Specialty Medications Research Articles

A descriptive survey of patient experiences and access to specialty medicines with alternative funding programs.

Alternative funding programs (AFPs) seek to reduce health plan sponsor costs, for example by excluding specialty drugs from a beneficiary's plan coverage and requiring patients to obtain medications through alternative sources (typically, the manufacturer's patient assistance programs) via an AFP vendor as a third-party. To describe patients' experiences and specialty medication access with AFPs. A survey method consisting of 26 optional single-choice and multiple-choice questions with branching logic divided across 5 sections (related to patient challenges with AFPs) was administered to patients recruited from an experienced AFP online patient panel and a patient advocacy group. The survey assessed patients' awareness of AFPs from their employers, experience with the patient assistance program application process via the AFP vendor, timeliness of medication access (if granted), and/or the health impact of delay in access. All descriptive and exploratory subgroup analyses were conducted by disease area and reported income levels; statistical analyses were carried out for the exploratory analyses. The final sample included 227 patients. Most patients (61% [136/223]) first heard of the AFP as part of their health benefit when trying to obtain their medication. Of 198 patients, 88% reported being stressed because of the medication coverage denial and the uncertainty of obtaining their medication. More than half of patients (54% [115/213]) reported being uncomfortable with the benefits manager from the AFP vendor. On average, patients reported waiting to receive their medication for 68.2 days (approximately 2 months); 24% (51/215) reported the wait for the medication worsened their condition and 64% (138/215) reported the wait led to stress and/or anxiety. Patients who indicated the wait time negatively affected them had considered a job change or left their job at a 3-5-fold higher rate than those who reported no impact from wait time. A significantly higher proportion of patients with hemophilia and other bleeding disorders reported receiving their prescribed medication less often than patients with other conditions (63% [19/30] vs 81% [52/64]; P = 0.022), whereas more patients with lower incomes (<$50,000 vs >$50,000) reported not receiving any medication (12% [7/57] vs 5% [7/129]; P = 0.657), although these differences were not significant. Most patients who obtain their specialty medicines via AFPs reported being uncomfortable with the process and experiencing treatment delays, which may have been linked to disease progression, worsened mental well-being, and consideration of a job change. Employers should be aware of the potential downstream impacts on employee health, retention, and the employee-employer relationship when considering implementing an AFP into their health plan.

Healthcare Access for Patients With Inflammatory Bowel Disease in the United States: A Survey by the Crohn's & Colitis Foundation.

A prior survey disseminated in 2017 identified that healthcare access barriers exist and significantly affect patients with inflammatory bowel disease (IBD). We sought to identify, through an updated survey, the healthcare access barriers that patients continue to face, with a focus on socioeconomic factors and patient awareness of resources to navigate existing barriers. A 52-question online survey evaluating (1) access to healthcare professionals, medications, and procedures; (2) associated financial challenges; and (3) patient awareness of education and advocacy tools to navigate IBD care barriers, was disseminated through multiple channels to IBD patients and their caregivers. Of the 2281 completed responses, patients on advanced specialty medications, younger than 65 years of age, or on employer insurance experienced significantly greater issues with insurance barriers to accessing medications and coverage of medically necessary tests/treatments. Patients who live in areas of concentrated poverty were more likely to experience poor health outcomes when subjected to step therapy compared to patients who did not. Additionally, patients were more likely to experience one or more financial barriers or trade-offs if the patient used an advanced specialty medicine or lived in an area with concentrated poverty. While there have been significant and numerous advancements in IBD treatments, patients with IBD continue to experience barriers to healthcare access and treatment and financial struggles. Ongoing awareness and advocacy efforts focused on healthcare system reform and related policies to further minimize care disparities and barriers remain vital.

