Characteristics and Treatment Patterns of Patients with Diabetic Macular Edema Non-Responsive to Anti-Vascular Endothelial Growth Factor Treatment in Ontario, Canada.

Purpose: To understand the demographics, clinical characteristics, treatment patterns, visual and anatomic responses of patients with diabetic macular edema (DME) initially treated with anti-vascular endothelial growth factor (anti-VEGF) agents in the real-world clinical setting. Patients and Methods: This retrospective cohort study used electronic health records to identify consecutively presenting patients with DME who received their first documented anti-VEGF injection (index injection) on or after 1 October 2015 and before 30 September 2016 (index period) at 4 clinical sites in Ontario, Canada. Patients receiving anti-VEGF injections in the study eye were followed for ≥18 months. After the first 3 monthly injections, patients were classified as "responder" (≥20% reduction in central retinal thickness [CRT] from index date) or "nonresponder" (<20% reduction in CRT) to anti-VEGF treatment. Results: At 12 months, change from baseline (CFB) in best visual acuity (BVA) of responders (n = 30) was mean (SD) 12.8 (13.00) letters; CFB in nonresponders (n = 56) was 3.2 (16.3) letters. Sensitivity analyses stratified by initial BVA were supportive. Mean (SD) change in CRT (µm) was -160.4 (111.4) in responders and -62.2 (98.6) in nonresponders. While changes in anti-VEGF therapy were lower in responders versus nonresponders (10.0% vs 23.2%), mean number of injections was similar (8.3 in each cohort). Conclusion: Despite receiving a substantial number of injections and requiring changes in therapy more frequently, nonresponders showed a lack of clinically meaningful change in BVA and CRT. Nonresponders could be identified after 3 anti-VEGF injections. There remains an unmet need for treatment options in patients with DME who show a nonresponse after 3 months of anti-VEGF treatment.

Clinical and economic burden of neovascular age-related macular degeneration by disease status: a US claims-based analysis.

BACKGROUND: New treatment alternatives have revolutionized the management of nAMD. However, there is limited evidence on the clinical and economic burden of nAMD in commercially insured US patients. OBJECTIVES: To examine the clinical and economic burden in patients with nAMD by disease status in the commercially insured US patient population and to identify drivers of nAMD-related costs. METHODS: Patients with at least 1 International Classification of Diseases, 10th Revision Clinical Modification (ICD-10-CM) diagnosis for nAMD were identified from the IQVIA PharMetrics Plus database between April 2016 and August 2017 (index period). Patients had continuous enrollment for at least 6 months before and at least 12 months after the index date. Eye-level disease status was reported, along with intravitreal anti-VEGF treatment patterns. Health care resource utilization (HRU) (all-cause and nAMD-related) and direct health care costs were estimated over the 12 month follow-up period. Outcomes associated with falls and fractures were also assessed. Multivariate analysis identified drivers of annual nAMD-related outpatient costs among patients with anti-VEGF therapy. Incident patients (defined as those without an nAMD diagnosis 6 months prior to the index date) with at least 18 months of continuous enrollment after the index date were identified for a subset analysis to evaluate documented changes in disease status. RESULTS: A total of 6,076 patients with nAMD were identified for the prevalent cohort; 60.1%, 17.2%, and 5.9% had active CNV, inactive CNV, and inactive scar disease stage at index, respectively. The nAMD-related outpatient visit costs were roughly 4 and roughly 7 times higher, respectively, for the active CNV group ($8,658 [SD = $11,612]) compared with the inactive CNV ($2,406 [SD = $5,510]) and inactive scar ($1,198 [SD = $3,035]) groups (P < 0.0001). About 10% of prevalent patients had a fall/fracture claim over 12 months of follow-up. A total of 3,623 prevalent patients (59.6%) were eligible for the anti-VEGF treatment patterns analysis (mean [SD] duration of therapy = 7.7 [4.5] months; mean [SD] number of injections = 6.0 [3.7]). Qualified incident cases comprised 17.8% (n = 1,081) of the prevalent cohort. Approximately 20% of incident eyes with active CNV at baseline transitioned to inactive CNV. A total of 427 incident patients (39.5%) qualified for anti-VEGF treatment patterns analysis (mean [SD] duration of therapy = 6.2 [4.7] months, mean [SD] number of injections = 5.2 [3.5]). Significant drivers of total nAMD-related costs were the initial anti-VEGF agent and anti-VEGF injection frequency (P < 0.0001) in both prevalent and incident cohorts. CONCLUSIONS: The clinical and economic burden of nAMD treatment is substantial to the US healthcare system, where economic burden is higher among those with active CNV. Appropriate treatment may increase the duration of inactive disease periods and preserve visual acuity while lowering costs. DISCLOSURES: This study was funded by Allergan, an AbbVie Company. Allergan employees were involved in the study design, interpretation of data, writing of the manuscript, and the decision to submit for publication. Keyloun and Campbell are employees of Allergan. Multani, McGuiness, and Chen are employees of IQVIA, which received funding from Allergan for conducting the analysis. Almony and Shah-Manek have nothing to disclose.

