Patient Assistance Program Research Articles

Immune Checkpoint Inhibitors Plus an Anti-VEGF Antibody as the First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Network Meta-Analysis and Cost-Effectiveness Analysis.

Background: Sintilimab + a bevacizumab biosimilar (IBI305) (SB) and atezolizumab + bevacizumab (AB) have been approved for the treatment of unresectable hepatocellular carcinoma (HCC). At present, oncologists and their patients remain indecisive on their preferred treatment regime. Therefore, assessing their efficacy via a network meta-analysis and determining their comparative cost-effectiveness is necessary. Objective: To evaluate the cost-effectiveness of SB and AB compared with sorafenib alone for the treatment of unresectable HCC. Materials and Methods: The data used in our analysis were obtained from patients in ORIENT-32 and IMbrave150 phase III randomized clinical trials. A Bayesian network meta-analysis and cost-effectiveness analysis that included 1,072 patients were performed in this study. A partitioned survival model was applied to the patients with unresectable HCC. The model was designed with a 15-year time horizon, 1-month cycle, and 5% discount rate for costs and outcomes. In China, an incremental cost-effectiveness ratio (ICER) value of less than $33,500 (three times the GDP per capita in 2020) per quality-adjusted life-year (QALY) is considered cost-effective. The influence of parameter uncertainty on the results was verified by one-way deterministic sensitivity analysis and probability sensitivity analysis. Furthermore, scenario analyses of the patient assistance program (PAP) were conducted to explore the cost-effectiveness of SB and AB. Results: For the model of 1,072 patients, treatment with SB produced an additional 0.617 QALYs compared with sorafenib, resulting in an ICER of $39,766.86/QALY. Similarly, treatment with AB produced an additional 0.596 QALYs compared with sorafenib, resulting in an ICER of $103,037.66/QALY. The probability sensitivity analysis showed that when the willingness-to-pay (WTP) threshold was $33,500/QALY, the cost-effectiveness of SB and AB was 15.4 and 0.4%, respectively. However, in the scenario analyses, the probability of SB and AB regimens being cost-effective was 65.4 and 15.8%, respectively, at a WTP of $33,500/QALY. Conclusion: The findings from our study showed that sintilimab + a bevacizumab biosimilar is a cost-effective regimen compared with sorafenib as the first-line therapy for unresectable HCC in China at a $33,500 WTP threshold if sintilimab PAP is considered. However, the atezolizumab + bevacizumab regimen is not cost-effective whether atezolizumab PAP is considered or not.

Successful biosimilar adoption in oncology: strategic approach to system standardization.

e18605 Background: In the United States, therapeutic substitution with oncologic biosimilars offer opportunities to reduce the rising costs of cancer care while improving access to safe and effective treatment. Current challenges include integration into clinical practice, state laws for biosimilar interchangeability and payer reimbursement policies. Methods: We developed an approach to standardize biosimilar utilization across our oncology enterprise by leveraging the electronic health record to integrate with clinical algorithm pathways and financial information. Institutionally preferred biosimilars drugs were selected through the oncology Pharmacy & Therapeutics committee as part of the formulary process. Physicians were permitted to opt-out of substitution within the electronic order sets. Patients were divided into two groups based as 1) main medical center 2) affiliated sites to assess feasibility of the enterprise-wide substitution, defined as an 80% compliance rate at the main medical center and a 75% compliance rate at the affiliates sites. This provided a minimum detectable difference of 5.7% and 8.9%, respectively using an exact one-sided Binomial test with 80% of power at 2.5% significance level with Sidak correction. Results: Between January and December 2021, a total of 811 cancer patients who initiated treatment with bevacizumab, rituximab or trastuzumab were identified, of whom 535 were eligible for this analysis (age 18-96; 61% female, 39% male). The overall substitution rate to biosimilars was 83% (76%-97%) compared to baseline of 55%, representing a 51% improvement. The conversion rate was higher at the main medical center compared to the affiliated sites (85% vs. 81%). Among 92 patients who did not have substitution to biosimilars, the most common reasons were off-label indication (35%), patient assistance program (17%), payer preferred alternative brand (15%) and clinician preferred reference brand (12%). Four patients (< 1%) were not converted due to infusion reactions possibly related to biosimilars. Based on the wholesale acquisition cost, we estimate reduction in direct spending of $1.2 million per month or an average 23% cost savings. Conclusions: This real-world data suggest use of an integrated electronic health record to standardize biosimilar utilization in oncology and reduce costs. This approach leverages existing infrastructure for successful biosimilar adoption in oncology while preserving quality and safety.[Table: see text]

