Provider perceptions of barriers to biosimilar utilization in community oncology practices.

BACKGROUND: Biosimilars reduce the burden of cost on patients and payers, and so doing, increase access to life-saving care. However, biosimilar uptake in the US has been inconsistent. OBJECTIVES: This study assessed provider perceptions of barriers to biosimilar use and their relationships to utilization rates in a large, national oncology network and examined if perceptions differed by demographic and practice characteristics. METHODS: A 28-item survey was administered to 400 network physicians, pharmacists, nurses, and administrators, spanning 25 provider groups, and measured 1) barriers to use categorized into 4 subscales-payer-related, provider-related, operational, and patient-related, using a Likert scale ranging from Never (1) to Always (5); and 2) demographic and practice characteristics. Utilization rates were assessed using aggregated patient-level drug administration data found in the electronic health record system. Descriptive and inferential statistics were used to describe responses and assess relationships between variables. RESULTS: A total of 46 responses were analyzed, with a response rate of 11.5%. Most respondents were female (55.6%), physicians (52.2%), with over 6 years of experience (67%). A majority worked in practices participating in the Oncology Care Model (86.7%) and received continuing education on biosimilars (84.8%). Overall scale score was moderately low (mean=2.31), indicating low levels of perceived barriers. The lowest subscale score was operational barriers (mean=2.21), while payer-related barriers was the highest (mean=2.78). Perceptions of barriers did not differ based on demographic and practice characteristics. The average biosimilar utilization rate was 66.2%, with practices in the West administering biosimilars most frequently (71.8%). Utilization was not impacted by perceptions of barriers. CONCLUSION: Perceived barriers to biosimilar utilization were not common and not associated with utilization. Infrequent impediments to utilization may be associated with network-wide emphasis on continuing education and a value-based care environment. Future research should consider other practice- and patient-level factors that may impact biosimilar utilization.

Impact of the Radiation Oncology Alternative Payment Model on Brachytherapy Reimbursement.

PURPOSE: The Radiation Oncology Alternative Payment Model (RO Model) will test prospective radiotherapy episode-based payments for 16 common disease sites. We created an automated analytics platform to calculate the impact of the RO Model vs historical fee-for-service episode reimbursements for brachytherapy treatments within five community oncology practices for prostate, uterine, and cervical cancer. METHODS AND MATERIALS: Claims data between January 1, 2017 and October 2, 2019 for prostate, uterine, and cervical cancer were analyzed as per the RO Model Final Rule methodology. Expected professional and technical component (PC and TC) reimbursements were compared for episodes that utilized brachytherapy alone vs combination modality (external beam and brachytherapy) in the RO Model vs historical reimbursements. RESULTS: 6,022 RO Model-defined episodes (60% prostate, 28% uterine, 13% cervical) were generated. Brachytherapy monotherapy episodes (14%) would have an average positive reimbursement in the RO Model (+$2,163 for prostate, +$711 for uterine, +$533 for cervical for the PC; +$12,168 for prostate, +$8,181 for uterine, +$11,322 for cervical for the TC), while combination modality episodes (15%) would have an average negative reimbursement in the RO Model (-$183 for prostate, -$1,701 for uterine, -$2,195 for cervical for the PC; -$374 for prostate, -$5,026 for uterine, -$2,801 for cervical for the TC). CONCLUSIONS: Brachytherapy monotherapy episodes for prostate, uterine, and cervical cancer will benefit from an increase in payment, whereas combination modality episodes will receive lower reimbursement. Large shifts in episodic payment may be related to practice-wide adjustments and pricing based on partial episodes of care that may ultimately limit access to care for vulnerable patient populations with cancer.

Impact of a G-CSF Policy to Reduce Low-Value Care on Guideline Adherence and Mortality.

PURPOSE: Practice guidelines recommend the prophylactic use of granulocyte colony-stimulating factors (G-CSFs) in patients with high risk of febrile neutropenia, but evidence suggests that G-CSFs are frequently overused. The objectives of this study were (1) to determine the prevalence and prescribing patterns of G-CSF and (2) to evaluate the impact of a program initiative on G-CSF prescribing patterns, adherence to guidelines, and mortality. METHODS: In this retrospective cohort study, data were used from the electronic health records of patients with metastatic colorectal cancer who received care at a multicenter oncology practice network during two time periods: July 01, 2013, to December 31, 2014, and July 01, 2017, to December 31, 2017. Beginning 2016, a site-wide program initiative that involved educational materials, appropriate nonuse recommendations, and prior authorization was introduced in the oncology practice network with an aim of reducing G-CSF overutilization. Descriptive statistics, t tests, and chi-squared tests were employed to analyze program impact. RESULTS: There were 3,426 chemotherapy regimens corresponding to 2,968 patients. There were a total of 387 (11.3%) G-CSF-treated patients and 3,095 G-CSF administrations during the study period. G-CSF use was significantly lower in the postperiod, compared with the preperiod (P < .0001). Adherence to guidelines was significantly higher in the postperiod, compared with the preperiod (P < .0001). Mortality rates did not significantly differ between the two time periods. CONCLUSION: This study demonstrates that policy initiatives have the potential to positively affect G-CSF prescription patterns and promote guideline adherence. These findings could help prescribers adopt a cost-effective approach in patients with metastatic colorectal cancer, leading to enhanced clinical practice and value-based care.