HER2-Positive Metastatic Breast Cancer: A Retrospective Cohort Study of Healthcare Costs in the Targeted-Therapy Age.

INTRODUCTION: Claims data (IBM MarketScan Commercial and MarketScan Medicare Supplemental databases) from June 30, 2011 to September 30, 2017 were used to evaluate the cost impact of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) in this retrospective cohort study. METHODS: The primary analysis compared short-term costs for patients diagnosed with HER2+ MBC at least 180 days after the end of first HER2-targeted treatment (MBC+ cohort) versus a propensity score matched cohort of patients with breast cancer who did not develop MBC (MBC- cohort). A pseudo-post period for patients in the HER2+ MBC- cohort was defined by indexing to the HER2+ treatment completion-MBC diagnosis time interval of the matched pair in the HER2+ MBC+ cohort; we then compared average monthly cost differences between these groups for the year preceding and following MBC diagnosis. In secondary analyses, we estimated medium-term aggregate and categorical healthcare costs for patients with HER2+ MBC up to 3 years post-diagnosis. RESULTS: In the short-term primary analysis, costs for the HER2+ MBC+ and HER2+ MBC- cohorts were largely comparable in the year preceding MBC diagnosis. Monthly direct costs were significantly higher for the HER2+ MBC+ cohort in the months immediately preceding MBC diagnosis, with differences in the range of $500-5000. Following diagnosis, total monthly costs were $13,000-34,000 higher for patients in the HER2+ MBC+ cohort vs. the HER2+ MBC- cohort. In the medium-term secondary analysis, mean per patient total costs were $218,171 [standard error (SE) $5450] in the first year following MBC diagnosis and $412,903 (SE $13,034) cumulatively over 3 years following diagnosis (among patients with complete follow-up). Primary cost contributors were outpatient visits ($195,162; SE $8043) and HER2-targeted therapy drug costs ($177,489; SE $8120). CONCLUSIONS: HER2+ MBC is associated with high short-term and medium-term direct healthcare costs. These could be alleviated with early diagnosis and optimal standard-of-care treatment for early breast cancer, which can significantly reduce the risk of recurrence.

Adherence to recommended clinical guidelines in extensive disease small-cell lung cancer across the US, Europe, and Japan.

PURPOSE: This study compared real-world treatment patterns of patients with extensive disease small-cell lung cancer (ED-SCLC) across regions and by platinum resistance/platinum sensitivity (PR/PS) and established if these patterns were in line with published guidelines. PATIENTS AND METHODS: The data source was the Oncology Monitor, a global database using retrospective medical chart reviews of oncology patients treated with anticancer drugs. All patients diagnosed with ED-SCLC from January 2014 through December 2016 in the US, and in France, Germany, Italy, Spain, and the UK (European Union; EU5), and Japan were included. RESULTS: Of 5,849 treated patients, 73.4%, 19.8% and 6.8% received first, second, or third/later lines (1L, 2L, 3L) of therapy, respectively. The most frequent 1L treatment, platinum + etoposide, was significantly more common in the US (87.0%) than in the EU5 (82.1%) or Japan (73.3%) (P<0.05). Platinum + irinotecan was a common 1L treatment in Japan (22.7%) but not in the US (2.0%) or EU5 (0.5%, P<0.0001). Topotecan was the most common 2L treatment in the US and EU5, but amrubicin was the most common in Japan. Among PR patients, 27.3%, 10.8%, and 36.4% received a platinum-based 2L therapy in the US, EU5, and Japan, respectively. Among PS patients, approximately half were not re-challenged with a 2L platinum-based therapy across all regions. CONCLUSION: In contrast to treatment guidelines, a significant proportion of real-world PR patients were re-challenged with a 2L platinum-based therapy, while conversely, many PS patients did not receive platinum-based therapies in 2L. This study highlights a lack of a consistent paradigm for 2L ED-SCLC treatment, limited therapeutic options, and an unmet need among SCLC patients.