Implementing a letter template to expedite specialty medication appeal letter submission

BackgroundPrior authorizations (PAs) for biologic medications, used to treat inflammatory bowel disease (IBD), are often denied by pharmacy benefits managers and can require a complex appeal process for patients to gain access to medication. ObjectiveThis quality improvement project evaluated the impact of implementing a standardized appeal letter template and customizable clinical rationale letter content on specialty pharmacist workflow and workload in an integrated hospital health system specialty pharmacy (HSSP) IBD clinic. Practice descriptionThis initiative was conducted in an IBD outpatient clinic at a tertiary academic medical center with an integrated HSSP whose specialty pharmacists work collaboratively with providers to manage specialty medications. Practice innovationA letter template was created in the electronic health record (EHR) for pharmacists to use when submitting appeal letters. The template automatically populates patient results from recent labs, imaging, and clinic visit notes as part of the appeal documentation. Clinical rationale letter content was developed for the most common appeal reasons using EHR functionality that allows the creation of standardized notes that can be shared among team members and customized at time of use. Evaluation methodAn analysis of 2 months of data preimplementation/postimplementation was conducted using descriptive statistics to report the number of appeals submitted, time from PA denial to appeal submission, and appeal approval rate. A pharmacist postimplementation satisfaction score was also collected. ResultsThe number of appeals submitted preimplementation (n = 73) and postimplementation (n = 73) was the same. Postimplementation, 89% of appeals were submitted within 3 days of PA denial compared to 29% preimplementation. PA approval rate was high (93%) preimplementation and postimplementation. Overall pharmacist satisfaction was 9.7 out of 10. ConclusionImplementation of an appeal letter template and standardized clinical rationale letter content in the EHR led to decreased time to appeal submission and high specialty pharmacist satisfaction.

Pharmacists as educators: Enhancing patient understanding and access to specialty medications through community workshops

Pharmacists are increasingly recognized as vital educators within the healthcare system, particularly in improving patient understanding and access to specialty medications. This review explores the expanding role of pharmacists as educators, emphasizing their unique expertise in providing accurate, accessible information and their impact on patient outcomes. The paper highlights community workshops as an effective tool for delivering education, focusing on the structure, content, and accessibility of these workshops to diverse patient populations. Furthermore, it examines patients' barriers to accessing specialty medications and how pharmacists can help overcome these challenges through education, support, and coordination with other healthcare providers. The review also discusses future directions for enhancing the educator role of pharmacists, the need for supportive policies, and the potential long-term benefits of pharmacist-led education on public health and healthcare costs. Recommendations for implementing and expanding community-based education initiatives are provided, emphasizing integrating these efforts into broader healthcare strategies. Keywords: Pharmacist-led education; Specialty medications; Community workshops; Healthcare access; Patient outcomes; Public health

Impact of 340B drug pricing program on specialty medication access: A policy analysis and future directions

The 340B Drug Pricing Program, initially designed to assist healthcare providers in offering affordable medications to vulnerable populations, has increasingly come under scrutiny, particularly concerning its impact on specialty medication access. This review critically examines the program’s effectiveness in improving access to high-cost specialty drugs, highlighting significant challenges such as program misalignment, economic pressures, and criticisms from the pharmaceutical industry. It further explores the regulatory landscape, stakeholder perspectives, and ethical considerations that shape the program’s implementation. The paper proposes reforms to refine eligibility criteria, enhance transparency, and adjust pricing structures to serve better patients needing specialty medications. Additionally, it discusses innovative strategies like digital health integration and industry partnerships that could enhance the program’s efficacy. The long-term implications of these proposed changes on healthcare systems, patients, and the pharmaceutical industry are considered, emphasizing the need for a balanced approach to sustain the 340B program’s mission in the evolving healthcare environment.

Impact of VA Hematology/Oncology Clinical Pharmacy Practitioners in the Review of Community Prescriptions for Specialty Medications.

Within the US Department of Veterans Affairs (VA), eligible veterans can receive covered health care through the community care network. Many prescriptions for specialty medications made by community care prescribers are filled by outpatient VA pharmacies. Trained hematology/oncology clinical pharmacy practitioners (CPPs) review specialty medication prescriptions from community-based prescribers. This study's primary objective was to evaluate clinical interventions initiated by hematology/oncology CPPs at the Veterans Affairs North Texas Health Care System (VANTHCS) during their review of hematology/oncology specialty prescriptions from community care prescribers. A retrospective chart review of VANTHCS patients enrolled in the community care program with a specialty hematology/oncology prescription received and reviewed by a VA clinical hematology/oncology CPP was conducted for records from January 1, 2015, to June 30, 2023. The primary outcome was the number and types of clinical interventions. Secondary outcomes include the number of interventions accepted and/or denied by the prescriber and the financial implications of these interventions. Two hundred twenty-one specialty hematology/oncology prescriptions met the study inclusion criteria. VANTHCS hematology/oncology CPPs completed clinical interventions for 82 prescriptions (37%). Among those prescriptions, CPPs documented 97 clinical interventions. The most commonly documented interventions included managing/preventing a drug interaction (26%) and dose adjustment requests (25%). Hematology/oncology CPPs at VANTHCS are essential in reviewing anticancer medication prescriptions from community-based practitioners ; CPPs completed clinical interventions for more than one-third of the prescriptions and prescribers approved most of these interventions.

