Published Online: May 10, 2012
Martin L. Raborn, MPharm, MBA; Elise M. Pelletier, MS; Daniel B. Smith, MA; and Carolina M. Reyes, PhD
This article was published as part of a special joint issue and also appears in the Journal of Oncology Practice.
Objectives: Oral oncolytics are an increasingly important treatment option for cancer. These agents often fall within the pharmacy benefit, with the potential for increased out-of-pocket (OOP) cost burden for patients. The purpose of this study was to evaluate patient OOP payments for oral oncolytic therapies in US managed care plans.
Materials and Methods: Patients aged >18 years who received 1 of 21 oral oncolytics were identified in 2009 US claims; the first oral therapy was the index therapy. OOP payments were calculated as the allowed amount (dollar amount a health plan allows for a therapy, including member liability) minus the paid amount (dollar amount paid by a health plan). Patient characteristics were provided, and per-claim OOP payments were evaluated for each of the 21 therapies in aggregate and stratified by payer type and index therapy.
Results: A total of 6094 patients who received at least 1 oral oncolytic therapy were identified. Mean age was 53 years; 54% were women; 77% had a commercial payer; prevalent cancer diagnoses included breast, colorectal, glioblastoma, and lung. Mean OOP payments were highest for dasatinib ($527; median, $36) and lowest for cyclophosphamide ($15; median, $10). Medicare Risk patients had higher mean OOP payments for most therapies compared with commercial, Medicaid, and self-insured patients.
Conclusions: Among 21 oral oncolytics, average OOP cost ranged from $15 to >$500. These results confirm previous findings showing OOP payments differing widely among oral oncolytic options. As cost for therapy becomes a greater part of treatment decisions, an understanding of patient OOP cost will be critical in informing choices.
(Am J Manag Care. 2012;18(5 Spec No. 2):SP57-SP64)
According to the National Cancer Institute, approximately 11.4 million Americans with a history of cancer were alive in January 2006, and approximately 1,529,560 new cancer cases were expected to be diagnosed in 2010.1 The National Institutes of Health estimates overall cost of cancer in 2010 at $263.8 billion: $102.8 billion for direct medical cost (total of all health expenditures), $20.9 billion for indirect morbidity cost (cost of lost productivity because of illness), and $140.1 billion for indirect mortality cost (cost of lost productivity because of premature death).1 A study reported in the Journal of the National Cancer Institute determined that the associated direct cost of cancer care would increase by 27%, from $125 billion in 2010 to $158 billion in 2020, assuming constant incidence, survival, and costs; if cost of care increased annually by 2% in the initial year after diagnosis and in the last year of life, the projected 2020 cost would increase to $173 billion, a 39% increase from 2010.2
Oral oncolytics are a relatively new addition to cancer treatment. Their benefits include ease of use and more flexibility and convenience for patients. Additionally, oral oncolytics may have different adverse effect profiles and therefore may be better tolerated.3 Initial research into patient preferences and quality-of-life issues in treatment options indicate that patients do prefer oral to intravenous chemotherapy.3
Prescription drugs, although accounting for only 10% of total health care expenditures in the United States in 2009, have been one of the fastest-growing segments, and the cost of these drugs, including oral oncolytics, can vary widely.4 The average wholesale price for temozolomide of $1500 per course is consistent with the pricing of approved intravenous chemotherapies, such as vinorelbine and gemcitabine, and is less than the price of paclitaxel or docetaxel; however, it is more expensive than 2 other approved oral therapies for advanced breast cancer: capecitabine, which has a typical acquisition price of $700 per 3-week course, and anastrazole, which can be acquired for $200 per month.5 Results from a US-based retrospective claims database study measuring the cost of oral sunitinib and sorafenib, 2 therapies for advanced renal cell carcinoma, showed mean total medical costs per patient per month of $8213 and $6998, respectively.6 The range of oral oncolytic cost varies widely. More recently introduced novel targeted agents are on the higher end of historical prices.