A phase 2 expanded access study of zanubrutinib (ZANU) in patients (pts) with Waldenström Macroglobulinemia (WM).

e19522 Background: Bruton tyrosine kinase (BTK) inhibition is an emerging standard of care for WM. The next-generation BTK inhibitor ZANU (BGB-3111), designed to maximize BTK occupancy and minimize off-target inhibition of other kinases, is approved by the United States (US) Food and Drug Administration, Health Canada, and the European Union at a dose of 320 mg once daily (QD) or 160 mg twice daily (BID) for adult pts with WM. BGB-3111-216 is a single-arm expanded access study of ZANU in treatment-naïve (TN) pts who were unsuitable for standard chemoimmunotherapy or pts with relapsed refractory (R/R) WM. This study provides real-world experience with ZANU in pts with WM. Methods: Eligible pts with TN or R/R WM received ZANU 320 mg QD or 160 mg BID orally. Primary endpoint was the number of pts enrolled/treated and enrolling sites. Secondary endpoints included treatment-emergent adverse events (TEAEs) of special interest, disease response rate, progression-free survival (PFS), and overall survival (OS). Response was evaluated by investigator assessment according to the 6th International Workshop on WM ( Br J Haematol. 2013;160(2):171-6) every 6 mo at minimum. The study was closed by the sponsor in July 2021 and active pts were transitioned to commercial ZANU via a patient assistance program. Results: Fifty pts with WM (17, TN; 33, R/R) were enrolled between December 2019 and June 2021 across 10 academic and community medical centers in the US. Median age was 72 years, 54% had intermediate-, 40% had high-risk disease, and the median number of prior therapies for R/R pts was 2. Median treatment exposure was 9.2 mo (range, 1.4-20.0). Thirty-eight (76%) pts had ≥1 TEAE, and 36 (72%) had ≥1 TEAE of special interest. Grade ≥3 TEAEs of special interest were hypertension (8%), infection (8%), atrial fibrillation/flutter (2%), neutropenia (2%), and second primary malignancy (2%). No new safety signals were observed. In pts with ≥1 response evaluation, 39% achieved a best overall response (BOR) of very good partial response. Overall response rate was 85.4% and major response rate was 73.2% (Table). Of the 4 pts with BOR of progressive disease, 3 had IgM values that met partial response criteria before the 6-mo response assessment. PFS and OS were immature due to short follow-up, and the median was not met. Conclusions: These real-world expanded access study results were consistent with the established ZANU profile in WM or other B-cell malignancies when administered as oral monotherapy at 160 mg BID or 320 mg QD in pts with intermediate or high-risk R/R or TN WM. Clinical trial information: NCT04052854. [Table: see text]

121-LB: Prescribing Patterns of Sodium–Glucose Cotransporter 2 Inhibitors in Patients with Heart Failure With or Without Type 2 Diabetes