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.

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. 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. A dual-center, retrospective review of monthly medication assessments completed by Vanderbilt Specialty Pharmacy and University of Illinois Hospital and Health Sciences System specialty pharmacy was conducted. Patients were included if they received at least 3 fills of a specialty medication from rheumatology or MS clinics from October 2019 to March 2022, excluding patients with more than a 30-day supply. Primary outcomes were the PROs of patient-reported adherence, medication tolerability, perceived effectiveness, and HCRU. For each of the 2 primary outcomes (adherence and tolerability), a mixed-effects logistic regression model was used to test for associations with age, sex, race, clinic, site, and the other PROs. A total of 61,926 assessments were completed from 3,677 patients (Site 1 = 3,346; 91.0% and Site 2 = 331; 9.0%). Patients were predominantly White (75.6%) and female (71.7%) with a median age of 50 years (IQR = 37-61). Assessments most frequently originated from rheumatology (76.0%). Nonadherence was reported 4.0% of the time, with the most common explanations being forgetfulness (33.1%) and medication being held because of a procedure or illness (29.5%). Most responses indicated perceived effectiveness as good/excellent (93.9%), with 98.5% of responses indicating no issues with tolerability. Patients who reported tolerability issues were 2.5 times more likely to report a missed dose (95% CI = 1.87-3.23, P < 0.001). An effectiveness rating of fair was associated with a 61% increase in the odds of a missed dose compared with a rating of good/excellent (95% CI = 1.33-1.94). Patients filling rheumatology or MS specialty medications within health system specialty pharmacies reported high rates of medication effectiveness and adherence and low rates of issues with tolerability and HCRU. Patients who report tolerability issues or lower perceived effectiveness may benefit from additional monitoring to prevent nonadherence.

The impact of multiple pharmacy use on medication adherence in individuals with colorectal cancer.

11041 Background: Colorectal cancer (CRC) is the third most common cancer diagnosed in the US. The pharmacological care of older and often comorbid members with CRC is a growing healthcare issue. Cancer members are prone to the unintended consequences of multiple pharmacy use, as they often receive chemotherapy and symptom-relieving agents, in addition to medications they may be taking for other comorbidities. The purpose of this study was to assess multiple pharmacy use and adherence in a cohort of individuals with CRC. Methods: Adult pharmacy benefit manager (PBM) members who had at least 2 fills of either regorafenib, encorafenib, or trifluridine + tipiracil at specialty pharmacies between 1/1/2022 and 12/31/2022 were included. Any fills must have included one of the following diagnosis codes: C18.X, C19.X, C20.X, C21.8, C78.5, C78.6, D37.4, D37.5. Members were excluded if they did not maintain continuous eligibility for the 180 days prior to initiation in the study. Specialty pharmacy type included CVS Specialty, Competitor Specialty and Competitor non-specialty. Multiple pharmacy use was defined as utilizing more than one pharmacy for medication fills. The primary outcome was adherence determined by the medication possession ratio (MPR), defined as the number of days supplied/number of days in the evaluation period; optimal adherence was defined as MPR ≥ 0.8. Continuous and categorical variables were assessed with standard statistical tests. Bivariate logistic regression models were constructed for each covariate; significant variables were included in the multivariate model. Odds ratios (OR) and 95% confidence intervals (CI) are presented; p values &lt; 0.05 were significant. Results: 891 members met all inclusion criteria; 362 (40.6%) met the definition of multiple pharmacy use. Members were on average 59.6 ± 11.2 years old and 54.3% were male. No differences in member demographics between specialty pharmacy type were found (all p &gt; 0.05). Adherence was high with 79.5% of members having a MPR ≥ 0.8. Members with multiple pharmacy use had significantly lower adherence rates (76.0% vs. 81.9%; p=0.04) and MPRs (mean ± SD) (1.06 ± 0.45 vs. 1.15 ± 0.53; p=0.011). Controlling for specialty pharmacy type, medication used, and gender, multiple pharmacy use was significantly associated with decreased likelihood of optimal adherence compared to single pharmacy use (OR [95% CI]: 0.705 [0.507-0.98]; p= 0.038). Male gender was associated with significantly higher likelihood of optimal adherence (OR [95% CI]: 1.517 [1.093-2.107]; p=0.013). Conclusions: In this study of individuals with CRC receiving regorafenib, encorafenib, or trifluridine + tipiracil, utilizing multiple pharmacies for non-CRC medications was associated with a 29.5% decreased likelihood of optimal adherence compared to those who only utilized one pharmacy. Further examinations are warranted that include other modulators of adherence.