The CASTRO study: Unsafe sexual behaviors and illicit drug use among gay and bisexual men who use anabolic steroids.

BACKGROUND AND OBJECTIVES: The majority of anabolic androgenic steroid (AAS) studies have focused on the general male population. Approximately 15% of gay or bisexual men are seropositive for HIV and many AASs are administered via injection. Thus, AAS use among gay and bisexual men likely poses a greater risk of spreading infectious disease. Gay and bisexual men who use AAS were compared with non-users regarding self-reported seropositivity for HIV and hepatitis B and C, sexual behaviors and injection practices, illicit drug and alcohol use, and psychiatric disorders. METHODS: The CASTRO (Castro Anabolic Steroid Research Observation) study was a 108-item cross-sectional survey of 153 gay and bisexual men who exercise. Data collection occurred outside four gyms in the San Francisco Castro District. RESULTS: The lifetime prevalence of AAS use among gay and bisexual men in the study was 21.6%. AAS users and non-users did not differ in self-reported seropositivity for HIV or hepatitis B and C, but AAS users reported higher rates of male-male condomless anal sex in the past year (84.8 vs 60.8%, p < .01) than non-users. More AAS users used ecstasy and methamphetamines (39.4 vs 16.7%, p < .01 and 18.2 vs 5.0%, p = .01, respectively) than non-users. DISCUSSION AND CONCLUSIONS: Gay and bisexual men who used AAS were more likely to engage in unsafe sexual behaviors and use illicit drugs relative to non-users. Multiple factors place AAS users at higher risks for spreading infectious diseases. SCIENTIFIC SIGNIFICANT: Our study suggests increased infectious disease risk among gay and bisexual men who use AAS. (Am J Addict 2019;XX:1-10).

Patient Perspective on the Burden of Skin and Joint Symptoms of Psoriatic Arthritis: Results of a Multi-National Patient Survey.

INTRODUCTION: Psoriatic arthritis (PsA) and psoriasis (PsO) have a significant impact on HRQOL and work productivity loss. In patients with both PsA and PsO, the full extent of the physical and emotional burden of joint- and skin-related symptoms is less understood from the patient perspective. METHODS: A cross-sectional study of PsO patients with PsA from the US, France, and Germany was conducted using an online survey. Data on demographics, PsO severity by patient-reported body surface area involvement (BSA), PsA severity by RAPID3, impact of PsO and PsA using Patient Global Assessment (1-5), and novel questions exploring the emotional burden of joint/skin-related symptoms were collected. Multivariate regression analyses examined severity of joint and skin symptoms as predictors of quality of life (QoL), measured by PsAQoL, and Work Productivity and Activity Impairment (WPAI). RESULTS: Of the 439 patients, 23.9% had mild (RAPID3 of 0-2) and 76.1% had moderate-severe PsA (RAPID3 of 2.1-10), while 51% had mild and 49% had moderate-severe PsO (≥ 3 palms of the hand for BSA). Multivariate analyses showed that severity of joint symptoms was strongly associated with lower QoL (t = 13.15), followed by impact of skin symptoms (t = 5.11), and age (t = - 4.73), all p < 0.0001. About 57% of all patients reported a DLQI > 5, indicating a moderate-to-extremely large effect of psoriasis on HRQoL. Joint severity and impact of joint symptoms were the strongest predictors of WPAI. Patients also associated skin and/or joint symptoms with a variety of emotions and QoL measures that were not captured on the validated scales (fatigue, how they think of themselves, how others thought of them, making a first impression etc.). CONCLUSIONS: In this study, both skin and joint symptoms had a broad, meaningful impact on patient QoL, work productivity, daily activities, and emotional well-being. These data highlighted the unique and significant impact of PsA among patients with PsO. FUNDING: Eli Lilly and Company.

Tetrabenazine Treatment Patterns and Outcomes for Chorea Associated with Huntington Disease: A Retrospective Chart Review.