Cost differential by site of service for cancer patients receiving chemotherapy.

OBJECTIVES: To compare the costs of: 1) chemotherapy treatment across clinical, demographic, and geographic variables; and 2) various cancer care-related cost categories between patients receiving chemotherapy in a community oncology versus a hospital outpatient setting. STUDY DESIGN: Data from the calendar years 2008 to 2010 from the Truven Health Analytics MarketScan Commercial Claims and Encounters Database were analyzed. During 2010, the data set contained approximately 45 million unique commercially insured patients with 70,984 cancer patients receiving chemotherapy. These patients were assigned to cohorts depending on whether they received chemotherapy at a community oncology or hospital outpatient setting. METHODS: Cost data for 9 common cancer types were extracted from the database and analyzed on a per member per month basis to normalize costs; costs included amounts paid by the payer and patient payment. Community oncology and hospital outpatient setting chemotherapy treatment costs were categorized and examined according to cancer diagnosis, patient demographics, and geographic location. RESULTS: Patients receiving chemotherapy treatment in the community oncology clinic had a 20% to 39% lower mean per member per month cost of care, depending on diagnosis, compared with those receiving chemotherapy in the hospital outpatient setting. This cost differential was consistent across cancer type, geographic location, patient age, and number of chemotherapy sessions. Various cost categories examined were also higher for those treated in the hospital outpatient setting. CONCLUSIONS: The cost of care for patients receiving chemotherapy was consistently lower in the community oncology clinic compared with the hospital outpatient setting, controlling for the clinical, demographic, and geographic variables analyzed.

Opening the black box: the impact of an oncology management program consisting of level I pathways and an outbound nurse call system.

PURPOSE: The Innovent Oncology Program aims to improve the value of cancer care delivered to patients. McKesson Specialty Health and Texas Oncology (TXO) collaborated with Aetna to launch a pilot program. The study objectives were to evaluate the impact of Innovent on Level I Pathway compliance, implement the Patient Support Services program, and measure the rate and costs associated with chemotherapy-related emergency room (ER) visits and hospital admissions. PATIENTS AND METHODS: This was a prospective, nonrandomized evaluation of patients enrolled in Innovent from June 1, 2010, through May 31, 2012. Data from the iKnowMed electronic health record, the McKesson Specialty Health financial data warehouse, and Aetna claims data warehouse were analyzed. RESULTS: A total of 221 patients were included and stratified according to disease and age groups; 76% of ordered regimens were on pathway; 24% were off pathway. Pathway adherence improved from TXO baseline adherence of 63%. Of the 221 patients, 81% enrolled in PSS. Within the breast, colorectal, and lung cancer groups, 14% and 24% of patients had an ER visit and in-patient admission (IPA; baseline) versus 10% and 18% in Innovent, respectively; average in-patient days decreased from 2.1 to 1.2 days, respectively. Total savings combined for the program was $506,481. CONCLUSION: Implementation of Innovent positively affected patient care in several ways: Fewer ER visits and IPAs occurred, in-patient days decreased, cancer-related use costs were reduced, and on-pathway adherence increased.

Creating a process to standardize regimen order sets within an electronic health record.

PURPOSE: US Oncology uses regimen order sets in clinical practice to treat patients. However, the process to assure accuracy and upkeep of these order sets has not been described. The purpose of this project was to evaluate the regimens housed in the electronic health record, iKnowMed, to determine their appropriateness and accuracy. MATERIALS AND METHODS: US Oncology conducted an audit of its standardized regimen library. A utilization review compared chemotherapy regimens in the library and consolidated order sets on the basis of past utilization. Next, internal and external clinical pharmacists were contracted to verify the accuracy, dose, duration, and cycle length of regimens. References cited in the regimen library were evaluated. New or updated references or clinical practice standards were added or modified when necessary. US Oncology corporate pharmacists reviewed the recommendations and discussed findings with an oversight committee. Final proposals were voted on before being incorporated into iKnowMed. An internal database tracking system tool for all reviewed recommendations was created to track and communicate needed changes to the electronic health record. RESULTS: Out of 511 regimen order sets, 51 were recommended for removal or consolidation. Of the remaining 460 regimen order sets, all had some administrative changes. Specifically, 75% had title changes, 14% had cycle-related changes, 31% had reference updates, and 13% had dosing updates. CONCLUSION: Electronic health records systems, such as iKnowMed, can provide standardized order sets for a large oncology network. However, the regimens need to be evaluated routinely using standardized procedures to ensure they are accurate and current.

