Trends in low-value cancer care during the COVID-19 pandemic.

OBJECTIVE: To assess the association between the onset of the COVID-19 pandemic and change in low-value cancer services. STUDY DESIGN: In this retrospective cohort study, we used administrative claims from the HealthCore Integrated Research Environment, a repository of medical and pharmacy data from US health plans representing more than 80 million members, between January 1, 2016, and March 31, 2021. METHODS: We used linear probability models to investigate the relation between the onset of the COVID-19 pandemic and 4 guideline-based metrics of low-value cancer care: (1) conventional fractionation radiotherapy instead of hypofractionated radiotherapy for early-stage breast cancer; (2) non-guideline-based antiemetic use for minimal-, low-, or moderate- to high-risk chemotherapies; (3) off-pathway systemic therapy; and (4) aggressive end-of-life care. We identified patients with new diagnoses of breast, colorectal, and/or lung cancer. We excluded members who did not have at least 6 months of continuous insurance coverage and members with prevalent cancers. RESULTS: Among 117,116 members (median [IQR] age, 60 [53-69] years; 72.4% women), 59,729 (51.0%) had breast cancer, 25,751 (22.0%) had colorectal cancer, and 31,862 (27.2%) had lung cancer. The payer mix was 18.7% Medicare Advantage or Medicare supplemental and 81.2% commercial non-Medicare. Rates of low-value cancer services exhibited minimal changes during the pandemic, as adjusted percentage-point differences were 3.93 (95% CI, 1.50-6.36) for conventional radiotherapy, 0.82 (95% CI, -0.62 to 2.25) for off-pathway systemic therapy, -3.62 (95% CI, -4.97 to -2.27) for non-guideline-based antiemetics, and 2.71 (95% CI, -0.59 to 6.02) for aggressive end-of-life care. CONCLUSIONS: Low-value cancer care remained prevalent throughout the pandemic. Policy makers should consider changes to payment and incentive design to turn the tide against low-value cancer care.

Trends in Medically Integrated Dispensing Among Oncology Practices.

PURPOSE: The integration of pharmacies with oncology practices-known as medically integrated dispensing or in-office dispensing-could improve care coordination but may incentivize overprescribing or inappropriate prescribing. Because little is known about this emerging phenomenon, we analyzed historical trends in medically integrated dispensing. METHODS: Annual IQVIA data on oncologists were linked to 2010-2019 National Council for Prescription Drug Programs pharmacy data; data on commercially insured patients diagnosed with any of six common cancer types; and summary data on providers' Medicare billing. We calculated the national prevalence of medically integrated dispensing among community and hospital-based oncologists. We also analyzed the characteristics of the oncologists and patients affected by this care model. RESULTS: Between 2010 and 2019, the percentage of oncologists in practices with medically integrated dispensing increased from 12.8% to 32.1%. The share of community oncologists in dispensing practices increased from 7.6% to 28.3%, whereas the share of hospital-based oncologists in dispensing practices increased from 18.3% to 33.4%. Rates of medically integrated dispensing varied considerably across states. Oncologists who dispensed had higher patient volumes (P < .001) and a smaller share of Medicare beneficiaries (P < .001) than physicians who did not dispense. Patients treated by dispensing oncologists had higher risk and comorbidity scores (P < .001) and lived in areas with a higher % Black population (P < .001) than patients treated by nondispensing oncologists. CONCLUSION: Medically integrated dispensing has increased significantly among oncology practices over the past 10 years. The reach, clinical impact, and economic implications of medically integrated dispensing should be evaluated on an ongoing basis.

Alcohol-Attributable Medical Costs in Commercially Insured and Medicaid Populations.

