriptions that were part of a patient assistance program where the medication was directly shipped from the manufacturer.In the 6-month time frame, 75 patients received financial assistance, with a total cost savings of $314,857. Financial assistance was most frequently applied to the following medications: peg-filgrastim, dasatinib, abiraterone, filgrastim and filgrastim-sndz, palbociclib, venetoclax, and ruxolitinib. The cost savings of these interventions ranged between $5 and $13,138 per prescription claim. The average days from date of insurance approval to date of financial grant approval was 1.2 days.This project demonstrates the importance of an oncology specialty pharmacy team in ensuring timely approval of a foundation grant and reducing financial toxicity, which can play a major role in access to therapy.No outside funding supported this project. The authors have no conflicts of interest to report. This project was presented at the Vizient University Health System Consortium Pharmacy Network Resident Poster Session; December 1, 2017; Orlando, FL.

PurposeThe development and dissemination of a specialty pharmacy service to optimize fingolimod therapy management are described.SummaryFingolimod was the first oral therapy developed to counter relapsing–remitting multiple sclerosis. Pharmacovigilance measures and individualized support are strongly recommended due to associated safety concerns. The Fingolimod Patient Support Program (F-PSP) was developed and disseminated within a community pharmacy network. The F-PSP aims to ensure responsible use of fingolimod and patient empowerment by promoting medication adherence and patient safety through a person-centered and integrated care approach. It complements basic pharmacy services through 2 interventions: medication adherence support and pharmacovigilance tailored to fingolimod. The adherence intervention combines motivational interviewing with longitudinal electronic medication adherence monitoring. The pharmacovigilance component consists of informing patients of fingolimod recommendations, reminding patients of recommended medical tests, and tracking and monitoring symptoms, especially those of potential serious adverse fingolimod reactions. A secure Web platform guides the pharmacist in conducting interviews and enables collection of patient-reported outcome data. A transition care pharmacist proposes program participation to all patients initiated on fingolimod, performs enrollment, and coordinates transfers to patient-designated community pharmacies for ongoing care.ConclusionThe F-PSP enables support of individual patients, and also provides real-world data, helping to bridge the gap between practice and research. The F-PSP is intended to be a generic model of a specialty pharmacy service that is transferable to any other healthcare context, specialty drug or disease.

Introduction Pharmaceutical firms have begun offering online prescription management systems to facilitate prescription processing. This study evaluated the impact of the HUMIRA Complete Pro (HCPro) online prescription management system on the rate of abandonment and the time to first fill for patients prescribed adalimumab (ADA). A retrospective cohort analysis of patients initiating ADA treatment with or without use of the HCPro online prescription processing system was used to evaluate the impact of HCPro on treatment initiation outcomes. Methods Patient-level data for patients with an ADA prescription processed through HCPro were mapped to Symphony Health claims for patients initiating ADA between January 2012 and January 2015. The sample included patients aged ≥ 18 years with a diagnosis of Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis who had data available 3 months before and after their first ADA claim (index date). Baseline characteristics, prescription abandonment rate, and time-to-first-prescription fill were compared between patients with a prescription processed through HCPro (HCPro cohort) and those without (non-HCPro cohort). The odds of abandonment were evaluated in the 3 months following the index date using a multivariate logistic regression model. Results The study included 24,767 patients (535 HCPro; 24,232 non-HCPro). HCPro patients had a greater frequency of initiation at a specialty pharmacy (66% vs. 56%; P

