The potential impact of monitoring disease activity biomarkers on rheumatoid arthritis outcomes and costs.

Rheumatoid arthritis (RA) management requires monitoring of disease activity to determine course of treatment. Global assessments are used in clinical practice to determine RA disease activity. Monitoring disease activity via biomarkers may also help providers optimize biologic and nonbiologic drug use while decreasing overall drug spend by delaying use of expensive biologic therapies. By testing multiple biologic domains at the same time, a multibiomarker disease activity test may have utility in RA patient management, through improved intra- and inter-rater reliability. This report provides a comprehensive review of studies of objective measures, single biomarkers and multibiomarker disease activity tests as disease activity measures to decrease uncertainty in treatment decisions, and of biomarkers' potential impact on economic and clinical outcomes of treatment choices.

Defining Value in Cancer Care: AVBCC 2013 Steering Committee Report.

The AVBCC Annual Meeting experiences exponential growth in attendance and participation as oncologists, payers, employers, managed care executives, patient advocates, and drug manufacturers convened in Hollywood, FL, on May 2-5, 2013, for the Third Annual Conference of the Association for Value-Based Cancer Care (AVBCC). The conference presented an all-inclusive open forum for stakeholder dialogue and integration across the cancer care continuum, facilitating an open dialogue among the various healthcare stakeholders to align their perspectives around the urgent need to address value in cancer care, costs, patient education, safety, outcomes, and quality. The AVBCC 2013 Steering Committee was held on the first day of the conference to define value in cancer care. The committee was divided into 7 groups, each representing a key stakeholder in oncology. The goal of the Steering Committee was to define value from the particular point of view of each of the stakeholder groups and to suggest how that particular perspective can contribute to the value proposition in oncology, by balancing cost, quality, and access to care to improve overall patient outcomes. The following summary highlights the major points addressed by each group.

Disparities in medical care among commercially insured patients with newly diagnosed breast cancer: opportunities for intervention.

BACKGROUND: African-American women have increased breast cancer mortality compared with white women. Diagnostic and treatment gaps may contribute to this disparity. METHODS: In this retrospective, longitudinal cohort study, Southern US health plan claims data and linked medical charts were used to identify racial disparities in the diagnoses, treatment, and mortality of commercially insured women with newly diagnosed breast cancer. White women (n = 476) and African-American women (n = 99) with newly diagnosed breast cancer were identified by breast cancer claims codes (International Classification of Diseases, Ninth Revision, Clinical Modification codes 174, 233.0, 238.3, and 239.3) between January 2000 and December 2004. Race, diagnoses (breast cancer stage, estrogen/progesterone receptor [ER/PR]-positive status), treatment (breast-conserving surgery, antiestrogen therapy, and chemotherapy interruption or reduction), and all-cause mortality were assessed from medical charts. Multivariate regression analyses were adjusted for age, geography, and socioeconomic status to test the association of race with diagnoses/treatment. RESULTS: White women were older (P < .001) and had higher rates of diagnosis at stage 0/I (55.2% vs 38.4%; P < .05) than African-American women. More white women had positive ER/PR status (75% vs 56% African-American; P = .001) and received antiestrogen therapy if they were positive (37.2% vs 27.3% African-American; P < .001). White women received slightly more breast-conserving surgery and chemotherapy dose modification than African-American women (P value nonsignificant). African-American women had a higher mortality rate (8.1%) than white women (3.6%; P = .06). In adjusted analyses, African-American women were diagnosed at later stages (odds ratio, 1.71; P = .02), and white women received more antiestrogen therapy (odds ratio, 2.1; P = .03). CONCLUSIONS: Disparities in medical care among patients with newly diagnosed breast cancer were evident between African-American women and white women despite health plan insurance coverage. Interventions that address the gaps identified are needed.

The working patient with cancer: implications for payers and employers.

Cancer is seen today more often as a manageable chronic disease, resulting in changing workplace characteristics of the patient with cancer. A growing number of employees continue to work while being treated for cancer or return to work shortly after their cancer treatment is completed. To respond to these changes and the potential impact on the working patient's attitude, employers need updated, factual information related to this patient population. This type of information will support future benefit considerations by employers on employee contributions and future employee health and productivity. In 2005, Amgen launched a 3-year initiative to better understand cancer as a chronic disease, as well as the impact on the working patient with cancer and on the employer. The data from this initiative described in this article provide insights into cancer as a chronic and manageable disease in the workforce, and the broader implications to payers and employers.

Impact of specialty drugs on the use of other medical services.

OBJECTIVE: To examine whether initiation of a biologic agent to treat 2 autoimmune disorders -- rheumatoid arthritis (RA) and multiple sclerosis (MS) -- affects use of other medical services. STUDY DESIGN: Longitudinal analysis from 1997 to 2005 examining linked pharmacy and medical claims from large, private employers. METHODS: The study sample included 30,761 individuals newly diagnosed with RA (92,660 person-years) and 8961 unique individuals with MS (25,100 person-years). Negative binomial models were used to estimate changes in inpatient, outpatient, and procedure use before and after initiating a biologic drug for each condition. RESULTS: Starting a biologic response modifier was associated with a reduction in physician visits and use of expensive procedures for patients with RA within 2 to 3 years of initiation. Use of immunomodulatory therapy for MS was associated with a reduced number of hospitalizations and expensive procedures within 2 years of initiation. Although biologics may reduce other types of service use, the savings do not come close to offsetting the full cost of these drugs. CONCLUSIONS: Given the high cost of many specialty drugs, health plans may rightly focus on making sure only patients who will most benefit receive them. But once such patients are identified, it makes little sense to limit coverage.