The goal of heart failure (HF) pharmacotherapy is to improve disease-related morbidity and mortality. Recent clinical trials demonstrated a reduction in cardiovascular death and HF-related hospitalizations with the addition of sodium glucose co-transporter 2 inhibitors (SGLT2i) in patients with HF with reduced ejection fraction (HFrEF) , as well as HF with preserved ejection fraction (HFpEF) with or without type 2 diabetes (T2D) . The objective of this study was to identify SGLT2i prescribing rates in these patients and to identify predictors of drug class utilization. The University of New Mexico (UNM) Health Sciences Center IRB approved this retrospective, single-center, descriptive study. Individuals ≥ 18 years with a diagnosis of HF, an eGFR of ≥ 20 ml/min/1.73m2, and a visit to the UNM Hospital system between August 17, 2020 to August 16, 2021 were included. Patients were excluded if they were diagnosed with type 1 diabetes or had no documented EF in their patient chart. A total of 2,905 patients with HF were identified, of which 1,101 were randomly reviewed. After exclusion, the study sample included: 377 with HFrEF, 335 with HFpEF, and 88 with HF with mid-range ejection fraction. The mean age was 65 years; 60% were female; 76% were white; 47% were Hispanic; and 49% had established atherosclerotic cardiovascular disease. Overall, 42% (n = 339) had T2D with a mean A1C of 8.0%. SGLT2is were prescribed in 6.5% of patients overall, 14.7% of patients with T2D, and 0.4% of patients without T2D. Predictors of SGLT2i prescribing were: T2D (OR = 38.4; 95% CI, 8.9 - 165.58) , HFrEF (OR = 3.7; 95% CI, 1.79 - 7.47) , having a cardiology provider (OR = 2.2; 95% CI, 1.79 - 7.47) , being seen by a pharmacist with prescriptive authority (OR = 4.1; 95% CI, 2.01 - 8.26) , and enrollment in UNM’s patient assistance program (OR = 2.3; 95% CI, 1.08 - 4.97) . Despite guideline recommendations, SGLT2is are underutilized in patients with HF with or without T2D. Future studies are needed to determine the barriers to utilization. Disclosure S. R. Bermudez: None. J. R. Anderson: None. G. Ray: None.

CARC18: Towards Equitable Care: Exploring The Association Between Geographic Household Median Income And Clinical Outcomes Following Left Ventricular Assist Device Implantation

Purpose: Socioeconomic status (SES) is hypothesized to be an important predictor of clinical outcomes following left ventricular assist device (LVAD) implantation due to high costs of care. We investigated whether median income of a patient’s residing neighborhood predicts mortality or rate of readmission in LVAD therapy. Methods: 210 patients implanted with an LVAD between January 2010 and April 2020 at a single tertiary care center in the United States were retrospectively enrolled in this study. Patients were classified into tertiles based on published neighborhood median income data and compared for survival and freedom from readmission. Results: The study cohort comprised 135 unique ZIP codes, with 34 (25.2%) above and 101 (74.8%) below the national median income level. The low, middle, and high income groups had a total survivorship of 92.8%, 95.5%, and 92.5% at 1 year and 85.5%, 89.4%, and 85.1% at 3 years, respectively. Low median income was not significantly associated with worse outcomes at 1-year (P=0.400) and 3-years (P=0.689) following LVAD implantation. There was similarly no significant difference in freedom from readmissions at 3 years. Conclusion: LVAD recipients with a lower geographic median income were not more likely to experience worse outcomes after LVAD implantation. These findings were contrary to prior published reports showing worse clinical outcomes in heart transplant patients with lower SES patients. Factors such as institution-specific and system-wide patient assistance programs and risk factor modification measures may have mitigated the impact of reduced SES on patient care and helped eliminate the effect of income disparity on long-term clinical outcome post LVAD implantation. Further research to study such potential association is warranted.

Impact of co-pay assistance on patient, clinical, and economic outcomes.

Patient assistance programs (eg, co-pay assistance) may reduce patients' out-of-pocket costs for prescription medicines, providing financial assistance to access medicines for reduced or no cost. A literature review to identify peer-reviewed articles on studies evaluating the impact of co-pay assistance on clinical, patient, and economic outcomes was conducted. A literature review was conducted by searching Embase and MEDLINE. The population of interest was patients who had received co-pay assistance; the intervention was co-pay assistance; comparator was no co-pay assistance; and outcomes were treatment adherence, compliance, discontinuation, interruption, barriers to adherence, and specific therapeutic outcomes. Articles from the United States published between January 2015 and June 2021 were included. A total of 1249 initial articles were identified, of which 19 published articles representing 12 studies were included. Most studies were retrospective claims analyses (n = 10); there was also 1 randomized controlled trial and 1 prospective and observational study. One article assessed the association between co-pay assistance and patient-reported outcomes, 7 explored the relationship between co-pay assistance and clinical outcomes, and 6 assessed the impact of policy/program changes on co-pay assistance. Co-pay assistance was associated with improved treatment persistence/adherence across various diseases, with limited indirect evidence of this translating into clinical outcomes improvements. Lack of long-term outcomes and uncertainty around program sustainment from co-pay assistance programs are limitations. Limited evidence suggests a potential link between co-pay assistance and clinical outcomes; future research addressing study design challenges in measuring the effects of co-pay assistance is needed.