Introduction: Despite its social acceptance, excessive alcohol use remains among the top causes of preventable deaths in the U.S. Although there is a recognition of alcohol-related health and social costs, there are no current studies quantifying the medical costs incurred under health plans. Methods: This study estimates the direct medical costs attributable to excessive alcohol use using claims records from a large national insurer. The sample consists of adults with commercial insurance and Medicaid between 2008 and 2019. A case-control matched study design is used to compare individuals with a condition considered 100% attributable to alcohol by the Centers for Disease Control and Prevention with similar individuals. Medical care use and costs are examined over a 12-month follow-up. Costs are broken down by healthcare setting and health conditions as defined by the Centers for Disease Control and Prevention's Alcohol-Related Disease Impact diagnoses codes. Results: We find that having a diagnosis attributable to alcohol is associated with higher annual per-person healthcare expenditures in both commercially insured and Medicaid-insured participants by $14,918 (95% CI=$14,540, $15,297) and $4,823 (95% CI=$4,489, $5,158), respectively. We find that 60%‒75% of the additional costs of excessive alcohol use are driven by heart disease and stroke; conditions of the liver, gallbladder, and pancreas; and certain cancers as well as acute conditions that may be attributable to alcohol. Conclusions: The findings suggest that public and private initiatives to target people vulnerable to the harms of excessive alcohol use may potentially help to cut down significant costs on the already strained healthcare system in the U.S.

Association Between a National Insurer's Pay-for-Performance Program for Oncology and Changes in Prescribing of Evidence-Based Cancer Drugs and Spending.

PURPOSE: Cancer drug prescribing by medical oncologists accounts for the greatest variation in practice and the largest portion of spending on cancer care. We evaluated the association between a national commercial insurer's ongoing pay-for-performance (P4P) program for oncology and changes in the prescribing of evidence-based cancer drugs and spending. METHODS: We conducted an observational difference-in-differences study using administrative claims data covering 6.7% of US adults. We leveraged the geographically staggered, time-varying rollout of the P4P program to simulate a stepped-wedge study design. We included patients age 18 years or older with breast, colon, or lung cancer who were prescribed cancer drug regimens by 1,867 participating oncologists between 2013 and 2017. The exposure was a time-varying dichotomous variable equal to 1 for patients who were prescribed a cancer drug regimen after the P4P program was offered. The primary outcome was whether a patient's drug regimen was a program-endorsed, evidence-based regimen. We also evaluated spending over a 6-month episode period. RESULTS: The P4P program was associated with an increase in evidence-based regimen prescribing from 57.1% of patients in the preintervention period to 62.2% in the intervention period, for a difference of +5.1 percentage point (95% CI, 3.0 percentage points to 7.2 percentage points; P < .001). The P4P program was also associated with a differential $3,339 (95% CI, $1,121 to $5,557; P = .003) increase in cancer drug spending and a differential $253 (95% CI, $100 to $406; P = .001) increase in patient out-of-pocket spending, but no significant changes in total health care spending ($2,772; 95% CI, -$181 to $5,725; P = .07) over the 6-month episode period. CONCLUSION: P4P programs may be effective in increasing evidence-based cancer drug prescribing, but may not yield cost savings.

Association of Utilization Management Policy With Uptake of Hypofractionated Radiotherapy Among Patients With Early-Stage Breast Cancer.