The ABCDEs of CKD: a simple approach to early detection and management.

BACKGROUND: National guidelines for identifying chronic kidney disease (CKD) have not been widely adopted in primary care settings. UnitedHealthcare (UHC) and United Resource Networks (URN) collaboratively identified barriers to and established solutions for achieving the guidelines' outcome goals. METHODS: UHC/URN identified primary care physicians (PCPs) with a high proportion of patients at risk for CKD in their greater Atlanta network. Together with Amgen, they piloted an outreach and education program attended by approximately 300 healthcare professionals. Physician surveys provided pre- and postprogram qualitative measures of self-described PCP practice trends; postprogram quantitative medical practice measures were captured via claims and laboratory tracking data. RESULTS: Participating PCPs expressed substantial interest in the program and indicated notable learning about the suggested CKD practices. Further, glomerular filtration rate requests and nephrologist referrals significantly increased following the program. CONCLUSION: The one-hour targeted, interactive seminars improved CKD understanding in the medical practice of participating PCPs. Participant feedback has been incorporated into the next implementation phase, which will include additional case studies, more precise PCP-identification techniques, and more comprehensive quantitative follow-up measures.

Beyond the myths: finding benefit design solutions that address the true costs of high healthcare use.

Chronic and severe health problems place an enormous financial burden on individuals, employers, and health plan providers, requiring all to make tough decisions about healthcare. Specialty pharmaceuticals are increasingly attractive treatment options, but employers need tangible ways to incorporate these medications into benefit plans. Benefit managers can take a proactive role in addressing cost and compliance issues, using evidence-based data about true patient costs to develop policies that encourage employees to seek appropriate care. Achieving savings in direct and indirect costs will require more than shifting coverage, which can lead to nonadherence and increase costs elsewhere.

Costs of severely ill members and specialty medication use in a commercially insured population.

This study examines the overall profile and costs associated with severely ill commercially insured people. We found severely ill members to have the highest costs, from both the insurer and member perspective. Even for the most costly members where specialty medication use was highest, biologics represented less than one-third of the pharmacy spending and 6.6 percent of overall spending. Out-of-pocket spending rose dramatically when medications were paid for under the pharmacy benefit rather than the medical benefit. The advantages of paying for specialty medications under the pharmacy benefit should be evaluated in conjunction with the potential consequences of increased out-of-pocket burden.

Current trends in pharmacy benefit designs: a threat to disease management in chronic complex diseases.

With a focus on those patients who are candidates for treatment with biologic agents, we review the impact that current pharmacy benefit trends have on patients with chronic complex diseases and how they affect opportunities for disease management in this unique patient population. Dramatic increases in health care costs have led to a variety of strategies to manage cost. Many of these strategies either limit access to care or increase the patient's responsibility for choosing and paying for care, especially for medications. These strategies have a disproportionate impact on patients with chronic complex diseases, particularly those who require the use of biologic medications. A fundamental prerequisite of disease management has been coverage of disease-modifying therapies. If current pharmacy benefit trends continue, unintended consequences will likely occur including lost opportunities for disease management. Current pharmacy benefit trends could adversely impact disease management, particularly for patients requiring the use of biologic agents. Health plans should consider innovative benefit designs that reflect an appropriate level of cost sharing across all key stake-holders, ensuring appropriate access to needed therapies. Additional research is needed to clarify the value of newer approaches to therapies or benefit design changes.

Benefit design and specialty drug use.

In this paper we examine spending by privately insured patients with four conditions often treated with specialty drugs: cancer, kidney disease, rheumatoid arthritis, and multiple sclerosis. Despite having employer-sponsored health insurance, these patients face substantial risk for high out-of-pocket spending. In contrast to traditional pharmaceuticals, we find that specialty drug use is largely insensitive to cost sharing, with price elasticities ranging from 0.01 to 0.21. Given the expense of many specialty drugs, care management should focus on making sure that patients who will most benefit receive them. Once such patients are identified, it makes little economic sense to limit coverage.

Chemotherapy dose intensity determination as a quality of care measure for managed care organizations in the treatment of early-stage breast cancer.