Projected environmental and public health benefits of extended-interval dosing: an analysis of pembrolizumab use in a US national health system

Health care is a major source of greenhouse gas emissions, leading to climate change and public health harms. Changes are needed to improve the environmental sustainability of health-care practices, but such changes should not sacrifice patient outcomes or financial sustainability. Alternative dosing strategies that reduce the frequency with which specialty drugs are administered, without sacrificing patient outcomes, are an attractive possibility for improving environmental sustainability. We sought to inform environmentally sustainable cancer care by estimating and comparing the environmental and financial effects of alternative, clinically equivalent strategies for pembrolizumab administration. We conducted a retrospective analysis using a cohort of patients from the Veterans Health Administration (VHA) in the USA who received one or more pembrolizumab doses between May 1, 2020, and Sept 30, 2022. Using baseline, real-world administration of pembrolizumab, we generated simulated pembrolizumab use data under three near-equivalent counterfactual pembrolizumab administration strategies defined by combinations of weight-based dosing, pharmacy-level vial sharing and dose rounding, and extended-interval dosing (ie, every 6 weeks). For each counterfactual dosing strategy, we estimated greenhouse gas emissions related to pembrolizumab use across the VHA cohort using a deterministic environmental impact model that estimated greenhouse gas emissions due to patient travel, drug manufacture, and medical waste as the primary outcome measure. We identified 7813 veterans who received at least one dose of pembrolizumab-containing therapy in the VHA during the study period. 59 140 pembrolizumab administrations occurred in the study period, of which 46 255 (78·2%) were dosed at 200 mg every 3 weeks, 12 885 (21·8%) at 400 mg every 6 weeks, and 14 955 (25·3%) were coadministered with infusional chemotherapies. Adoption of weight-based, extended-interval pembrolizumab dosing (4 mg/kg every 6 weeks) and pharmacy-level stewardship strategies (ie, dose rounding and vial sharing) for all pembrolizumab infusions would have resulted in 24·7% fewer administration events than baseline dosing (44 533 events vs 59 140 events) and an estimated 200 metric tons less CO2 emitted per year as a result of pembrolizumab use within the VHA (650 tons vs 850 tons of CO2, a relative reduction of 24%), largely due to reductions in distance travelled by patients to receive treatment. Similar results were observed when weight-based and extended-interval dosing were applied only to pembrolizumab monotherapy and pembrolizumab in combination with oral therapies. Alternative pembrolizumab administration strategies might have environmental advantages over the current dosing and compounding paradigms. Specialty medication dosing can be optimised for health-care spending and environmental sustainability without sacrificing clinical outcomes. None.

Comparison of time to treatment initiation of specialty medications between an integrated health system specialty pharmacy and external specialty pharmacies.

