Ultra-complex specialty medications: Meeting the challenges of significant medication requirements through an integrated specialty pharmacy model.

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A primer on copay accumulators, copay maximizers, and alternative funding programs.

Insurer or self-insured employer's plans are increasingly using copay accumulator, copay maximizer, and alternative funding programs (AFPs) to reduce plan spending on high-priced prescriptions. These programs differ in their structure and impact on patient affordability but typically decrease the insurer or self-insured employer's financial responsibility for high-priced drugs and increase the complexity of specialty medication access for patients. The aim of this primer is to describe the structure of copay accumulator, copay maximizer, and AFPs to improve understanding of these cost-shifting strategies and help clinicians and patients navigate medication access and affordability issues to minimize treatment delays or non-initiation.

Evaluating patient-reported adherence and outcomes in specialty disease states: A dual-site initiative.

Background: Patient-reported outcomes (PROs) are often used by clinicians to evaluate patient response to specialty medications used to treat multiple sclerosis (MS) and rheumatologic conditions. Identifying associations among PROs and patient characteristics could inform patient-centered treatment monitoring.

Objective: To examine the association among patient characteristics and PROs, including patient-reported adherence (defined as no missed doses), medication tolerance, patient perceived effectiveness, and health care resource utilization (HCRU; defined as emergency department visits or hospitalizations), for patients prescribed specialty medications in 2 health system specialty pharmacies.

Financial impact of integrated specialty pharmacy efforts to avoid oral anticancer medication waste.

Background: The growing number of oral anticancer medications represents a significant portion of pharmacy spending and can be costly for patients. Patients taking oral anticancer medications may experience frequent treatment changes following necessary safety and effectiveness monitoring, often resulting in medication waste. Strategies to avoid medication waste could alleviate the financial burden of these costly therapies on the payer and the patient.

Cost avoidance from health system specialty pharmacist interventions in patients with multiple sclerosis.

Background: Specialty pharmacists monitor patients taking multiple sclerosis (MS) disease-modifying therapies (DMTs) to evaluate response to therapy and intervene on adverse effects. These interventions have the potential to avoid health care costs by discontinuing inappropriate therapies and avoiding downstream health care utilization.

Objective: To calculate the costs avoided by specialty pharmacist interventions in MS.

Retraining transplant pharmacy staff to reduce Medicare Part B prescription billing errors post-transplant.

Background: Medicare Part B (MedB) imposes penalties for certain errors in prescription billing of post-transplant medications, which can greatly affect pharmacy revenue. To prevent MedB billing fines, pharmacy staff must be cognizant of specific MedB requirements.

Objective: This quality improvement project aimed to retrain certified pharmacy technicians (CPhTs) on common billing errors and evaluate changes in error rates and potential fines after retraining.

Adherence and discontinuation of prescription cannabidiol for the management of seizure disorders at an integrated care center.

Objective: Evaluate adherence, discontinuation rates, and reasons for non-adherence and discontinuation of prescription CBD during the 12-months post-initiation period at an integrated care center.

Methods: This was a prospective study of patients prescribed CBD by a neurology clinic provider with initial prescription fulfillment through the center's specialty pharmacy from January 2019 through April 2020. Baseline demographics and reasons for non-adherence and/or discontinuation were collected from the electronic health record and pharmacy claims history was used to calculate adherence using proportion of days covered (PDC).

Insurance Approval Delay of Biologic Therapy Dose Escalation Associated with Disease Activity in Patients with Inflammatory Bowel Disease.

Background: Dose escalation of self-injectable biologic therapy for inflammatory bowel diseases may be required to counteract loss of response and/or low drug levels. Payors often require completion of a prior authorization (PA), which is a complex approval pathway before providing coverage. If the initial PA request is denied, clinic staff must complete a time and resource-intensive process to obtain medication approval.

Therapy outcomes associated with prescription cannabidiol use at 12 months post-initiation.

Objective: This study evaluated prescription cannabidiol (CBD) outcomes during the first 12 months of therapy.

Methods: A single-center, prospective cohort study was performed including patients prescribed CBD from January 2019 - April 2020, excluding clinical trial patients and those using external specialty pharmacy services. The primary outcome wasepilepsy-related emergency healthcare service (EHS) use within 12 months of initation.

Patient-reported outcomes and pharmacist actions in patients with multiple sclerosis managed by health-system specialty pharmacies.

Purpose: This study evaluated patient-reported outcomes (PROs) and pharmacist actions for patients on disease-modifying therapies (DMTs) for multiple sclerosis (MS) through health-system specialty pharmacies (HSSPs).

Methods: A multisite, prospective cohort study of patients utilizing an HSSP for DMT fulfillment was performed. Primary outcomes were affirmative answers to PRO questions regarding impacted productivity, hospitalization, and relapse and pharmacist actions.

Primary medication nonadherence rates to specialty disease-modifying antirheumatic drugs for rheumatoid arthritis within a health system specialty pharmacy.

Assessing primary medication nonadherence, the rate at which a medication is prescribed for a patient but is not obtained or replaced with an alternative medication within a reasonable time period, can provide a better understanding of the frequency and impact of these barriers to medication access. Previous literature has reported high rates of primary medication nonadherence, ranging from approximately 20% to 55% in patients with rheumatoid arthritis (RA) treated with specialty disease-modifying antirheumatic drugs (DMARDs). The high primary medication nonadherence rate may reflect the difficulties associated with obtaining specialty medications, such as high costs, extended prior authorizations, and pretreatment safety requirements.

