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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...

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.

BACKGROUND: Patients who are prescribed specialty medications require close monitoring, including assessment of laboratory parameters, toxicities, and adherence. Specialty pharmacies integrated wit...

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 ...

BACKGROUND: In 2019, the Utilization Review Accreditation Commission (URAC) required a new reporting measure for specialty pharmacies related to completion of therapy for hepatitis C virus (HCV). O...

Managed care pharmacy has a relatively short history, but one that is defined by significant achievements. Since the late 1960s, managed care pharmacists have applied their unique skills to formulary management, clinical programs, benefit design, and contract negotiations to support patient access to life-saving therapies, while also ensuring cost-effective use of limited health care resources. Key milestones include establishing the pharmacy benefit as an essential component of the U.S. health care system, launching the Medicare Part D program, and expanding medication therapy management services. The year 2020 brings another milestone-the 25th anniversary of AMCP's flagship publication, the Journal of Managed Care + Specialty Pharmacy. This year also serves as an inflection point. As managed care pharmacy professionals prepare for change and the challenges ahead-including the imperative to address the rising costs of health care and health disparities-the use of evidence, utilization management strategies, and innovation will support our continued success. DISCLOSURES: No funding supported the writing of this commentary. The authors have nothing to disclose.

Adherence to antiretroviral (ARV) therapy is critical in order to achieve and maintain viral suppression and improve immune function. Clinical pharmacists and pharmacies focused on human immunodeficiency virus (HIV) have demonstrated the ability to increase ARV medication adherence and subsequently have a positive effect on these lab markers.To evaluate the effect of an integrated health system specialty pharmacy service with a clinic-embedded, HIV-trained pharmacist and pharmacy technician on ARV medication adherence rate, viral load, and CD4 count.This was a single-center, retrospective cohort study conducted from August 7, 2017, to June 30, 2018, at an indigent outpatient infectious disease clinic within Atrium Health (AH), a not-for-profit health system based in Charlotte, NC. The intervention group (opt-in group) received HIV patient care that involved the health system specialty pharmacy service. Once a patient was enrolled in the specialty pharmacy service, medication reconciliation was completed by the pharmacist, financial assistance and prior authorizations were completed if needed; prescriptions were delivered to the patient; and monthly refills calls were conducted to assess adherence, tolerability, and medication changes. The control group (opt-out group) received HIV patient care that did not incorporate the health system specialty pharmacy. The primary endpoints were medication adherence, viral suppression, and CD4 counts. Within-group comparisons from baseline to follow-up were made along with group-to-group comparisons. Adherence was calculated using medication possession ratio.For those patients using Atrium Health Specialty Pharmacy Service (AH SPS; n = 46), the overall median adherence rate was higher at 100% versus only 94% for those patients (n = 50) that opted out of the service (AH SPS was able to demonstrate improved ARV adherence in those patients using an integrated specialty pharmacy with an embedded pharmacy team, coordinated monthly medication delivery, and refill reminder and adherence calls. This in turn led to improved viral suppression and immune markers by the end of the observation window for patients using AH SPS.No outside funding supported this study. The authors have nothing to disclose.

Adherence to treatment is correlated with treatment success in chronic myeloid leukemia (CML). CVS Specialty explored novel methods to improve adherence in this population to ensure optimal adherence and lower the risk of unsuccessful treatment. One novel program explored involved an interactive 2-way clinical messaging technology that coaches patients with adherence and knowledge about taking their treatment and managing their conditions. Clinical secure messaging is a 2-way messaging program distinct from the 1-way refill reminders and order status messages that patients were receiving if opted into the messaging program.To assess the effect on adherence of 2-way clinical messaging in a CML population treated with tyrosine kinase inhibitors (TKIs) compared with patients enrolled in 1-way refill reminders.A retrospective cohort study was conducted using prescription claims data. Patients new to TKI therapy and enrolled in at least 1-way messaging were identified and divided into control and study cohorts based on clinical messaging enrollment status. Participants were followed for 365 days after their first fill. Adherence outcomes were defined by medication possession ratio (MPR), length of therapy, first fill drop-off rate, and gap days between refills. Optimal adherence was defined as an MPR ≥ 85%.Patients receiving clinical messaging had on average a 7.64% higher MPR score (MPR: 73.94% vs. 66.30%) compared with the control arm (Two-way clinical messaging positively affected adherence outcomes in a CML population. This effect was in addition to 1-way refill reminders and order status messages. The nature of the clinical content encourages further investigation into this novel execution of adherence coaching and counseling through a digital platform.Funding for this research was provided by CVS Health. The sponsor was involved at all stages of the study's conduct and reporting. Sawicki and Friend are employed by CVS Health. The other authors were employed by CVS at the time of this study. The authors have nothing more to disclose. Posters based on this work were presented at the AMCP Managed CareSpecialty Pharmacy Annual Meeting 2016; April 19-22, 2016; San Francisco, CA, and AMCP Nexus 2016; October 3-6, 2016; National Harbor, MD.