PH Roundtable: Disparities in PH

PH Roundtable: Disparities in PH

Patient Assistance Programs and the Anti-Kickback Statute

This Viewpoint discusses how patient assistance programs help patients pay for expensive name-brand drugs, which help ensure profit, and recommends anti-kickback statutes be used to ensure the programs help those most in need.

Perceptions of PGY-2 Oncology Programs on Financial Toxicity Education and Preparedness.

Cancer patients experience a rising monetary burden due to increased direct and in-direct costs associated with cancer treatment. This as a result has an adverse effect on the financial well-being of a cancer patient, also known as financial toxicity. Currently, there is a lack of literature surrounding the implementation of financial toxicity in post-graduate oncology residency training for pharmacists. The objective of this study was to describe the perceptions of PGY-2 oncology pharmacy residents and residency program directors on the incorporation of financial toxicity within their training programs and to assess self-perceptions of their level of abilities and experience managing financial toxicity for patients.A qualitative RedCap electronic survey was emailed in December 2020 to resident and directors of PGY-2 oncology programs in the United States.Out of 40 respondents, 64% of residency program directors were highly comfortable with the concept of financial toxicity, while 73% of pharmacy residents were uncomfortable with the concept of financial toxicity within their program. Furthermore, a majority of residents were either uncomfortable or highly uncomfortable managing financial toxicity for patients. In addition, the most commonly utilized method of incorporating the concept of financial toxicity in all programs was through specialty pharmacy and patient assistance programs (PAPs); residents also preferred these methods along with guest speakers to provide this training.Financial toxicity concepts should be considered as an educational standard and incorporated through unique methods of education. We suggest introducing the concept through guest speakers, followed by practical applications integrated in specialty pharmacies and PAPs.

The Downstream Impacts of High Drug Costs for PrEP Have Hindered the Promise of HIV Prevention.

Prior to the recent introduction of generic TDF/FTC in the U.S., access to pre-exposure prophylaxis (PrEP) for HIV was greatly limited due to the downstream effects of the high cost of the medication. This article argues that despite drug copay cards and patient assistance programs, the promise of drastically reduced HIV diagnoses has never been fully realized, and more policy reforms on drug pricing are needed to make ending the HIV epidemic a reality.

Which injected antiosteoporotic medication is worth paying for? A cost-effectiveness analysis of teriparatide, zoledronate, ibandronate, and denosumab for postmenopausal osteoporotic women in China.

The purpose of this study was to evaluate the cost-effectiveness of four injected antiosteoporotic medications including teriparatide, zoledronate, ibandronate, and denosumab for postmenopausal osteoporotic women in China. A Markov microsimulation model was used to compare the cost-effectiveness of the four drugs above in Chinese postmenopausal osteoporotic women with no fracture history of hip, vertebral, or wrist at various ages (65, 70, 75, and 80) of therapy initiation from the health care payer perspective. Denosumab was dominant (ie, lower costs and greater quality-adjusted life-years [QALYs]) compared with other strategies at all ages studied. The incremental cost-effectiveness ratios (ICERs) of zoledronate or ibandronate versus no treatment were $4,482.88/ QALYs or $11,378/QALYs, respectively, at age 65 years, and the results at other ages were similar. In contrast, the incremental cost-effectiveness ratio of teriparatide strategy compared with no treatment exceeded the pre-determined threshold of a willingness-to-pay of $31,512/QALY regardless of the adoption of the patient assistance program at all ages studied, and a threshold analysis showed that teriparatide without patient assistance program became cost-effective when the annual drug cost is decreased to $1,644.87 (current cost: $8,764.65). The cost-effectiveness decision did not change in most of the one-way sensitivity analyses. A scenario analysis considering no offset effect of denosumab showed that zoledronate had the potential to become the optimal option relative to denosumab. In probabilistic sensitivity analyses, the probabilities of denosumab being cost-effective compared with other strategies were 100% at a willingness-to-pay of $31,512/QALY. Among postmenopausal osteoporotic women in China, denosumab therapy is cost-effective at all ages examined from the health care payer perspective, compared with teriparatide, zoledronate, or ibandronate. This study will help clinicians and policymakers make better decisions about the relative economic value of osteoporosis treatments in China.