Specialty medications are commonly dispensed through specialty pharmacies equipped to meet unique monitoring and dispensing requirements. Integrated health system specialty pharmacies (HSSPs) coordinate with health system providers to deliver specialty medications to patients and ameliorate barriers to care. However, payors may restrict specialty medication fills to specialty pharmacies external to the health system, potentially leading to delayed treatment. To compare time to treatment initiation among patients whose specialty medications were transferred to external pharmacies and patients whose medications were filled at an internal HSSP. This was a retrospective, propensity-matched cohort study examining time to treatment initiation in patients with a specialty medication referral to the University of Kentucky HealthCare Specialty Pharmacy between July 1, 2021, and July 1, 2022. Patients were classified into cohorts by receipt of dispensing services from the internal HSSP or an external specialty pharmacy. Data collected via chart review included insurance type, reason for prescription transfer, dates of service (including prescription order, transfer, and receipt of medication), and whether a prior authorization or clinical intervention was performed. Subgroup analyses were performed for patients requiring a prior authorization or clinical intervention. The Wilcoxon signed-rank test was used to assess for statistically significant differences in time to treatment initiation between cohorts. A total of 560 patients with external transfers were identified for inclusion into the study, and after exclusion criteria were applied, 408 external transfer patients were propensity matched 1:1 to 408 patients with internal fills (total n = 816). Time to treatment initiation was significantly longer in the external transfer cohort as compared with the internal fill cohort, (18 days vs 12 days; P < 0.0001). The internal fill cohort had a greater mean days from provider order to the medication being ready to fill compared with the external transfer cohort (10 days vs 6 days; P < 0.0001). The internal fill cohort had fewer mean days from the medication being ready to fill to patient receipt of the medication as compared with the external transfer cohort (2 days vs 12 days; P < 0.0001). Similar findings were observed in the subgroup analyses. Average time to treatment initiation was 6 days shorter for patients whose specialty medications were filled at this HSSP compared with externally transferred patients. Delays in therapy can cause a negative impact on patient care and disease state management, with increased concern for specialty populations. The results of this study highlight the need for continued discussion about policies that limit patient choice to in-network pharmacies.

Incorporating social determinants of health into patient care workflows within a health-system specialty pharmacy

BackgroundThe influence of adverse factors on social determinants of health (SDOH) and their impact on patient outcomes is widely recognized. Pharmacists, as accessible healthcare professionals, can play a pivotal role in identifying and addressing SDOH concerns. Health-system specialty pharmacies have consistently assisted patients in accessing expensive specialty medications and ensuring adherence to therapy. As such, they are uniquely positioned to address SDOH concerns of patients. ObjectiveTo assess the effectiveness of incorporating standardized SDOH screening and referral methods into the patient care workflows of a health-system specialty pharmacy. Practice descriptionThe University of North Carolina Health Care (UNC Health) Specialty and Home Delivery Pharmacy is a health-system owned specialty pharmacy serving patients in North Carolina, South Carolina, and Virginia. It holds accreditations from the Utilization Review Accreditation Commission and Accreditation Commission for Health Care. Practice innovationA standardized SDOH screening and referral method were integrated into patient care workflows of a health-system specialty pharmacy. If SDOH concerns were identified upon screening by a specialty pharmacist, patients were referred to an entity within the health-system responsible for connecting patients to local community resources to address their SDOH concerns. Evaluation methodsThe types of SDOH concerns, frequency of SDOH referrals, referral turnaround time, outcomes of the referrals, and patient demographics were evaluated to determine the impact of this project. Descriptive statistics were used to analyze results. ResultsSixty-nine patients were included (female: n = 38, 55.1%; age (mean±SD: 48.9 ± 16.3). Eighty-seven SDOH concerns were reported, 54 patients (78.3%) were connected to local resources upon referral, and the average turnaround time of referrals was 2.2 business days. ConclusionThe findings of this pilot study highlight the effectiveness of incorporating SDOH screening and referral methods into specialty pharmacy workflows. Specialty pharmacies can successfully identify and address nonmedical factors impacting patients.

Specialty drug use for autoimmune conditions varies by race and wage among employees with employer-sponsored health insurance.