The rapid growth of the specialty pharmacy industry will require many pharmacists with experience and/or training in specialty pharmacy practice (SPP). Unfortunately, there is no standard requirement set forth by the Accreditation Council for Pharmacy Education (ACPE) for specialty pharmacy education among pharmacy schools, which has resulted in graduates with doctor of pharmacy degrees (PharmD) having little to no didactic or experiential training in SPP.To (a) assess PharmD student perspectives on coverage of specialty pharmacy in their respective curricula and (b) identify whether attitudes and perspectives towards SPP vary based on student work experience.Study investigators created a 16-item web-based survey that assessed student work experience in pharmacy practice, presence of learning experiences that cover SPP in PharmD curricula, and familiarity with, exposure to, and interest in SPP, SPP learning experiences, and SPP careers. The survey was made available to students at ACPE-accredited colleges of pharmacy from January to April 2018.643 students from 20 different colleges of pharmacy completed the survey. Over half of the surveys (63.3%) originated from schools in the Midwest region of the United States. Just over one third (37.7%) of students reported that their curricula offered a learning experience specifically dedicated to SPP, whereas 17.6% reported that SPP was integrated into other pharmacy coursework. 28% reported that SPP was covered using a mixture of dedicated courses and class integration. Students with current or previous work experience in SPP or managed care were more likely to report willingness to take an experiential rotation in SPP and pursue a career in SPP than students with no or other pharmacy-related work experience. These students were also more likely to report that their curriculum performed poorly in preparing students to pursue a career in SPP.In a convenience sample survey of pharmacy students at ACPE-accredited colleges of pharmacy, perspectives on SPP, curricular coverage of SPP, and SPP careers varied significantly based on student work experience.This study received funding support from the Wayne State University Department of Pharmacy Practice ResearchDevelopment Fund. The authors do not have any conflicts of interest or financial disclosures to declare.

DISCLOSURES: Rubinstein provides consulting services to the pharmaceutical industry, health plans, employers, and specialty pharmacies and is a member of the editorial advisory board of Specialty Pharmacy News. He was a participant on the Amgen Biosimilar Report Advisory Board and reports consulting fees from Amgen.

The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors alirocumab and evolocumab were approved by the FDA in 2015. In anticipation of provider interest and a potential increase in referrals to the on-site specialty pharmacy, we created a pharmacist-managed consultation service.The development of a clinic-based pharmacist-managed consultation service for the management of the PCSK9 inhibitor agents alirocumab and evolocumab is described. Key implementation steps included (a) creation of a pharmacy team and collaboration with cardiology; (b) completion of a needs assessment; (c) service creation; (d) collaboration with the on-site specialty pharmacy; (e) development of an electronic consult order and consult pool; (f) personnel training; and (g) service approval and marketing. The service development occurred over 9 months (July 2015-April 2016) and was implemented hospital-wide in May 2016.The University of Illinois Hospital and Health Sciences System PCSK9 inhibitor consultation service successfully integrated the benefits of a clinical review process, information technology capabilities of an electronic medical record system, and collaboration with the on-site specialty pharmacy to provide a comprehensive service that aimed to facilitate appropriate medication management from prescribing to patient administration and provide monitoring for this class of specialty medications.The PCSK9 pharmacist-managed consultation service provides a method for complex therapies to be managed comprehensively through the collaboration of ambulatory care clinics and outpatient specialty pharmacies.No outside funding supported this study. Groo reports speaker bureau fees from Pfizer and Bristol-Myers Squibb. The other authors have nothing to disclose. All the authors contributed to study concept and design. Atande took the lead in data collection, and data interpretation was performed by Groo and Atanda. The manuscript was written by Atanda and revised by all the authors.