Cost Reduction Behaviors and Cost-Related Medication Nonadherence in Older Adults with Atrial Fibrillation

While factors such as forgetfulness may result in medication nonadherence, 2.7 million older adults in the US experience cost-related nonadherence (CRN). Limited research has explored CRN and associated cost-reduction behaviors (CRB) in older adults with atrial fibrillation. The objectives of this study were to 1) describe the prevalence of CRN, CRB and spending less on basic needs to afford medication and 2) examine factors associated with CRB among older adults with atrial fibrillation. Data were drawn from the Systematic Assessment of Geriatric Elements in Atrial Fibrillation (SAGE-AF), a prospective cohort of older adults with atrial fibrillation (>65 years). Using a self-administered survey, all participants completed a validated CRN measure. Chi-square and t-tests were used to evaluate differences in participant characteristics across CRB and significant characteristics (p<0.05) were entered into a logistic regression model. Participants (N=1244) were on average 76 years and 49% were female. Among all participants, 4.2% reported CRN; 69.1% reported CRB; and 5.9% reported spending less on basic needs. Compared to participants who did not engage in CRB, participants who engaged in CRB were less likely to be cognitively impaired and more likely to be a race/ethnicity other than non-Hispanic white; have Medicare insurance; and have comorbidities. CRB were common among older adults with atrial fibrillation and was associated with in-tact cognitive function, the presence of medical comorbidities and non-White race. Clinicians might consider providing patients with cognitive impairment additional support such as patient assistance programs or referrals to pharmacists for medication therapy management to assist with CRB.

Cost-Effectiveness Analysis of Pembrolizumab Plus Pemetrexed and Platinum Versus Chemotherapy Alone as First-Line Treatment in Metastatic Non-Squamous Non-Small Cell Lung Cancer: A Reconstruction of Partitioned Survival Model Based on Time Dependent Pricing Mechanism of Patient Assistance Program.

ObjectivesA new patient assistance program (PAP) for pembrolizumab was started in China in 2021. The researchers aimed to evaluate the economic outcomes of pembrolizumab plus pemetrexed and platinum versus chemotherapy alone in the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer, based on the pricing mechanism of PAP.Material and MethodsSurvival analysis and partitioned survival model were performed to evaluate the incremental cost-effectiveness ratio (ICER) in the pembrolizumab group compared with the chemotherapy group. Survival probabilities were extracted from the data of the KEYNOTE-189 trial. Cost and utility data were gathered from published literature. The pricing mechanism of PAP was set in each cycle in the partitioned survival model, according to the progression-free survival (PFS) data of the KEYNOTE-189 trial, which included PFS-1 and PFS-2. Deterministic sensitivity analysis and probabilistic sensitivity analysis were conducted.ResultsThe ICER of the pembrolizumab group versus chemotherapy group was $65,272/quality-adjusted life year (QALY), which still exceeded the willingness-to-pay threshold of three times per capita gross domestic product (GDP) of China ($33,581.22), although PAP was calculated. Sensitivity analysis implied that the price of chemotherapeutic drugs combined with pembrolizumab was one of the main influencing factors of ICER.ConclusionsDue to various prices set by PAP and the payment for combined chemotherapy, the economic advantage of pembrolizumab plus chemotherapy in the first-line treatment of non-small cell lung cancer (NSCLC) is still not achieved in China.