Importance: Breast cancer accounts for the largest portion of cancer-related spending in the United States. Although hypofractionated radiotherapy after breast-conserving surgery is a cost-effective and convenient treatment strategy for patients with early-stage breast cancer, less than 40% of eligible women received hypofractionated radiotherapy in 2013. Objective: To assess the association of a large commercial payer's utilization management policy with the use of hypofractionated radiotherapy among women with early-stage breast cancer and its associated cost. Design, Setting, and Participants: A retrospective, adjusted difference-in-differences economic analysis was conducted using administrative claims data from January 1, 2012, to June 1, 2018, of women 18 years or older with early-stage breast cancer who were eligible for hypofractionated radiotherapy according to 2011 guidelines from the American Society for Radiation Oncology and were continuously enrolled in 14 geographically diverse commercial health plans covering 6.9% of US adult women. Women who received mastectomy, brachytherapy, or less than 11 or more than 40 external beam fractions of radiotherapy were excluded. A utilization management policy was used to encourage the use of hypofractionated radiotherapy among women in fully insured and Medicare Advantage (fully insured) plans. Under the new policy, claims for extended-course radiotherapy were not reimbursed for fully insured women who were eligible for hypofractionated radiotherapy. This policy did not apply to women in self-insured or Medicare supplemental insurance (self-insured) plans, allowing these groups to serve as a comparison group. Main Outcomes and Measures: The primary outcome was use of hypofractionated radiotherapy, and the secondary outcome was the cost of this type of radiotherapy. Results: Of 10 540 eligible women, 3619 (34.3%) were in fully insured plans and thus subject to the policy. There were no meaningful differences between the fully insured and self-insured groups in mean (SD) age at the start of radiotherapy (63.8 [8.6] vs 65.0 [8.9] years), mean (SD) Charlson Comorbidity Index score (3.0 [1.5] vs 3.2 [1.6]), or practice setting (outpatient hospital setting, 2982 of 3619 [82.4%] vs 5600 of 6921 [80.9%]). The policy was associated with an increase in use of hypofractionated radiotherapy among fully insured patients subject to the policy (adjusted percentage point difference-in-difference, 4.2%; 95% CI, 0.0%-8.4%; P = .05) and a nonsignificant decrease in radiotherapy-associated expenditures (-$2275 relative to self-insured patients; P = .09). Spillover analyses revealed a significantly higher uptake of hypofractionated radiotherapy among self-insured patients who were indirectly exposed to the policy (adjusted percentage point difference-in-difference, 8.5%; 95% CI, 3.6%-13.5%; P < .001) compared with those who were not exposed. Conclusions and Relevance: This study suggests that a payer's utilization management policy was associated with direct and spillover increases in the use of hypofractionated radiotherapy, even after accounting for a long-term secular trend in the uptake of hypofractionated radiotherapy in the control groups. Utilization management may promote evidence-based cancer care.

Use of Optimal Evidence-Based Anticancer Drug Regimens in Physician Offices Versus Hospital Outpatient Facilities.

PURPOSE: Cancer care has increasingly shifted from physician offices (MDOs) to hospital-based outpatient departments (HOPDs). This study compared the proportion of patients receiving optimal, evidence-based anticancer drug regimens and the cost of care when administered in these sites. METHODS: Patients with breast, lung, or colorectal cancer were identified from a large health insurance database. Anticancer drug regimens were considered on pathway when they were on the payer's program list of optimal regimens when administered. Anticancer drug-related costs included all patient- and plan-paid costs on claims for anticancer drugs over the 6-month postindex period; total per-patient costs were summed over all claims in that period. RESULTS: A total of 38,140 patients (MDO, n = 18,998; HOPD, n = 19,142) were included. On-pathway status was similar in HOPDs (59.5%; 95% CI, 58.6% to 60.4%) versus MDOs (60.8%; 95% CI, 59.8% to 61.8%; P = .069). HOPDs had substantially higher costs. Adjusted cancer drug-related costs were $63,763 (95% CI, $62,301 to $65,224) for HOPDs versus $36,500 (95% CI, $35,729 to $37,271) for MDOs (P < .001); adjusted total costs were $115,843 (95% CI, $113,642 to $118,044) for HOPDs versus $77,346 (95% CI, $76,072 to $78,620) for MDOs (P < .001). For Medicare Advantage, adjusted total costs were $61,812 for HOPDs compared with $62,769 for MDOs; adjusted drug-related costs were $31,610 for HOPDs compared with $33,168 for MDOs. For commercial insurance, total costs were $119,288 for HOPDs compared with $77,613 for MDOs; drug-related costs were $65,930 for HOPDs compared with $36,366 for MDOs. CONCLUSION: Total and cancer drug-related per-patient costs were higher in HOPDs versus MDOs, but on-pathway status was similar. The cost differential between HOPDs and MDOs was driven by commercially insured members rather than Medicare Advantage members.