Pathways, outcomes, and costs in colon cancer: retrospective evaluations in two distinct databases.

PURPOSE: The goal of this study was to use two separate databases to evaluate the clinical outcomes and the economic impact of adherence to Level I Pathways, an evidence-based oncology treatment program in the treatment of colon cancer. PATIENTS AND METHODS: The first study used clinical records from an electronic health record (EHR) database to evaluate survival according to pathway status in patients with colon cancer. Disease-free survival in patients receiving adjuvant treatment and overall survival in patients receiving first-line therapy for metastatic disease was calculated. The second study used claims data from a national administrative claims database to examine direct medical costs and use, including the cost of chemotherapy and of chemotherapy-related hospitalizations according to pathway status. RESULTS: Overall costs from the national claims database-including total cost per case and chemotherapy costs-were lower for patients treated according to Level I Pathways (on-Pathway) compared with patients not treated according to Level I Pathways. Use of pathways was also associated with a shorter duration of therapy and lower rate of chemotherapy-related hospital admissions. Survival for patients on-Pathway in the EHR database was comparable with those in the published literature. CONCLUSION: Results from two distinct databases suggest that treatment of patients with colon cancer on-Pathway costs less; use of these pathways demonstrates clinical outcomes consistent with published evidence.

Pathways, outcomes, and costs in colon cancer: retrospective evaluations in 2 distinct databases.

OBJECTIVE: The goal of this study was to use 2 separate databases to evaluate the clinical outcomes and the economic impact of adherence to Level I Pathways, an evidence-based oncology treatment program in the treatment of colon cancer. PATIENTS AND METHODS: The first study used clinical records from an electronic health record (EHR) database to evaluate survival according to pathway status in patients with colon cancer. Disease-free survival in patients receiving adjuvant treatment and overall survival in patients receiving first-line therapy for metastatic disease was calculated. The second study used claims data from a national administrative claims database to examine direct medical costs and use, including the cost of chemotherapy and of chemotherapy-related hospitalizations according to pathway status. RESULTS: Overall costs from the national claims database-including total cost per case and chemotherapy costs-were lower for patients treated according to Level I Pathways (on- Pathway) compared with patients not treated according to Level I Pathways. Use of pathways was also associated with a shorter duration of therapy and lower rate of chemotherapy-related hospital admissions. Survival for patients on- Pathways in the EHR database was comparable with that in the published literature. CONCLUSION: Results from 2 distinct databases suggest that treatment of patients with colon cancer on-Pathways costs less; use of these pathways demonstrates clinical outcomes consistent with published evidence.

Benchmarks for value in cancer care: an analysis of a large commercial population.

PURPOSE: Cancer costs are increasing at an unprecedented rate. Key cost drivers include chemotherapy, hospital admissions/emergency room visits, and aggressive end-of-life care. We sought to evaluate these costs in a commercial payer population in collaboration with consultants from Milliman. PATIENTS AND METHODS: We used a retrospective analysis of Medstat 2007 to evaluate chemotherapy costs and use. Included patients had a cancer diagnosis; received chemotherapy during the evaluation period; had at least 1 day of coverage between January 1 and December 31, 2007 (medical and prescription coverage); was younger than age 70, and had active employment or was the spouse of an active employee. Costs are allowed amounts and are trended until 2009. Admission rates and emergency room visits are reported. Hospice use and chemotherapy during the last 14 and 30 days of life were also evaluated. RESULTS: In this commercial population of 14 million patients, 0.68% had claims for a cancer diagnosis; approximately 22% of those received chemotherapy during the study time period. Patients with cancer receiving chemotherapy averaged $111,000 per year in total medical and pharmacy costs. The average hospitalization rate for any reason was 1 admission/yr. Approximately 40% (or 0.4 admits/year) were identified as being chemotherapy related. Of the 3.5% of patients who died in the hospital, 51% received chemotherapy within 30 days of death. CONCLUSION: Understanding the costs of cancer care offers opportunities to formulate a strategic plan to control cancer costs and maintain quality care. Comprehensive cancer solutions to address the full spectrum of care will facilitate improved quality and patient outcomes.

Epidermal growth factor receptor inhibitor-associated cutaneous toxicities: an evolving paradigm in clinical management.