Hereditary cancer panel testing challenges and solutions for the latinx community: costs, access, and variants

Hereditary breast and ovarian cancers (HBOCs) are common among the Latinx population, and risk testing is recommended using multi-gene hereditary cancer panels (HCPs). However, little is known about how payer reimbursement and out-of-pocket expenses impact provider ordering of HCP in the Latinx population. Our objective is to describe key challenges and possible solutions for HCP testing in the Latinx population. As part of a larger study, we conducted semi-structured interviews with key provider informants (genetic counselors, oncologist, nurse practitioner) from safety-net institutions in the San Francisco Bay Area. We used a deductive thematic analysis approach to summarize themes around challenges and possible solutions to facilitating HCP testing in Latinx patients. We found few financial barriers for HCP testing for the Latinx population due to laboratory patient assistance programs that cover testing at low or no cost to patients. However, we found potential challenges related to the sustainability of low-cost testing and out-of-pocket expenses for patients, access to cascade testing for family members, and pathogenic variants specific to Latinx. Providers questioned whether current laboratory payment programs that decrease barriers to testing are sustainable and suggested solutions for accessing cascade testing and ensuring variants specific to the Latinx population were included in testing. The use of laboratories with payment assistance programs reduces barriers to HCP testing among the US population; however, other barriers are present that may impact testing use in the Latinx population and must be addressed to ensure equitable access to HCP testing for this population.

P-199: Real-world toxicity and efficacy of ixazomib, lenalidomide and dexamethasone in Asian RRMM patients supported by the patient assistance program

Background The all-oral triplet therapy, ixazomib, lenalidomide, and dexamethasone (IRd), has shown superior progression-free survival (PFS) with excellent safety profile compared with Rd doublet therapy in relapsed and refractory multiple myeloma (RRMM) both in the prospective and retrospective studies. Still, there is limited report of IRd regimen in the real-world Asian RRMM population in terms of the safety and the efficacy Method Sixty RRMM patients treated with ixazomib, which was supported by the patient assistance program, in combination with Rd were retrospectively analyzed by the meticulous electronic medical record review. Results The median age was 68 years. Trial-ineligible patients due to ECOG performance status ≥ 3, platelet count <75,000/µL, creatinine clearance <30 mL/min, underlying heart or chronic active hepatitis B, unmeasurable disease, primary refractoriness to bortezomib, and remaining peripheral neuropathy after previous therapy were included in 35%. Patients had received a median 1 prior line of therapy. The overall response rate and the clinical benefit rate were 80% and 90%, respectively, and the PFS and overall survival was not reached after a median follow-up of 9.2 months. Thalidomide non-refractoriness and thalidomide response duration of ≥ 12 months in thalidomide responders significantly reduced the risk of progression. Non-hematologic adverse events (AEs) were more common than hematologic AEs, most commonly skin rash followed by gastrointestinal toxicities, and infections, and peripheral neuropathies. Grade 3 or higher AEs were observed but mostly in less than 5%. Conclusion Ixazomib and Rd combination therapy showed a comparable efficacy with a favorable toxicity profile especially in the early relapse of Asian RRMM patients. The all-oral triplet therapy, ixazomib, lenalidomide, and dexamethasone (IRd), has shown superior progression-free survival (PFS) with excellent safety profile compared with Rd doublet therapy in relapsed and refractory multiple myeloma (RRMM) both in the prospective and retrospective studies. Still, there is limited report of IRd regimen in the real-world Asian RRMM population in terms of the safety and the efficacy Sixty RRMM patients treated with ixazomib, which was supported by the patient assistance program, in combination with Rd were retrospectively analyzed by the meticulous electronic medical record review. The median age was 68 years. Trial-ineligible patients due to ECOG performance status ≥ 3, platelet count <75,000/µL, creatinine clearance <30 mL/min, underlying heart or chronic active hepatitis B, unmeasurable disease, primary refractoriness to bortezomib, and remaining peripheral neuropathy after previous therapy were included in 35%. Patients had received a median 1 prior line of therapy. The overall response rate and the clinical benefit rate were 80% and 90%, respectively, and the PFS and overall survival was not reached after a median follow-up of 9.2 months. Thalidomide non-refractoriness and thalidomide response duration of ≥ 12 months in thalidomide responders significantly reduced the risk of progression. Non-hematologic adverse events (AEs) were more common than hematologic AEs, most commonly skin rash followed by gastrointestinal toxicities, and infections, and peripheral neuropathies. Grade 3 or higher AEs were observed but mostly in less than 5%. Ixazomib and Rd combination therapy showed a comparable efficacy with a favorable toxicity profile especially in the early relapse of Asian RRMM patients.