Low rates of primary medication nonadherence in patients prescribed oral oncology agents across health system specialty pharmacies.

New oral oncology medications bring novel challenges when patients are initiating treatment. Rates of primary medication nonadherence (PMN), the rate at which a medication is prescribed but not obtained, of up to 30% have been reported for oral oncology medications. More research is needed to identify causes and develop strategies for health system specialty pharmacies (HSSPs) to improve cancer treatment initiation rates.

Optimizing HIV PrEP Persistence: Does Your Pharmacy Matter?

Persistence to human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) is integral to preventing new HIV infections. Previous studies have shown real-world PrEP persistence is low and insight is needed into PrEP delivery strategies that improve persistence. This single-center, retrospective, cohort study measured persistence in patients filling PrEP through an integrated health-system specialty pharmacy (HSSP) compared to those filling at external pharmacies.

Adherence and persistence to self-administered disease-modifying therapies in patients with multiple sclerosis: A multisite analysis.

Background: Though there are several disease-modifying therapy (DMT) options for patients with multiple sclerosis (MS), treatment outcomes rely on patient adherence and persistence. Previous studies have demonstrated suboptimal adherence rates and high rates of early treatment discontinuation. Health-system specialty pharmacies (HSPPs) are a growing practice model that have demonstrated adherence and persistence benefits through single site evaluations.

Patient-Tailored Interventions to Improve Specialty Medication Adherence: Results from a Prospective Randomized Controlled Trial.

Background: Specialty medication nonadherence results in poor clinical outcomes and increased costs. This study evaluated the impact of patient-tailored interventions on specialty medication adherence.

Methods: A pragmatic, randomized controlled trial was conducted at a single-center health-system specialty pharmacy from May 2019 to August 2021.

2022 ASHP Survey of Health-System Specialty Pharmacy Practice: Clinical Services.

Purpose: Results of the first ASHP national survey of clinical services provided by health-system specialty pharmacies (HSSPs) are presented.

Methods: A survey questionnaire was developed by 26 HSSP contacts after reviewing available literature on the role and services of HSSPs. After pilot and cognitive testing resulting in a final questionnaire of 119 questions, a convenience sample of 441 leaders in HSSPs was contacted using email and invited to participate in the survey.

Assessing Pharmacist Interventions at an Outpatient Renal Transplant Clinic Under a Collaborative Pharmacy Practice Agreement.

Collaborative pharmacist practice agreements (CPPAs) advance the role of pharmacists by granting prescriptive authority without direct oversight from participating physicians. To assess the quantity of prescriptions authorized by pharmacists and frequency and types of interventions performed under a CPPA in an outpatient renal transplant clinic. Clinical pharmacists in the outpatient renal transplant clinic began prescribing medications under a CPPA in March 2017.

Development and implementation of a laboratory monitoring dashboard to reduce treatment gaps in inflammatory bowel disease.

Purpose: Patients receiving biologic therapy for inflammatory bowel disease (IBD) require routine laboratory monitoring to ensure the safety and efficacy of therapy. The purpose of this quality improvement project was to evaluate the implementation of a dashboard to prevent treatment gaps by prospectively identifying patients with IBD and outdated laboratory results receiving biologics.

Methods: We performed a pre/post analysis of dashboard implementation to assess the number of patients with overdue laboratory work resulting in treatment gaps.

Individual and Community-Level Characteristics and Adherence to Specialty Medications.

Understanding risk factors for nonadherence can help specialty pharmacies optimize resources to prevent nonadherence and inform risk-stratification processes. To determine which individual and community-level characteristics are associated with nonadherence to specialty medications. We analyzed a cohort of patients enrolled in a prospective randomized controlled trial having filled a specialty medication at least 4 times in the previous 12 months with a proportion of days (PDC) covered < 0.

Specialty pharmacy integration and the role of an advanced certified pharmacy technician in prescription cannabidiol access.

Background: Insurance requirements that limit access to prescription cannabidiol (CBD), an adjunct therapy for uncontrolled seizure disorders, may lead to treatment initiation delays. Integrated health-system specialty pharmacies (IHSSPs) use pharmacists and advance certified pharmacy technicians (CPhTs) to help navigate prescription CBD access requirements.

Objective(s): Evaluate time from initial specialty pharmacy referral to prescription CBD shipment.

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

Integrated health-system specialty pharmacies (IHSSP) have shown high medication access, adherence, and provider satisfaction. The goal of this study was to explore healthcare providers' experiences with specialty medications distributed via Limited Distribution Networks (LDN) that do not include IHSSPs. We investigated healthcare providers' perceived impact of LDNs on clinic workflow, clinical practice, and patient outcomes.

Health-system specialty pharmacy role and outcomes: A review of current literature.

Purpose: Specialty medications can have life-altering outcomes for patients with complex diseases. However, their benefit relies on appropriate treatment selection, patients' ability to afford and initiate treatment, and ongoing treatment optimization based on patient response to therapy. Mounting research demonstrates the benefits of the health-system specialty pharmacies (HSSPs) in improving specialty medication access, affordability, and outcomes.