Axitinib is approved by the FDA for the treatment of advanced renal cell carcinoma (RCC) after failure of 1 previous systemic therapy and is distributed primarily through specialty pharmacies. Although the efficacy and safety of axitinib have been established in clinical trials, information from real-world populations will help to elucidate patients' clinical profiles and utilization patterns. Prescription records alone provide limited information on patient characteristics and other treatment experiences. Expansion of these data with information from medical claims databases should yield observational real-world data that may help to optimize therapy for patients with advanced RCC.To link information from a specialty pharmacy database with information from medical and pharmacy claims databases to characterize real-world treatment patterns of axitinib as subsequent systemic therapy in patients with RCC in the United States.This retrospective, observational, cohort study linked de-identified patient-level data from 22 specialty pharmacies that dispense axitinib with databases of longitudinal medical and pharmacy claims. Eligible patients had a diagnosis of RCC (1 claim for RCC defined as ICD-9-CM code 189.0), previously received1 systemic therapy, had the first prescription for axitinib dispensed between May 2012 and April 2013 (index), and had consistent claims reporting by pharmacies and physicians. All treatment data were used to calculate cycle, line of therapy, and duration of therapy; prescription data were used to determine axitinib dose modifications. Multivariate and logistic regression analyses were conducted to assess the effect of patient/prescriber characteristics on duration of axitinib therapy and dose modifications, respectively.In all, 1,175 patients met the study inclusion criteria and had data present in specialty pharmacy and claims databases. Most patients (74%) were male, and 68% were aged 55-74 years. Mean (SD) Charlson Comorbidity Index score was 2.7 (± 1.1); the most common comorbidity was hypertension (in 199 patients, 17%). Based on Rx-Risk-V, the most frequent concomitant conditions were pain (40%) and ischemic heart disease/hypertension (30%); the most frequent concomitant medications were antihypertensive medications (46%) and opiates (40%). Most prescribers (63%) were affiliated with an academic center, and all U.S. geographic regions were represented. In all, 847 patients (72%) had commercial insurance. Axitinib was prescribed as second-line therapy in 659 patients (56%), as third-line therapy in 326 patients (28%), and as fourth-line or later therapy in 190 patients (16%). In the overall population, mean (SD) duration of axitinib therapy was 168.6 (± 148.4) days. Axitinib treatment duration was 21 days longer in males than females (P = 0.013); 28 days longer in patients in the Northeast than in the Midwest or West (P = 0.010 and P = 0.016, respectively); and 26 days longer in patients receiving baseline hypothyroidism treatment (P = 0.004). In patients receiving second-line axitinib, the most common first-line therapy was sunitinib (56%), followed by pazopanib (16%) and everolimus (12%). Mean (SD) duration of second-line axitinib treatment was 172.3 (± 150.6) days and ranged from 127 days in patients who previously received temsirolimus to 196 days in those who previously received sorafenib. Of 1,025 patients who initiated axitinib at the standard 5 mg twice daily starting dose, 70% remained at this dose throughout treatment, whereas 10% had a dose increase. Younger age and gender (male) were associated with dose increases (OR = 0.958, 95% CI = 0.941-0.975 and OR = 0.573, 95% CI = 0.364-0.903, respectively). Baseline hypothyroidism treatment was associated with dose decreases and increases (OR = 1.662, 95% CI = 1.088-2.539 and OR = 2.149, 95% CI = 1.353-3.413, respectively).This analysis demonstrates the feasibility and utility of linking specialty pharmacy data to other longitudinal databases to better understand patient, provider, and reimbursement characteristics. These data provide insight into routine clinical use of axitinib as subsequent RCC therapy in the United States in the period following FDA approval, as well as additional information on sequencing of targeted agents in patients with advanced RCC.This study was sponsored by Pfizer. MacLean and Cisar are employees of and hold stock in Pfizer. At the time of this analysis, Mehle, Eremina, and Quigley were employees of IMS Health who were paid consultants to Pfizer during the conduct of this study and in connection with the development of this manuscript. MacLean and Cisar contributed to study design and manuscript development. Mehle, Eremina, and Quigley contributed to study design, analysis, and manuscript development.