Assessing effectiveness of a self-guided training program for oncology financial advocates.

271 Background: Financial toxicity can be a devastating side effect for patients with cancer and their families, and may impact access to and delivery of care, treatment compliance, and outcomes. Financial advocates mitigate financial toxicity for patients and their families, liaise between payers/providers/pharmacies/patients, support shared decision-making and care planning processes through provision of cost and coverage information, and mitigate institutional financial toxicity. Training on effective financial navigation interventions, financial health literacy, patient engagement, oncology fundamentals, and measurement of impact is critical for advocates. Methods: The Association of Community Cancer Centers (ACCC) Financial Advocacy Boot Camp is a self-paced eLearning program consisting of 9 modules designed to build knowledge and skills of financial advocates. Users interact with education across two levels within the ACCC Learning Management System. To evaluate effectiveness of this content, pre- and post-assessments and evaluation forms for registered learners from 1/1/2020 to 12/31/20 were exported and exploratory analysis was performed on this data set of 538 participants. Results: 51% of respondents are oncology financial advocates; 7% are industry representatives; and the remaining 42% are a mix of patient navigators, nurse navigators, social workers, pharmacists, APPs, and nurses. 363 participants fully completed at least one of two levels. Most participants agreed or strongly agreed that each of the modules improved their knowledge and skills: 94% increased their ability to incorporate effective screening methods to identify patients at risk of financial toxicity, 95% are better able to review the evolving landscape of health insurance provided by public and private payers, and 97% both increased their ability to find patient assistance programs and resources for patients and can describe how to guide patients through the process of improving insurance coverage. 79% identified specific examples of what they will do differently after the training, including implementing screening and follow-up protocols, adjusting communication approaches with patients, proposing quality improvement projects, and accessing resources. Conclusions: Training, such as the Financial Advocacy Boot Camp, that builds knowledge and skills in financial screening, communication, and navigation can help cancer programs improve staffs’ ability to mitigate patient and institutional financial toxicity. Future research efforts should further define financial advocacy competencies, measure patient and institutional impact of financial navigation interventions, and assess effective practices for implementation of financial advocacy training in cancer programs.

Financing Strategies to Facilitate Access to High-Cost Anticancer Drugs: A Systematic Review of the Literature.

Each country manages access to anticancer drugs differently due to variations in the structure and financing of the health system, but a summary of the various strategies used is absent. This study aimed to review and summarize financing strategies implemented across countries to facilitate access to high-cost anticancer drugs. We conducted a systematic review of articles referenced in PubMed, Embase, and Web of Science through May 12, 2021. Articles published in the English language from 2000 that describe strategies implemented in different countries to facilitate access to high-cost anticancer drugs were included. Letters, news articles, and proposed strategies were excluded. Quality assessment was not performed as we aimed to summarize the strategies. Data were analyzed by thematic analysis. A review protocol was registered at PROSPERO (CRD42018068616). The review included 204 studies from 176 countries. Three themes of financing strategies were identified: (1) Basic pharmaceutical reimbursement and pricing policies, (2) Alternative funding strategies specific to high-cost drugs, and (3) Financial assistance for individual patients. Access in most countries depends mainly on basic pharmaceutical reimbursement policies (165 of 176 countries). Apart from that, high-income countries (HICs) tended to use funding strategies targeting high-cost drugs (72% of HICs vs 0%-24% of the rest), such as managed entry agreements (MEAs) or dedicated funds for high-cost drugs. In contrast, lower-income countries tended to implement financial assistance programs for cancer patients as a tool to increase access (32% of HICs vs 62%-79% of the rest). Many countries have implemented a combination of strategies to increase access to high-cost anticancer drugs. Most low- and middle-income countries utilized placement of anticancer drugs on a national list of essential medicines and patient assistance programs (PAPs) to facilitate access, while many HICs implemented a broader range of strategies.

