Sabrina Livezey

Background: Deutetrabenazine, a vesicular monoamine transporter 2 inhibitor, is one of few treatment options available for Huntington's disease (HD) chorea. There is limited data describing clinical experience with deutetrabenazine doses >48 mg daily. Objective: Describe treatment outcomes for deutetrabenazine >48 mg daily. Methods: A dual site retrospective cohort study of patients on deutetrabenazine titrated to doses >48 mg/day for HD chorea from April 2017 through December 2021 was conducted. Patients using concomitant strong CYP2D6 inhibitors at time of deutetrabenazine initiation, those who became deceased or lost to follow-up within six months of dose increase above 48 mg/day, or previously enrolled in a study on >48 mg daily and moving to commercial product were excluded. Outcomes were reported descriptively including therapeutic response, adverse effects (AEs), adherence (measured by proportion of days covered [PDC]), and discontinuation. Results: Thirty patients were included: 47% female, 93% White, median age 56 years. Most patients required dose escalations for inadequate response. The rate of AEs reported before and after transitioning to doses >48 mg/day was the same. Psychiatric changes were less commonly reported at doses >48 mg/day, but extrapyramidal symptoms were more common. The median total maximum chorea score in the Unified HD Rating Scale was 13 (IQR 9–19) and 13 (IQR 7–18) at baseline and follow-up, respectively. Median PDC was 0.99 (IQR 0.94–1.00); two patients discontinued therapy due to AEs. Conclusions: Deutetrabenazine >48 mg daily appears safe and well tolerated in patients with uncontrolled HD chorea, though no significant change in total maximal chorea score was found.

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. 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. 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). Median time to approval decreased postintegration. The SP performed valuable monitoring and interventions.

Background: Emerging data supports the transplantation of organs from hepatitis C-positive (HCV) donors into HCV negative recipients to expand the donor pool. Access to HCV direct-acting antivirals (DAAs) has been cumbersome and expensive for use in patients seeking approval for on-label indications through insurance and assistance programs. Access has not been well described in the donor derived-HCV (dd-HCV) solid organ transplant (SOT) population where off label use has been more common. Objectives: Evaluate HCV DAA prescription access, cost, timing, and barriers to the first dose (FD) in patients with dd-HCV infection post heart, kidney, lung, or liver SOT in the real-world, standard practice. Methods: We conducted a retrospective review of all patients prescribed DAAs at our center following dd-HCV SOT between October 2016 and July 2019. Our on-site specialty pharmacy (SP) managed the DAA access process for all patients. We collected dates of transplant, DAA request, approval, and FD. Univariate proportional odds logistic regression assessed whether the length of time from DAA request to FD was associated with insurance type, insurance appeal, pharmacy location, transplant type, or off-label use. Results: There were 91 patients in the study period (54% private insurance; 46% ledipasvir/sofosbuvir, 41% glecaprevir/pibrentasvir, 13% velpatasvir/sofosbuvir; transplant types: 52% heart, 30% kidney, 11% liver, 2% lung, 5% dual organ). All accessed DAA therapy: 97% insurance, 3% assistance programs. Among 88 insured patients, 65% had DAAs approved on initial prior authorization (PA) while 35% required an appeal. Common PA denials were the absence of chronic HCV diagnosis (42%) and request for more than 8 weeks of therapy (36%). Median time from SOT to DAA request was 28 days [IQR 18.5–41.5], DAA request to approval was 6 days [IQR 4–12] and approval to FD was 8 days [IQR 6–12.5]. Private insurance, first fill at an off-site SP, non-kidney transplant, and need for insurance appeal were all associated with significantly longer time from DAA request to FD, but off-label use was not. Of the 63 patients who filled DAA therapy at our center’s on-site SP, 49% used copay assistance, reducing average monthly out-of-pocket costs from $2003 [range $7–7536] to $2 [range $0–5]. Conclusions: Access to outpatient DAA therapy in dd-HCV post-solid-organ transplant patients is achievable and affordable. The use of an on-site specialty pharmacy is associated with a significantly shorter time to the first dose. Background: A collaborative pharmacy practice agreement (CPPA) permits pharmacists to perform clinical services under the guidance of a supervising physician without direct physician intervention. A CPPA has been in use within the Vanderbilt Renal Transplant Clinic since March 2017. Objective: We aimed to quantify and categorize interventions performed by two clinical pharmacists with a CPPA at an academic renal transplant clinic and determine the impact of interventions on patient care. Methods: Clinic notes were reviewed to collect pharmacist interventions (defined as an encounter with one or more actions to improve patient outcomes), performed between 1 January 2019 and 30 June 2019, for adult patients prescribed immunosuppressant or non-immunosuppressant medication. Interventions were categorized by type (medical record assessments, medication counseling, or the resolution of barriers to medication continuation), then further classified into subcategories. The number and type of interventions performed were summarized with frequency distributions. We also calculated the number of prescription orders entered by the clinical pharmacists during this time. Results: During the 6-month window, clinical pharmacists under a CPPA placed 5793 prescription orders and performed 1821 clinical chart reviews for 1233 patients. Five percent of all orders were audited by the attending physician with a zero percent error rate. Within all clinical chart reviews, 3852 interventions were performed: 2695 medical record assessments, 734 medication counseling, and 423 resolutions of barriers to medication continuation. Conclusions: Pharmacists practicing under a CPPA were able to reduce provider burden and improve patient care by managing the prescribing of transplant medications. The most common intervention performed was medical record assessment, which facilitates the prescribing of appropriate medication and dosage. Pharmacist interventions ensured treatment adherence and persistence in patients that were evaluated. Background: Denosumab is a subcutaneous injection administered in the clinic every six months for patients with osteoporosis at high risk of bone fracture. Reasonable interruptions to therapy include dental procedures, fractures from trauma, infections, and certain adverse effects. Little research has explored rates and reasons for lapses in denosumab therapy in real-world settings. Objectives: To assess the reasons for treatment lapses in patients taking denosumab and discuss potential interventions to aid in adherence. Methods: At a large academic medical center in the United States, we conducted a retrospective review of adult patients who received ≥2 denosumab injections between January 2010 and December 2018. Patient demographics and treatment dates were collected from electronic medical records. We calculated how many patients had a lapse in therapy defined as 240 or more days between injections (excluding lapses due to death, transfer of care, temporary medication change, or patient discontinuation of therapy). Reasons for lapses were collected and categorized. Logistic regression was used to test whether the occurrence of lapse was associated with patient race, smoking status, sex, BMI, or age. Results: We included 534 patients: 86% female, 95% White, mean age 69 years. After starting denosumab, 152 patients incurred a lapse, and 45 patients incurred...