Introduction Novel oral oncolytic agents have become the standard of care and first-line therapies for many malignancies. However, issues impacting access to these drugs are not well explored. As part of a quality improvement project in a large tertiary academic institution, we aim to identify potential barriers that delay treatment for patients who are prescribed novel oral oncolytics. Methods This was a retrospective review of adults who were newly prescribed a novel oral oncolytic for Food and Drug Administration-approved indications at a single tertiary care center. Patients were identified via electronic prescription data (e-Scribe). Demographics, insurance information, and prescription dates were extracted from the electronic medical record and pharmacy claims data. Statistical analyses were performed to determine whether time-to-receipt was associated with insurance category, pharmacy transfers, cost assistance, and drug prescribed. Results Of the 270 successfully filled prescriptions, the mean time-to-receipt was 7.3 ± 10.3 days (range: 0–109 days). Patients with Medicare experienced longer time-to-receipt (9.1 ± 13.1 days) compared to patients with commercial insurance (4.4 ± 3.3). Uninsured patients experienced the longest time-to-receipt (15.7 ± 7.8 days) overall. Pharmacy transfers and cost assistance programs were also significantly associated with longer time-to-receipt. Ten prescriptions remained unfilled 90 days after the study period and were considered abandoned. Conclusion Insurance has a significant effect on the time-to-receipt of newly prescribed novel oral oncolytics. Pharmacy transfers and applying for cost assistance are also associated with longer wait times for patients. Our retrospective analysis identifies areas of improvement for future interventions to reduce wait times for patients receiving novel oral oncolytics.

Background: There is 1 multiple myeloma (MM) quality metric available (treatment with bisphosphonates, developed by the American Society of Hematology) to evaluate the quality of cancer care delivered to improve patient experience and outcomes. As many community practices integrate specialty pharmacy (SP) services into their practice, patient education, treatment adherence, and visit scheduling coordination are becoming increasingly complex, particularly for treatments with Risk Evaluation and Mitigation Strategies (REMS) programs. We sought to understand the fundamental challenges facing a multisite community oncology practice undergoing SP centralization to identify potential quality gaps for patients with MM. Methods: Structured, in-depth interviews were conducted with physicians treating the highest volume of MM patients across 5 different urban and rural sites of a single multisite community practice. The interviews covered 6 domains: access to care or clinical advice/communication (ACC/AC); care coordination (CC); disease management for MM (DMMM); patient education (PE); medication management (MedMgmt); and data and quality improvement (DQI). Results: Five providers treating 304 MM patients from January 2016 through April 2018 identified several key issues related to the interaction between the SP and clinical sites: ACC/AC, coordination of efforts to ensure patient affordability of both oral/intravenous components; CC, centralize pharmacy workflow processes (specifically REMS enrollment) to ensure timely receipt of medication (high priority); DMMM/PE, inconsistent patient education regarding the role of the centralized pharmacy in the REMS programs, side-effect management, and intent of therapy; MedMgmt, limited concern/understanding of the impact of oral therapy adherence; DQI, no set standards for MM-specific quality measures for benchmarking performance between SP and practices. Conclusions: This qualitative survey identified several areas for improving MM-related quality of care in terms of the relationship between a centralized SP and satellite offices. To address these themes, the practice further integrated licensed practical nurses into the SP. Additionally, 2 quality improvement measurement opportunities were proposed: (1) measuring adherence using pharmacy refill data and (2) overall treatment delay (number of days from prescribing to pick-up/ship to patient).

Background Access to proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors that lower low-density lipoprotein cholesterol in patients at high risk of atherosclerotic cardiovascular disease events has proven challenging. Methods to overcome access barriers are needed to fully realize the benefits of these novel agents. Objective This study evaluated medication access rates in patients prescribed a PCSK9 inhibitor at a health care system with integrated specialty pharmacy services. Methods We performed a single-center, ambispective cohort study of patients prescribed a PCSK9 inhibitor between September 2015 and December 2016 at Vanderbilt University Medical Center outpatient clinics. The primary end point was the percentage of PCSK9 inhibitor prescriptions resulting in access of the total prescriptions triaged to Vanderbilt Specialty Pharmacy. Secondary end points assessed among patients approved for therapy included time between benefits investigation and insurance approval, financial assistance use, and treatment initiation rates. Results Two hundred ninety-nine patients met inclusion criteria (average age = 63 years). Forty-six percent were female, 57% held commercial insurance, and 70% had an atherosclerotic cardiovascular disease indication. Overall, 96% of prescriptions resulted in access to a PCSK9 inhibitor. Most patients were approved with an initial prior authorization (58%) or after one appeal (29%). The median time to approval was 8 days. Among patients approved for therapy, 53% received financial assistance and 94% initiated therapy. Conclusion An integrated specialty pharmacy service model in outpatient clinics produced high rates of PCSK9 inhibitor therapy access and initiation. This high level of access supports this model as a best practice for prescribing PCSK9 inhibitor therapy.