Impact of Pharmacy Services on Time to Elexacaftor-Tezacaftor-Ivacaftor Initiation

The approval of elexacaftor-tezacaftor-ivacaftor (ELX/TEZ/IVA) expanded highly effective cystic fibrosis transmembrane receptor modulator therapy to approximately 90% of persons age 12 and older with cystic fibrosis. Clinical pharmacists and pharmacy technicians played a key role in planning for ELX/TEZ/IVA initiation prior to FDA approval as well as initiating therapy after approval. This study evaluates the impact of pharmacy services on time to ELX/TEZ/IVA initiation. A retrospective chart review evaluated patients qualifying for ELX/TEZ/IVA at a single health system between October 21, 2019 and April 1, 2020. Patients filling ELX/TEZ/IVA at an integrated health system specialty pharmacy (HSSP) versus an outside specialty pharmacy (SP) started on therapy an average of 10.8 days faster (10.8 days ± 14.0 vs 21.6 days ± 18.8 respectively; p=0.006). More patients filling at a HSSP received ELX/TEZ/IVA within 14 days of the prescription being written compared to outside SPs (82.0% vs 41.4% respectively; p=0.001). Pre-ELX/TEZ/IVA initiation, patients were hospitalized for a CF related complication for an average of 6.26 days (range 0-183) compared to 1.16 days (range 0-91) post-ELX/TEZ/IVA initiation. Lastly, an estimated $134,810 was saved in the 105 patients that were able to fill ELX/TEZ/IVA at a HSSP by initiating drug an average of 10.8 days quicker than outside SPs. The results of this study demonstrate the value of an integrated HSSP model. Further advocacy for inclusion of integrated HSSPs by pharmacy benefit managers is needed to optimize medication access, control costs, and improve patient outcomes for patients receiving care within a health system.

A Retrospective Observational Descriptive Study on the Effectiveness and Usage of Emicizumab and Antihemophilic Factor (recombinant), Fc Fusion Protein in Patients with Hemophilia A in the US

Introduction Hemophilia A is a rare bleeding disorder characterized by coagulation Factor VIII (FVIII) deficiency. Symptoms are primarily bleeding episodes that occur spontaneously or following injury, trauma, or surgical procedure. The treatment for hemophilia A involves replacement of FVIII for on-demand or prophylactic care. The aim of this analysis was to describe treatment outcomes and patterns between patients with hemophilia A who switch to emicizumab (Hemlibra®), Fc fusion protein (rFVIIIFc; Eloctate®), or other factor therapy using specialty pharmacy data from the US. Methods This was a retrospective observational descriptive study conducted between November 2014 and January 2021 using specialty pharmacy data including over 5,000 total patients with hemophilia A in the US. Patients included in the analysis were male, had a diagnosis of hemophilia A without a history of inhibitors, and had a minimum of 6 months baseline pre-index data and 6 months follow-up data post-index. Index date was defined as the first dispense of emicizumab after October 2018 or rFVIIIFc after May 2015. Patient reported and claims-based treatment outcomes assessed pre- and post-treatment included: annualized bleeding rate (ABR, calculated from patient bleed logs), any factor usage including on-demand FVIII use, prescribed and dispensed dosage of treatment, and frequency. Wastage as a percentage was a calculated as: (prophylaxis logged - prophylaxis prescribed)/prophylaxis dispensed. Results 118 patients treated with emicizumab and 55 patients treated with rFVIIIFc were included in the analysis. Additionally, 26 patients switched from rFVIIIFc to emicizumab, and therefore met inclusion criteria for both treatment groups (these patients are described separately). Baseline characteristics are reported in Table 1; the majority of patients in all cohorts had severe hemophilia and prior prophylaxis therapy. The most frequently prescribed dosing patterns for patients in the emicizumab cohort was once every 2 weeks (Q2W) for 56 patients (47.5%) and once weekly (Q1W) for 51 patients (43.2%). Whereas the most frequently prescribed dosing patterns for the rFVIIIFc only cohort was twice per week (BIW) in 27 patients (49.1%), every 4 days (Q4D) in 15 patients (27.3%), and Q1W in 2 patients (3.6%). Total mean (95% confidence intervals [CI]) weekly prophylaxis consumption was 1.68 (1.65; 1.72) mg/kg in the emicizumab cohort and 83.17 (72.06; 94.29) IU/kg in the rFVIIIFc cohort post index. Mean (95% CI) weekly dispensed dosage for prophylaxis was 1.81 (1.76; 1.86) mg/kg emicizumab and 83.83 (72.55; 95.11) IU/kg rFVIIIFc post index. Mean (95% CI) total supplied FVIII for on-demand factor on hand was 5.14 (2.92; 7.35) IU/kg in the emicizumab cohort and 11.76 (9.06; 14.46) IU/kg in the rFVIIIFc cohort post index. Weekly percentage of supplied dosage wasted was 6.03% (4.50; 7.57; p<0.01) emicizumab for the overall cohort, with a mean (standard deviation [SD]) of 10.46% (12.21) wasted per patient within the emicizumab age <12 years cohort. Weekly percentage of supplied dosage wasted was 0.70 (-0.10; 1.50; p=0.09) rFVIIIFc for the overall cohort, with a mean (SD) of 2.63% (3.53) wasted per patient within the rFVIIIFc age <12 years cohort. Mean (95% CI) change in overall ABR pre- and post-treatment was -1.14 (-2.16; -0.18) in the rFVIIIFc cohort and -0.91 (-1.36; -0.50) in the emicizumab cohort (Table 2). Mean (95% CI) changes in spontaneous ABR and spontaneous joint ABR pre- and post-treatment were -0.36 (-1.12; 0.27) and -0.16 (-0.70; 0.31), respectively, in patients treated with rFVIIIFc, whereas within the emicizumab group they were -0.40 (-0.71; -0.13) and -0.37 (-0.66; -0.12). Conclusion Patients were prescribed emicizumab labeled dosing primarily on a Q1W or Q2W pattern, whereas patients prescribed rFVIIIFc had more individualized dosing primarily being prescribed Q4D or BIW. FVIII for on-demand treatment use was found post index in both the factor and non-factor treated cohorts. Overall product wastage with emicizumab is higher than previously reported. Product wastage was highest among emicizumab patients under 12 years, but wastage was still considerable in patients 12 or older. This descriptive analysis indicated that both treatments remained effective with lower bleed rates than prior FVIII therapies. Figure 1 Figure 1. Disclosures Cockerham: Sanofi: Current Employment, Current equity holder in publicly-traded company. Wilson: Sanofi: Current Employment, Current equity holder in publicly-traded company; Alexion: Current equity holder in publicly-traded company. Frick: Trio Health, Inc.: Current Employment; Sanofi S.A.: Research Funding. Dasmahapatra: Sanofi: Current Employment, Current equity holder in publicly-traded company.