Access to hepatitis C direct-acting antiviral therapy in hepatitis C-positive donor to hepatitis C-negative recipient solid-organ transplantation in a real-world setting

BackgroundEmerging data supports expanding the solid organ donor pool with transplantation from hepatitis C virus (HCV)-positive donors into HCV-negative recipients. However, concerns exist regarding the ability to access direct-acting antivirals (DAAs) post-transplant in a real-world setting. MethodsThis single-center, retrospective study evaluated DAA access rates, time to first dose, and patient cost in donor-derived HCV solid-organ transplant recipients utilizing an integrated specialty pharmacy process. ResultsAmong 91 patients, all accessed DAAs through prescription insurance (97%) or patient assistance programs (3%). Of those who received DAAs through insurance, only 65% received approval on initial insurance submission. Median time from transplant to first dose was 45d [IQR 34–66]. The on-site specialty pharmacy was used by 69% of patients. Copay assistance programs reduced the median monthly patient cost from $1914 [range $7-7536] to $0 [range $0–5]. ConclusionOur findings indicate that access to DAAs in donor-derived HCV post-transplant is achievable and affordable; however, significant added administrative efforts may be required for insurance approval as well as obtaining copay assistance, which is a limited resource.

Characterizing Out-of-Pocket Payments and Financial Assistance for Patients Prescribed Abiraterone and Enzalutamide at an Academic Cancer Center Specialty Pharmacy.

Abiraterone and enzalutamide are commonly used oral cancer therapies for patients with prostate cancer, both with potentially high out-of-pocket costs for patients. We investigated the prevalence of financial assistance mechanisms used to alleviate out-of-pocket costs and the association of these mechanisms with timing of treatment initiation of abiraterone or enzalutamide. Using data from the medical center's specialty pharmacy, we identified first prescriptions for abiraterone or enzalutamide between January 1, 2017, and March 31, 2019. Prescriptions dispensed at an external pharmacy or that were discontinued for reasons unrelated to cost were excluded. Patient demographics, insurance coverage, out-of-pocket cost, and number of days between prescribed date and pill-to-mouth date were collected. Among 220 prescriptions in our final cohort, 185 were filled through our internal specialty pharmacy, 23 through a manufacturer-sponsored patient assistance program (PAP), and 12 were never filled because of cost. One third of the prescriptions in our final cohort (n = 66) were filled with financial assistance: PAP (10%), copay cards (9%), and grants (11%). The median amount of assistance received for the first fill was $2,860 US dollars (USD) (interquartile range $1,856-$10,717 USD). Prescriptions with an out-of-pocket cost < $100 USD were filled in the shortest time (median 5 days), whereas those filled through a PAP had the longest time to initiation (median 30.5 days). Among patients prescribed oral therapies for prostate cancer at a single institution, one third of patients received financial assistance. Although receiving assistance is likely to improve financial toxicity, waiting for assistance may lead to longer time to initiation of medication.

LB763 Characteristics and outcomes of dermatologic patient assistance programs

Several biologics and small molecule inhibitors are approved for psoriasis and atopic dermatitis; however, high costs limit accessibility for patients with inadequate insurance. Patient Assistance Programs (PAPs) are designed to provide free or discounted medications. This study characterizes PAPs for patient-administered biologics and small molecule inhibitors with FDA-approval for psoriasis and atopic dermatitis. Online PAP application forms for 13 medications were reviewed for application characteristics, patient eligibility, and outcomes.