The relationship between race and ethnicity, wage status, and specialty medication (SpRx) use among employees with autoimmune conditions (AICs) is poorly understood. Insight into sociodemographic variations in use of these medications can inform health equity improvement efforts. To assess the association of race and ethnicity and wage status on SpRx use and adherence patterns among employees with AICs enrolled in employer-sponsored health insurance. In this observational, retrospective cohort analysis, data were obtained from the IBM Watson MarketScan database for calendar year 2018. Employees were separated into race and ethnicity subgroups based on employer-provided data. Midyear employee wage data were used to allocate employees into the following annual income quartiles: $47,000 or less, $47,001-$71,000, $71,001-$106,000, and $106,001 or more. The lowest quartile was further divided into 2 groups ($35,000 or less and $35,001-$47,000) to better evaluate subgroup differences. Outcomes included monthly days SpRx-AIC supply, proportion of days covered (PDC), and medication discontinuation rates. Generalized linear regressions were used to assess differences while adjusting for patient and other characteristics. From a sample of more than 2,000,000 enrollees, race and ethnicity data were available for 617,117 (29.8%). Of those, 47,839 (7.8%) were identified as having an AIC of interest, with prevalence rates of AICs differing by race within wage categories. Among those with AICs, 5,358 (11.2%) had filled at least 1 SpRx-AIC prescription. Following adjustment, except for the highest wage category, prevalence of SpRx-AIC use was significantly less among Black and Hispanic subpopulations. Black patients had significantly lower SpRx-AIC use rates than White patients (≤$35,000: 4.9 vs 9.4%, >$35,000-$47,000: 5.5 vs 10.6%, >$47,000-$71,000: 8.5 vs 11.1%, and >$71,000-$106,000: 9.1 vs 12.7%; P <0.001 for all). For Hispanic patients, prevalence rates were significantly lower than White patients in 3 different wage categories (≤$35,000: 4.5 vs 9.4%, >$35,000-$47,000: 6.1 vs 10.6%, and >$71,000-$106,000: 8.6 vs 12.7%; P < 0.001). PDC and 90-day discontinuation rates did not differ among race and ethnicity groups within the respective wage bands. Race and ethnicity and wage-related disparities exist in SpRx use, but not PDC or discontinuation rates for treatment of AICs among non-White and low-income populations with employer-sponsored insurance, and may adversely impact clinical outcomes.

Material financial hardship and insurance-related experiences among Utah's rural and urban cancer survivors.

Describe material financial hardship (e.g., using savings, credit card debt), insurance, and access to care experienced by Utah cancer survivors; investigate urban-rural differences in financial hardship. Cancer survivors were surveyed from 2018 to 2021 about their experiences with financial hardship, access to healthcare, and job lock (insurance preventing employment changes). Weighed percentage responses, univariable and multivariable logistic regression models for these outcomes compared differences in survivors living in rural and urban areas based on Rural-Urban Commuting Area Codes. The N = 1793 participants were predominantly Non-Hispanic White, female, and 65 or older at time of survey. More urban than rural survivors had a college degree (39.8% vs. 31.0%, p = 0.04). Overall, 35% of survivors experienced ≥ 1 financial hardship. In adjusted analyses, no differences were observed between urban and rural survivors for: material financial hardship, the overall amount of hardship reported, insurance status at survey, access to healthcare, or job lock. Hispanic rural survivors were less likely to report financial hardship than Hispanic urban survivors (odds ratio (OR) = 0.24, 95%CI = 0.08-0.73)). Rural survivors who received chemo/immune therapy as their only treatment were more likely to report at least one instance of financial hardship than urban survivors (OR = 2.72, 95%CI = 1.08-6.86). The relationship between rurality and financial hardship among survivors may be most burdensome for patients whose treatments require travel or specialty medication access. The impact of living rurally on financial difficulties after cancer diagnoses is complex. Features of rurality that may alter financial difficulty after a cancer diagnosis may vary geographically and instead of considering rurality as a stand-alone factor, these features should be investigated independently.

Evaluation of the impact of a health-system specialty pharmacy patient management program on achieving predefined clinical outcome measures.

Specialty medications often have high costs, pose difficulties with payor approval, and require additional monitoring. Earlier articles have defined various examples of clinical outcome measures (COMs); however, goals and benchmarks have not been well defined, and a gap in the literature exists. This study evaluated the effectiveness of our health-system specialty pharmacy (HSSP) patient management program (PMP) in achieving predefined COM goals. Disease state protocols were developed within the HSSP, and clinical and adherence goals were created for each COM based on primary literature. This retrospective, single-center review examined outcomes and adherence data on patients enrolled in the PMP during 2022. The primary outcome was the number of predefined disease state COM goals met. Secondary outcomes included the number of predefined adherence goals met and annual financial impact. Of 1,431 patients whose records were reviewed, 1,053 met criteria for inclusion. The primary outcome analysis showed that 85% (33 of 39) of the predefined disease state goals were met. Predefined adherence goals were met, with an average proportion of days covered (PDC) for all specialty medications of >90%. The PMP yielded $5,167,043 in direct patient cost savings and $167,260 in cost avoidance. The PMP yielded positive results in meeting goals set for the COMs in the disease states managed within the HSSP. COMs will remain a focus for HSSPs to help patients achieve desired clinical outcomes and HSSPs adhere to accreditation standards. More research in this field and standardization of COM goals may benefit the larger HSSP community.