Improving Delays in Obtaining Lenalidomide at a Large Safety Net Hospital

Introduction: Lenalidomide is an immunomodulatory agent used primarily in the management of multiple myeloma and non-Hodgkin's lymphomas. Owing to the risks of birth defects and fetal death, lenalidomide is only available under a restricted program through Celgene called Revlimid Risk Evaluation and Mitigation Strategy (REMS). The Revlimid REMS program includes various requirements for patients and providers aimed to avoid embryo-fetal exposure from lenalidomide. Prescribers and patients are required to complete periodic mandatory surveys attesting that the patient is aware of the risks. Once the surveys are completed, a unique and time-limited authorization number is generated by Celgene, which must be included on the prescription. Each prescription is restricted to a 4-week supply with no automatic refills and must be sent to certified specialty pharmacy. In addition, the patient may require insurance authorization or may need to enroll in financial assistance program. Given this multi-step process, patients from our safety net hospital, LAC+USC Medical Center, experience delays in receiving their lenalidomide prescriptions. Such delays may lead to interruptions in cancer treatment and additional clinic visits. Our aim was to assess the effectiveness of the following interventions: creation of a standardized process flowchart, training of clinic staff, and additional patient support from Celgene to reduce delays in the dispensing of lenalidomide prescriptions. Methods: This is a retrospective study of patients prescribed lenalidomide through the hematology clinic at LAC+USC Medical Center, Los Angeles, CA from June 1, 2020 to December 31, 2020. Patients were identified through the Celgene REMS database. The electronic medical record was reviewed for: patient demographics, insurance, and specialty pharmacy dispensing of lenalidomide. Each prescription was reviewed for the authorization number, days from prescription submission to dispensing, and days between each prescription dispensing. A delay was defined as > 2 weeks from the time from prescription submission to pharmacy dispensing. The medical chart was reviewed to identify the reason for the delay. A standardized process was created between July 2020 and August 2020. This included the creation of a workflow flowchart and training of the clinic staff. Additionally, a patient access specialist from Celgene was assigned to support patients and providers through the multi-step process for each prescription. The percentage of pre-intervention delays (before Sept 2020) and post-intervention delays (after Sept 2020) was compared. Results: A total of 196 lenalidomide prescriptions were reviewed. Prior to the intervention, the median time from prescription sent to date of dispensing was 3 days (range: 0-27 days), with a mean time of 5.9 days. 14 of 128 prescriptions (10.9%) had a delay of > 2 weeks. Causes for delay included: awaiting completion of patient survey, insurance issues (need for prior authorization, insurance changes), clinic visit missed or not in correct timeframe to submit new prescription, hospitalization, and medication hold due to toxicity. Following the intervention, 3 of 68 prescriptions (4.4%) were delayed. Median time from prescription sent to date dispensed was 2.5 days (range: 0-29 days) with a mean time of 4.2 days. One prescription was not sent to the correct specialty pharmacy and one was on hold in setting of disease progression. Conclusion: Given the multi-step process, on-time dispensing of the specialty drug lenalidomide is a challenge at our safety net hospital. We identified several delays in the dispensing of lenalidomide prescriptions, including the timeliness of patient survey completion, drug coverage/insurance issues, and coordination of clinic visits with the time that the patient was due for the refill. Formalizing the workflow, training the clinic staff, and having a Celgene patient support specialist led to an improvement in prescription dispensing delays. With the continual addition of specialty medications into hematology/oncology clinics, establishing a standardized workflow with engagement of the clinic staff and specialty pharmacies/drug companies may help reduce delays in the dispensing of specialty drugs. Figure 1 Figure 1. Disclosures Piatek: Rigel: Consultancy, Research Funding; Alexion: Consultancy, Research Funding; Apellis: Research Funding; Dova: Consultancy, Speakers Bureau.