Using claims data to attribute patients with breast, lung, or colorectal cancer to prescribing oncologists.

BACKGROUND: Alternative payment models frequently require attribution of patients to individual physicians to assign cost and quality outcomes. Our objective was to examine the performance of three methods for attributing a patient with cancer to the likeliest physician prescriber of anticancer drugs for that patient using administrative claims data. METHODS: We used the HealthCore Integrated Research Environment to identify patients who had claims for anticancer medication along with diagnosis codes for breast, lung, or colorectal lung cancer between July 2013 and September 2017. The index date was the first date with a record for anticancer medication and cancer diagnosis code. Included patients had continuous medical coverage from 6 months before index to at least 7 days after index. Patients who received anticancer drugs during the 6 months prior to index were excluded. The three methods attributed each patient to the physician with whom the patient had the most evaluation and management (E&M) visits within a 90-day window around the index date (Method 1); the most E&M visits with no time window (Method 2); or the E&M visit nearest in time to the index date (Method 3). We assessed the performance of the methods using the percentage of the study cohort successfully attributed to a physician, and the positive predictive value (PPV) relative to available physician-reported data on patient(s) they treat. RESULTS: In total, 70,641 patients were available for attribution to physicians. Percentages of the study cohort attributed to a physician were: Method 1, 92.6%; Method 2, 96.9%; and Method 3, 96.9%. PPVs for each method were 84.4%, 80.6%, and 75.8%, respectively. CONCLUSION: We found that a claims-based algorithm - specifically, a plurality method with a 90-day time window - correctly attributed nearly 85% of patients to a prescribing physician. Claims data can reliably identify prescribing physicians in oncology.

Results From a Health Insurer's Clinical Pathway Program in Breast Cancer.

PURPOSE:: Pathway regimens are value-driven, evidence-based therapies that aim at high-quality, affordable cancer care. There are few real-world data to support the value of such regimens, especially for patients with breast cancer. MATERIALS AND METHODS:: Using nationally representative claims data from Anthem, together with clinical data from its Cancer Care Quality Program, we identified patients with breast cancer for whom chemotherapy was initiated between January 2015 and October 2016. On the basis of demographic and clinical characteristics, patients receiving a pathway regimen (on-pathway cohort) were matched to those who did not (off-pathway cohort) using 1:1 propensity score matching. We compared post-6-month quality-of-care outcomes including hospitalization, emergency department visits, need for supportive drugs such as granulocyte colony-stimulating factor, and cost outcomes between the cohorts. RESULTS:: There were 959 patients in each cohort after matching. Patients in both cohorts had a similar age distribution (median age, 52 years in the off-pathway cohort v 53 years in the on-pathway cohort), and most presented with stage II disease (49.4% in the off-pathway cohort v 49.8% in the on-pathway cohort); nearly two thirds of each cohort had hormone receptor positive cancer (67.3% in the off-pathway cohort v 64.9% in the on-pathway cohort). The two cohorts had similar rates of hospitalization and emergency department visits; however, the rate of granulocyte colony-stimulating factor use was significantly lower in the on-pathway cohort (72.5% in the on-pathway cohort v 82.8% in the off-pathway cohort; odds ratio, 0.55; P ≤ .0001). The average post-6-month cost of care was $16,176 lower (95% CI, -$24,291 to -$8,061; P ≤ .0001) in the on-pathway cohort. CONCLUSION:: Pathway regimens for breast cancer demonstrate an example of high-value care. They are associated with a reduced cost of care without compromising quality of care.

Intravenous Versus Subcutaneous Anti-TNF-Alpha Agents for Crohn's Disease: A Comparison of Effectiveness and Safety.