For patients with cancer, initial concerns after a diagnosis usually focus on prognosis and treatment choices. Financial aspects are only a secondary concern.7 The SUPPORT study (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment) found that approximately 33% of families lost most or all of their savings after a cancer diagnosis.8 Additionally, researchers at the National Cancer Institute, using data from the Centers for Disease Control and Prevention National Health Interview Survey, found that more than 1 million cancer survivors in the United States are foregoing necessary medical care because of the cost, with 7.8% foregoing general medical care and 9.9% going without prescription medication.9 These cost concerns are great enough that the American Society of Clinical Oncology recently published guidance measures to assist patients with managing the cost of cancer care.10
With the increase in multitier formularies and other costcontrol mechanisms, the growth in outpatient prescription drug spending decreased from 16% in 2000 to 8% in 2004; in contrast, the demand for specialty drugs continues to accelerate. 11 Recent reports have suggested that oral oncolytics account for approximately 25% of the current oncology pipeline.12 As insurers contemplate a variety of payment and distribution strategies to control their use and cost, more patients are being placed at financial risk for higher OOP spending, which can result in patients not following or completing their cancer treatment plans.11
Currently, limited data are available on patient OOP cost for oral oncolytic therapies. The objective of this study was to evaluate claims-level data and to characterize patient OOP payments for 21 oral oncolytic therapies in aggregate and by payer type in a sample of >100 US managed care plans during calendar year 2009.
Materials and Methods
Anonymous patient-level data were obtained from the IMS LifeLink: Health Plan Claims Database (Watertown, Massachusetts), which contains adjudicated medical and pharmaceutical claims for >100 health plans across the United States. The database includes inpatient and outpatient diagnoses (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] format) and procedures (Current Procedural Terminology, Fourth Edition, and Healthcare Common Procedure Coding System formats) as well as prescription records. It also includes demographic variables; product and payer types; provider specialty; charged, allowed, and paid amounts; and dates inclusive of plan enrollment. In compliance with the Health Insurance Portability and Accountability Act,13 patient data used in the analysis were de-identified; therefore, this study was exempt from institutional review board review.
Health insurance claims were screened to identify all patients aged >18 years with at least 1 claim for 1 of 21 oral oncolytic therapies (Table 1) between January 1, 2009, and December 31, 2009; claims were identified by National Drug Code. The date of the first prescription for any of the oral oncolytics during this time period represented the index date for each patient. Patients were required to have continuous health plan enrollment from 6 months before through 6 months after the index date. Patients were classified as having one of 12 specific cancer types or as having other cancer. Cancer type was defined as the closest claim involving one of the 12 cancer diagnoses (identified using ICD-9-CM codes; Table 2) on the index date or within 90 days before or after the index therapy. If none of the 12 cancer types were identified, the nearest other cancer diagnosis was identified, and the patient was classified as having other cancer. Patients aged >65 years were included only if they were in a Medicare Risk (private Medicare) plan to ensure complete data collection (Medicare Part D data not available).
The primary outcome of interest was the claim-level OOP cost for oral oncolytic therapies during calendar year 2009. OOP payment was calculated as the allowed amount (dollar amount a health plan contracted for a therapy, including member liability) minus the paid amount (dollar amount paid by the health plan for the therapy). Per-claim OOP payments were evaluated for each of the 21 oral oncolytic therapies in aggregate and by individual therapy using all available data during the year 2009. OOP payments also were stratified by payer type (commercial, Medicaid, Medicare Risk, selfinsured, unknown). Patient-level demographics (age, sex, geographic region, health plan and payer types) and clinical characteristics (cancer type) were evaluated from data obtained on the index date or during the preindex period. Per-claim per-patient OOP cost, calculated for the index therapy on the index date and for corresponding index therapies identified during the 6-month follow-up period and summed across the time frame, were categorized by cost category ($0, $1 to $50, $51 to $100, $101 to $500, and >$500).
Patient-level descriptive statistics were used to illustrate patient characteristics, including numbers and percentages for categorical variables and arithmetic means, medians, and standard deviations for continuous variables. OOP payments were reported as per claim averages (arithmetic means) and medians and by distribution of payment categories. Differences in OOP payments by payer type were calculated using parametric analysis of variance testing. All data management and analyses were conducted using SAS versions 8.2 and 9.1 (SAS Institute, Cary, North Carolina).
A total of 6094 patients with evidence of receiving at least 1 of 21 oral oncolytic therapies in 2009 were identified. Of those therapies identified in 2009, altretamine had the smallest number of claims (n = 24), whereas capecitabine had the largest sample (n = 7726). Demographics and clinical characteristics are presented in Table 3. The average age of the patient sample was 53 years, and 54% were women. Approximately 77% of the patients were enrolled in a health maintenance organization or preferred provider organization plan, and 77% were insured by a commercial payer. An evaluation of preindex neoplasms revealed that of the 12 cance specifically identified, breast cancer was the most commonly found cancer indication, followed by colorectal cancer, glioblastoma, and lung cancer.
OOP Payments for Oral Oncolytic Therapies During Calendar Year 2009
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