Patient Out-of-Pocket Payments for Oral Oncolytics: Results From a 2009 US Claims Data Analysis
Published Online: May 10, 2012
Martin L. Raborn, MPharm, MBA; Elise M. Pelletier, MS; Daniel B. Smith, MA; and Carolina M. Reyes, PhD
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).
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