Background: Patient access to pimavanserin treatment, an antipsychotic agent used to treat Parkinson’s disease-related psychosis, is limited by insurance approval and navigating a limited distribution network. Once initiated, safety and efficacy monitoring is needed to ensure adherence and clinical benefit. Aims: To determine the impact of specialty pharmacist integration on time to pimavanserin access. A secondary objective is to describe pharmacist interventions related to pimavanserin. Methods: This was a single-center, retrospective cohort study with a pre–post design. Patients prescribed pimavanserin through the center’s neurology clinic during May 2016 through July 2018 were included. An electronic chart review was performed to collect data for patient demographics (age, race, gender), insurance information (type, prior authorization process), and pharmacist interventions. The primary outcome was defined as time to medication access (in days) between the initial intent to treat and insurance approval. Univariate analysis and multiple logistic regression were performed to assess the associations between medication access time and pharmacist integration. Results: Ninety-four patients met inclusion criteria. Patients were mostly male (80%) and Caucasian (96%). Median age was 74 years. Baseline demographics between the pre- and post-integration cohorts were similar. Pre-integration, 33 patients were prescribed pimavanserin, with 82% attaining insurance approval and 79% starting therapy. Post-integration, 61 patients were prescribed pimavanserin, with 95% attaining insurance approval and 93% starting therapy. Median time to access decreased following integration (3 days compared to 24.5 days). Patients prescribed pimavanserin pre-integration had a 23-fold increase in odds of experiencing a longer time to access compared to post-integration (OR = 23; 95% CI = 8–69; p < 0.001). In addition, patients with non-commercial insurance were more likely to have a shorter medication access time compared to patients with commercial insurance. The pharmacist performed at least one intervention for 85% of patients, including medication counseling (n = 58) and interventions to improve clinical care (n = 120) and medication access (n = 135). Conclusions: Integration of a specialty pharmacist decreased time to pimavanserin access and facilitated pharmacy interventions to ensure safety and efficacy of use. Additional research is needed to evaluate the impact of faster medication access on clinical outcomes.