Impact of a hospital specialty pharmacy in partnership with a free-standing care coordination organization on time to delivery and receipt of oral anticancer drugs.

43 Background: Most oral anti-cancer drugs (OACD) prescriptions require extensive coordination between providers and payers, which can delay drug receipt. Specialty pharmacies are intended to facilitate communication between multiple entities to deliver OACDs with increased efficiency. In 2018, our cancer center partnered with Shields Health Solutions (SHS), a freestanding organization providing care coordination to implement a hospital-based specialty pharmacy. We evaluated the rate of failed drug receipt (FR) and time to drug receipt (TTR) before and after specialty pharmacy implementation. Methods: We prospectively collected data on all new OACD prescriptions for adult oncology patients at a large, urban cancer center from 1/1/2018 to 12/31/2019. In fall 2018, a specialty pharmacy was opened to facilitate drug procurement for patients. We collected patient demographic, clinical, and insurance data, OACD name, date prescribed, delivery date, and interactions with payers and financial assistance groups. For prescriptions received, TTR was the number of days from OACD prescription to patient receipt of the drug. FR was defined as failure to receive a prescribed OACD. We excluded OACD prescriptions for a washout period of two months during pharmacy initiation. We used multivariable logistic regression to examine factors associated with TTR > 7 days and FR before and after specialty pharmacy implementation. Results: In total, 883 patients were prescribed 1145 new OACDs. The majority of prescribed drugs were targeted treatment (56%, N = 646) and 72% (N = 819) required prior authorization (PA). Of all prescriptions, 86% (N = 999) were successfully received with an overall median TTR of 7 days. Adjusted analyses showed that patients were more likely to receive their drugs in less than 7 days after specialty pharmacy implementation (OR: 1.4 95% CI 1.04 – 1.81), p = 0.03). In an unadjusted analysis, patients were more likely to receive their initial medications after specialty pharmacy implementation, compared to before specialty pharmacy implementation (89% vs. 84%, p = 0.04). Multivariable analysis showed a trend toward more patients receiving drugs after specialty pharmacy implementation (OR: 1.42, 95% CI 0.98 – 2.03, p = 0.06). Conclusions: The implementation of a hospital-based specialty pharmacy in partnership with SHS decreased TTR. This difference is in part attributable to improved care coordination and communication. A centralized approach may improve overall efficiency due to fewer clinical practice disruptions.

Implementation of an oral chemotherapy adherence tool at an NCCN comprehensive cancer center.