Assessment of long-term medication adherence with cystic fibrosis: An integrated approach.

Cystic fibrosis (CF) is a genetic disorder that creates a multisystem pathology resulting in complex treatment regimens. In 2014, 43% of people with CFat an academic medical center experienced medication acquisition barriers. The creation of an integrated specialty pharmacy with an embedded CF team pharmacist was launched in 2016. In addition to filling specialty medications, this specialty pharmacy filled all patient medications through a service called total care pharmacy (TCP). This service was hypothesized to positively impact medication adherence. Adherence analysis was performed by utilizing the proportion of days covered (PDC). PDC was analyzed during years 1, 2, and 3of therapy. PDC was calculated for medications with at least three fills during each year. Patients with PDC less than 80% were considered nonadherent and underwent manual chart review to identify a documented reason for nonadherence. Patients in the first year of dornase alfa therapy had significantly higher adherence in the TCP cohort compared to non-TCP (81.3% PDC vs. 66.0%; p = .006), which was largely driven by adult patients (73.3% vs. 56.5% for pediatric). Analysis of other medications and groups did not yield statistically significant differences. Many patients who had been classified as nonadherent had valid clinical reasons that explained gaps in therapy. When filling medications at a specialty pharmacy integrated within the academic medication center, dornase alfa adherence was higher in the TCP group. Further studies comparing TCP with services offered by pharmacies external to the health system would better characterize the impact of TCP services.

A Review of Therapeutic Escalation for Pediatric Patients Admitted for Inflammatory Bowel Disease Flares.

The objective was to complete a single hospital quality assessment to characterize the use, safety, and outcomes of the 5 specialty medications (infliximab, adalimumab, tofacitinib, ustekinumab, and vedolizumab) used for the treatment of pediatric inflammatory bowel disease following admission due to a disease flare. This was a single-center, retrospective, quality assessment of the current clinical practice. The electronic medical record was queried to identify patients ages 0 to 18 years admitted to our institution during a 2-year period from September 1, 2019, to September 30, 2021, who received infliximab, adalimumab, tofacitinib, ustekinumab, and/or vedolizumab for the treatment of Crohn's disease or ulcerative colitis followed by manual data collection and cohort analysis. The total population comprised 20 patients during 23 encounters. The biologic-naive group included 12 patients during 12 encounters, 2 of which are also included in the biologic-experienced group, which captured a total of 10 patients during 11 encounters. In the biologic-naive group, infliximab monotherapy comprised the largest percentage of therapy plans across encounters (91.6%), with a statistically significant greater number of readmissions within 6 months of discharge (p = 0.00031). The biologic-experienced cohort had a statistically significant longer duration of intravenous corticosteroid administration (p = 0.016) and a large variety of therapy plans. The diversity of practice observed within our institution supports the need for guidelines to define standard of therapy or guide selection of second-line therapies based on patient-specific factors.

Impact of the end of public health emergency oral dispensing flexibilities for at-risk patients in a community oncology practice.