The objective of this study was to demonstrate how a clinical practice database can be used to illustrate the variations in adjunctive chemotherapy for breast cancer, to describe a measure of dose intensity (DI) to monitor that variation, and to design interventions to maximize a full-planned dose. An arbitrary sample of oncology practices across the United States was selected, each providing data on 10-20 patients treated with adjuvant chemotherapy for early-stage breast cancer. Data on 17,566 patients from 1,438 sites were collected, consisting of patient characteristics including age, number of positive nodes, planned and delivered chemotherapy agents, and a sample of absolute neutrophil or white blood cell counts by cycle. Mean age of the patient cohort was 48.5 years, and 54% of patients were below the age of 49. Treatment for the disease has changed during the 2 periods studied, 1983-1994 and 1995-1999. Use of Adriamycin/Cytoxan (AC) increased, whereas use of Cytoxan/Adriamycin/Fluorouracil (CAF) and full-dose Cytoxan/Methotrexate/Fluorouracil (CMF1) decreased. However, the less intense Cytoxan/Methotrexate/Fluorouracil combination (CMF2) has seen an actual increase in use during the 2 periods. Within the context of oncology care, including chemotherapy, full-dose intensive therapy and cure has always been the ultimate goal. In this study only 10% of the patients given AC received less than 85% of the full referenced dose, whereas about 20% of those receiving the other combinations fell into this category. Also, the summation dose intensity (SDI), a measure tying level of dose to survival, was highest in the AC group and lowest in the CMF2 group. Dose delays and dose reductions appear to account for the decrease in DI in the CMF1, CMF2, and CAF groups. DI, particularly SDI of adjuvant chemotherapy, which ties level of dose to survival in breast cancer patients, appears to be a reliable measure with which to assess the quality of care in community oncology practices. The 2 measures presented in this paper may be useful to managed care organizations for monitoring quality outcomes in this serious disease. Because one of the major reasons for reduction in chemotherapy dose appears to be neutropenia and its complications, these organizations can establish programs using DI as a basis for developing guidelines to optimize the clinical benefits of growth factors.

Impact of age and colony-stimulating factor use on hospital length of stay for febrile neutropenia in CHOP-treated non-Hodgkin's lymphoma.

BACKGROUND: In intermediate-grade non-Hodgkin's lymphoma (NHL) patients, full-dose CHOP improves survival but increases myelosuppression, causing febrile neutropenia hospitalization (FNH) in 28% of patients 65 years of age or greater. Several risk factors for FNH are known, but their relationship to length of stay (LOS), an indicator of the total burden of FNH, is unclear. METHODS: We conducted a study to identify factors associated with the incidence, recurrence, and duration of hospitalizations for FN and to describe the frequency of administration of colony-stimulating factor (CSF) as primary and secondary prophylaxis and its association with repeated hospitalization episodes. RESULTS: Compared with patients who did not experience hospitalizations for FN, those who did were significantly older, had more comorbid conditions, were planned for standard dose intensity, and received CSF less often during the first 5 days of cycle 1 (early CSF). Overall, 73% of these hospitalizations occurred within the first 2 cycles of chemotherapy, with 56% occurring within the first cycle. Patients age > or = 65 years accounted for 66% of cycle 1 FNH. Patients receiving early CSF were less likely to experience repeated hospitalizations (0% vs 12%; P<.05). Multiple regression analysis of those hospitalized found a 3.9-day longer LOS for patients age > or = 65 years and a 5.13-day longer LOS for those not receiving early CSF. CONCLUSIONS: Older NHL patients have a higher risk of hospitalization for FN and longer LOS. The majority of hospitalization days occur in the first 2 cycles of chemotherapy. Early CSF use is associated with decreased risk of repeated hospitalizations and shorter total LOS. Secondary CSF use is also associated with reduced risk of repeated FNH.

Outpatient cancer drug costs: changes, drivers, and the future.

BACKGROUND: To the authors' knowledge, no analysis has examined the specific components of drug spending for overall cancer care. The authors' objective was to quantify and characterize trends in outpatient drug expenditures for cancer patients. METHODS: The authors retrospectively analyzed pharmacy and outpatient professional claims data from commercial and Medicare health maintenance organization enrollees with a solid tumor diagnosis in 1995 and 1998. Charges were subdivided by type of drug (antineoplastic drugs, chemotherapy adjuncts, supportive drugs, and drugs unrelated to cancer treatment). RESULTS: In 1995, 14,663 cancer patients received outpatient drug treatment and 13,829 patients in 1998. Total charges increased from $17.9 million (mean charge of $1218 per patient) to $27.9 million (mean charge of $2003 per patient), an average annual increase of 16%. Antineoplastic therapy constituted the largest component of cancer-related drug costs (67%) and represented 76% of the increase from 1995 to 1998. Most charges were incurred in the professional setting for agents administered by injection. The primary explanation for the increases appeared to be a shift in treatment patterns toward newer, more expensive antineoplastic agents. Supportive therapy represented 17% of the increase in cancer drug costs, followed by chemotherapy adjuncts (7%). Charges for drugs unrelated to cancer therapy increased by 21% per year. CONCLUSIONS: Antineoplastic therapy administered in an office or clinic was the single most important cost driver, with newer more expensive agents replacing older, less expensive drugs. Attempts to understand and control outpatient drug cost increases for cancer patients should focus primarily on antineoplastic therapy, especially the appropriate substitution of newer agents for older, less expensive alternatives. Some non-chemotherapy cancer drugs may offer an opportunity to improve quality of life with a relatively small effect on overall cancer drug costs.