BACKGROUND: In recent years, there have been a number of pharmacological innovations for Crohn's disease (CD), a difficult-to-treat condition, including new treatment philosophies (e.g., top-down therapy) and new therapeutic options in terms of the agent and the route of administration. Three anti-tumor necrosis factor (anti-TNF-alpha) agents are available for use among CD patients in the United States: infliximab, an intravenous agent, and adalimumab and certolizumab pegol, 2 newer subcutaneous products. Infliximab is considered the "gold standard" because it has the longest clinical experience, and adalimumab and certolizumab pegol have each gained significant market share. OBJECTIVE: To examine differences in effectiveness and safety between currently available intravenous and subcutaneous anti-TNF-alpha agents used to treat patients with CD. METHODS: Data for this retrospective, administrative claims analysis were obtained from pharmacy and medical claims from major U.S. health plans geographically dispersed across 14 states during 2007-2011. Patients had at least 1 ICD-9-CM diagnosis for CD, 6 months pre-index eligibility, and initiated anti-TNF-alpha therapy on the index date. Patients in each cohort were propensity score matched on pre-index demographics, clinical characteristics, and baseline health care use. During the post-index period, age-sex adjusted incidence rate ratios (IRRs) of CD-related symptoms, infections, cancers, and hepatic-related conditions were compared using Cox (PH) models. RESULTS: The matched cohorts included 515 patients in each group, with an average age of 39 years. Median follow-up was 17.5 months in the intravenous cohort and 17.7 months in the subcutaneous cohort. In terms of effectiveness outcomes, age-sex adjusted IRRs for the subcutaneous group, with the intravenous cohort as a reference, were as follows: 0.61 (95% CI = 0.32-1.18, P = 0.14) for anal fissures; 0.97 (95% CI = 0.72-1.30, P = 0.85) for abscess; 1.08 (95% CI = 0.79-1.04, P = 0.64) for fistulas; 1.12 (95% CI = 0.83-1.54, P = 0.45) for gastrointestinal hemorrhage; and 1.22 (95% CI = 0.93-1.59, P = 0.14) for a combined measure of obstruction, occlusion, stenosis, and stricture of intestine. In terms of safety outcomes, age-sex adjusted IRRs for the subcutaneous group were as follows: 0.85 (95% CI = 0.62-1.16, P = 0.30) for infections; 1.16 (95% CI = 0.71-1.89, P = 0.55) for cancers; and 1.23 (95% CI = 0.79-1.92, P = 0.35) for hepatic-related conditions. CONCLUSIONS: After adjusting for baseline characteristics, effectiveness and safety outcomes appear to be comparable between intravenous and subcutaneous anti-TNF-alpha agents in patients with CD. With similar outcomes, other considerations such as convenience of administration and patient preference may play a more prominent role in choice of agent. Health care providers and health payers should inform CD patients about the range of options available when selecting an anti-TNF-alpha agent.

Uptake and costs of hypofractionated vs conventional whole breast irradiation after breast conserving surgery in the United States, 2008-2013.