BACKGROUND: Huntington disease (HD) is a neurodegenerative disorder characterized by motor impairments (including chorea), along with behavioral, psychiatric, and cognitive symptoms. Tetrabenazine was the first US Food and Drug Administration (FDA)-approved treatment for chorea related to HD. OBJECTIVE: To examine pharmacologic treatment patterns among patients using tetrabenazine, including reasons for treatment initiation, non-initiation, dose adjustments, and discontinuation, and to quantify the burden of chorea based on healthcare resource utilization. METHODS: In this retrospective patient chart review, neurologists were recruited from the Medefield (http://www.medefield.com) opt-in panel, and selected ≤5 medical charts based on the criteria provided and abstracted data on demographics, disease history, healthcare resource use, and treatment patterns. RESULTS: 138 neurologists participated and 512 HD patient charts were reviewed. Among these patients, 26.4% did not initiate tetrabenazine. Most HD patients (66.5%) received a tetrabenazine dose ≤50 mg. The most common reasons for stopping upward titration were optimal chorea control (55.5%), intolerability of higher doses (31.2%), and reaching the maximum recommended dosage despite suboptimal chorea control (11.4%). Chorea severity and non-persistence to tetrabenazine were associated with increased emergency room visits, hospitalizations, and days hospitalized. CONCLUSIONS: Although tetrabenazine was the sole FDA-approved treatment for HD chorea until April 2017, more than one-quarter of respondents never initiated therapy. Tetrabenazine dosing was lower than predicted, and many patients experienced adverse symptoms of intolerability at high doses. New safer and more tolerable treatment options, such as deutetrabenazine, may improve treatment outcomes and reduce healthcare resource use.

Gender-Based Differences Among Pharmacy Students Involved in Academically Dishonest Behavior.

Objective. To determine whether differences based on gender exist among pharmacy students involved in cases of admitted cheating or other academic dishonesty and to assess perceptions of academic dishonesty. Methods. Two cohorts of second-year male and female pharmacy students from four Northern California pharmacy programs were invited to complete a 45-item cross-sectional survey. Descriptive statistics and Pearson's chi-squared test were used for statistical analysis. Results. There were 330 surveys completed with a 59% response rate. No significant gender-based differences were found regarding admitted cheating in pharmacy school and in regards to participating in various forms of academically dishonest behavior. Female students were more likely than male students to report witnessing a classmate copying another student's assignment. Male students were less likely than female students to perceive a student who distributed a stolen exam as a cheater. Conclusion. No gender-based differences were noted in cases of admitted cheating or with regards to taking part in various forms of academically dishonest behavior. However, female students report witnessing cheating more than male students, and male students may have a more lenient perception toward academically dishonest behavior than female students. The information gathered from this study may provide further insight to pharmacy programs and educators regarding academic dishonesty at their institution.

Use of condensed videos in a flipped classroom for pharmaceutical calculations: Student perceptions and academic performance.

BACKGROUND AND PURPOSE: The flipped teaching method was implemented through a series of multiple condensed videos for pharmaceutical calculations with student perceptions and academic performance assessed post-intervention. EDUCATIONAL ACTIVITY AND SETTING: Student perceptions from the intervention group were assessed via an online survey. Pharmaceutical exam scores of the intervention group were compared to the control group. The intervention group spent a greater amount of class time on active learning. FINDINGS: The majority of students (68.2%) thought that the flipped teaching method was more effective to learn pharmaceutical calculations than the traditional method. The mean exam scores of the intervention group were not significantly different than the control group (80.5 ± 15.8% vs 77.8 ± 16.8%; p = 0.253). DISCUSSION: Previous studies on the flipped teaching method have shown mixed results in regards to student perceptions and exam scores, where either student satisfaction increased or exam scores improved, but rarely both. SUMMARY: The flipped teaching method was rated favorably by a majority of students. The flipped teaching method resulted in similar outcomes in pharmaceutical calculations exam scores, and it appears to be an acceptable and effective option to deliver pharmaceutical calculations in a Doctor of Pharmacy program.

Physician perceptions of pharmacologic treatment options for chorea associated with Huntington disease in the United States.