Epidermal growth factor receptor inhibitors (EGFRIs) have demonstrated improved overall survival in patients with non-small cell lung cancer, pancreatic cancer, and colorectal cancer; however, their use is associated with dermatologic reactions of varying severity. The similar spectrum of events observed with monoclonal antibodies and tyrosine kinase inhibitors suggests such toxicities are a class effect. While such reactions do not necessarily require any alteration in EGFRI treatment, being best addressed through symptomatic treatment, there is limited evidence on which to base such therapies. In October 2006, at an international and interdisciplinary EGFRI dermatologic toxicity forum, the underlying mechanisms of these toxicities were discussed and commonly used therapeutic interventions were evaluated. Our aim was to reach a current consensus on management strategies. A three-tiered, EGFRI-focused toxicity grading system is suggested for the purposes of therapeutic decision making, and as a framework on which to build a stepwise approach to intervention. This approach to successful management is specifically tailored to accurately categorize dermatologic toxicity associated with EGFRIs, and can be easily applied by all health care professionals. The goal is to maximize quality of life in patients who are being treated with these agents--many of whom will be on these drugs for several months or even years.

Managing dermatologic toxicities of epidermal growth factor receptor inhibitors.

There is considerable evidence that epidermal growth factor receptor (EGFR) plays an important role in non-small-cell lung cancer tumor growth and proliferation. Clinical experience with EGFR inhibitors, such as erlotinib, gefitinib, and cetuximab, has suggested that there are subgroups of patients with non-small-cell lung cancer that demonstrate dramatic responses to these agents. Researchers have sought to determine whether molecular or clinical characteristics correlate with therapeutic outcomes. Rash, the most commonly reported adverse effect of anti-EGFR therapy, has also been examined as a potential marker of response. Several trials evaluating anti-EGFR therapies have reported a positive correlation between rash and response and even rash and survival. If rash is truly a predictor of outcome, it becomes imperative that clinicians identify effective methods for managing this toxicity to avoid unwanted dose reduction, therapy interruption, delay, or discontinuation in patients experiencing a therapeutic benefit. Unfortunately, because of a lack of well-defined rash etiology, variability of use, and interpretation of rash grading scales, as well as a lack of clinical trials evaluating approaches to rash management, we are left without systematic, evidence-based guidelines for treatment. Preliminary results of a prospective study evaluating a rash treatment algorithm developed at the University of Texas M. D. Anderson Cancer Center have been positive, and there is universal agreement that initiation of more prospective trials to evaluate EGFR-inhibitor rash management is needed.

Management of rash and other toxicities in patients treated with epidermal growth factor receptor-targeted agents.

Inhibition of the epidermal growth factor receptor (EGFR) represents one of the most important avenues for research and development in the field of cancer therapy. The EGFR is a member of the ErbB receptor tyrosine kinase (TK) family, which also includes ErbB-2 (HER2/neu), ErbB-3 (HER3), and ErbB-4 (HER4). Current EGFR therapies available for use include monoclonal antibodies, such as cetuximab, and small-molecule EGFR TK inhibition by agents such as erlotinib. Side effects of these agents include dermatologic manifestations without the bone marrow suppressive properties of chemotherapy. Understanding of rash and how it relates to EGFR inhibitor toxicity and, perhaps more importantly, EGFR inhibitor response must be more clearly defined with clinical trials. The optimum management of rash in patients receiving anti-EGFR therapy remains somewhat controversial; this is secondary to imprecise classification of rash as well as the lack of clinical trials to determine the most appropriate treatment algorithm for these patients. We propose a treatment strategy to help aggressively treat dermatologic side effects allowing patients to continue receiving therapy without dose interruption or drug discontinuation.

Pemetrexed therapy for malignant pleural mesothelioma.

OBJECTIVE: To review pemetrexed, a novel multi-targeted antifolate agent. DATA SOURCES: A literature search was conducted (1985-September 2004) using MEDLINE and CANCERLIT. Recent abstracts from the American Society of Clinical Oncology were also included, along with the manufacturer's information. Key words were pemetrexed, LY-231514, Alimta, multi-targeted antifolate, malignant pleural mesothelioma. STUDY SELECTION AND DATA EXTRACTION: Relevant information on pharmacology, pharmacokinetics, and safety and efficacy of pemetrexed from clinical trials was selected. DATA SYNTHESIS: Pemetrexed inhibits folate metabolism and purine/pyrimidine synthesis. Based on Phase I and II trials, pemetrexed has antitumor activity in solid tumors such as lung, colorectal, and cervical. A pivotal Phase III study in patients with malignant pleural mesothelioma (MPM) demonstrated survival superiority of pemetrexed-cisplatin regimen versus cisplatin. CONCLUSIONS: Pemetrexed is a promising new drug for the treatment of solid malignancies, most notably MPM.