IMPORTANCE: Based on randomized evidence, expert guidelines in 2011 endorsed shorter, hypofractionated whole breast irradiation (WBI) for selected patients with early-stage breast cancer and permitted hypofractionated WBI for other patients. OBJECTIVES: To examine the uptake and costs of hypofractionated WBI among commercially insured patients in the United States. DESIGN, SETTING, AND PARTICIPANTS: Retrospective, observational cohort study, using administrative claims data from 14 commercial health care plans covering 7.4% of US adult women in 2013, we classified patients with incident early-stage breast cancer treated with lumpectomy and WBI from 2008 and 2013 into 2 cohorts: (1) the hypofractionation-endorsed cohort (n = 8924) included patients aged 50 years or older without prior chemotherapy or axillary lymph node involvement and (2) the hypofractionation-permitted cohort (n = 6719) included patients younger than 50 years or those with prior chemotherapy or axillary lymph node involvement. EXPOSURES: Hypofractionated WBI (3-5 weeks of treatment) vs conventional WBI (5-7 weeks of treatment). MAIN OUTCOMES AND MEASURES: Use of hypofractionated and conventional WBI, total and radiotherapy-related health care expenditures, and patient out-of-pocket expenses. Patient and clinical characteristics included year of treatment, age, comorbid disease, prior chemotherapy, axillary lymph node involvement, intensity-modulated radiotherapy, practice setting, and other contextual variables. RESULTS: Hypofractionated WBI increased from 10.6% (95% CI, 8.8%-12.5%) in 2008 to 34.5% (95% CI, 32.2%-36.8%) in 2013 in the hypofractionation-endorsed cohort and from 8.1% (95% CI, 6.0%-10.2%) in 2008 to 21.2% (95% CI, 18.9%-23.6%) in 2013 in the hypofractionation-permitted cohort. Adjusted mean total health care expenditures in the 1 year after diagnosis were $28,747 for hypofractionated and $31,641 for conventional WBI in the hypofractionation-endorsed cohort (difference, $2894; 95% CI, $1610-$4234; P < .001) and $64,273 for hypofractionated and $72,860 for conventional WBI in the hypofractionation-permitted cohort (difference, $8587; 95% CI, $5316-$12,017; P < .001). Adjusted mean total 1-year patient out-of-pocket expenses were not significantly different between hypofractionated vs conventional WBI in either cohort. CONCLUSIONS AND RELEVANCE: Hypofractionated WBI after breast conserving surgery increased among women with early-stage breast cancer in 14 US commercial health care plans between 2008 and 2013. However, only 34.5% of patients with hypofractionation-endorsed and 21.2% with hypofractionation-permitted early-stage breast cancer received hypofractionated WBI in 2013.

Considering patient preferences when selecting anti-tumor necrosis factor therapeutic options.

BACKGROUND: Anti-tumor necrosis factor (TNF) medications for the treatment of chronic inflammatory conditions represent a large and growing expenditure for health plans. Over the past few years, there has been an increase in options for patients receiving anti-TNFs, including choice of agent, route of administration, and location for receiving the medication. OBJECTIVE: To examine patient preferences regarding available anti-TNF agents and mode of administration options. METHODS: This cross-sectional survey and claims study was based on administrative claims in the HealthCore Integrated Research Database. Patients were identified for this study if they were receiving infliximab (the intravenous [IV] group) or adalimumab, golimumab, etanercept, or certolizumab pegol (the subcutaneous [SC] group) between March 2012 and August 2012 and were diagnosed with conditions for which these agents are indicated by the US Food and Drug Administration. The survey questionnaire was developed specifically for this study. Participants were asked about their use of anti-TNF agents, locations of administration, preferences for IV or SC therapy, interest in anti-TNF home therapy options, and their physician's role in their decision-making process. A validated instrument, the Treatment Satisfaction Questionnaire for Medication (TSQM) version II, was used to assess treatment satisfaction by the patients. RESULTS: A total of 6000 patients were included in the final list of patients, and the study was stopped when the targeted number of 500 surveys were completed. The IV group consisted of 202 (40%) patients, and the SC group consisted of 298 (60%) patients. Patients in the SC group had a higher preference for the administration route they were using compared with patients in the IV group: 89.9% of the SC group preferred the SC route of administration, whereas 71.8% of the IV group preferred the IV route (P <.001). The global treatment satisfaction scores were similar in both groups (81.9 in the IV group, 80.1 in the SC group; P = .247). The reported likelihood of patients discussing alternative anti-TNF options with their physician was low (45.5% in the IV group vs 49.7% in the SC group; P = .366). CONCLUSIONS: When asked to make a hypothetical choice between IV and SC administration, patients had stronger preferences for SC routes than for IV routes. There was a strong correlation between the route of administration in use and the preference, indicating high level of satisfaction with the current treatment used, which was confirmed with the TSQM version II results. An opportunity for patient education exists, because conversations with physicians about alternative anti-TNF therapies and administration appear to be lacking.