OBJECTIVE: To survey neurologists and obtain clinical perceptions of tetrabenazine for the treatment of chorea in patients with Huntington disease (HD). METHODS: Board-certified/board-eligible neurologists, in practice for ≥5 years, who had treated treat ≥3 HD patients in the past 2 years, were recruited from an online physician panel to participate in a cross-sectional, web-based survey. Respondents provided information about themselves, their practice, approaches to HD chorea management and perceptions of available treatments. RESULTS: Two hundred neurologists responded to the survey. Based on clinician responses, the most common reasons to treat chorea are impairment in activities of daily living (54%) and quality of life (41%). Although tetrabenazine was the only approved treatment for chorea in HD patients at the time of this analysis, it was only prescribed to ∼50% of patients with HD-related chorea. More than half of physicians perceive tetrabenazine as having minimal or no effectiveness in improving chorea. More than 40% of physicians consider tetrabenazine to be a non-optimal treatment, and 51% of physicians agree that they are unable to titrate to efficacious doses due to adverse side effects or tolerability concerns. Physicians report that side effects leading to dose interruptions (33%) and reductions (30%) occur in their patients "often" or "almost always". The most common side effects that led to insufficient dosing and disruptions in titration were sedation and somnolence (41%), depression (24%) and anxiety (22%). CONCLUSIONS: Many physicians who treat HD-related chorea report that tolerability issues with tetrabenazine impact their ability to effectively use tetrabenazine in their clinical practice.

Oncologists' Perceptions of Drug Affordability Using NCCN Evidence Blocks: Results from a National Survey.

BACKGROUND: The increasing prevalence of cancer coupled with approvals of new drugs and technologies used in therapy have brought increased scrutiny to the cost and value of treatments in oncology. To address the rising concern about oncology drug costs, several organizations have developed value frameworks to help assess the value of oncology regimens. The objective of this study was to assess oncologists' perceptions, awareness, and knowledge of all oncology value frameworks in the United States and to understand oncologists' perceptions of affordability in the context of National Comprehensive Cancer Network (NCCN) Evidence Blocks. OBJECTIVES: To (a) assess oncologists' awareness, knowledge, perceptions, and ratings of the American Society of Clinical Oncology Value Framework (AVF), the Institute for Clinical and Economic Review (ICER) value framework, NCCN Evidence Blocks, and Memorial Sloan Kettering Cancer Center's DrugAbacus; (b) assess oncologists' knowledge and perceptions of drug affordability as defined by the NCCN Evidence Blocks methodology; and (c) determine the factors that influence drug affordability ratings. METHODS: Data were collected from an electronic cross-sectional survey of 200 U.S.-based oncologists from a variety of practice settings. Oncologists were asked about their knowledge and perceptions of 4 value frameworks-NCCN Evidence Blocks, AVF, the ICER value framework, and DrugAbacus. Using NCCN Evidence Blocks, oncologists were asked to rate a variety of hypothetical cancer therapies and assign costs (in U.S. dollars) to the 5 levels of affordability. Additional questions that assessed perceived patient out-of-pocket (OOP) costs and comfort level in assessing affordability were also included in the survey. RESULTS: Oncologists were most familiar with NCCN Evidence Blocks (90%), followed by the AVF (84%), ICER value framework (57%), and DrugAbacus (56%). Oncologists rated affordability higher (mean rating 3: moderately expensive) versus the actual NCCN panel affordability rating (mean rating 1: very expensive). The affordability rating was similar across a variety of hypothetical cancer therapies and tumor types (rating: 3). Oncologists estimated the costs for this rating of 3 to range from $4,600 to $6,000 per month, which was inconsistent with actual drug costs. Oncologists estimated the mean monthly OOP costs for patients with insurance to range from $1,260 for a new oral medication to $1,700 for a new infused medication. Only 26% of oncologists were comfortable or very comfortable with rating costs associated with affordability levels. CONCLUSIONS: Surveyed oncologists rated cancer therapies as more affordable (per NCCN Evidence Blocks criteria) than NCCN panel ratings. Costs associated with affordability were not consistent with actual treatment costs; however, most oncologists were not comfortable with rating affordability. Patient OOP costs had the biggest influence on affordability ratings; however, physicians overestimated patient OOP costs significantly. There is an opportunity to improve the value frameworks, especially with regard to affordability assessment. DISCLOSURES: This study was funded by Genentech. Shah-Manek is employed by Ipsos Healthcare, a health care consulting company that received funding from Genentech to conduct this study. DiBonaventura was employed by Ipsos Healthcare at the time of this study. Wong and Ravelo are employed by Genentech. Shah-Manek has consulted with Genentech, Merck, Alkermes, Avanis, Alnylam, Novo Nordisk, Teva, Lilly, and BMS. This work was presented as an oral presentation at the ASCO 2017 Annual Meeting in Chicago, Illinois, on June 2-6, 2017.