265 Background: Adherence to oral chemotherapy (OC) is a critical factor in achieving optimal oncologic outcomes. Correct dosing, education, and symptom management are essential to maximizing adherence. As part of the 2020 Quality Oncology Practice Initiative Certification Program Fox Chase Cancer Center (FCCC), a NCCN Comprehensive Cancer Center, learned that only 33% of patients on OC had a documented OC plan, 7% were assessed for adherence, and 0% had documentation reflecting efforts to address non-adherence. Methods: Our goal was to create and implement an electronic medical record (EMR) tool (Oral Chemo Smart Form) to address the variance and deficiencies in monitoring adherence to OC. The Smart Form (SF) was designed to include fields to document the OC plan (drug, indication, dose, schedule, duration of cycle, initial start/end date) as well as provide a standard for documentation of education, management of toxicity and non-adherence. We integrated the SF into nursing, pharmacy, and physician workflows to capitalize on shared EMR tools. A series of Plan-Do-Study-Act cycles were conducted over 8 weeks within pilot clinics. Weekly review of the SF and feedback forms generated real-time progress reports which were serially appraised and shared with stakeholders. Results: Two oncologists (piloted in Genitourinary and Breast Cancer clinics), two pharmacists, and several nurses used the SF March 15, 2021 to May 7, 2021. Over these 8 weeks, 223 patients on OC were seen in clinic. If the OC was dispensed from FCCC, pharmacists were to complete the SF at the time of initial OC prescription, 7 days after dispensing, and with each refill. Pharmacists also identified patients receiving OC through a specialty pharmacy and routed a message to clinic nurses via an EMR message pool. The message became the trigger for nurses to call patients within two weeks to troubleshoot dispensing issues and/or complete the SF. Oncologists were to complete the SF with each clinic visit for a patient on OC. Feedback from the clinical and pharmacy teams motivated changes in the content fields of the SF and workflow. Ultimately, 45% of patients on OC had the SF completed. An OC plan was documented in 41% of patients, compared to 33% at baseline; 87% had an administration schedule compared to 81%. There was an increase in the number of patients contacted following start of OC, 35% from 4%. Medication adherence was assessed in 35% of patients, up from 7%. Documented discussions addressing medication adherence increased to 78%, from 0%. Conclusions: Introduction of the Oral Chemo SF in pilot clinics improved documented OC plans and administration schedules. Its use introduced a standard process for monitoring safety, assessing and addressing non-adherence, while troubleshooting specialty pharmacy dispensing issues. The SF will be implemented throughout FCCC and further evaluated with efforts focused on adopting and streamlining this as standard work.

Health-system specialty pharmacy impact on oral chemotherapy outcomes.

240 Background: Oral chemotherapy usage has grown significantly over the years as it provides a more convenient and less invasive administrative option for patients.In 2019, 89% of large hospitals owned and operated their own Health System Specialty Pharmacies (HSSP)1.Pharmacist-led medication therapy management services are crucial to provide patient education, monitoring of medication adherence and adverse effect management. With the current vertical integration of health plans and pharmacy benefit managers (PBMs) increasing their dominance over specialty dispensing channels, HSSP are often excluded from specialty networks. The objective of this study is to compare outcomes of oncology patients filling their oral chemotherapy at Cedars Sinai Medical Center (CSMC) Specialty Pharmacy versus those who are filling their medications at outside specialty pharmacies (OSP). Methods: Electronic health records were used to conduct a retrospective chart review of patients started on oral chemotherapy at CSMC between January 2019 to January 2021. Primary endpoints included time to treatment (TTT) and proportion of days covered (PDC). Secondary endpoints included drug-related problems (DRPs) and treatment-related ED visits and hospitalizations. DRPs were categorized by severity and type of intervention. Results: There were 100 patients included in the study: CSMC group (n = 50) and OSP group (n = 50). Patients in the CMSC group had significantly shorter TTT compared to OSP group (4 days vs. 9.5 days, respectively [P < 0.0026]), as well as a higher PDC (99.5% vs 91%, respectively [P < 0.0005]). Pharmacists identified and resolved 31 DRPs in CSMC arm with 19 DRPs categorized as serious and 1 DRP categorized as life-threatening. For the OSP group, 23 preventable DRPs were identified with 12 DRPs categorized as serious and 1 DRP categorized as life-threatening. There were no treatment-related ED visits or hospitalizations in either group. Conclusions: Patients filling their oral chemotherapy at CSMC Specialty Pharmacy had significantly quicker TTT and higher adherence rates as measured by PDC. Numerous DRPs were identified for OSP patients; potential pharmacist-interventions could have led to optimized and safer medication therapy if filled at a HSSP. Continued research comparing treatment outcomes and interventions made between HSSP and OSP can create a strong argument for health plans and PBMs to consider inclusion of HSSPs into their specialty networks. References: Pedersen CA, Schneider PJ, Ganio MC, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: Prescribing and transcribing—2019. American Journal of Health-System Pharmacy. 2020;77(13):1026-1050. doi:10.1093/ajhp/zxaa104