209 Background: Many studies have shown the benefit of medically integrated pharmacies for cancer specialty oral drugs in improving patient adherence and reducing waste compared to external pharmacies. Anti-kickback regulations have limited practice’s ability to deliver prescriptions to patient’s homes from physician offices. During the Covid Public Health Emergency (PHE), flexibility for prescription delivery by a physician owned pharmacy was allowed leading many practices to deliver oral cancer therapies to patients who could not otherwise come to clinics to fill their medications. With the end of the PHE, CMS reversed this flexibility. We sought to determine the impact on patients with this change in CMS regulations. Methods: Utilizing the pharmacy database of prescriptions delivered to a patient’s home for a large statewide community oncology practice in Texas during the PHE, we identified patients with Medicare part D who would no longer be able to utilize their physician’s pharmacy for home delivery of their specialty medications. We determined the distance of those patient’s primary address to the nearest clinic and further matched them to the address deprivation index (ADI) a well-validated approach that rank orders zip codes in deciles from lowest to highest need. Results: We found 970 patients receiving home delivered prescriptions with traditional Medicare Part D. 687 or 71% of patients lived within 20 miles of the nearest clinic. 213 or 22% lived between 20 and 50 miles with 70 or 7% more than 50 miles from the nearest clinic. 60 addresses could not be matched to the ADI database. Focusing on those available addresses in the top half of the ADI at highest need, we found that 40% of patients living within 20 miles of the clinic are at significant risk of disparity vs 67% of those 20-50 miles and 61 % of those living more than 50 miles from the clinic. Conclusions: The removal of the PHE flexibility for home delivery of prescriptions from physician offices will significantly increase the burden on patients in Texas, forcing many to drive long distances to obtain drugs and disproportionately affecting those at greatest risk of disparity. We encourage revising policies to allow medically integrated pharmacies to allow home delivery of cancer specialty drugs to meet CMS stated goals of improving health equity.

ASHP Survey of Health-System Specialty Pharmacy Practice: Practice Models, Operations, and Workforce - 2022.

The results of the 2022 American Society of Health-System Pharmacists (ASHP) Survey of Health-System Specialty Pharmacy (HSSP) Practice: Practice Models, Operations, and Workforce are presented. A total of 273 leaders in HSSPs were contacted by email to complete a survey hosted using Qualtrics. The survey sample was compiled from ASHP member lists, the presence of a specialty pharmacy indicated in previous ASHP surveys, and outreach to ASHP member organizational leaders. The survey response rate was 35.9%. Most HSSPs dispense 30,000 or fewer specialty prescriptions annually. Most respondents have an annual revenue of $100 million or less, are part of a 340B-covered entity, operate one location, have 1 to 2 specialty pharmacy accreditations, dispense both nonspecialty and specialty medications, and employ an average of 15.5 pharmacists and 17.6 technicians. The majority (66.7%) dispense 50% or less of prescriptions written by internal providers due to payor and manufacturer network restrictions. Over one-third employ nonpharmacist and nontechnician professionals. Specialty pharmacists are involved in treatment decisions and therapy selection before prescription generation (69.8%), and 47.7% of respondents report pharmacists operating under collaborative practice agreements. Most (82.6%) offer experiential or formal education in specialty pharmacy. The top point of pride remains patient satisfaction and level of service. Top challenges include access to payor networks, the ability to hire and retain qualified staff, and shrinking reimbursement from payors. The HSSP is a continually maturing integrated advanced practice model focused on providing patient-centric care to all patients and employees of the health system regardless of network status. HSSPs are raising the standards for quality in specialty pharmacy care.

Provision of ambrisentan from a health-system specialty pharmacy affiliated with a pulmonary hypertension Center of Comprehensive Care.

This descriptive report describes the process used to obtain access to providing ambrisentan from a health-system specialty pharmacy (HSSP) affiliated with a pulmonary hypertension Center of Comprehensive Care, develop a pulmonary arterial hypertension (PAH) care team at the HSSP, and characterize medication adherence and access metrics. PAH is a rare disease treated with several specialty medications requiring intensive monitoring. Historically, specialty medications used to treat PAH have been provided by only select specialty pharmacies due to restricted drug distribution channels. It is recommended that patients with PAH receive their care at centers with expertise in the diagnosis and management of this disorder, but the HSSPs at these expert centers are unable to provide specialty PAH medications. The current care model for PAH leads to patients receiving their medical and pharmaceutical care from separate entities. This descriptive report describes a multidisciplinary team's approach to gaining access to providing ambrisentan and developing a disease state care team within an established HSSP. After implementing this service, specialty pharmacy metrics were assessed, including proportion of days covered (PDC), time to first fill, patient contact rate, Risk Evaluation and Mitigation Strategy (REMS) program compliance, time to prior authorization (PA) approval, rate of optimal adherence (PDC of >80%), and PA renewal rate, to demonstrate a proof-of-concept HSSP model for PAH. In this model, the HSSP was able to demonstrate high-quality specialty pharmacy metrics with regard to medication adherence, medication access, and REMS program compliance. The development of a PAH care team to provide ambrisentan at an existing HSSP was associated with high adherence rates, efficient and reliable medication access, and REMS program compliance.