Real-world usage and clinical outcomes of alectinib among post-crizotinib progression anaplastic lymphoma kinase positive non-small-cell lung cancer patients in the USA.

BACKGROUND: Alectinib is an approved treatment for anaplastic lymphoma kinase (ALK)-positive patients with advanced non-small-cell lung cancer. Despite positive supporting clinical data, there is a lack of real-world information on the usage and patient outcomes of those treated with alectinib post-crizotinib progression. METHODS: Participating oncologists (N=95) in the USA were recruited from an online physician panel to participate in a retrospective patient chart review. Physicians randomly selected eligible patients (ie, patients who progressed on crizotinib as their first ALK inhibitor and were treated with alectinib as their second ALK inhibitor), collected demographics and clinical history from their medical charts, and entered the data into an online data collection form. RESULTS: A total of N=207 patient charts were included (age: 60.1±10.4 years; 53.6% male). The patients in our sample were older (median age of 60 vs 53 years), were more likely to be current smokers (12% vs 1%), had better performance status (45% vs 33% had an Eastern Cooperative Oncology Group [ECOG] of 0), and were less likely to have an adenocarcinoma histology (83% vs 96%) relative to published clinical trials. The objective response rate was higher than in clinical trials (67.1% vs 51.3%, respectively) as was the disease control rate (89.9% vs 78.8%, respectively), though it varied by race/ethnicity, ECOG, and prior treatment history. Discontinuation (0.0%) and dose reductions (3.4%) due to adverse events were uncommon in alectinib. CONCLUSION: Patients using alectinib post-crizotinib in clinical practice are older, more racially/ethnically and histologically diverse than patients in published trials. Real-world response rates were high and similar to those reported in clinical studies, though there is some variation by patient characteristics. Alectinib was well tolerated in clinical practice as reflected by the rates of discontinuation, dose reductions, and dose interruptions.

What are pharmacists recommending for infant teething treatment?

OBJECTIVES: In 2011, the Food and Drug Administration issued a warning to avoid the use of any benzocaine-containing products for infant teething treatment owing to a risk of methemoglobinemia. Several benzocaine-containing products targeted for infant teething are currently available over the counter. Pharmacists are commonly asked for medical advice in the community, and there is no current literature evaluating what pharmacists are recommending for infant teething. The objectives of this study were to evaluate what pharmacists are currently recommending for infant teething treatment and assess what percentage would inappropriately recommend a benzocaine-containing product. METHODS: From March to June 2016, a 16-item in-person paper-and-pen questionnaire was administered to 200 pharmacists in the San Francisco Bay area at 115 outpatient over-the-counter pharmacies. Questions included demographic information, work and educational background, infant teething recommendations, and preferred educational resources. RESULTS: The overall response rate was 94.3%. One-half (50.5%) of the pharmacists' approaches to infant teething treatment was to recommend a nondrug option first and then, if needed, an over-the-counter medication. A majority (63.0%) of the pharmacists surveyed would inappropriately select a benzocaine-containing product. CONCLUSION: Despite warnings, the majority of pharmacists would still inappropriately recommend a benzocaine-containing product for treatment of infant teething. Further education is warranted to ensure that all pharmacists, health care providers, and consumers are aware of the potential harm of benzocaine use in infants.

Point/Counterpoint: Are Outstanding Leaders Born or Made?

The question of whether outstanding leaders are born or made has been debated for years. There are numerous examples of historical figures that came naturally to leadership, while others developed their leadership skills through tenacity and experience. To understand leadership, both nature (the genetic component) and nurture (the environmental influences) must be considered. This article represents the work of two Academic Leadership Fellows Program groups who debated each position at the 2016 American Association of Colleges of Pharmacy (AACP) Interim Meeting in Tampa, Fla., in February 2016.

Value Frameworks for the Patient-Provider Interaction: A Comparison of the ASCO Value Framework Versus NCCN Evidence Blocks in Determining Value in Oncology.

BACKGROUND: To address the rising concern about oncology drug costs, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) recently developed unique tools to help providers and patients make informed decisions about the value of an anticancer regimen. The ASCO Value Framework (AVF) allows users to generate a net health benefit (NHB) score along with drug acquisition costs for oncology regimens that have been compared in a prospective randomized clinical trial. In contrast, the NCCN Evidence Blocks (NEB) derives ratings from an expert panel assessment in the categories of efficacy, safety, quality and consistency of evidence, and affordability. OBJECTIVE: To compare the results of the AVF and NEB by applying each tool to the same clinical scenarios. METHODS: We evaluated 2 regimens using the AVF and NEB scores: (1) enzalutamide for treatment of metastatic castration-resistant prostate cancer and (2) nivolumab versus docetaxel in treatment of advanced squamous and nonsquamous non-small cell lung cancer (NSCLC). RESULTS: Enzalutamide generated a total NHB score of 44.8 (range 0-180) for use before chemotherapy and 70.8 for use after chemotherapy with a monthly cost of $8,495 in the AVF. The NEB scored enzalutamide 4 (very effective) for efficacy, 4 (occasionally toxic) for safety, and 2 (expensive) for affordability in the no visceral metastases block. It scored 3 (moderately effective) for efficacy, 4 for safety, and 2 for affordability in the visceral metastases block. Nivolumab in advanced nonsquamous NSCLC scored 36.0 and 73.2 in advanced squamous NSCLC, with a monthly cost of $7,010 in the AVF. The NEB gave nivolumab a score of 4 for efficacy and safety and 1 (very expensive) for affordability in the NEB in advanced nonsquamous and advanced squamous NSCLC. CONCLUSIONS: The AVF and NEB are novel tools that take different approaches in assessing the value of an oncology treatment regimen. From this study, it is clear that the findings generated by these tools are distinct. The AVF provides a summary score for treatments across all clinical benefit and toxicity categories, whereas the NEB provides component scores for treatment efficacy, safety, quality and consistency of evidence, and affordability. Both tools are novel and come with their own challenges. DISCLOSURES: No outside funding supported this study. Shah-Manek is also employed by Ipsos Healthcare, a consulting firm. The authors have no conflicting interests to report. Study concept and design were contributed by Shah-Manek and Ignoffo. Galanto and Nguyen collected the data, and data interpretation was performed by all the authors. All the authors contributed to writing the manuscript, which was revised primarily by Shah-Manek, along with Galanto, Nguyen, and Ignoffo. This research was previously presented as a poster and podium presentation at the Academy of Managed Care Pharmacy Nexus 2016 held October 3-6 in National Harbor, Maryland.

Medication Regimen Complexity and A1C Goal Attainment in Underserved Adults With Type 2 Diabetes.

BACKGROUND: From 2009 to 2012, 51.8% of American adults with diabetes had a hemoglobin A1C (A1C) >7.0%. The complexity of antidiabetic medication regimens may have an impact on glycemic control. OBJECTIVE: The primary objective was to test the hypothesis that higher diabetes-specific medication regimen complexity index (MRCI) was associated with lower attainment of A1C goal <7.0% in an underserved, predominantly Hispanic population of adults with type 2 diabetes. Secondary analyses included less stringent A1C goals of <8.0% and <9.0% and overall patient-level MRCI. METHODS: This study was a retrospective, observational, cross-sectional study of individuals with type 2 diabetes from January 2011 to January 2016. Data was obtained from the electronic medical record and MRCI was calculated using the 65-item validated Microsoft Access Version 1.0 medication regimen complexity electronic data capture tool. Logistic regression was used to compute unadjusted and adjusted odds ratios. RESULTS: A total of 368 patients were included in the analysis. High diabetes-specific MRCI was associated with lower attainment of A1C goal <7.0% (adjusted OR = 0.09; 95% CI = 0.04-0.18) controlling for age, gender, ethnicity, insurance, body mass index, smoking status, hypertension, and hyperlipidemia. Similar results were obtained for the less stringent A1C goals. However, results for overall patient-level MRCI were mixed. CONCLUSIONS: Higher diabetes-specific medication regimen complexity was associated with poorer glycemic control. Simplifying antidiabetic medication regimens, especially where the treatment guidelines give no preference, could be a step toward achieving treatment goals.